Heviran pph

Package leaflet: Information for the user

Heviran PPH, 800 mg, tablets
Aciclovirum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Heviran PPH is and what it is used for
2. Important information before taking Heviran PPH
3. How to take Heviran PPH
4. Possible side effects
5. How to store Heviran PPH
6. Contents of the pack and other information

1. What Heviran PPH is and what it is used for

Heviran PPH is an antiviral medicine.
It is used in the treatment of infections caused by the varicella-zoster virus.

2. Important information before using Heviran PPH

When not to use Heviran PPH

• if the patient is allergic to acyclovir, valacyclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Heviran PPH, discuss this with your doctor.
Special caution is required when using Heviran PPH:

• if the patient has kidney impairment
• if the patient is taking other medicines that may damage the kidneys
• if the patient has significantly weakened immunity
• if the patient is dehydrated
• in elderly patients.

During treatment, the patient should drink plenty of fluids to avoid the risk of kidney damage and to reduce the risk of adverse effects.
Heviran PPH with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially:

• probenecid – a medicine used for gout
• cimetidine – a medicine mainly used for peptic ulcer disease
• mycophenolate mofetil – a medicine used after organ transplants
• theophylline – a medicine used in the treatment of asthma and other respiratory disorders.

Taking Heviran PPH with food and drink
This medicine can be taken independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the opinion of the doctor, the expected benefit to the mother outweighs the risk to the fetus.
Acyclovir passes into human breast milk. Due to the risk of adverse effects in the breastfed infant, a decision should be made in consultation with the doctor whether to discontinue the medicine or to stop breastfeeding during treatment.
Driving and operating machinery
This medicine may cause adverse effects that could impair the ability to drive. Do not drive or operate machinery unless the patient is certain that he or she feels well.
Heviran PPH contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is considered "sodium-free".

3. How to use Heviran PPH

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Dosage may vary for different patients.
Treatment should be started immediately after diagnosis of infection.
During treatment, it is recommended to drink plenty of fluids to avoid the risk of kidney damage and to reduce the likelihood of adverse effects.
Tablets should be swallowed with water.

Treatment of infections caused by varicella-zoster virus
The medicine should be taken at a dose of 800 mg four to five times daily (approximately every 4 hours), with a nighttime break. Treatment usually lasts 5 to 7 days. In patients with severely reduced immunity (e.g. after bone marrow transplantation) or gastrointestinal absorption disorders, the physician may consider intravenous administration of the drug.

Dosage in patients with renal impairment
Caution should be exercised when using Heviran PPH in patients with impaired kidney function.
Plenty of fluids should be consumed during treatment.
During treatment of herpes simplex virus infections or prophylaxis in patients with severe renal failure (creatinine clearance less than 10 ml/min), the physician may recommend reducing the dose to 1 tablet (200 mg) twice daily, approximately every 12 hours.
During treatment of varicella-zoster virus infections in patients with moderate renal failure (creatinine clearance 10–25 ml/min), the physician may recommend reducing the dose to 800 mg three times daily, approximately every 8 hours; in patients with severe renal failure (creatinine clearance less than 10 ml/min), the dose may be reduced to 800 mg twice daily, approximately every 12 hours.

Dosage in elderly patients
In elderly patients, the physician will consider the possibility of impaired kidney function and adjust the dosage accordingly (see: Dosage in patients with renal impairment). Plenty of fluids should be consumed during treatment.

Dosage in children
Treatment of varicella-zoster virus infections

• Children aged 6 years and older – 800 mg four times daily.
• Children aged 2 to 5 years – 400 mg four times daily.
• Children under 2 years – 200 mg four times daily. The physician may also determine the dose more precisely by calculating 20 mg/kg body weight (up to a maximum dose of 800 mg) four times daily. Treatment should continue for 5 days.

If a dose smaller than 800 mg is required, lower-strength formulations of the medicine are available.

Use of a higher than recommended dose of Heviran PPH
In case of overdose, seek medical advice immediately, so that appropriate treatment can be initiated.

Missed dose of Heviran PPH
If a dose is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose.

Stopping Heviran PPH treatment
Do not stop taking the medicine even if the patient feels well, unless otherwise advised by the physician.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following rare (occurring in 1 to 10 out of 1,000 treated patients) symptoms occur, contact a doctor immediately:

• shortness of breath, angioedema (e.g. swelling of the face, tongue and airway, causing breathing difficulties)
• allergic reaction (often manifesting as skin rash, skin blisters and mouth and/or eye ulcers, sometimes with high fever).

The following adverse reactions may also occur during treatment.
Common (occurring in 1 to 10 out of 100 treated patients):

• headache, dizziness
• nausea, vomiting, diarrhoea, abdominal pain
• itching, rash (including photosensitivity)
• fatigue, fever

Uncommon (occurring in 1 to 10 out of 1,000 treated patients):

• urticaria
• increased hair loss

Very rare (occurring in fewer than 1 out of 10,000 treated patients):

• agitation, tremor
• movement coordination disorders (ataxia)
• speech disorders
• disorientation, hallucinations
• psychotic symptoms
• brain damage (encephalopathy)
• seizures, somnolence, coma
• hepatitis and jaundice
• acute renal failure, kidney pain. Kidney pain may be associated with kidney (renal) failure. Patients should be given adequate fluid intake. Renal dysfunction usually resolves rapidly after fluid replacement and/or dose reduction or discontinuation of the medicine. Cases of acute renal failure have been reported.

Heviran PPH may cause changes in blood parameters, therefore the doctor may recommend regular blood tests. During treatment the following may occur:
Rare

• increased blood creatinine and urea levels (substances indicating kidney function).
• increased liver enzyme activity and serum bilirubin (substances indicating liver function).

Very rare

• decreased platelet count, which may affect blood clotting. If unexplained bruising or red or purple spots appear on the skin, inform a doctor.
• decreased white blood cell count or anaemia.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Heviran PPH

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Heviran PPH contains

• The active substance is acyclovir. Each tablet contains 800 mg of acyclovir.
• The other ingredients are: microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate.

What Heviran PPH looks like and contents of the pack
The tablets are white, elongated, and biconvex.
The pack contains 30 tablets.
Marketing authorisation holder and manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01