Heviran comfort

Package leaflet: Information for the patient

Heviran Comfort, 200 mg, tablets
Aciclovirum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or additional information is needed, please consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or if the patient feels worse, contact a doctor.

Table of contents of the leaflet

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

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

Heviran Comfort is an antiviral medicine.
The active substance in Heviran Comfort is aciclovir, which inhibits the replication of pathogenic
human viruses of the Herpes group.
Heviran Comfort is used in the treatment of:

• recurrent herpes labialis and facial herpes caused by herpes simplex virus (Herpes simplex) in adults;
• recurrent external genital herpes caused by herpes simplex virus (Herpes simplex) in adults.

Heviran Comfort may only be used in patients who have previously been diagnosed with herpes simplex virus infection.
If there is no improvement after 5 days or if the patient feels worse, consult a doctor.

2. Important information before using Heviran Comfort

When not to use Heviran Comfort

• 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 Comfort, consult your doctor or pharmacist.
Do not use Heviran Comfort without prior medical consultation:

• in patients with impaired kidney function
• in patients taking other medicines that may damage the kidneys
• in elderly patients (aged 65 years or older)
• in pregnant or breastfeeding women
• in immunocompromised individuals (e.g. after bone marrow transplantation, HIV-infected). Immunocompromised patients should consult a doctor regarding treatment of any infection.
• in patients who have experienced particularly severe recurrent herpes labialis
• in patients who have experienced particularly severe recurrent genital herpes
• if frequent recurrences (more than 6 per year) occur, lasting longer than before (no positive treatment effect after 5 days of therapy), with more severe clinical symptoms (e.g. development of new infection sites after 3–4 days of treatment). This may indicate immunodeficiency or absorption disorders requiring diagnosis and possible adjustment of drug dosage.

During treatment, drink plenty of fluids to avoid kidney damage.
Children and adolescents
Heviran Comfort must not be used in children and adolescents under 18 years of age.
Heviran Comfort and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, especially:

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

Heviran Comfort with food and drink
This medicine can be taken independently of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Use of this medicine during pregnancy should be avoided. The medicine may be used during pregnancy only if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus.
Acyclovir passes into breast milk. Due to the risk of adverse effects in the breastfed infant, a decision must be made in consultation with the doctor whether to discontinue the medicine or to stop breastfeeding during treatment.
Driving and operating machinery
There are no data available on the effect of the medicine on the ability to drive or operate machinery.
However, the possibility of adverse effects of acyclovir such as dizziness, confusion, and seizures should be considered. Do not drive or operate machinery unless the patient is certain that he or she feels well.
Heviran Comfort contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Heviran Comfort

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
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.

Adults
Heviran Comfort should be taken orally at a dose of 200 mg five times daily, every 4 hours (with a nighttime break), for 5 days.
In cases of recurrent infections, it is particularly important to start treatment during the prodromal phase—before the appearance of symptoms such as itching, burning, or tingling—or immediately after the first lesions appear.

Dosage in patients with renal impairment
Patients with impaired kidney function should drink large amounts of fluids during treatment (see also section 2, "Warnings and precautions").
In patients with severe renal impairment, with creatinine clearance less than 10 ml/min, dosage of acyclovir must be determined exclusively by a doctor. In such patients, the doctor may recommend reducing the dose to 1 tablet (200 mg) twice daily, approximately every 12 hours.

Dosage in elderly patients
In elderly patients, impaired kidney function should be taken into consideration.
In patients with severe renal impairment, with creatinine clearance less than 10 ml/min, dosage of acyclovir must be determined exclusively by a doctor, who will adjust the dose accordingly (see: Dosage in patients with renal impairment).
During treatment, drink plenty of fluids.

Use of a higher than recommended dose of Heviran Comfort
It is unlikely that accidental intake of an excessive dose of the medicine will cause serious problems. Single oral doses of acyclovir up to 20 g have generally not caused toxicity symptoms. However, unintentional, repeated oral overdosing of acyclovir over several days has been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
If an excessive dose is taken, inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Heviran Comfort
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for a missed one.

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 experiences them.
If any of the following rare (occurring in no more than 1 in 1,000 patients) symptoms occur, contact your doctor immediately:

• shortness of breath, angioedema (e.g. swelling of the face, tongue, and trachea causing breathing difficulties)
• anaphylactic reaction (often manifested by itching, urticaria, shortness of breath, drop in blood pressure, rapid heartbeat).

The following adverse effects may also occur during treatment:
Common (occurring in no more than 1 in 10 patients)

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

Uncommon (occurring in no more than 1 in 100 patients)

• urticaria
• diffuse, accelerated hair loss. Since diffuse, accelerated hair loss may be associated with many diseases and with the use of many drugs, its relationship to acyclovir is uncertain.

Very rare (occurring in no more than 1 in 10,000 patients)

• agitation, tremor
• movement coordination disorders (ataxia)
• speech disorders
• disorientation, hallucinations
• psychotic symptoms
• brain damage (encephalopathy)
• seizures, somnolence, coma
• hepatitis and jaundice
• acute kidney failure, kidney pain. Kidney pain may be associated with kidney failure. Impaired kidney function usually resolves quickly after fluid supplementation in the patient and (or) after dose reduction or discontinuation of the medicine.

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

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

Very rare

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Heviran Comfort

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Heviran Comfort contains

• The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.
• The other ingredients are: microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate.

What Heviran Comfort looks like and contents of the pack
The 200 mg tablets are white, round, and biconvex.
The pack contains 25 tablets.

Marketing Authorisation Holder and Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Pelplinska Street 19, 83-200 Starogard Gdanski
Tel. + 48 22 364 61 01