Acyl 5 krem инструкция на русском

Страница осмотрена фармацевтом Олейник Елизаветой Ивановной Последнее обновление 2022-03-31

ACYL TABLET 200 MG
It is taken orally.

• Active substance: Each tablet contains 200 mg acyclovir.
• Excipients: Avicel PH 101, Sodium Starch Glycolate, P.V.P, Talc, Magnesium
  stearate

Carefully follow this USE INSTRUCTIONS before you start using this medicine.
read it because it contains important information for you.

• Keep these instructions for use. You can need to read again.
• If you have other questions, please talk your doctor or pharmacist.
• This medicine has been prescribed for you personally, do not pass it on to others.
• During the use of this medicine, when you go to the doctor or hospital,
• Tell your doctor.
• Follow exactly what is written in this instruction. Other than the recommended dose for the drug, high or
• Do not use low doses

In this Instructions for Use:
1. What is ACYL and what is it used for?
2. Things to consider before using ACYL
3. How to use ACYL?
4. What are the possible side effects?
5. Storage of ACYL

Headings are included.

1. What is ACYL and what is it used for?
ACYL is an antiviral drug effective against Herpes simplex virus (HSV) type 1 and 2 viruses.
ACYL contains acyclovir as an active ingredient and is available in blisters of 25 tablets.

ACYL, skin infections (herpes), chickenpox, shingles (a painful nerve inflammation due to
skin disease), AIDS and severe immune system deficiency following bone marrow transplant
used in the treatment of patients.

2. Things to consider before using ACYL

DO NOT USE ACYL in the following cases

If;

If an allergic reaction develops (rash, regional pain or swelling) while using ACYL
Stop using the medicine and tell your doctor.
If you are allergic to acyclovir or valaciclovir (a type of antiviral medicine), do not use this medicine.
do not use.

USE ACYL CAREFULLY in the following situations

If;

• If you have kidney failure, the dose of ACYL you take should be reduced.
• If you are elderly (over the age of 65) because your kidney function is likely to decrease,
• If you are in this patient group, you may need a dose reduction.
• If you are using high doses, take care to get enough water.
• If you have active lesions (blisters or blisters) about not transmitting the virus
  take necessary precautions.

If these warnings are valid for you, even at any time in the past, please
Consult your doctor.

Using ACYL with food and drink

There is no data.

Pregnancy
Consult your doctor or pharmacist before using this medication.
If you are pregnant or think you may be pregnant, tell your doctor. ACYL
It should only be used during pregnancy if the benefits are more than the risks.
If you notice that you are pregnant during your treatment, contact your doctor or pharmacist immediately.
Please consult.

Breast-feeding
Consult your doctor or pharmacist before using this medication
If you are going to use ACYL during breastfeeding, you should be careful.

Vehicle and machine use
Studies have not been done to affect your ability to drive or use machines.

Important information about some of the excipients contained in ACYL
ACYL contains less than 1 mmol (23 mg) sodium at a 200 mg tablet dose; so
essentially «free of sodium».

Use with other drugs
It has no significant interaction.

Probenecid (used to treat gout) and cimetidine (to treat ulcers)
a drug used) increases the effect of ACYL. Similarly, ACYL, organ transplant and
with high dose mycophenolate mofetil used in immunocompromised patients
Its effect increases when used together. However, dose adjustment is not required.
If you are currently using any prescription or over-the-counter medication or have recently
If you have used it, please inform your doctor or pharmacist about this issue.

3. How to use ACYL?
Instructions for appropriate use and dose / frequency of administration:
Follow your doctor’s advice on how to use ACYL.

In adults;
Treatment of herpes; 200 mg 5 times a day at 4-hour intervals, skipping the night dose,
must be taken.
Treatment should continue for 5 days, but in severe onset infections,
may need to be extended. In patients with severe immunodeficiency (eg bone marrow transplant)
in patients with intestinal malabsorption, the dose should be doubled to 400 mg.
suppression of the flight; Herpes infection in patients with normal immune system
For suppression, 200 mg ACYL should be taken 4 times a day at approximately 6-hour intervals.
In many patients, doses of 400 mg taken twice a day, approximately every 12 hours, were sufficient.
By reducing the dose, taking 200 mg ACYL 3 times a day at 8-hour intervals, even twice a day.
It may also be sufficient to take it at 12-hour intervals.

Protection from cold sores; 200 mg ACYL should be administered 4 times a day approximately every 6 hours. Heavy
in immunocompromised cases (eg after bone marrow transplant) or absorption from the intestine
In patients with the disorder, the dose can be doubled to 400 mg (one tablet).
Chickenpox and shingles; 800 mg ACYL 5 times a day, approximately 4 hours apart, omitting the night dose
must be taken. The treatment should last 7 days.
In patients with severe immune deficiency; 800mg ACYL 4 times a day, approximately 6
It should be taken at hourly intervals.

Application way and method:
It is taken orally.

