Aciclovir Biofarm

Package Leaflet: Information for the Patient

Acyclovir Biofarm, 200 mg, Tablets

Aciclovirum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Acyclovir Biofarm and what is it 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 package and other information

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

Acyclovir, the active substance of Acyclovir Biofarm, is a synthetic antiviral medicine that inhibits the multiplication of herpes viruses.
Acyclovir Biofarm is indicated for use in adults for:

• treatment of recurrent herpes labialis or genital herpes caused by herpes simplex virus. If after 5 days there is no improvement or the patient feels worse, they should consult a doctor.

In the case of recurrent infections, it is particularly important to start treatment during the prodromal period, such as itching, burning, or tension.

• prevention of recurrent herpes simplex in patients with normal immunity. If after 1 month there is no improvement or the patient feels worse, they should consult a doctor.

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

2. Important information before taking Acyclovir Biofarm

When not to take Acyclovir Biofarm

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

Warnings and precautions

Before starting treatment with Acyclovir Biofarm, the patient should discuss it with their doctor or pharmacist.
The patient should not take Acyclovir Biofarm without prior consultation with a doctor if they:

• have kidney problems,
• are taking other medicines that may damage the kidneys,
• are 65 years of age or older,
• have severe recurrent herpes labialis,
• have severe recurrent genital herpes,
• experience frequent (>6 per year) and prolonged (after 5 days of therapy, no positive effects) recurrences of herpes, with more severe clinical symptoms (e.g., when after 3-4 days of therapy, new foci of infection appear). This may indicate an immune deficiency or absorption disorders requiring diagnosis and possible different dosing of the medicine.

The patient should not take Acyclovir Biofarm without prior consultation with a doctor if they are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").
The patient should not take Acyclovir Biofarm if they have impaired immunity (e.g., after transplantation, HIV infection). Patients with impaired immunity should consult their doctor about treatment for any infection.
Patients who experience herpes during preventive treatment with Acyclovir Biofarm should consult their doctor.
Hydration status
If the patient is taking acyclovir, they should drink plenty of fluids to maintain proper hydration.

Children and adolescents

Acyclovir Biofarm should not be used in children and adolescents under 18 years of age.

Acyclovir Biofarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor especially if they are taking any of the following medicines:

• probenecid (used to treat gout),
• cimetidine (used to treat stomach and duodenal ulcers),
• tacrolimus, cyclosporine, or mycophenolate mofetil (used in patients after organ transplantation),
• theophylline (used to treat asthma and other respiratory diseases).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
The patient should avoid taking the medicine during pregnancy, unless the doctor considers that the benefits of taking the medicine outweigh the potential risks to the fetus.
The patient should exercise caution when taking the medicine while breastfeeding, due to the passage of the medicine into breast milk. The medicine can only be used after consultation with a doctor.

Driving and operating machinery

There is no data on the effect of Acyclovir Biofarm on the ability to drive and operate machinery. However, the patient should consider the possibility of side effects of acyclovir, such as dizziness, disorientation, seizures.

Acyclovir Biofarm contains lactose

One tablet contains 14.25 mg of lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Acyclovir Biofarm contains sodium

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

3. How to take Acyclovir Biofarm

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
During treatment, the patient should drink plenty of fluids to avoid the risk of kidney damage and reduce the likelihood of side effects.
Adults
Treatment of recurrent herpes labialis or genital herpes
The patient should take:

• 1 tablet (200 mg) five times a day, every 4 hours (with a night break) for 5 days.

In the case of recurrent infections, it is particularly important to start treatment during the prodromal period, such as itching, burning, or tension, or immediately after the appearance of the first changes.
Prevention of recurrent herpes simplex in patients with normal immunity
The patient should take 2 tablets (400 mg) twice a day, every 12 hours.
Without consulting a doctor, the medicine can be used for a maximum of 1 month, especially during periods of exposure to factors that trigger recurrences of herpes (e.g., increased sun exposure, stress, fever).
Use in elderly patients
In elderly patients, the possibility of impaired kidney function should be considered. In patients with severe kidney impairment, with a creatinine clearance of less than 10 ml/min, the dosage may be determined only by a doctor, who may recommend reducing the dose of the medicine (see: Use in patients with kidney impairment).
During treatment, the patient should drink plenty of fluids.
Use in patients with kidney impairment
During treatment with Acyclovir Biofarm in patients with kidney impairment, the patient should drink plenty of fluids (see also section 2 "Warnings and precautions").
In patients with severe kidney impairment, with a creatinine clearance of less than 10 ml/min, the dosage may be determined only by a doctor. In such patients, the doctor may recommend reducing the dose of the medicine to 1 tablet (200 mg) twice a day, every 12 hours.

Overdose of Acyclovir Biofarm

In case of overdose, the patient should immediately inform their doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Acyclovir Biofarm

If the patient misses a dose, they should take it as soon as they remember, unless it is time for the next dose. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Acyclovir Biofarm can cause side effects, although not everybody gets them.
The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• anaphylactic reaction (a life-threatening allergic reaction with symptoms such as itching, hives, difficulty breathing, low blood pressure, rapid heartbeat)
• rarely (affecting up to 1 in 1,000 patients);
• angioedema (swelling of the soft tissues of the face, lips, tongue, and sometimes with simultaneous swelling of the larynx, which can make breathing difficult) - rarely (affecting up to 1 in 1,000 patients).

Common side effects(may affect up to 1 in 10 patients):

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

Uncommon side effects(may affect up to 1 in 100 patients):

• urticaria, cases of accelerated, widespread hair loss. Accelerated, widespread hair loss may be associated with many diseases and the use of many medicines, so its relationship to the effect of acyclovir is not certain.

Rare side effects(may affect up to 1 in 1,000 patients):

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

Very rare side effects(may affect up to 1 in 10,000 patients):

• reduction in the number of various types of blood cells (anemia; reduced number of white blood cells; thrombocytopenia, which can affect blood clotting. If the patient experiences bruising, red or purple spots on the skin of unknown cause, they should inform their doctor.),
• excitement, disorientation, hallucinations, psychotic symptoms, tremors, ataxia, speech disorders, seizures, somnolence, brain damage (encephalopathy), coma; these events are usually transient and most often occur in patients with impaired kidney function or other predisposing factors (see section 2),
• jaundice, hepatitis,
• acute kidney failure, kidney pain.

Kidney pain may be associated with kidney failure. Kidney function impairment usually resolves quickly after fluid supplementation in the patient and (or) after reducing the dose or discontinuing the medicine.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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 to gather more information on the safety of the medicine.

5. How to store Acyclovir Biofarm

Store in a place 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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Acyclovir Biofarm contains

• The active substance of the medicine is acyclovir. One tablet contains 200 mg of acyclovir.
• The other ingredients of the medicine are: microcrystalline cellulose (type 102), sodium carboxymethylcellulose (type A), lactose monohydrate, povidone (K 30), magnesium stearate.

What Acyclovir Biofarm looks like and contents of the package

White or almost white, round, biconvex tablets with a diameter of 10 mm ± 0.3 mm.
The tablets are packaged in PVC/PVDC/Aluminum blisters, together with the patient package leaflet in a cardboard box.
The package contains 10, 15, 20, 30, or 60 tablets.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Date of last revision of the package leaflet: