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1. Name of the medicinal product
Aspirin 75mg Gastro-Resistant Tablets
2. Qualitative and quantitative composition
Each tablet contains aspirin 75 mg.
Also includes 17mg/tablet lactose.
For the full list of excipients, see 6.1.
3. Pharmaceutical form
Gastro-resistant tablet.
White, film coated, round tablet.
4. Clinical particulars
4.1 Therapeutic indications
For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery.
4.2 Posology and method of administration
Posology
For the management of cardiovascular or cerebrovascular disease:
Patients should seek the advice of a doctor before commencing therapy for the first time.
The usual dosage, for long-term use, is 75mg-150mg once daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor. In general, acetylsalicylic acids should be used with caution in elderly patients who are more prone to adverse events. The usual adult dose is recommended in the absence of severe renal or hepatic insufficiency (see sections 4.3 and 4.4). Treatment should be reviewed at regular intervals.
Children:
Aspirin 75mg Tablet is not indicated in children and young people aged 0 to 16 years (see ‘Special Warning and Precautions for Use’).
Method of administration
Aspirin 75 mg is for oral administration to adults only.
Take the tablet with water, do not cut, chew or crush the tablet. Swallow whole.
4.3 Contraindications
• Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria), or to any of the excipients (see section 6.1).
• Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.
• Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia Patients who are suffering from gout.
• Severe hepatic impairment.
• Severe renal impairment.
• Doses >100 mg/day during the third trimester of pregnancy (see section 4.6);
• Methotrexate used at doses >15mg/week (see section 4.5).
4.4 Special warnings and precautions for use
Aspirin 75 mg tablet is not suitable for use as an anti-inflammatory/ analgesic/ antipyretic.
Recommended for use in adults and adolescents from 16 years of age. This medicinal product is not recommended for use in adolescents/children under 16 years unless the expected benefits outweigh the risks. Acetylsalicylic acid may be a contributory factor in the causation of Reye’s Syndrome in some children.
There is an increased risk of haemorrhage particularly during or after operative procedure (even in cases of minor procedures, e.g. tooth extraction). Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary.
Aspirin is not recommended during menorrhagia where it may increase menstrual bleeding.
Aspirin 75 mg Tablets is to be used with caution in cases of hypertension and when patients have a past history of gastric or duodenal ulcer or haemorrhagic episodes or are undergoing therapy with anticoagulants.
Patients should report any unusual bleeding symptoms to their physician. If gastrointestinal bleeding or ulceration occurs the treatment should be withdrawn. Acetylsalicylic acid should be used with caution in patients with moderately impaired renal or hepatic function (contraindicated if severe), or in patients who are dehydrated, since the use of NSAIDs may result in deterioration of renal function. Liver function tests should be performed regularly in patients presenting slight or moderate hepatic insufficiency.
Aspirin may promote bronchospasm and asthma attack or other hypersensitivity reactions. Risk factors are existing asthma, hay fever, nasal polyps or chronic respiratory diseases. The same applies for patients who also show allergic reaction to other substances (e.g. with skin reactions, itching or urticaria).
Serious skin reactions, including Steven-Johnsons syndrome, have rarely been reported in association with the use of acetylsalicylic acid (see section 4.8). Aspirin Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including acetylsalicylic acid especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Where prolonged therapy is required, patients should be reviewed regularly.
Concomitant treatment with Aspirin and other drugs that alter haemostasis (i.e. anticoagulants such as warfarin, thrombolytic and antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors) is not recommended, unless strictly indicated, because they may enhance the risk of haemorrhage (see section 4.5). If the combination cannot be avoided, close observation for signs of bleeding is recommended
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration, such as oral corticosteroids, selective serotonin-reuptake inhibitors and deferasirox (see section 4.5).
Acetylsalicylic acid in low doses reduces uric acid excretion. Due to this fact, patients who tend to have reduced uric acid excretion may experience gout attacks (see section 4.5).
The risk of hypoglycaemic effect with sulfonylureas and insulins may be potentiated with Aspirin 75mg tablets taken at over dosage (see section 4.5).
Aspirin should be avoided in late pregnancy and generally during breast feeding (see section 4.6).
Patients with congenital lactase deficiency, galactosaemia or glucose-galactose intolerance must not be given this medicine unless strictly necessary.
4.5 Interaction with other medicinal products and other forms of interaction
Contraindicated combinations
Methotrexate (used at doses >15 mg/week):
The combined drugs, methotrexate and acetylsalicylic acid, enhance haematological toxicity of methotrexate due to the decreased renal clearance of methotrexate by acetylsalicylic acid. Therefore, the concomitant use of methotrexate (at doses >15 mg/week) with Aspirin 75 mg tablets is contraindicated (see section 4.3).
Not recommended combinations
Uricosuric agents, e.g. probenecid and sulfinpyrazone:
Salicylates reverse the effect of probenecid and sulfinpyrazone. The combination should be avoided.
Combinations requiring precautions for use or to be taken into account
Anticoagulants e.g. coumarin, heparin, warfarin and phenindione:
Increased risk of bleeding due to inhibited thrombocyte function, injury of the duodenal mucosa and displacement of oral anticoagulants from their plasma protein binding sites. The bleeding time should be monitored (see section 4.4).
Anti-platelet agents (e.g clopidogrel and dipyridamole) and selective serotonin re-uptake inhibitors (SSRIs; such as sertraline or paroxetine):
Increased risk of gastrointestinal bleeding (see section 4.4).
Antidiabetics, e.g. sulphonylureas:
Salicylics may increase the hypoglycaemic effect of sulphonylureas.
Digoxin and lithium:
Acetylsalicylic acid impairs the renal excretion of digoxin and lithium, resulting in increased plasma concentrations. Monitoring of plasma concentrations of digoxin and lithium is recommended when initiating and terminating treatment with acetylsalicylic acid. Dose adjustment may be necessary.
Diuretics and antihypertensives:
NSAIDs may decrease the antihypertensive effects of diuretics and other antihypertensive agents. Patients with hypertension should be carefully monitored. As for other NSAIDs concomitant administration with ACE-inhibitors increases the risk of acute renal insufficiency. Diuretics: Risk of acute renal failure due to the decreased glomerular filtration via decreased renal prostaglandin synthesis. Hydrating the patient and monitoring renal function at the start of the treatment is recommended.
Carbonic anhydrase inhibitors (acetazolamide):
May result in severe acidosis and increased central nervous system toxicity.
Systemic Corticosteroids:
The risk of gastrointestinal bleeding and ulceration is increased when acetylsalicylic acid and corticosteoids are co-administered (see section 4.4).
Methotrexate (used at doses <15 mg/week):
The combined drugs, methotrexate and acetylsalicylic acid, may increase haematological toxicity of methotrexate due to decreased renal clearance of methotrexate by acetylsalicylic acid. Weekly blood count checks should be done during the first weeks of the combination. Enhanced monitoring should take place in the presence of even mildly impaired renal function, as well, as in elderly
Other non-steroidal anti-inflammatory drugs (NSAIDs):
Increased risk of ulcerations and gastrointestinal bleeding due to synergistic effects.
Ibuprofen:
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Ciclosporin, tacrolimus:
Concomitant use of NSAIDs and ciclosporin or tacrolimus may increase the nephrotoxic effect of ciclosporin and tacrolimus. The renal function should be monitored in case of concomitant use of these agents and acetylsalicylic acid.
Valproate
Acetylsalicylic acid has been reported to decrease the binding of valproate to serum albumin, thereby increasing its free plasma concentrations at steady state.
Phenytoin (Anti-epileptics)
Salicylate diminishes the binding of phenytoin to plasma albumin. This may lead to decreased total phenytoin levels in plasma, but increased free phenytoin fraction. The unbound concentration, and thereby the therapeutic effect, does not appear to be significantly altered.
Alcohol
Concomitant administration of alcohol and acetylsalicylic acid increases the risk of gastrointestinal bleeding.
Metamizole
Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation, when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.
4.6 Fertility, pregnancy and lactation
Pregnancy
Low doses (up to 100 mg/day):
Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Doses of 100- 500 mg/day:
There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.
Doses of 500 mg/day and above:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
• Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension)
• Renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy
• Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses
• Inhibition of uterine contractions resulting in delayed or prolonged labour
Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy.
Breast-feeding:
Low quantities of salicylates and of their metabolites are excreted in breast milk. Since adverse effects for the infant have not been reported up to now, short-term use of the recommended dose does not require suspending breastfeeding. In cases of long-term use and/or administration of higher doses, breastfeeding should be discontinued.
4.7 Effects on ability to drive and use machines
Aspirin does not usually affect the ability to drive or operate machinery.
4.8 Undesirable effects
Side effects are grouped on the basis of System Organ Class. Within each system organ class the frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
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Blood and lymphatic system disorders |
Common: Increased bleeding tendencies. Rare: Thrombocytopenia, granulocytosis, aplastic anaemia. Not known: Cases of bleeding with prolonged bleeding time such as epistaxis, and gingival bleeding. Symptoms may persist for a period of 4–8 days after acetylsalicylic acid discontinuation. As a result there may be an increased risk of bleeding during surgical procedures. Existing (haematemesis, melaena) or occult gastrointestinal bleeding, which may lead to iron deficiency anaemia (more common at higher doses). |
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Immune system disorders |
Rare: Hypersensitivity reactions, angio-oedema, allergic oedema, anaphylactic reactions including shock. |
|
Metabolism and digestive system disorders |
Not known: Hyperuricemia. |
|
Nervous system disorders |
Rare: Intracranial haemorrhage. Not known: Headache, vertigo. |
|
Ear and labyrinth disorders |
Not known: Reduced hearing ability; tinnitus. |
|
Vascular disorders |
Rare: Hemorrhagic vasculitis. |
|
Respiratory, thoracic and mediastinal disorders |
Uncommon: Rhinitis, dyspnoea. Rare: Bronchospasm, asthma attacks. |
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Reproductive System and mammary disorders |
Rare: Menorrhagia. |
|
Gastrointestinal disorders |
Common: Dyspepsia. Rare: Severe gastrointestinal haemorrhage, nausea, vomiting. Not known: Gastric or duodenal ulcers and perforation, diarrhoea. |
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Hepatobiliary disorders |
Not known: Hepatic insufficiency. |
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Skin and subcutaneous tissue disorders |
Uncommon: Urticaria. Rare: Steven-Johnsons syndrome, Lyells syndrome, purpura, erythema nodosum, erythema multiforme. |
|
Renal and urinary tract disorders |
Not known: Impaired renal function, salt and water retention. |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.
4.9 Overdose
Although considerable inter-individual variations are involved, it can be considered that the toxic dose is about 200mg/kg in adults and 100mg/kg in children. The lethal dose of acetylsalicylic acid is 25-30 grams. Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Plasma concentration above 500 mg/l in adults and 300 mg/l in children generally cause sever toxicity. Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Overdose may harmful for elderly patients and particularly for small children (therapeutic overdose or frequent accidental intoxications may be fatal).
Symptoms of moderate intoxications:
Common features of salicylate poisoning include vomiting, nausea, abdominal pain, dehydration, tinnitus, vertigo, headache, deafness, sweating, warm extremities with bounding pulses.
Symptoms of severe intoxications:
Some degree of acid-base disturbance is present in most cases.
In the first instance hyperventilation occurs, which results in respiratory alkalosis. Respiratory acidosis ensues due to suppression of the respiratory centre.
In addition metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years as a result of the presence of salicylate. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Since younger children are often not seen until they have reached a late stage of intoxication, they are usually in the stage of acidosis.
Furthermore, the following symptoms may occur: haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema, hyperthermia and perspiration, resulting in dehydration: feeling of restlessness, convulsions and hallucinations.
Central nervous system features including confusion, disorientation, convulsions may lead to coma cardiovascular collapse or respiratory arrest is less common in adults than in children.
Treatment of overdose
If a toxic dose has been ingested, hospital admission is required. In the event of moderate intoxication, including the patient to vomit should be attempted.
If this fails, gastric lavage may be attempted during the first hour after ingestion of substantial amount of the medicine.
Give activated charcoal (50g for an adult, 1g/kg body weight for a child up to 12 years) within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate.
The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L) or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
Other symptoms to be treated symptomatically.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: blood and blood forming organs-antithrombotic agents: Platelet Aggregation Inhibitor excl. Heparin.
ATC code: B01AC06
Aspirin inhibits platelet aggregation. Blocking the platelet cyclooxygenase by acetylation, it inhibits thromboxane A2 synthesis, a physiological activating substance released by the platelets and which would play a role in the complications of the atheromatosic lesions.
Inhibition of TXA2-synthesis is irreversible, because thrombocytes, which have no nucleus, are not capable (due to lack of protein synthesis capability) to synthesise new cyclooxygenase, which had been acetylated by acetylsalicylic acid.
The repeated doses from 20 to 325 mg involve an inhibition of the enzymatic activity from 30 to 95%. Due to the irreversible nature of the binding, the effect persists for the lifespan of a thrombocyte (7-10 days). The inhibiting effect does not exhaust during prolonged treatments and the enzymatic activity gradually begins again upon renewal of the platelets 24 to 48 hours after treatment interruption. Acetylsalicylic acid extends bleeding time on average by approximately 50 to 100%, but individual variations can be observed.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of aspirin on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex-vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
5.2 Pharmacokinetic properties
Absorption: After oral administration, acetylsalicylic acid is rapidly absorbed from the gastrointestinal tract. However, a significant portion of the dosage is already hydrolysed to salicylic acid in the intestinal wall during the absorption process.
Distribution: Acetylsalicylic acid as well as the main metabolite salicylic acid, are extensively bound to plasma proteins, primarily albumin, and distributed rapidly into all parts of the body. Maximum plasma concentration is reached after 0.3 – 2 hours (total salicylate). The volume of distribution of acetylsalicylic acid is ca. 0.16 l/kg of body weight.
Biotransformation: Acetylsalicylic acid is rapidly metabolised to salicylic acid, with a half-life of 15-30 minutes. Salicylic acid is subsequently predominantly converted into glycine and glucuronic acid conjugates. Elimination kinetics of salicylic acid is dose-dependent, because the metabolism is limited by liver enzyme capacity. Thus, elimination half-time varies and is 2-3 hours after low doses (75 mg – 160 mg).
Excretion: Salicylic acid and its metabolites are predominantly excreted via the kidneys.
5.3 Preclinical safety data
The nonclinical safety profile of acetylsalicylic acid is well documented.
In experimental animal studies, salicylates have shown no other organ injury than renal damage. In rat studies, fetotoxicity and teratogenic effects were observed with acetylsalicylic acid at maternotoxic doses. Clinical relevance is unknown as the doses used in non-clinical studies are much higher (7 times at least) than the maximal recommended doses in targeted cardiovascular indications. Acetylsalicylic acid was extensively investigated with regard to mutagenic and carcinogenic effects. The results as a whole show no relevant signs for any mutagenic or carcinogenic effects in mice and rat studies.
6. Pharmaceutical particulars
6.1 List of excipients
Microcrystalline cellulose
Lactose monohydrate
Corn starch
Colloidal anhydrous silica
Stearic acid
Enteric coating constituents:
Methacrylic acid — ethyl acrylate copolymer (1:1) dispersion 30%
Talc
Triethyl citrate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Blister made of PVDC opaque (child resistant aluminium blister foil)
28, 56, 84 or 100 tablets per pack
Not all pack sizes may be marketed
6.6 Special precautions for disposal and other handling
No special requirements
7. Marketing authorisation holder
Dexcel®-Pharma Ltd.
7 Sopwith Way
Drayton Fields, Daventry,
Northamptonshire NN11 8PB
UK
8. Marketing authorisation number(s)
PL 14017/0022
9. Date of first authorisation/renewal of the authorisation
16/05/2005
10. Date of revision of the text
17/08/2021
Медикамент запрещен для реализации в аптеках.
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Patient Information leaflet
PATIENT INFORMATION LEAFLET
NU-SEALS
75
aspirin (acetylsalicylic acid)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet please tell your doctor or pharmacist.
THE INFORMATION IN THIS LEAFLET HAS BEEN DIVIDED INTO THE FOLLOWING
SECTIONS:
1.
WHAT NU-SEALS 75 IS AND WHAT IT IS TAKEN FOR
2. CHECK BEFORE YOU TAKE NU-SEALS 75
3. HOW TO TAKE NU-SEALS 75
4. POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NU-SEALS 75
6.
FURTHER INFORMATION
1. WHAT NU-SEALS 75 IS AND WHAT IT IS TAKEN FOR
Nu-Seals 75 contains aspirin. Aspirin is used:
•
to prevent recurrence of heart attacks or strokes by thinning the
blood. If
someone who has previously had a heart attack or stroke takes Nu-Seals
75 regularly, it reduces the risk of a blood clot occurring in the
heart or
brain. This can prevent further heart attacks or strokes.
IF YOU TAKE ASPIRIN IN HIGH DOSES OR OVER A LONG PERIOD OF TIME, IT
CAN
IRRITATE YOUR STOMACH LINING. TO PREVENT STOMACH IRRITATION, THESE
TABLETS
HAVE A SPECIAL COATING (CALLED ENTERIC) SO THAT THE ASPIRIN IS NOT
RELEASED
UNTIL IT HAS PASSED THROUGH THE STOMACH.
Aspirin is released slowly from these tablets, so Nu-Seals 75 is not
suitable
for the short-term relief of pain, such as headaches or toothache.
2. CHECK BEFORE YOU TAKE NU-SEALS 75
DO NOT TAKE NU-SEALS 75:
•
if you are allergic to aspirin or if you are allergic to any of the
ingredients in
Nu-Seals 75 (see Section 6 Further information)
•
if you have ever had the problem of your blood not clotting properly
•
if you have ever had an ulcer in your stomach or small intestine.
TAKE SPECIAL CARE WITH NU-SEALS 75
Before you take Nu-Seals 75 tell your doctor if you:
•
think yo
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 75mg Gastro-Resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains aspirin 75 mg.
Also includes 17mg/tablet lactose.
For the full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablet.
White, film coated, round tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the secondary prevention of thrombotic cerebrovascular or
cardiovascular
disease and following by-pass surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_For the management of cardiovascular or cerebrovascular disease_:
Patients should seek the advice of a doctor before commencing therapy
for the
first time.
The
usual
dosage,
for
long-term
use,
is
75-150mg
once
daily.
In
some
circumstances a higher dose may be appropriate, especially in the
short term,
and up to 300mg a day may be used on the advice of a doctor. In
general,
acetylsalicylic acids should be used with caution in elderly patients
who are
more prone to adverse events. The usual adult dose is recommended in
the
absence of severe renal or hepatic insufficiency (see sections 4.3 and
4.4).
Treatment should be reviewed at regular intervals._ _
_Antithrombotic action: _
150mg at diagnosis and 75mg daily thereafter. Tablets taken at
diagnosis
should be chewed in order to gain rapid absorption.
_Children:_
Do not give to children aged under 16 years, unless specifically
indicated (e.g. for
Kawasaki's disease). See section 4.4.
Method of administration
Aspirin 75 mg is for oral administration to adults only.
Take the tablet with water, do not cut, chew or crush the tablet.
Swallow whole.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to salicylic acid compounds or prostaglandin
synthetase
inhibitors (e.g. certain asthma patients who may suffer an attack or
faint and
certain patients who may suffer from bronchospasm, rhinitis and
urticaria), or
to any of the excipients (see section 6.1).
•
Active, or history of peptic ulceration and/or gastric/intestinal
haemorrha
Read the complete document
Q: What is the difference between Aspirin and Disprin?
A: Aspirin is an anti-inflammatory medicine. At high doses, it is used as a pain killer and at low doses, it is an antiplatelet medicine that can be used to treat and prevent heart attacks, strokes and heart-related chest pain (angina). Disprin contains Aspirin as its active ingredient. It is available in various strengths and is widely used as a pain killer.
Q: Can Aspirin be taken for headaches, toothache and muscle aches?
A: Aspirin is an anti-inflammatory medicine. At high doses, it is used as a pain killer and at low doses, it is an antiplatelet medicine that can be used to treat and prevent heart attacks, strokes and heart-related chest pain (angina). The higher dose of aspirin can be used for headaches, toothache and muscle aches under medical supervision.
Q: Can I take an Aspirin tablet for pain?
A: No, the Aspirin tablet is not a pain killer. It is only for the prevention of heart disease or stroke. At high doses, Aspirin works as a pain killer.
Q: What is an Aspirin tablet?
A: Aspirin tablet is an antiplatelet medicine that contains acetylsalicylic acid (also known as aspirin) which is used to prevent blood clot formation within the body. This tablet is also used to prevent heart attacks, stroke and heart-related chest pain (angina).
Q: What are the precautions I need to follow while taking the Aspirin tablet?
A: Before you undergo any surgeries or during medical emergencies, tell your doctor that you are on treatment with the Aspirin tablet, as an excess of Aspirin can cause bleeding disorders.
Q: Does Aspirin tablet cause acidity?
A: You may sometimes experience acidity or heartburn while taking an Aspirin tablet.
Q: Is Aspirin tablet a blood thinner?
A: Yes, the Aspirin tablet is a blood thinner medicine.
Q: When should I take Aspirin gastro resistant 75mg tablet?
A: Aspirin tablet is meant for oral use. The tablets should be swallowed with sufficient fluid (1/2 glass of water). To avoid stomach discomfort, this tablet should be taken after a meal. The frequency and schedule of taking this tablet will be decided by your treating doctor.
Q: Can I take Aspirin gastro resistant 75mg for stomach ache?
A: No, Aspirin gastro resistant 75mg tablet is a low-dose aspirin. It acts as a blood thinner medicine and helps prevent heart attacks and strokes. It does not help relieve stomach aches.
Q: Can I use Aspirin gastro resistant for pimples?
A: No, it is a blood thinner and is not effective in controlling pimples or acne. Acne is caused due to clogging of pores in the skin which is followed by infection and inflammation of clogged pores. Seek medical advice for the treatment of acne and do not self-medicate.
Q: Can I take Aspirin with ibuprofen?
A: No, do not take Aspirin with ibuprofen at a time without talking to a doctor. Both medicines belong to the same group of medicines called non-steroidal anti-inflammatory drugs. Speak to your doctor if you have any doubts.
Q: Can Aspirin cause stomach bleeding?
A: Prolonged use or regular use can cause stomach upset or bleeding in the stomach and intestine, as a side effect. So it is strictly advised to take it in the prescribed dose and duration.
Q: Is Aspirin safe for lactating mothers?
A: Aspirin tablet passes into the breast milk in small quantities. Long-term use or high doses when breastfeeding a baby is not recommended. However, it is recommended to monitor your baby for bruising and bleeding while on this medicine. Consult your doctor for more information.
Q: What is the dose of Aspirin tablet?
A: The doctor will decide the specific dose for a specific duration depending upon the severity of the condition. Do not stop or modify the dose on your own without consulting a doctor.
Q: Can I stop taking Aspirin on my own?
A: No, do not stop the treatment without consulting a doctor. Otherwise, it may lead to treatment failure and worsen the condition. You must take Aspirin in prescribed dose and duration.
Аспирин® (Aspirin®) инструкция по применению
📜 Инструкция по применению Аспирин®
💊 Состав препарата Аспирин®
✅ Применение препарата Аспирин®
📅 Условия хранения Аспирин®
⏳ Срок годности Аспирин®
Описание лекарственного препарата
Аспирин®
(Aspirin®)
Основано на официально утвержденной инструкции по применению препарата и подготовлено для электронного издания справочника Видаль 2014 года, дата обновления: 2023.04.06
Владелец регистрационного удостоверения:
Контакты для обращений:
БАЙЕР АГ
(Германия)
Код ATX:
N02BA01
(Ацетилсалициловая кислота)
Лекарственная форма
| Аспирин® |
Таб. 500 мг: 10, 20 или 100 шт. рег. №: П N013664/01 |
Форма выпуска, упаковка и состав
препарата Аспирин®
Таблетки белого цвета, круглые, слегка двояковыпуклые, скошенные к краю, с оттиском в виде фирменного знака («байеровский» крест) с одной стороны и «ASPIRIN 0.5» — с другой.
Вспомогательные вещества: целлюлоза микрокристаллическая, крахмал кукурузный.
10 шт. — блистеры (1) — пачки картонные.
10 шт. — блистеры (2) — пачки картонные.
10 шт. — блистеры (10) — пачки картонные.
Фармако-терапевтическая группа:
НПВП
Фармакологическое действие
Ацетилсалициловая кислота (АСК) принадлежит к группе нестероидных противовоспалительных препаратов (НПВП) и обладает обезболивающим, жаропонижающим и противовоспалительным действием, что обусловлено ингибированием энзимов циклооксигеназ, участвующих в синтезе простогландинов.
АСК в диапазоне доз от 0.3 до 1.0 г применяется для снижения температуры при таких заболеваниях, как простуда и грипп, и для облегчения суставных и мышечных болей. АСК ингибирует агрегацию тромбоцитов, блокируя синтез тромбоксана А2 в тромбоцитах.
Показания препарата
Аспирин®
- для симптоматического облегчения головной боли, зубной боли, боли в горле, боли при менструациях, боли в мышцах и суставах, боли в спине;
- повышенная температура тела при простудных и других инфекционно-воспалительных заболеваниях (у взрослых и детей старше 15 лет).
Режим дозирования
Препарат предназначен для взрослых и детей старше 15 лет:
При болевом синдроме слабой и средней интенсивности и лихорадочных состояниях разовая доза составляет 0.5- 1 г , максимальная разовая доза — 1 г. Интервалы между приемами препарата должны быть не менее 4 ч. Максимальная суточная доза не должна превышать 3 г (6 таб.).
Принимать внутрь, после еды, запивая большим количеством жидкости.
Длительность лечения (без консультации с врачом) не должна превышать 7 дней при назначении в качестве обезболивающего средства и более 3 дней — в качестве жаропонижающего средства.
Побочное действие
Со стороны ЖКТ: боли в животе, тошнота, рвота, изжога, явные (рвота с кровью, дегтеобразный стул) или скрытые признаки желудочно-кишечного кровотечения, которые могут приводить к железодефицитной анемии, эрозивно-язвенным поражениям (в том числе и с перфорацией) желудочно-кишечного тракта, повышение активности печеночных ферментов.
Со стороны ЦНС: головокружение и шум в ушах (обычно являются признаками передозировки).
Со стороны системы кроветворения: повышенный риск кровотечения.
Аллергические реакции: крапивница, анафилактические реакции, бронхоспазм, отек Квинке.
Противопоказания к применению
- эрозивно-язвенные поражения ЖКТ (в фазе обострения);
- геморрагический диатез;
- бронхиальная астма, индуцированная приемом салицилатов и других НПВП;
- сочетанное применение с метотрексатом в дозе 15 мг в неделю и более;
- I и III триместры беременности и период грудного вскармливания;
- повышенная чувствительность к АСК, другим НПВП или любым вспомогательным веществам препарата.
Препарат не назначают детям до 15 лет с острыми респираторными заболеваниями, вызванными вирусными инфекциями, из-за риска развития синдрома Рейе (энцефалопатия и острая жировая дистрофия печени с острым развитием печеночной недостаточности).
С осторожностью — при сопутствующем лечении антикоагулянтами, подагре, гиперурикемии, язвенной болезни желудка и/или двенадцатиперстной кишки (в анамнезе), включая хроническое или рецидивирующее течение язвенной болезни, а также желудочно-кишечные кровотечения; бронхиальной астме, полипозе носа, хронических бронхолегочных заболеваниях; при нарушении функции почек и/или печени; во II триместре беременности.
Применение при беременности и кормлении грудью
При необходимости применения препарата в период лактации грудное вскармливание следует прекратить.
Противопоказан к применению во I и III триместры беременности, во II триместре требуется осторожность.
Применение при нарушениях функции печени
С осторожностью — при нарушении функции печени.
Применение при нарушениях функции почек
С осторожностью при нарушении функции почек.
Применение у детей
Препарат не назначают детям до 15 лет с острыми респираторными заболеваниями, вызванными вирусными инфекциями, из-за риска развития синдрома Рейе (энцефалопатия и острая жирован дистрофия печени с острым развитием печеночной недостаточности).
Особые указания
Детям до 15 лет нельзя назначать препарат, содержащий ацетилсалициловую кислоту, поскольку в случае вирусной инфекции повышается риск возникновения синдрома Рейе.
Ацетилсалициловая кислота может вызвать бронхоспазм, приступ бронхиальной астмы или другие реакции повышенной чувствительности. Факторами риска являются наличие бронхиальной астмы в анамнезе, лихорадки, полипов носа, хронических бронхолегочных заболеваний, случаев аллергии в анамнезе (аллергические риниты, высыпания на коже).
Ацетилсалициловая кислота может повышать склонность к кровоточивости, что связано с ее ингибирующим влиянием на агрегацию тромбоцитов. Это следует учитывать при необходимости хирургического вмешательства, включая небольшие вмешательства, как удаление зуба. Перед хирургическим вмешательством, для уменьшения кровоточивости в ходе операции и в послеоперационном периоде, следует отменить приме препарата за 5-7 дней и поставить в известность врача.
Ацетилсалициловая кислота уменьшает выведение мочевой кислоты из организма, что может стать причиной острого приступа подагры у предрасположенных пациентов.
Передозировка
Симптомы
Для передозировки средней тяжести характерны тошнота, рвота, шум в ушах, нарушение слуха, головная боль, головокружение и спутанность сознания. Эти симптомы проходят при снижении дозы препарата.
Для передозировки тяжелой степени тяжести характерны лихорадка, гипервентиляция, кетоз, респираторный алкалоз, метаболический ацидоз, кома, кардиогенный шок, дыхательная недостаточность, выраженная гипогликемия.
Лечение: госпитализация, лаваж, прием активированного угля, контроль кислотно-щелочного баланса, щелочной диурез для получения значений рН мочи в пределах 7.5-8.0 (форсированный щелочной диурез считается достигнутым, когда концентрация салицилата в крови составляет более 500 мг/л (3.6 ммоль/л) у взрослых и 300 мг/л (2.2 ммоль/л) у детей, гемодиализ, возмещение потери жидкости, симптоматическая терапия.
Лекарственное взаимодействие
Ацетилсалициловая кислота усиливает токсичность метотрексата, эффекты наркотических анальгетиков, других НПВП, гипогликемических средств для приема внутрь, гепарина, непрямых антикоагулянтов, тромболитиков — ингибиторов агрегации тромбоцитов, сульфаниламидов (в т.ч. ко-тримоксазола), трийодтиронина; снижает — урикозурических препаратов (бензбромарон, пробенецид). гипотензивных средств и диуретиков (спиронолактон, фуросемид).
Глюкокортикостероиды, алкоголь и этанолсодержащие препараты увеличивают повреждающее действие на слизистую оболочку ЖКТ, повышают риск развития желудочно-кишечных кровотечений.
Ацетилсалициловая кислота повышает концентрацию дигоксина, барбитуратов и препаратов лития в плазме крови.
Антациды, содержащие магния и/или алюминия гидроксид, замедляют и ухудшают всасывание ацетилсалициловой кислоты.
Условия хранения препарата Аспирин®
Хранить при температуре не выше 30°С, в недоступном для детей месте.
Срок годности препарата Аспирин®
Условия реализации
Без рецепта.
Контакты для обращений
БАЙЕР АГ
(Германия)
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Организация, принимающая |
Если вы хотите разместить ссылку на описание этого препарата — используйте данный код
Аналоги препарата
Аспинат®
(ВАЛЕНТА ФАРМАЦЕВТИКА, Россия)
Аспирин® Экспресс
(BAYER CONSUMER CARE, Швейцария)
Ацетилсалициловая ки…
(ОБНОВЛЕНИЕ ПФК, Россия)
Ацетилсалициловая ки…
(ФАРМСТАНДАРТ-ЛЕКСРЕДСТВА, Россия)
Ацетилсалициловая ки…
(ИРБИТСКИЙ ХФЗ, Россия)
Ацетилсалициловая ки…
(ТАТХИМФАРМПРЕПАРАТЫ, Россия)
Ацетилсалициловая ки…
(ДАЛЬХИМФАРМ, Россия)
Ацетилсалициловая ки…
(ФАРМСТАНДАРТ-ТОМСКХИМФАРМ, Россия)
Ацетилсалициловая ки…
(ПФКО-1, Россия)
Ацетилсалициловая ки…
(АТОЛЛ, Россия)
Все аналоги
Document: leaflet ALMUS PHARMACEUTICALS_PL 14017-0022 change
® n®
AUVIIJS* .
Almus Pharmaceuticals
Font Size 9pt
155mmx240mm
Aspirin 75mg Gastro-Resistant Tablets
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without prescription. Nevertheless you still need to use Aspirin 75mg Gastro-Resistant Tablets carefully to get the best results from it.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Aspirin is and what it is used for
2. What you need to know before you take Aspirin
3. How to take Aspirin
4. Possible side effects
5. How to store Aspirin
6. Contents of the pack and other information
1. WHAT Aspirin IS AND WHAT IT IS USED FOR
The name of your medicine is Aspirin 75mg Gastro-Resistant Tablets.