Additional information on special populations:
Use in children:

For the treatment of herpes and for the protection of herpes in those with insufficient immunity; Over 2 years old
adult dose for children, half the adult dose for children under 2 years of age
must be applied.

Treatment of chickenpox infections; Children over 6 years old 800 mg 4 times a day (two
tablets) and in children between the ages of 2-6, 400 mg ACYL should be given 4 times a day. 2 years
In children under 200 mg ACYL 4 times a day may be given. The dose to be given is 20 mg / kg at this age.
(total dose not exceeding 800 mg per day) can also be calculated. Duration of treatment 5 days
should be applied with.

Herpes or shingles infections of children who do not have immunodeficiency
There is no specific data for suppression. Over 2 years of age
Limited data are available in children with insufficiency and adult dosage may be given.

Use in the elderly:
If you are going to use high doses of ACYL, be sure to get enough water. Kidney
Special attention should be paid to reducing the dose if you have a disorder.

Special use cases:
In severe kidney failure; In the treatment and prevention of herpes, the dose should be reduced to approximately twice a day.
It is recommended to be adjusted to 200 mg every 12 hours. Chickenpox and shingles infections
and in the treatment of patients with severe immunodeficiency, the dose is taken twice a day, 12
800mg every hour, and 800mg 3 times a day, every 8 hours in patients with poor renal function
recommended to be set to. If the effect of ACYL is too strong or too weak
If you have an impression, talk to your doctor or pharmacist.

If you have used more ACYL than you should:
Digestive system disorders if you have accidentally taken repeated high doses of ACYL for days
(nausea-vomiting) and neurological symptoms (headache, confusion) can be seen. Hemodialysis
It significantly increases the release of ACYL from the blood.
If you have used more than you should use ACYL, contact a doctor or pharmacist.
talk.

If you forget to use ACYL
Do not take a double dose to make up for forgotten doses.

Effects that may occur when treatment with ACYL is terminated
Do not stop using your medication without consulting your doctor.

4. What are the possible side effects?
Like all medicines, side effects in people who are sensitive to the substances contained in ACYL
may be.

If any of the following occur, stop using ACYL and IMMEDIATELY
Inform your doctor or contact the emergency department of your nearest hospital:

Hypersensitivity reactions

• Allergic reactions such as rash, itchy skin or hives
• Swelling of the face, lips, tongue, or other parts of the body
• Difficulty breathing, shortness of breath, wheezing
• Unexplained fever
• Hypersensitivity reactions are very rare.

Side effects are listed as shown in the following categories:
Very common: It can be seen in at least one of 10 patients.
Common: less than one in 10 patients, but more than one in 100 patients.
Uncommon: less than one in 100 patients, but more than one in 1,000 patients.
Rare: less than one in 1,000 patients can be seen.
Very rare: less than one in 10,000 patients.
Unknown: It cannot be estimated from the available data.

Common side effects

• Headache, dizziness
• Nausea, vomiting, diarrhea, abdominal pain
• Itching, rash
• Tiredness, fever

Uncommon side effects

• Hives
• Acceleration in hair loss
• Rare side effects
• Reversible increases in bilirubin and liver related enzymes, blood urea and
  increased creatinine (a substance used to monitor kidney function)

Very rare side effects

• Anemia, decrease in the number of white blood cells, decrease in the number of platelets-blood platelets
• Hallucinations, psychotic syndromes, restlessness, confusion
• Tremors, gait disturbance due to difficulty in movement control, with speech or language
  related disorder, seizures, drowsiness, encephalopathy (a type of brain inflammation)
• Hepatitis, jaundice
• Acute kidney failure, kidney pain and coma

Reporting of side effects
In case of any side effects that are included in the instructions for use or not,
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the «Drug Side Effects Notification» icon on www.titck.gov.tr ​​or by clicking on 0 800 314
00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center (TÜFAM) What
report. The safety of the drug you are using by reporting the side effects that occur
You will contribute to obtaining more information about.

5. Storage of ACYL
Keep ACYL in places where children can not see or reach and in its package.
Store at room temperature below 30 ° C, protected from moisture and light.

Use in accordance with expiration dates.

Do not use ACYL after the expiry date on the package.

тонкая брошюра

                                                                             
                                             
                        1 / 4 
 
 
 
KULLANMA TALİMATI 
 
ACYL
®
 %5 KREM   
HARICEN KULLANILIR.  
 

  _ETKIN MADDE: _Her 1 g krem %5 a/a 50 mg asiklovir
içerir.  

 
_YARDIMCI  MADDELER:  _Tween  60,  setostearil  alkol,  sodyum  lauril  sülfat,  vazelin  flant, 
vazelin likid, propilen glikol, deiyonize su  
 
BU  ILACI  KULLANMAYA  BAŞLAMADAN  ÖNCE  BU  KULLANMA  TALİMATINI  DIKKATLICE 
OKUYUNUZ, ÇÜNKÜ SIZIN IÇIN ÖNEMLI BILGILER IÇERMEKTEDIR. 

 
_Bu kullanma talimatını saklayınız. Daha sonra tekrar okumaya
ihtiyaç duyabilirsiniz. _

  _E_ğ_er ilave sorularınız olursa, lütfen doktorunuza
veya eczacınıza danı_ş_ınız. _

 
_Bu ilaç ki_ş_isel olarak size için reçete edilmi_ş_tir,
ba_ş_kalarına vermeyiniz. _

 
_Bu  ilacın  kullanımı  sırasında,  doktora  veya  hastaneye  gitti_ğ_inizde  doktorunuza  bu _
_ilacı kullandı_ğ_ınızı söyleyiniz. _

 
_Bu  talimatta  yazılanlara  aynen  uyunuz.  İlaç  hakkında  size  önerilen  dozun  dı_ş_ında _
_YÜKSEK VEYA DÜ_Ş_ÜK doz kullanmayınız. _
 
BU KULLANMA TALIMATINDA:  
_1. ACYL NEDIR VE NE IÇIN KULLANILIR? _ 
_2. ACYL’I KULLANMADAN ÖNCE DIKKAT EDILMESI GEREKENLER _ 
_3. ACYL NASIL KULLANILIR? _ 
_4. OLASI YAN ETKILER NELERDIR? _ 
_5. ACYL’IN SAKLANMASI _ 
BAŞLIKLARI YER ALMAKTADIR.  
 
1. ACYL NEDIR VE NE IÇIN KULLANILIR?  
ACYL,  _Herpes  simplex  _(HSV)  tip  I  ve  II  ile  _Varicella  zoster  adlı  _virüslere  karşı  etkili  antiviral 
       
bir ilaçtır.  
ACYL etken madde olarak asiklovir içerir ve 10 g’lık tüp
ambalajlar halindedir.  
ACYL, ilk ve tekrarlayan genital Herpes ve Herpes labiali
                                
                                Прочитать полный документ
                                
                            

Характеристики продукта

                                 
 
1 / 6 
 
 
 
 
 
KISA ÜRÜN BİLGİSİ 
 
1. BEŞERİ TIBBİ ÜRÜNÜN ADI  
ACYL
®
 %5 Krem  
 
2. KALİTATİF VE KANTİTATİF BİLEŞİM  
ETKIN MADDE:  
Her 1 g krem;  
50 mg (%5 a/a) asiklovir içerir.  
 
YARDIMCI MADDELER:  
Setostearil alkol…67.5 mg / 1 g 
Propilen glikol…...400 mg/ 1 g 
Diğer yardımcı maddeler için 6.1’e bakınız  
 
3. FARMASÖTİK FORM  
Krem  
Beyaz renkli, homojen krem 
 
4. KLİNİK ÖZELLİKLER  
 
4.1. TERAPÖTIK ENDIKASYONLAR  
ACYL,  ilk  ve  tekrarlayan  genital  Herpes  ve  Herpes  labialis  de  dahil  olmak  üzere  Herpes 
simplex deri enfeksiyonlarının tedavisinde endikedir.  
 
4.2. POZOLOJI VE UYGULAMA ŞEKLI  
POZOLOJI/UYGULAMA SIKLIĞI VE SÜRESI:  
ACYL,  günde  5  kez,  gece  dozu  atlanmak  suretiyle  yaklaşık  4  saatlik  aralıklarla 
uygulanmalıdır.  
ACYL  lezyonlara  veya  enfeksiyonun  başlamasından  sonra  belirmesi  beklenen  lezyonlara 
mümkün olduğu kadar erken, tercihen ilk belirtilerde uygulanmalıdır (eritem veya prodrom). 
Tedavi sonraki belirtilerde de (papül
veya blister) başlatılabilir.  
Tedavi  herpes  labialis  için  en  az  4  gün  ve  genital  herpes  için  de  en  az  5  gün  devam 
ettirilmelidir. Eğer iyileşme olmazsa, tedaviye toplam 10 gün
(5+5) kadar devam edilebilir.  
 
UYGULAMA ŞEKLI:  
Haricen kullanılır.  
 
ÖZEL POPÜLASYONLARA ILIŞKIN EK BILGILER:  
 
BÖBREK/KARACIĞER YETMEZLIĞI:  
Veri yoktur.  
 
 
 
 
 
2 / 6 
 
 
PEDIYATRIK POPÜLASYON:  
Veri yoktur.  
 
GERIYATRIK POPÜLASYON:  
Veri yoktur.  
 
4.3. KONTRENDIKASYONLAR  
Asiklovir,  valasiklovir,  propilen  glikol  veya  kremin  içeriğindeki  herhangi  bir  maddeye  aşırı 
duyarlılığı bilinen hastalarda kontrendikedir.  
 
4.4. ÖZEL KULLANIM UYARILARI VE
                                
                                Прочитать полный документ