Patient Information Leaflet

Acyclovir Promedo, 200 mg, tablets
Aciclovirum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days of treatment, or if your condition worsens, contact your doctor.

Table of Contents

What Acyclovir Promedo is and what it is used for
Important information before taking Acyclovir Promedo
How to take Acyclovir Promedo
Possible side effects
How to store Acyclovir Promedo
Contents of the pack and other information

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

Acyclovir Promedo 200 mg tablets contain the active substance aciclovir—a synthetic antiviral agent that inhibits the replication of viruses from the Herpes group.
Acyclovir 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 infections caused by herpes simplex virus in adults.

In cases of recurrent infections, it is particularly important to start treatment during the early symptomatic phase, such as itching, burning, or tingling sensations.
Acyclovir Promedo 200 mg tablets should only be used in patients who have previously been diagnosed by a physician with herpes simplex virus infection.
If there is no improvement after 5 days of treatment, or if your condition worsens, consult your doctor.

2. Information before taking Acyklowir Promedo

When not to take Acyklowir Promedo

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

Warnings and precautions
Before starting treatment with Acyklowir Promedo, discuss this with your doctor or pharmacist. Do not take Acyklowir Promedo without prior consultation with a doctor:

if the patient has impaired kidney function,
if the patient is taking other medicines that may damage the kidneys,
in elderly patients (65 years of age or older),
in patients with weakened immune systems (e.g. after bone marrow transplantation, HIV infection). Patients with weakened immunity should consult a doctor regarding treatment of any infection,
in pregnant or breastfeeding women,
if the patient has experienced particularly severe recurrent herpes labialis,
if the patient has experienced particularly severe recurrent genital herpes,
if recurrent herpes episodes are frequent (>6 per year) and last longer than before (no positive treatment effect after 5 days of therapy), with more severe clinical symptoms (e.g. when new lesions appear after 3–4 days of treatment). This may indicate immunodeficiency or impaired absorption requiring diagnosis and different dosing of the drug.

If in doubt whether any of the above conditions apply, consult a doctor before starting treatment with Acyklowir Promedo.

Hydration status
If the patient is taking aciclovir, they should drink plenty of fluids to maintain adequate hydration.

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

Acyklowir Promedo with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, especially when using:

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).

Acyklowir Promedo with food and drink
This medicine may be taken independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.

This medicine should not be used during pregnancy unless the doctor considers that the benefits to the mother outweigh the possible risks to the fetus.

Caution should be exercised when using aciclovir during breastfeeding due to its passage into human milk. This medicine should only be used during breastfeeding after consultation with a doctor.

Driving and operating machinery
There are no data on the effect of aciclovir on the ability to drive or operate machinery. However, the possibility of adverse effects such as dizziness, confusion, or seizures should be taken into account.

Acyklowir Promedo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, 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 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.
Tablets should be swallowed with water.

Adults
Acyklowir Promedo should be taken orally at a dose of 200 mg five times daily, every 4 hours (with a night break), for 5 days.
In recurrent infections, it is particularly important to start treatment during the prodromal phase—characterized by itching, burning, or a sensation of tension—or immediately after the first lesions appear.

Use in patients with renal function impairment
Exercise caution when administering Acyklowir Promedo to patients with impaired renal function. In patients with severe renal impairment, with creatinine clearance less than 10 mL/min, dosage adjustment of acyclovir must be determined solely by a physician, who will appropriately modify the dose. In such patients, the physician may recommend reducing the dose to 1 tablet (200 mg) twice daily, approximately every 12 hours.
Patients with impaired renal function should drink large amounts of fluids during treatment with Acyklowir Promedo (see also section 2, "Warnings and precautions").

Use in elderly patients
In elderly patients, consider the possibility of impaired renal function.
In elderly patients with severe renal impairment, with creatinine clearance less than 10 mL/min, dosage of acyclovir must be determined solely by a physician, who will appropriately adjust the dose (see: "Use in patients with renal function impairment").
Patients should drink plenty of fluids during treatment.

Taking more Acyklowir Promedo than recommended
Acyclovir is generally not harmful unless excessively high doses are taken over several days. Accidental, repeated oral overdosage over several days has been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
If an excessive dose of Acyklowir Promedo is taken, inform a doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missing a dose of Acyklowir Promedo
If a dose is missed, take it as soon as possible unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur (rarely, i.e. in no more than 1 in
1,000 patients), seek immediate medical advice or go to the nearest hospital emergency department:

shortness of breath, angioedema (most commonly affecting the face, particularly around the lips and eyelids; may also involve the tongue, larynx or trachea and thus may pose a direct threat to life),
anaphylactic reaction (a severe, life-threatening allergic reaction often characterized by itching, urticaria, shortness of breath, drop in blood pressure, rapid heartbeat).

Other adverse reactions
Common adverse reactions (may affect no more than 1 in 10 people):

headache, dizziness,
nausea, vomiting, diarrhoea, abdominal pain,
itching, skin rash (including photosensitivity),
fatigue, fever (high body temperature).
Uncommon adverse reactions (may affect no more than 1 in 100 people):
urticaria,
cases of accelerated, widespread hair loss (this may be associated with various diseases and with the use of other medicines; the relationship with acyclovir is uncertain).
Rare adverse reactions (may affect no more than 1 in 1,000 people):
transient increase in blood bilirubin concentration and liver enzyme activity,
increased blood urea and creatinine levels.
Very rare adverse reactions (may affect no more than 1 in 10,000 people):
reduction in the number of red blood cells (anaemia), white blood cells (leukopenia), platelets (thrombocytopenia),
agitation, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, 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),
hepatitis, jaundice,
acute kidney failure, kidney pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Acyklowir Promedo

Keep this medicine 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 specified month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Acyklowir Promedo contains

The active substance is acyclovir. One tablet contains 200 mg of acyclovir.
Other components of the medicine are: microcrystalline cellulose, povidone K30, sodium carboxymethyl starch (type A), magnesium stearate.

What Acyklowir Promedo looks like and contents of the pack
White or almost white, round, biconvex tablets, with the imprint "ACL" on one side. Acyklowir Promedo is available in PVC/Aluminum blisters, packed in a cardboard box. The pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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