Aspirin is a non-steroidal anti-inflammatory drug (NSAID). It has anti-platelet activity which means that it can stop the blood from clotting and blocking blood flow to important areas like the heart or the brain. This product can help prevent further heart attack and strokes in patients who have a history of these conditions and helps prevent unstable angina (a type of chest pain). This product has been specially coated so that aspirin release is delayed. However because the aspirin release is delayed these tablets are not useful for relieving pain.
2. BEFORE YOU TAKE Aspirin
Do not take Aspirin if:
• You have ever had an allergic reaction (rash, itching, wheezing) to aspirin (or another salicylate) or any of the other ingredients listed above
• You have any bleeding disorders which prevent your blood clotting properly (e.g. haemophilia)
• You have a stomach or duodenal ulcer
• You are under 16 years
Do not take antacids (indigestion remedies) at the same time as this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirin if:
• You have a history of stomach problems
• You have a history of blood clotting problems
• You have asthma, allergic disease, liver or kidney problems or dehydration
• You have taken mifepristone (to terminate pregnancy) in the last 8-12 days
If you need to have any blood or urine tests, or dental surgery tell your doctor or dentist that you are taking this product.
There is possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.
Pregnancy:
If you are pregnant or likely to become pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding:
If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients of Aspirin:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking other medicines:
The effect of treatment may be influenced if aspirin is taken at the same time as some other medicines for:
• Thinning of the blood/prevention of clots (e.g. warfarin)
• Organ rejection after transplantation (e.g. ciclosporin, tacrolimus)
• High blood pressure (e.g. atenolol, diuretics and ACE-inhibitors)
• Pain and inflammation (e.g. anti-inflammatory medicines such as ibuprofen, or steroids)
• Cancer or rheumatoid arthritis (e.g. methotrexate)
• Oral medicines for diabetes (e.g. glibenclamide)
• Epilepsy (e.g Phenytoin, sodium valproate)
• Gout (e.g Probenacid)
• Corticosteroids (e.g. prednisolone, hydrocortisone)
• Sulphonamide antibiotics (e.g. trimethoprim).
Font Size 9pt
Before using aspirin you should inform a healthcare professional about the medicines you are taking or have recently taken, even those not prescribed. If you are using aspirin regularly you should seek advice before taking any other medicine (including other medicines you may have bought).
3. HOW TO TAKE Aspirin
This medicine should be swallowed whole with a drink of water, do not crush or chew the tablets.
Adults and children over 16 years: The usual dose for long term use is one to two tablets daily. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor.
Do not take more than the recommended dose.
• Patients should consult their doctor before starting long term aspirin treatment in order to prevent a further heart attack or stroke.
If you take more Aspirin than you should:
It is important to keep to the dose on the label or follow the instructions above. Taking more than this could make you ill. If an overdose is taken, DO NOT DELAY, ask your doctor what to do or contact your nearest accident and emergency department.
If you forget to take Aspirin:
If you miss a dose, wait and take your next dose at the usual time. Do not take a double dose to make up for forgotten individual doses.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of these serious side effects, stop taking the tablets. See a doctor at once:
• Difficulty in breathing, asthma, and wheezing
• Hypersensitivity reactions such as swelling of the face, neck, tongue or throat
Rarely, after prolonged use you may get blood disorders (such as hypoprothrombinaemia or thrombocytopenia) or severe stomach pain. If you notice any unusual bruising, bleeding or disturbance in blood clotting, or vomit blood talk to your doctor at once.
These other effects are less serious. If they bother you talk to your doctor or pharmacist.
• Stomach pain and indigestion
• Nausea or vomiting
• Skin rash or itching
• Ringing in the ears
• Difficulty in passing urine — this may be a sign of kidney stones
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO STORE Aspirin
Keep out of the reach and sight of children.
Do not store above 25oC.
Do not use this medicine after the expiry date printed on the label.
Do not throw away any medicines via wastewater or household water. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
REMEMBER: this medicine is for you. Do not give it to anyone else it may harm them even if their symptoms appear to be the same.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Aspirin 75mg Gastro-Resistant Tablets contain The active substance is: aspirin 75 mg.
The other ingredients are: lactose, microcrystalline cellulose, maize starch, stearic acid, colloidal anhydrous silica, talc, triethyl citrate and methacrylic acid — ethyl acrylate copolymer (1:1) dispersion 30%.
What Aspirin 75mg Gastro-Resistant Tablets look like and contents of the pack
This medicine can be identified as white, film-coated, round tablets.
It is packed in cartons containing 28, 56, 84 or 100 tablets in foil blister strips.
The manufacturer/holder of the marketing authorization is:
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire NN11 8PB UK This leaflet was last revised in: June 2014
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