Aciklovir Promedo

Leaflet attached to the packaging: patient information

Acyklowir Promedo, 200 mg, tablets

Aciclovir

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

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this 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 any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Acyklowir Promedo and what is it used for

Acyklowir Promedo, 200 mg, tablets contain the active substance acyclovir, a synthetic antiviral medicine that inhibits the multiplication of herpes viruses. Acyklowir Promedo, 200 mg, tablets are indicated for the treatment of:

• recurrent herpes labialis (cold sores) caused by herpes simplex virus in adults;
• recurrent genital herpes caused by herpes simplex virus in adults.

In the case of recurrent infections, it is especially important to start treatment during the prodromal period, such as itching, burning, or tingling. Acyklowir Promedo, 200 mg, tablets can only be used in patients who have been previously diagnosed with herpes simplex virus infection by a doctor. If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

2. Important information before taking Acyklowir Promedo

When not to take Acyklowir Promedo

• 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 Acyklowir Promedo, the patient should discuss it with their doctor or pharmacist. The patient should not take Acyklowir Promedo without consulting their doctor:

• if they have kidney problems;
• if they are taking other medicines that may harm their kidneys;
• in patients over 65 years of age;
• in patients with impaired immune systems (e.g., after bone marrow transplantation, HIV infection). Patients with impaired immune systems should consult their doctor about treatment for any infection;
• in pregnant or breastfeeding women;
• if the patient has experienced severe recurrent herpes labialis;
• if the patient has experienced severe recurrent genital herpes;
• if the patient has frequent (>6 per year) and prolonged (after 5 days of treatment, no positive effects) recurrences of herpes, with more severe clinical symptoms (e.g., when new lesions appear after 3-4 days of treatment). This may indicate an immune deficiency or absorption disorders that require diagnosis and a different dosage of the medicine.

If the patient is unsure whether any of the above conditions apply to them, they should consult their doctor before starting treatment with Acyklowir Promedo. Hydration statusIf the patient is taking acyclovir, they should drink plenty of fluids to maintain proper hydration.

Children and adolescents

Acyklowir Promedo should not be used in children and adolescents under 18 years of age.

Acyklowir Promedo 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, especially:

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

Acyklowir Promedo with food and drink

The medicine can be taken with or without food.

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. This medicine should not be used in pregnant women unless the doctor considers that the benefits of the medicine to the mother outweigh the potential risks to the fetus. Caution should be exercised when using acyclovir in breastfeeding women due to its excretion into human milk. During breastfeeding, this medicine should only be used after consulting a doctor.

Driving and using machines

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

Acyklowir Promedo contains sodium

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

3. How to take Acyklowir Promedo

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If the patient has any doubts, they 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. The tablets should be swallowed with water.

Adults

Acyklowir Promedo should be taken orally in a dose of 200 mg five times a day, every 4 hours (with a night interval), for 5 days. In the case of recurrent infections, it is especially important to start treatment during the prodromal period, such as itching, burning, or tingling, or immediately after the appearance of the first lesions.

Use in patients with kidney problems

Caution should be exercised when using Acyklowir Promedo in patients with kidney problems. In patients with severe kidney problems, with a creatinine clearance of less than 10 mL/min, the dosage of acyclovir should be determined by the doctor, who may reduce the dose of the medicine to 1 tablet (200 mg) twice a day, approximately 12 hours apart. During treatment with Acyklowir Promedo, patients with kidney problems should drink plenty of fluids (see also section 2 "Warnings and precautions").

Use in elderly patients

In elderly patients, the possibility of kidney problems should be considered. In patients with severe kidney problems, with a creatinine clearance of less than 10 mL/min, the dosage of acyclovir should be determined by the doctor, who may reduce the dose of the medicine (see: Use in patients with kidney problems). During treatment, the patient should drink plenty of fluids.

Overdose of Acyklowir Promedo

Acyklovir is usually not harmful, unless too high a dose is taken for several days. Unintentional, repeated oral overdose of acyclovir over several days has been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion). If the patient has taken too much Acyklowir Promedo, they should tell their doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Acyklowir Promedo

If a dose is missed, it should be taken as soon as possible, unless it is time for the next dose. A double dose should not be taken to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Acyklowir Promedo can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms (occurring rarely, i.e., in no more than 1 in 1,000 patients), they should immediately contact their doctor or go to the nearest hospital emergency department:

• shortness of breath, angioedema (most commonly occurs in the face, mainly in the area of the lips and eyelids, may also affect the tongue, glottis, or larynx, and can be life-threatening);
• anaphylactic reaction (a severe, life-threatening allergic reaction characterized by itching, hives, shortness of breath, low blood pressure, rapid heartbeat).

Other side effects

Common side effects (may affect no more than 1 in 10 people):

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

Uncommon side effects (may affect no more than 1 in 100 people):

• hives;
• cases of accelerated, widespread hair loss (may be associated with many diseases and the use of other medicines, its connection to the action of acyclovir is uncertain).

Rare side effects (may affect no more than 1 in 1,000 people):

• 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 no more than 1 in 10,000 people):

• decrease in red blood cell count (anemia), white blood cell count (leukopenia), platelet count (thrombocytopenia);
• excitement, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, brain damage (encephalopathy), coma; these events are usually transient and most often occur in patients with impaired renal function or other predisposing factors (see section 2);
• hepatitis, jaundice;
• acute kidney failure, kidney pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Acyklowir Promedo

The medicine should be stored 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 stated. 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 packaging and other information

What Acyklowir Promedo 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, povidone K30, sodium carboxymethylcellulose (type A), magnesium stearate.

What Acyklowir Promedo looks like and what the pack contains

White or almost white, round, biconvex, with the inscription "ACL" on one side. Acyklowir Promedo is available in a PVC/Aluminum blister pack, in a cardboard box. The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Promedo Pharma Products GmbH, Anklamer Straße 28, 10115 Berlin, Germany, e-mail: [email protected]

Manufacturer

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice

Date of last revision of the leaflet: