Acyclovir biofarm

Package leaflet: Information for the user

Acyclovir Biofarm, 200 mg, tablets
Aciclovirum
Read the entire leaflet carefully before use, 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
a doctor or pharmacist.

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

Table of contents

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

1. What Acyclovir Biofarm is and what it is used for

Acyclovir, the active substance in Acyclovir Biofarm, is a synthetic antiviral agent
that inhibits the replication of Herpes group viruses.
Acyclovir Biofarm is indicated for use in adults for:

• Treatment of recurrent herpes labialis and facial herpes or external genital herpes caused by herpes simplex virus (Herpes simplex). If there is no improvement after 5 days or if the patient feels worse, consult a doctor.

In recurrent infections, it is particularly important to start treatment during the prodromal phase, characterized by symptoms such as itching, burning, or tingling sensations.

• Prevention of recurrent herpes simplex in immunocompetent individuals. If there is no improvement after 1 month or if the patient feels worse, consult a doctor.

The medicine may only be used in patients who have previously been diagnosed with herpes simplex virus infection.

2. Important information before using Acyclovir Biofarm

When not to use Acyclovir Biofarm

• If the patient is allergic to aciclovir or valaciclovir, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Acyclovir Biofarm, discuss this with your doctor or pharmacist.
Do not use Acyclovir Biofarm without prior consultation with a doctor if the patient:

• has impaired kidney function,
• is taking other medicines that may damage the kidneys,
• is 65 years of age or older,
• has particularly severe recurrent herpes labialis,
• has particularly severe recurrent genital herpes,
• experiences frequent recurrences (>6 per year) that last longer than before (no positive effect after 5 days of treatment) and are associated with more severe clinical symptoms (e.g. development of new infection lesions after 3–4 days of treatment). This may indicate immunodeficiency or absorption disorders requiring diagnosis and possible adjustment of dosing.

Do not use Acyclovir Biofarm without prior consultation with a doctor in women who are
pregnant or breastfeeding (see section "Pregnancy and breastfeeding").
Do not use Acyclovir Biofarm in patients with reduced immunity (e.g. after organ transplantation, or HIV-infected individuals). Patients with reduced immunity should consult a
doctor regarding treatment of any infection.
Patients who develop herpes while taking Acyclovir Biofarm for prophylaxis should
consult their doctor.
Hydration status
If the patient is taking aciclovir, they should drink plenty of fluids to maintain adequate
hydration.
Children and adolescents
Acyclovir Biofarm must not be used in children and adolescents under 18 years of age.
Acyclovir Biofarm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Especially inform your doctor if the patient is taking any of the following
medicines:

• probenecid (used in the treatment of gout),
• cimetidine (used in peptic ulcer disease),
• tacrolimus, cyclosporine, or mycophenolate mofetil (used in organ transplant recipients),
• theophylline (used in the treatment of asthma and other respiratory disorders).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Use during pregnancy should be avoided unless the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
Caution should be exercised when using this medicine in breastfeeding women due to passage of the drug into human milk. The medicine may be used only after consultation
with a doctor.
Driving and operating machinery
There are no data on the effect of Acyclovir Biofarm on the ability to drive or operate machinery. However, the possibility of adverse effects of aciclovir such as dizziness, confusion, or seizures should be taken into account.
Acyclovir Biofarm contains lactose
One tablet contains 14.25 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
Acyclovir Biofarm contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Acyclovir Biofarm

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

Adults
Treatment of recurrent herpes labialis and facial herpes or external genital herpes
The recommended dose is:

• 1 tablet (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 a sensation of tension—or immediately after the first skin lesions appear.

Prevention of recurrent herpes simplex in immunocompetent individuals
The recommended dose is 2 tablets (400 mg) twice daily, every 12 hours.
Without consulting a doctor, the medicine may be used for a maximum period of 1 month, especially during periods of exposure to factors that trigger herpes recurrences (e.g. increased exposure to sunlight, stress, fever).

Use in elderly patients
In elderly patients, impaired kidney function should be considered. In patients with severe renal impairment, in whom creatinine clearance is less than 10 ml/min, dosage adjustment may only be decided by a doctor, who may recommend reducing the dose (see: Use in patients with renal impairment).
During treatment, drink plenty of fluids.

Use in patients with renal impairment
When using Acyclovir Biofarm in patients with impaired kidney function, it is important to drink plenty of fluids (see also section 2, "Warnings and precautions").

In patients with severe renal impairment, in whom creatinine clearance is less than 10 ml/min, dosage adjustment must be decided 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.

Taking more Acyclovir Biofarm than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department for advice.

Missing a dose of Acyclovir Biofarm
If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
Immediately inform a doctor or go to the nearest hospital if any of the following occur:

• anaphylactic reaction (a potentially life-threatening allergic reaction with symptoms such as: itching, urticaria, shortness of breath, drop in blood pressure, rapid heartbeat);
• angioedema (swelling of soft tissues of the face, lips, tongue, sometimes with simultaneous swelling of the larynx, which may cause breathing difficulties) – occurs rarely (in no more than 1 in 1,000 patients).

Common adverse reactions (may affect up to 1 in 10 patients):

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

Uncommon adverse reactions (may affect up to 1 in 100 patients):

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

Rare adverse reactions (may affect up to 1 in 1,000 patients):

• shortness of breath,
• transient increase in bilirubin concentration and liver enzyme activity in blood,
• increased blood urea and creatinine levels.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

• decreased number of various types of blood cells (anaemia; reduced white blood cell count; thrombocytopenia, which may affect blood clotting. If unexplained bruising or red or purple spots appear on the skin, inform a doctor),
• agitation, confusion, hallucinations, psychotic symptoms, tremors, ataxia, speech disorders, seizures, somnolence, encephalopathy, coma; these events are usually transient and generally observed in patients with impaired renal function or other predisposing factors (see section 2),
• jaundice, hepatitis,
• acute renal failure, renal pain.

Renal pain may be associated with kidney (renal) failure. Impaired kidney function usually resolves quickly after fluid supplementation in the patient and/or after dose reduction or discontinuation of the medicine.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Acyclovir Biofarm

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Acyclovir Biofarm contains

• The active substance is acyclovir. Each tablet contains 200 mg of acyclovir.
• Other components of the medicine are: microcrystalline cellulose (type 102), sodium carboxymethyl starch (type A), lactose monohydrate, povidone (K 30), magnesium stearate.

What Acyclovir Biofarm looks like and contents of the pack
White or almost white, round, biconvex tablets with a diameter of 10 mm ± 0.3 mm.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed together with the patient leaflet in a cardboard box.
Pack sizes: 10, 15, 20, 30 or 60 tablets.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]