Aceflex th инструкция по применению - Инструкции, руководства, мануалы

Tablet

100 mg

Unit Price:

৳ 5.00

(5 x 10: ৳ 250.00)

Strip Price:
৳ 50.00

Aceflex is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:

Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
Diuretics: may interact the activity of diuretics.
Anticoagulants: may enhance the activity of anticoagulant.
Methotrexate: may increase the plasma level of methotrexate.

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

Aceflex is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

There are no clinical data on the use of Aceflex in children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

keep in a dry place away from light and heat. Keep out of the reach of children.

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Источник

TabletWise.com

Use
How to use
Dosage
Precautions
Side-effects
Warnings
Interactions
Contraindications

Why it’s used

Aceflex Plus Tablet is used to relieve severe pain and swelling in joint stiffness, long-term inflamed joint, joint inflammation affecting the spine, pain or inflammation of ear, throat, or nose, dental pain, low back pain, and reproductive organs pain. This medicine works by blocking prostaglandin synthesis.

Nonsteroidal Anti-inflammatory Drugs

Aceflex Plus is a prescription medicine that belongs to a class of medicines called Nonsteroidal Anti-inflammatory Drugs. Nonsteroidal anti-inflammatory drugs, also called as NSAIDs, help reduce fever, decrease pain, and prevent clotting of blood. NSAIDs also reduce inflammation in the body when used in higher doses.

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How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Aceflex Plus Tablet. If you have any questions related to this medicine, ask your doctor or pharmacist. Eat this medicine as recommended by your doctor.

Aceflex Plus Tablet is eaten with or after food. Aceflex Plus tablets should be taken with a sufficient amount of liquid. Aceflex Plus Tablet is eaten Aceflex Plus tablet should be taken two times a day, one tablet in the morning and one tablet in the evening.

Typical Dosage

The typical dose of Aceflex Plus is one dose of Aceflex Plus twice daily. The maximum adult dose of Aceflex Plus is 4000 mg/ day in a day.

This medicine is to be used for longer periods of time.

If you have issues with the health of your liver, The dose should be reduced in the patient with liver disease.

Taking a higher dose of this medicine may increase the risk of side-effects.

Use in Children

If you are giving Aceflex Plus Tablet to a child, be sure to use a product that is meant for children. Before giving this medicine to a child, use the child’s weight or age to find the right dose from the product package. If the product package does not provide specific information as to how the medicine can be given to children, consult with your doctor and follow their recommendation.

Avoid Alcohol

Avoid the consumption of alcohol with Aceflex Plus.

Storage

Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Aceflex Plus Tablet for conditions for which it was not prescribed. Do not give Aceflex Plus Tablet to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

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How to take Aceflex Plus

The dose and frequency of using Aceflex Plus will depend on the following factors:

the health of the patient’s kidneys

Aceflex Plus Dosage

Dosage for painful & inflammatory conditions

Adult

Recommended: one dose twice daily

Forms

Film-coated bilayered tablet

Strength: 100/500 mg

Overdose

What to do if you overdose on Aceflex Plus?

In the case of Aceflex Plus overdose, activated charcoal is recommended to use and elimination of poisons from the stomach should be done possibly within the first one hour. Aceflex Plus elimination from the body should be done by inducing vomiting and excessive urine production. Use of oral methionine or intravenous N-acetylcysteine after up to at least 48 hours shows beneficial effects in case of overdose. Complete monitoring of liver and functioning of kidneys should be done in patients especially for the first four hours following the overdose. For convulsions, diazepam should be given through veins.

Symptoms of an overdose of Aceflex Plus

If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:

alters brain function or structure
breathing disorder
coma
convulsions
diarrhea
dizziness
drowsiness
eating disorder
excitation
fatality
headache
inflammation of pancreas
irregular heartbeat
kidney failure
liver damage
low blood pressure
nausea
pale color of the skin
ringing in the ears
stomach bleeding
stomach irritation
stomach pain
unconsciousness
vomiting

If you think you have overdosed on Aceflex Plus Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Aceflex Plus

Before you use Aceflex Plus, tell your doctor of your medical and health history including the following:

allergic reaction
difficulty in breathing
hives
inflammation of the mucous membrane
stomach and intestinal disorders (perforation, bleeding, ulcer)
swelling of the lower layer of skin

Bronchial asthma leads to narrowing of the bronchi. Allergic reactions progress into difficulty in breathing, inflammation of the mucous membrane, swelling of the lower layer of skin, hives. Also, stomach and intestinal disorders lead to blood-related abnormalities and inflammation of the digestive tract.

Before you use Aceflex Plus Tablet, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Tell your doctor if you are allergic to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

The use of this medicine may change liver enzyme. There is an increase in liver enzyme level.

The use of Aceflex Plus Tablet may change the blood urea level. There is an increase in blood urea level.

The use of this medicine may change blood creatinine level. There is an increase in blood creatinine level.

The use of this medicine may change blood alkaline phosphatase level. There is an increase in blood alkaline phosphatase level.

The use of Aceflex Plus Tablet may change blood phosphatase level. There is an increase in blood phosphatase level.

Alcohol

Avoid the consumption of alcohol with Aceflex Plus Tablet. Drinking alcohol may cause serious liver damage.

Use in Pregnancy

Aceflex Plus Tablet is not safe for use in pregnant women. If you are pregnant or planning to become pregnant, you should discuss with your doctor the impact this medicine may have on the baby before you start to use this medicine. There are known risk of Aceflex Plus causing blood vessel closure connected to the fetus and increased blood pressure in newborns. Using Aceflex Plus during the 28th week of pregnancy, cause decreased uterine contraction. Aceflex Plus can be used during the first 26 weeks of pregnancy or labor if its benefit to the mother justifies the risk to the baby. Aceflex Plus Tablet belongs to the NSAID class of medicines. NSAIDs should not be taken after 29 weeks of pregnancy as these medicines may cause serious harm to the unborn baby.

Use while Breastfeeding

Aceflex Plus is known to be safe for use in women who are breastfeeding. There are very limited studies available for Aceflex Plus in breastfeeding. Aceflex Plus has been shown to pass in breast milk. Therefore, it is not recommended during breastfeeding. But aceclofenac is used during breastfeeding if its possible benefit to the mother explains the possible risk to the baby.

Dizziness

Aceflex Plus Tablet can make you feel sleepy. Be careful while driving, using machinery, or doing any other activity that needs you to be alert. The consumption of alcohol with Aceflex Plus Tablet can make you feel more sleepy.

Increased Risk

This medicine can cause stomach bleeding. The use of alcohol/tobacco with Aceflex Plus may increase the risk. Talk to your doctor if you drink alcohol or smoke regularly. This medicine may increase your sensitivity to sunlight. If this happens, limit your time outdoors and prevent sunburns. Cover your skin or use a sunscreen.

Side-effects in Children

Aceflex Plus Tablet may cause an increased risk of side-effects in younger patients. Children using this medicine may see an increased risk of serious liver damage.

Side-effects in Older Patients

Aceflex Plus Tablet may increase side-effects in older patients. Elderly patients may see an increased risk of stomach bleeding, and rupturing of the wall of the stomach or intestine.

Long Term Use

There is a risk of heart attack for long term use of Aceflex Plus.

What precautions should be taken during Pregnancy and Nursing, and administering Aceflex Plus to Children or the Older Adults?

Pregnant Women

Contraindicated or Not Recommended

Warning: Aceflex Plus delays the start and increases the duration of labor with increased bleeding in both mother and baby. There are known risk of Aceflex Plus causing closure of the blood vessel connecting to the fetus and increased blood pressure in newborns. Therefore Aceflex Plus should not be used during the 28th week of pregnancy, causing decreased uterine contraction.

Breastfeeding

Contraindicated or Not Recommended

Warning: There is very limited data available for Aceflex Plusduring breastfeeding. Aceflex Plus has been shown to pass in breast milk. Therefore, it is not recommended in breastfeeding. But aceclofenac is used during breastfeeding if its possible benefit to the mother justifies the possible risk to the baby.

Younger Adults Population

Precaution

Warning: If more than 5 doses of Aceflex Plus per day is used in children it can cause serious liver damage.

Older Adults Population

Precaution

Warning: It is advised to take care while using Aceflex Plus alone or with other medicines in elderly patients with kidney, liver, heart disease or having other drugs. Aceflex Plus can cause increased side effects in elderly patients like stomach bleeding and rupturing of the wall of the stomach or intestine which may be dangerous.

Aceflex Plus Side-effects

The following side-effects may commonly occur in older patients on the use of Aceflex Plus Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:

stomach and intestinal rupture or bleeding
stomach ulcers

The following severe side-effects may also occur when using Aceflex Plus Tablet:

Immune system disorders

Symptoms: severe allergic reactions
Stomach and intestinal disorders

Symptoms: inflammation of stomach, mouth ulcer, constipation, stomach ulcer, inflammation of the pancreas, inflammation of mucous membrane, stomach and intestinal bleeding, blood vomiting vomiting
Skin and subcutaneous tissue disorders

Symptoms: red or purple spots on the skin swelling of the lower layer of the skin
Skin disorders

Symptoms: severe skin reactions sensitivity to light

Discontinuation should be done at the first appearance of skin rash, mucosal lesions, or any other sign of allergic reactions.
Blood and lymphatic system disorders

Symptoms: decrease in granulocytes, low level of thrombocytes, low level of neutrophils a decrease in the number of red blood cells
Symptoms: increased potassium level low blood glucose level
Nervous system disorders

Symptoms: sleepiness blood clot in an artery
Liver disorder

Symptoms: inflammation of the liver liver damage

If an abnormality in liver function tests worsens or persists, liver disease signs develop or eosinophilia, the rash occurs, the patient should discontinue the drug. Monitoring of kidney and liver function should be done properly.
Kidney disorders

Symptoms: kidney failure, kidney damage inflamed spaces between the kidney tubules

Your doctor has prescribed Aceflex Plus Tablet because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Aceflex Plus Tablet.

If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Aceflex Plus by Severity and Frequency

Severe Side-effects

Following are the severe side-effects of this medicine:

agranulocytosis
anaphylaxis
anemia
angioedema
aplastic anemia
arterial thrombotic
aseptic meningitis
asthma
bronchospasm
confusion
constipation
depression
dermatitis
dermatitis bullous
dyspnea
exanthema
fever
gastritis
hallucinations
hematemesis
hemolytic anemia
hepatitis
hyperkalemia
hypoglycemia
increased alkaline phosphatase
increased liver enzyme
increased serum potassium
interstitial nephritis
kidney insufficiency
liver damage
mouth ulceration
nephrotic syndrome
neutropenia
optic neuritis
pancreatitis
peptic ulcer
photosensitivity
purpura
somnolence
stevens-johnson syndrome
stomach and intestinal disorders (hemorrhage, perforation or bleeding)
stomach ulcer
stomatitis
thrombocytopenia
toxic epidermal necrolysis
vasculitis
visual disturbances
vomiting

Side-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:

stomach and intestinal rupture or bleeding
stomach ulcers

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:

face swelling
hives
mucosal lesions
rash
severe itching
skin rash
swelling

Discontinuation should be done at the first appearance of skin rash, mucosal lesions, or any other sign of allergic reactions.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:

bullous dermatitis
red or purple spots on the skin
severe skin reaction
swelling of the lower layer of skin

Warnings

Skin Related Disorders

Patients who were using Aceflex Plus in the first month of treatment are at highest risk for these reactions. Serious skin reactions including redness and scaling of the skin have been reported rarely with the use of Aceflex Plus. There is a risk of severe liver damage when doses are higher than the recommended one. Discontinue the drug at the first sign of skin rash, mucosal lesions, or any allergic reaction. Perform liver function tests if liver damage is suspected.

Allergic Reactions

Allergic reactions may occur without exposure to the drug with any of the NSAIDs including Aceflex Plus.

Blood Disorders

Aceflex Plus use can block clumping of platelets.

Long-term Treatment

Patients with an abnormality of heart, liver or functioning of kidneys and elderly patients are at an increased risk while using this medicine. Precaution should be taken in patients who are at increased risk of suffering from conditions such as coagulation disorders, history of stomach ulcers. Also from inflammation of the digestive tract, pregnancy, and lactation, bleeding in the brain, skin or nerve problems having enzyme deficiency in the liver. Caution is also needed in patients on diuretic or at risk of decreased blood volume. Patients receiving prolonged therapy should be monitored regularly for liver function, functioning of kidneys tests, and blood counts.

Respiratory Disorders

Patients suffering from or with a history of inflammatory lung disease are at an increased risk when using this medicine. Aceflex Plus have been reported to accelerate spasm of a bronchial smooth muscle in such patients. The patient should be cautious when using Aceflex Plus in patients suffering from or with a history of inflammatory lung disease.

Liver Damage

Patient taking alcohol (more than 3 drinks) every day, an adult taking a dose of more than 4000 mg in 24 hours are at an increased risk. Also, a child taking > 5 doses in 24 hours and if taken with other drugs containing paracetamol are at a higher risk when using these medicines. If paracetamol is taken more than the recommended dose, it can cause liver damage. Due to large doses of paracetamol allergic reactions such as swelling of the face, throat, and mouth, breathing difficulty, a rash may happen.

Heart and Brain Disorders

Patients with heart disease (e.g. high blood pressure, high level of cholesterol, high sugar level, smoking) are at an increased risk while using this medicine. Use of Aceflex Plus (at high doses and in long term treatment) may lead to a small increased risk of blood clot disorders (e.g heart attack or stroke), fluid retention and swelling. Patients with uncontrolled high blood pressure, heart failure, established heart disease, peripheral arterial disease, or heart disease should be treated only after careful monitoring. The patient should be careful before starting long-term therapy in patients with risk factors for heart disease.

Stomach & Intestinal Disorders

Elderly patients, patients with a history of ulcer (especially hemorrhage or perforation) are at higher risk when using this medicine. There is a risk of stomach and intestine disorders, which can be fatal any time during treatment. Patients should be cautious when receiving Aceflex Plus in combination with oral corticosteroids, anticoagulants, antiplatelet agents, and SSRIs. Monitoring patients with stomach-intestinal disorders, colon inflammation, or blood disorders as it may get worse. Patients who are at increased risk should start their treatment on a low dose and with protective agents. Therapy with Aceflex Plus should be discontinued if stomach and intestine bleeding occurs.

Mixed Connective Tissue Disorders

Patients with mixed connective tissue disorders including systemic lupus erythematosus (SLE) are at an increased risk when using this medicine. These patients may have a risk of inflammation of the brain linings.

Interactions with Aceflex Plus

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.

This page does not contain all the possible interactions of Aceflex Plus Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Quinolone Antibiotics

Your doctor’s guidelines may need to be followed while taking this medicine along with quinolone antibiotics which are used to treat a variety of illnesses such as respiratory and urinary tract infections. The combined use of Aceflex Plus with quinolones may increase the risk of developing convulsions.

Amethopterin

Aceflex Plus Tablet interacts with amethopterin (methotrexate) which treats cancer, autoimmune diseases, and for medical abortions. The combined use of methotrexate and Aceflex Plus shows a decrease in the elimination of methotrexate. Precaution should be taken if Aceflex Plus and methotrexate are used within 24 hours of each other. As Aceflex Plus can increase blood levels which may result in increased harmful effects.

Steroids

There may be an interaction of Aceflex Plus with steroids (mifepristone, corticosteroids) which are used to treat a variety of inflammatory diseases and conditions. The combined use of mifepristone and Aceflex Plus can cause a reduction in the effect of mifepristone. Combined therapy of aceclofenac with corticosteroids can increase the risk of stomach bleeding. Aceflex Plus use should be avoided for 8-12 days after the use of mifepristone.

Cardiac Glycosides

Aceflex Plus Tablet may interact with cardiac glycosides which are used to treat heart disease. The combined use of Aceflex Plus with cardiac glycosides may worsen the risk of heart failure, reduce kidney efficiency, and increase blood glycoside level.

Nucleoside Reverse Transcriptase Inhibitors

Special instructions need to be followed while taking this medicine along with nucleoside reverse transcriptase inhibitors (zidovudine) which are used to treat HIV. The combined use of Aceflex Plus with zidovudine increases the risk of bleeding into the joints and collection of blood outside the blood vessels in HIV(+) patients having a blood clotting disorder.

Antidiabetic Agents

Your doctor’s guidelines may need to be followed while taking this medicine along with antidiabetic agents which are used to control increased blood sugar level. The combined use of aceclofenac with oral antidiabetic agents can cause a decrease and increase in blood sugar level.

Anti-Hypertensives

Aceflex Plus Tablet interacts with anti-hypertensives which are used to treat high blood pressure of the body. The combined use of aceclofenac with anti-hypertensives drugs shows a reduction in the effect of anti-hypertensives.

Antiplatelet Agents and SSRIs

Special instructions need to be followed while taking this medicine along with Anti-platelet agents which are used to prevent the formation of blood clots and selective serotonin reuptake inhibitors which are used to treat the depressive disorder. The combined use of aceclofenac with anti-platelet agents and selective serotonin reuptake inhibitors shows an increase in the risk of stomach bleeding.

Diuretics

There may be an interaction of Aceflex Plus with diuretics (potassium-sparing diuretics) which are used to promote diuresis, the increased production of urine. The combined use of diuretics with Aceflex Plus reduces the diuretics effects. Also, diuretics increase the risk of kidney damage when used with Aceflex Plus. While using the Aceflex Plus with potassium-sparing diuretics, it is necessary to monitor blood potassium level in patients.

Other Nonsteroidal Anti-inflammatory Drugs

Aceflex Plus Tablet may interact with nonsteroidal anti-inflammatory drugs (aspirin, cyclooxygenase-2 selective inhibitors, ibuprofen) which are used to reduce pain, fever and prevent blood clots. The combined use of Aceflex Plus with other NSAIDs may increase the risk of side effects including stomach bleeding. Combined therapy with ibuprofen may increase the risk of bleeding into the joints and collection of blood outside the blood vessels in HIV(+) patients having a blood clotting disorder.

Immunosuppressants

Aceflex Plus Tablet may interact with immunosuppressants (ciclosporin) which are used to prevent organ refusal after a kidney, heart, or liver transplant. The combined use of aceclofenac with ciclosporin increase the risk of kidney damage.

Antibacterial Agents

Your doctor’s guidelines may need to be followed while taking this medicine along with antibacterial agents (chloramphenicol, rifampicin, and St. John’s wort extract) which are used to treat bacterial infections. The combined use of chloramphenicol and paracetamol may affect the absorption of chloramphenicol mainly in patients suffering from malnutrition. Use of paracetamol with enzyme producing agents like rifampicin and St. John’s wort extract (hypericum) may cause a decrease in the level of paracetamol.

Uricosuric Drugs

Special instructions need to be followed while taking this medicine along with uricosuric drugs (probenecid), which are used to treat severe pain, redness, and tenderness in joints and excess of uric acid. The combined use of probenecid and paracetamol shows decrease metabolism of paracetamol which can influence the clearance of paracetamol.

Anticonvulsants

Aceflex Plus Tablet interacts with anticonvulsants (alcohol, barbiturates) which are used to treat epileptic seizures. The combined use of paracetamol and drugs which induce liver microsomal enzymes like anticonvulsants may increase the liver damage of paracetamol.

Antimanic Agents

There may be an interaction of Aceflex Plus with antimanic agents (lithium) which are used to treat manic-depressive illness. The combined use of lithium and Aceflex Plus shows a decrease in the elimination of lithium.

Antiepileptic Drugs

Interactions of Aceflex Plus by Severity

When should Aceflex Plus be not used?

Drug Sensitivity

Aceflex Plus should not be used in the patients those who are sensitive to paracetamol, aceclofenac or any of the substance of the drug.

Stomach Disorders

Aceflex Plus should not be used in patients with current or previous history of repeated stomach ulcer or bleeding. Stomach ulcers can be possibly fatal.

Allergic Reactions

Aceflex Plus should not be used in the patients previously known to have allergic reactions in response to aspirin, ibuprofen, or other NSAIDs. These patients may have the following symptoms if they use this medicine:

lungs inflammation
inflammation in nose
swelling of the lower layer of skin
hives

Heart Disorders

Aceflex Plus should not be used in patients with serious heart failure, high blood pressure.

Liver and Kidney Disorders

Aceflex Plus should not be used in patients with liver or kidney failure.

Pregnancy

Aceflex Plus should not be used during pregnancy particularly in the 28 weeks of pregnancy unless there are not many reasons to doing so. It is preferred to use the lowest effective dose. There is an increased risk of improper blood circulation in the newborn. The frequent use of Aceflex Plus may reduce contraction in uterine muscles on using it in the last trimester of pregnancy.

Traveling With Medication

Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country’s embassy or website.
Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Aceflex Plus is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

If there are disposal instructions on the package, please follow the instructions.
If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.

This page provides information for Aceflex Plus Tablet .

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Источник

Trade Name	Aceflex
Generic	Aceclofenac
Aceclofenac Other Names	Aceclofenac, Acéclofénac, Aceclofenac betadex, Aceclofenaco, Aceclofenacum
Type	Injection
Formula	C₁₆H₁₃Cl₂NO₄
Weight	Average: 354.18 Monoisotopic: 353.0221633
Protein binding	It is reported to be highly protein-bound (>99%) .
Groups	Approved, Investigational
Therapeutic Class	Aceclofenac is a non-steroidal agent with antiinflammatory and analgesic properties. Its mode of action is largely based on inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins. It also stimulates cartilage matrix (glycosaminoglycans) synthesis.
Manufacturer	Zee Laboratories Ltd
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Aceflex

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Aceflex is a NSAID that inhibits both isoforms of COX enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Aceflex displays more selectivity towards COX-2 (IC50 of 0.77uM) than COX-1 (IC50 of >100uM), which promotes its gastric tolerance compared to other NSAIDs. The primary metabolite, 4′-hydroxyaceclofenac, also minimally inhibits COX-2 with IC50 value of 36uM . Although the mode of action of aceclofenac is thought to mainly arise from the inhibition of synthesis of prostaglandins (PGE2), aceclofenac also inhibits the production of inflammatory cytokines, interleukins (IL-1β, IL-6), and tumor necrosis factors (TNF) . It is also reported that aceclofenac also affects the cell adhesion molecules from neutrophils [A19763]. Aceflex also targets the synthesis of glycosaminoglycan and mediates chrondroprotective effects .

Uses

Aceflex is used for the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain etc.

Aceflex is also used to associated treatment for these conditions:

Ankylosing Spondylitis (AS), Osteoarthritis (OA), Rheumatoid Arthritis

How Aceflex works

Through COX-2 inhibition, aceclofenac downregulates the production of various inflammatory mediators including prostaglandin E2 (PGE2), IL-1β, and TNF from the arachidonic acid (AA) pathway. Inhibition of IL-6 is thought to be mediated by diclofenac converted from aceclofenac . Suppressed action of inflammatory cytokines decreases the production of reactive oxygen species. Aceflex is shown to decreased production of nitrous oxide in human articular chondrocytes . In addition, aceclofenac interferes with neutrophil adhesion to endothelium by decreasing the expression of L-selectin (CD62L), which is a cell adhesion molecule expressed on lymphocytes . Aceflex is proposed to stimulate the synthesis of glycosaminoglycan in human osteoarthritic cartilage which may be mediated through its inhibitory action on IL-1 production and activity . The chrondroprotective effects are generated by 4′-hydroxyaceclofenac which suppresses IL-1 mediated production of promatrix metalloproteinase-1 and metalloproteinase-3 and interferes with the release of proteoglycan from chrondrocytes .

Aceflex

Aceflex
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Dosage

Aceflex dosage

Adults: The maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Children: There is no clinical data on the use of aceclofenac in children.

Elderly: The pharmacokinetics of aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency.

Renal insufficiency: There is no evidence that the dosage of aceclofenac needs to be modified in patients with mild renal impairment.

Hepatic insufficiency: The dose of aceclofenac should be reduced in patients with hepatic impairment. An initial daily dose of 100 mg should be administered.

Aceflex SR tablet:

The recommended dose is 200 mg once daily.

Side Effects

Generally aceclofenac is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.

Toxicity

Some common adverse effects include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness . Oral LD50 value in rats is 130 mg/kg .

Precaution

Aceflex should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with a history of peptic ulceration, ulcerative colitis, Crohn\’s disease, hepatic porphyria, and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored.

Interaction

Lithium and Digoxin: Aceflex, like many NSAIDs may increase plasma concentrations of lithium and Digoxin.

Diuretics: Aceflex, like other NSAIDs, may interact the activity of diuretics.

Anticoagulants: Like other NSAIDs, Aceflex may enhance the activity of anticoagulant. Close monitoring of patients on combined anticoagulants and Aceflex therapy should be undertaken.

Methotrexate: Caution should be exercised if NSAIDs and Methotrexate are administered within 24 hours of each other, since NSAIDs may increase Methotrexate plasma levels, resulting in increased toxicity.

Food Interaction

Take with or without food.

Volume of Distribution

The volume of distribution is approximately 25 L .

Elimination Route

Aceflex is rapidly and completely absorbed from the gastrointestinal tract and circulates mainly as unchanged drug following oral administration. Peak plasma concentrations are reached around 1.25 to 3 hours post-ingestion, and the drug penetrates into the synovial fluid where the concentration may reach up to 60% of that in the plasma . There is no accumulation in regular dosing, with similar maximum plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax) after single and multiple doses .

Half Life

The mean plasma elimination half-life is approximately 4 hours .

Clearance

The mean clearance rate is approximately 5 L/h .

Elimination Route

The main route of elimination is via the urine where the elimination accounts for 70-80% of clearance of the drug . Approximately two thirds of the administered dose is excreted via the urine, mainly as glucuronidated and hydroxylated forms of aceclofenac . About 20% of the dose is excreted into feces .

Pregnancy & Breastfeeding use

Pregnancy: There is no information on the use of aceclofenac during pregnancy. Aceflex should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective dose should be administered.

Lactation: There is no information on the secretion of aceclofenac in breast milk. The use of aceclofenac should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children.

Contraindication

Aceflex should not be administered to patients with active or suspected peptic ulcer or gastro-intestinal bleeding. It should not be given to patients with moderate to severe renal impairment. Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function. It should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. Aceflex should not be administered to patients previously sensitive to Aceflex or in whom aspirin or NSAIDs precipitate attacks of asthma, acute rhinitis or urticaria or who are hypersensitive to these drugs.

Acute Overdose

There is no human data available on the consequences of aceclofenac overdosage. After overdosage, following therapeutic measures to be taken: absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications.

Storage Condition

Keep at a cool and dry place, protected from light and moisture.

Innovators Monograph

You find simplified version here Aceflex

FAQ

What is Aceflex used for?

Is Aceflex is a painkiller?

Anti-inflammatory painkillers like Aceflex are also called non-steroidal anti-inflammatory drugs (NSAIDs), or sometimes just ‘anti-inflammatories’. Aceflex is prescribed for people with painful rheumatic conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

How safe is Aceflex?

Aceflex 100 mg orally twice daily, is a safe, effective, and convenient treatment for active AS.

Is Aceflex safe for kidneys?

Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly. Effects on renal function are usually reversible on withdrawal of Aceflex.

Who should not take Aceflex?

Aceflex is not recommended if you have asthma or a history of asthma in your family. Impaired function of the kidney- Aceflex is not recommended if you have impaired kidney function. Impaired function of the liver- Use with caution with an initial dose of 100 mg once daily for mild liver failure.

Can Aceflex used for teeth pain?

Aceflex has anti-inflammatory properties similar to those of diclofenac and yields good results in the control of dental pain.

Does Aceflex make me sleepy?

It may cause dizziness, drowsiness or visual disturbances. Use caution while driving or doing anything that requires concentration. Avoid consuming alcohol while taking Aceflex as it can cause excessive drowsiness and increase your risk of stomach problems.

Does Aceflex increase blood pressure?

Aceflex may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, including the following: ACE inhibitors such as captopril.

Is Aceflex a muscle relaxant?

Aceflex is a non-steroidal anti-inflammatory drug (NSAID) which works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling). Thiocolchicoside is a muscle relaxant.

What is the Dosage of Aceflex?

Aceflex Dosage

Adults: The maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Children: There is no clinical data on the use of Aceflex in children.

Elderly: The pharmacokinetics of Aceflex are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency.

Renal insufficiency: There is no evidence that the dosage of Aceflex needs to be modified in patients with mild renal impairment.

Hepatic insufficiency: The dose of Aceflex should be reduced in patients with hepatic impairment. An initial daily dose of 100 mg should be administered.

Aceflex SR tablet:

The recommended dose is 200 mg once daily.

What is the Side Effects of Aceflex?

Generally Aceflex is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.

Is Aceflex safe during pregnancy?

There is no information on the use of Aceflex during pregnancy. Aceflex should not be administered during pregnancy, unless there are compelling reasons for doing so. The lowest effective dose should be administered.

Is Aceflex safe during breastfeeding?

There is no information on the secretion of Aceflex in breast milk. The use of Aceflex should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children.

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Aceflex-TH Tablets

We are a quality centric company and thus, we follow strict quality standards throughout to offer quality products to the customers. Our Aceflex-TH Tablets are available in different packaging sizes and used to treat toothache, ear pain and other conditions. With our years of experience, our company name figures amidst the most responsive and responsible Suppliers of Aceflex-TH Tablets. Details : 2 X 5 X 10 Tablets Alu Alu Pack Aceclofenac 100 mg. + Thiocolchhicoside 4mg. Indication : Pain Inflammation, Muscle Relaxant, Spondylitis & Spondolosis.

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Manufactured byZee Laboratories

ContainsAceclofenac (100 mg) + Paracetamol (325 mg) + Chlorzoxazone (250 mg)

Description

Aceflex-MR Tablet is a combination medicine that consists of aceclofenac, paracetamol and chlorzoxazone. It is used for the treatment of pain, swelling, and tenderness associated with muscle injury and muscle spasms. This medicine works by blocking the release of certain chemical messengers that causes pain, swelling and fever.

Aceflex-MR Tablet may cause side effects like nausea, vomiting, stomach pain, heartburn, loss of appetite and diarrhoea. If any of these side effects persist for a long time or worsen, consult your doctor at the earliest. This medicine may cause dizziness or sleepiness. Avoid driving or operating machines if you feel dizzy or sleepy after taking this medicine.

Aceflex-MR Tablet should be taken with food to avoid stomach irritation. Adhere to the dose and frequency prescribed by your doctor. You should keep taking the medicine even if you feel better until your doctor says to stop using it.

Aceflex-MR Tablet may interact with other medicines. Inform your doctor if you have other medical conditions such as liver, kidney or heart conditions, peptic ulcers, etc., before taking Aceflex-MR Tablet. Let your doctor know all the other medicines you are using, to make sure this medicine is safe. Inform your doctor if you are pregnant, planning a pregnancy or breastfeeding.

Aceflex-MR Tablet may cause excessive drowsiness and increase the risk of liver damage if you consume alcohol while on treatment with it. This medicine is most effective when taken along with proper rest and exercise.

Side effects

Major & minor side effects for Aceflex-MR Tablet

Bloody and cloudy urine
Bloody stool
Dark urine
Dizziness
Nausea and vomiting
Drowsiness
Weakness
Stomach pain
Tightness of chest
Constipation
Diarrhoea
Skin rash
Heartburn
Loss of appetite

Uses of Aceflex-MR Tablet

What is it prescribed for?

Pain due to muscle spasm

Concerns

Commonly asked questions

How long does it take for this medicine to take effect?

The pain-relieving effect of Aceflex-MR Tablet can be observed within one hour of intake.
How long do the effects of this medicine last?

Aceflex-MR Tablet remains active in the body for up to 12-16 hours.
Is it safe to consume alcohol while taking this medicine?

Consumption of alcohol with Aceflex-MR Tablet may lower your blood pressure and can cause dizziness, headache, gastrointestinal bleeding, weakness, fatigue, etc.
Is this a habit forming medicine?

Aceflex-MR Tablet has no habit forming tendency.
Can this medicine be taken during pregnancy?

Aceflex-MR Tablet is not recommended in pregnancy as it may cause miscarriage or may affect foetal heart growth. Discuss the potential benefits and risks with your doctor before starting the therapy.
Can this medicine be taken while breast-feeding?

Aceflex-MR Tablet is known to pass into breastmilk. It is recommended to discontinue breastfeeding or taking Aceflex-MR Tablet, based on your clinical condition. Discuss all the benefits and risks with your doctor before starting the therapy.

When not to use?

Allergy

Avoid taking Aceflex-MR Tablet if you are allergic to it. However, seek immediate medical help if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulties, etc.

Kidney diseases

Aceflex-MR Tablet is extensively excreted through the kidneys. The damaged kidneys cannot filter out this medicine effectively and this leads to its accumulation. This may worsen the condition of impaired kidneys. Hence, consult your doctor before taking this medicine.

Severe liver impairment

People with liver problems need special consideration while taking Aceflex-MR Tablet. The use of this medicine is generally not recommended in severe liver problems because it can increase the risk of liver damage. Hence, consult your doctor before taking this medicine.

Gastrointestinal perforation

Aceflex-MR Tablet is not recommended for use in perforation disorders since it may cause stomach and intestinal bleeding and ulcers.

Peptic Ulcer

Avoid taking Aceflex-MR Tablet if you have peptic ulcers. It can cause severe swelling and bleed in the stomach, colon, and anus.

Coronary artery bypass surgery

A coronary artery bypass graft (CABG) is a surgical procedure used to treat coronary heart disease. It diverts blood around narrowed or blocked parts of the major blood vessels to improve blood flow and oxygen supply to the heart. Do not take Aceflex-MR Tablet for relieving pain due to heart surgery.

Warnings

Warnings for special population

Pregnancy

Aceflex-MR Tablet is not recommended in pregnancy as it may cause miscarriage or may affect foetal heart growth. Discuss the potential benefits and risks with your doctor before starting the therapy.

Breast-feeding

Aceflex-MR Tablet is known to pass into breastmilk. It is recommended to discontinue breastfeeding or taking Aceflex-MR Tablet, based on your clinical condition. Discuss all the benefits and risks with your doctor before starting the therapy.

General warnings

Chronic Malnutrition

Malnutrition and fasting can increase the risk of Aceflex-MR Tablet overdose. Your doctor will adjust the dose depending on your body weight.

Gastro-intestinal toxicity

Long term use of Aceflex-MR Tablet can cause damage to the stomach and intestine.

Heart surgery

Aceflex-MR Tablet is not recommended for use in peoplewho have undergone recent heart surgery as it may worsen their condition.

Driving or operating machines

Aceflex-MR Tablet may cause sleepiness or dizziness. Avoid driving vehicles and operating heavy machines after taking this medicine.

Dosage

Missed Dose

If you forget to take a dose of Aceflex-MR Tablet at the scheduled time, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not double the dose to make up for the missed one.

Overdose

Never take more than the prescribed dose. If you suspect that you might have taken an overdose of Aceflex-MR Tablet, go to the emergency department of your local hospital.

Interactions

All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.

Instructions

Consumption of alcohol with Aceflex-MR Tablet may lower your blood pressure and can cause dizziness, headache, gastrointestinal bleeding, weakness, fatigue, etc.

Interaction with Medicine

Carbamazepine

Lithium

Phenytoin

Tramadol

Sodium Nitrite

Leflunomide

Prilocaine

Digoxin

Corticosteroids

Antihypertensives

Disease interactions

Liver disease

Do not take Aceflex-MR Tablet if you have liver problems as it may cause liver damage.

NSAID-induced asthma

NSAID-induced asthma is an allergic condition of the respiratory system caused by the use of NSAIDs (Non-steroidal Anti-inflammatory Drugs- medicines that are widely used to relieve pain and reduce swelling). In this, there is a narrowing of the airways of your lungs leading to severe breathing difficulty. Aceflex-MR Tablet is not recommended for use in this condition.

Kidney diseases

If you take Aceflex-MR Tablet in high doses for a prolonged period of time, it may cause kidney problems, such as painful urination and protein or blood in the urine. Hence, close monitoring of kidney function is necessary.

Food interactions

Information not available.

Lab interactions

5-HIAA Urine Test

5-HIAA urine test measures the amount of serotonin (a key hormone that stabilizes our mood, feelings of well-being, and happiness) in the body. Aceflex-MR Tablet can interfere with a urine test and may give a false-positive result. Inform your doctor and lab technician about all your current medicines before undergoing any lab test.

This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.

General Instructions

Take Aceflex-MR Tablet with food to avoid stomach irritation. Drink adequate water for easy swallowing. Never take more than the prescribed dose.

Avoid consuming alcohol when taking Aceflex-MR Tablet as it may cause excessive drowsiness and increase the risk of liver damage.

Older adults may have increased drowsiness, confusion, and a higher risk of falling as a result of taking Aceflex-MR Tablet.

Do not take Aceflex-MR Tablet with any other medicine containing acetaminophen (drugs for pain/fever or cough-and-cold) without asking your doctor first.

Take Aceflex-MR Tablet at around the same time daily. Do not stop the use of this medicine without consulting your doctor. Do not break, crush or chew the tablet in the mouth. Take it immediately after peeling it from the strip.

Keep the medicine out of reach of children and pets. Do not use Aceflex-MR Tablet after the expiry date. Ensure that the unused or expired medicine is disposed of properly.

Other details

Miscelleneous

To be taken with food

To be taken as instructed by doctor

May cause sleepiness

How it works

Aceflex-MR Tablet is a combination of aceclofenac, paracetamol and chlorzoxazone.
Aceclofenac and Paracetamol work by blocking the release of certain chemical substances in your brain that cause pain and swelling and fever.
Chlorzoxazone is a muscle relaxant. It works on the centres of the brain and spinal cord to relieve muscle stiffness or spasm, thereby improving muscle movement.

Legal Status

Approved

Unknown

Classification

References

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