Heviran Pph

Package Leaflet: Information for the User

Heviran PPH, 800 mg, Tablets

Aciclovir

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This package leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, inform a doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Heviran PPH and what is it 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. Package contents and other information

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

Heviran PPH is an antiviral medication.
It is used to treat infections caused by the herpes zoster and varicella viruses.

2. Important information before taking Heviran PPH

When Not to Take Heviran PPH

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

Warnings and Precautions

Before starting treatment with Heviran PPH, discuss it with a doctor.
Particular caution should be exercised when taking Heviran PPH:

• if the patient has kidney failure
• if the patient is taking other medications that may damage the kidneys
• if the patient has significantly reduced 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 reduce the risk of side effects.

Heviran PPH and Other Medications

Inform a doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take, especially:

• probenecid - a medication used for gout
• cimetidine - a medication mainly used for stomach and duodenal ulcers
• mycophenolate mofetil - a medication used after transplants
• theophylline - a medication used to treat asthma and other respiratory diseases.

Taking Heviran PPH with Food and Drink

The medication can be taken independently of meals.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
The medication may only be used during pregnancy if the expected benefit to the mother outweighs the risk to the fetus.
Acyclovir passes into breast milk. Due to the risk of side effects in the breastfed child, a decision should be made with a doctor to either not take the medication or stop breastfeeding during treatment.

Driving and Operating Machines

The medication may cause side effects that impair the ability to drive vehicles. Do not drive vehicles or operate machines unless the patient feels well.

Heviran PPH Contains Sodium

The medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to Take Heviran PPH

This medication should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist.
Doses may vary for different patients.
Treatment should be started immediately after diagnosis.
During treatment, it is recommended to drink plenty of fluids to avoid the risk of kidney damage and reduce the likelihood of side effects.
Tablets should be swallowed with water.

Treatment of Herpes Zoster and Varicella Infections

The medication should be taken in a dose of 800 mg four to five times a day (approximately every 4 hours),
with a nighttime break. The medication is usually taken for 5 to 7 days. In patients with significantly reduced immunity (e.g., after bone marrow transplantation) or with impaired absorption from the gastrointestinal tract, the doctor may consider intravenous administration of the medication.

Dosing in Patients with Renal Impairment

Caution should be exercised when taking Heviran PPH in patients with renal impairment.
During treatment, plenty of fluids should be consumed.
When treating herpes simplex or preventing it in patients with severe renal impairment (creatinine clearance less than 10 ml/min), the doctor may recommend reducing the dose to 1 tablet (200 mg) taken twice a day, approximately every 12 hours.
When treating herpes zoster in patients with moderate renal impairment (creatinine clearance 10-25 ml/min), the doctor may recommend reducing the dose to 800 mg taken three times a day, approximately every 8 hours, and in patients with severe renal impairment (creatinine clearance less than 10 ml/min) - reducing the dose to 800 mg taken twice a day, approximately every 12 hours.

Dosing in Elderly Patients

In elderly patients, the doctor will consider the possibility of renal impairment and adjust the dose accordingly (see: Dosing in patients with renal impairment). During treatment, plenty of fluids should be consumed.

Dosing in Children

Treatment of Herpes Zoster Infections

• Children aged 6 and over - 800 mg four times a day.
• Children aged 2 to 5 - 400 mg four times a day.
• Children under 2 - 200 mg four times a day. The doctor may also determine the dose more precisely, calculating 20 mg/kg body weight (up to a maximum dose of 800 mg) four times a day. Treatment should be continued for 5 days.

If a dose smaller than 800 mg is required, formulations with a lower active substance content are available.

Taking a Higher Than Recommended Dose of Heviran PPH

In case of overdose, immediatelyconsult a doctor, who will provide appropriate treatment.

Missing a Dose of Heviran PPH

If a dose is missed, it should be taken as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping Treatment with Heviran PPH

Do not stop taking the medication even if the patient feels well, unless advised to do so by a doctor.

In Case of Further Doubts About Taking This Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all medications, Heviran PPH can cause side effects, although not everybody gets them.
In case of the following rare (occurring in 1 to 10 out of 1000 treated patients)
symptoms, immediately contact a doctor:

• shortness of breath, angioedema (e.g., swelling of the face, tongue, and larynx, causing breathing difficulties)
• allergic reaction (often manifested as skin rashes, blisters, and ulcers of the mouth and (or) eyes, sometimes with high fever).

During Treatment, the Following Side Effects May Also Occur.

Common (occurring in 1 to 10 out of 100 treated patients):

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

Uncommon (occurring in 1 to 10 out of 1000 treated patients):

• hives
• excessive hair loss

Very Rare (occurring in less than 1 out of 10,000 treated patients):

• agitation, tremors
• coordination disorders (ataxia)
• speech disorders
• disorientation, hallucinations
• psychotic symptoms
• brain damage (encephalopathy)
• seizures, drowsiness, coma
• hepatitis and jaundice
• acute kidney failure, kidney pain. Kidney pain may be related to kidney failure. The patient should be given adequate fluids. Kidney function disorders usually quickly resolve after fluid supplementation in the patient and (or) after dose reduction or withdrawal of the medication. Cases of acute kidney failure have been reported.

Heviran PPH may cause changes in blood test results, and therefore, the doctor may recommend control blood tests. During treatment, the following may occur:

Rare

• increased creatinine and urea levels in the blood (substances that indicate kidney function).
• increased liver enzyme activity and bilirubin in serum (substances that indicate liver function).

Very Rare

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

Reporting Side Effects

If any side effects occur, including those not listed in this package leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Heviran PPH

Store the medication out of sight and reach of children.
Store in the original packaging.
Do not use the medication after the expiration date stated on the box and blister. The expiration date refers to the last day of the given month.
The inscription on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medications should not be disposed of in the sewage system or household waste containers. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Heviran PPH Contains

• The active substance of the medication is acyclovir. Each tablet contains 800 mg of acyclovir.
• Other ingredients are: microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A), magnesium stearate.

What Heviran PPH Looks Like and What the Package Contains

The tablets are white, oval, and biconvex.
The package contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the Last Update of the Package Leaflet: