ACICLOVIR STADA 200 mg TABLETS

Introduction

Package Leaflet: Information for the User

Aciclovir Stada 200 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Aciclovir Stada is and what it is used for.
2. What you need to know before you take Aciclovir Stada.
3. How to take Aciclovir Stada.
4. Possible side effects.
5. Storing Aciclovir Stada.
6. Contents of the pack and other information.

1. What Aciclovir Stada is and what it is used for

Aciclovir Stada belongs to a class of medicines that are effective against viral infections (antivirals).

Aciclovir Stada is used

• for the treatment of immunocompetent patients with skin and mucous membrane infections caused by the herpes simplex virus, especially when there is a possibility of severe evolution, such as in the case of primary genital herpes (excluding infections caused by the herpes simplex virus in newborns and infections caused by the herpes simplex virus in children with reduced immune system function (their body is less able to fight infections).
• for the prophylaxis of frequently recurring genital herpes virus infections in immunocompetent patients.
• for the prophylaxis of herpes simplex infections that occur after bone marrow or organ transplants and during the periods of remission after treatment for acute leukemia.

2. What you need to know before you take Aciclovir Stada

Do not take Aciclovir Stada

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

Warnings and precautions

Consult your doctor or pharmacist before taking Aciclovir Stada.

If you are receiving treatment for a genital herpes infection and the lesions or blisters are visible on the genitals, it is recommended to avoid sexual contact to prevent possible infection of your partner.

Taking Aciclovir Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

• Interferon(a medicine used to treat multiple sclerosis), may increase the effects of both medicines.
• Zidovudine(a medicine used to treat AIDS), may cause disorders in the nervous system (neuropathies), seizures, and lethargy.
• Theophylline(used in asthma and other respiratory problems).
• Cimetidine(used to treat peptic ulcers) and probenecid (used to treat gout), as they increase the concentration of aciclovir.
• Myphenolate mofetil(a medicine used in transplanted patients). Caution should be exercised if you are taking high doses of aciclovir, as the blood levels of both medicines may be increased.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is not enough information available on the consequences of using aciclovir during pregnancy. You should consult your doctor or pharmacist if you are pregnant.

Breastfeeding

Aciclovir is excreted in breast milk. Similarly, not enough is known about its consequences. Therefore, consult your doctor or pharmacist if you are breastfeeding.

Driving and using machines

It is not known whether aciclovir affects the ability to drive or use machines. Although the properties of aciclovir make such an effect unlikely, fatigue, headache, and effects on the nervous system have been reported. You should take this into account if you intend to drive or use machines during treatment with aciclovir.

Aciclovir Stada contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Aciclovir Stada

The dose will be determined by your doctor, individually for each patient.

Always take this medicine exactly as your doctor has told you. In some cases, the dose may be different from the recommended dose. Consult your doctor if you are not sure.

The recommended dose is:

• Treatment of herpes virus infections in immunocompetent patients:

One tablet of aciclovir 5 times a day, every 4 hours for 5 days. No dose will be taken at night. If the infection is severe, your doctor may decide to treat you for a longer period. The first dose should be taken as soon as symptoms appear.

• Prophylaxis of frequently recurring genital herpes virus infections in immunocompetent patients:

Two tablets of aciclovir, twice a day, every 12 hours.

• Prophylaxis of herpes simplex infections after bone marrow or organ transplants and during the periods of remission after treatment for acute leukemia:

One tablet of aciclovir, 4 times a day, every 6 hours.

In patients with severely impaired immune systems, the dose may be increased to 2 tablets of aciclovir, 4 times a day.

Prophylactic therapy with aciclovir should start at the same time as the beginning of the risk period, i.e., when the immune system is depressed.

Use in children

For children over 2 years of age, the same dose as for adults should be used. These tablets are not designed for use in younger children (i.e., under 2 years of age).

Patients with reduced kidney function

Cautions should be exercised if kidney function is altered.

Herpes simplex virus infections:

In patients with severe kidney impairment (creatinine clearance less than 10 ml/min), a dose adjustment to 200 mg of aciclovir, twice a day, approximately every 12 hours, is recommended.

Elderly patients

In principle, no dose adjustment is required in elderly patients. Only in cases of renal insufficiency may your doctor decide to adjust the dose.

Method of administration

Take the tablets with half a glass of water or other liquid.

In patients with kidney impairment or elderly patients, it is recommended to drink plenty of liquid during treatment with aciclovir. It is also important that patients treated with high doses of aciclovir drink sufficient liquid.

If you take more Aciclovir Stada than you should

Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 62 04 20, indicating the medicine and the amount taken.

The symptoms of an overdose include effects on the stomach and intestines, such as nausea or vomiting, and effects on the central nervous system, such as headache and confusion.

If you forget to take Aciclovir Stada

If you have recently forgotten to take a tablet, you can still take it. However, if the time when you should have taken the tablet has already passed, you should omit the missed dose. Wait until it is time for your next dose and continue with your normal dosing schedule as prescribed. Do not take a double dose of aciclovir to make up for missed doses.

If you stop taking Aciclovir Stada

Your doctor has told you how long to take aciclovir. Do not stop treatment before you should without consulting your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects usually disappear once treatment has finished. The following is a list of possible side effects.

Common: may affect up to 1 in 10 people

• Confusion
• Hallucinations
• Headache, dizziness, somnolence

The above-mentioned reversible side effects generally occurred in patients with impaired renal function and in cases of overdose, as well as with other predisposing factors, but cannot be entirely attributed to these characteristics.

• Nausea, Vomiting, Diarrhea, Abdominal pain
• Itching, Rash (including photosensitivity)
• Fatigue, Fever, Weakness
• Rare: may affect up to 1 in 1,000 people
• Insomnia
• Hives, Hair loss (its relationship with treatment is unclear)

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction (anaphylaxis)
• Difficulty breathing (dyspnea)
• Reversible increases in bilirubin and liver enzymes
• Angioedema, Increase in blood urea and creatinine

Very rare: may affect up to 1 in 10,000 people

• Changes in blood count (anemia, leucopenia, thrombocytopenia)
• Feeling of detachment (reversible after treatment discontinuation), agitation, psychotic symptoms, Tremor, ataxia, dysarthria, seizures, encephalopathy, changes in consciousness up to coma

The above-mentioned reversible side effects generally occurred in patients with impaired renal function or with other predisposing factors, but cannot be entirely attributed to these characteristics.

• Hepatitis, Jaundice
• Acute kidney failure, Kidney pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Aciclovir Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, after "Do not use after" or "CAD".

Do not store above 25°C.

Medicines should 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

• The active substance of Aciclovir Stada is aciclovir. One tablet contains 200 mg of aciclovir.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A) (derived from potato starch), copolyvidone, magnesium stearate, and anhydrous colloidal silica.

What Aciclovir Stada looks like and contents of the pack

Aciclovir Stada 200 mg tablets are white, round, and flat.

Each pack of Aciclovir Stada 200 mg tablets contains 25, 50, 100, or 500 tablets or 25x1 tablets (unit dose) in blisters of 5 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

STADA Arzneimittel AG,

Stadastrasse 2-18

61118 Bad Vilbel (Germany)

or

LAMP San Prospero S.p.A

Via della Pace 25/A

41030 San Prospero, Modena

(Italy)

or

Centrafarm Services, B.V

Van de Reijtstraat 31-E

4814 NE Breda

(Netherlands)

or

Sanico NV

Veedijk 59

2300 Turnhout

Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Aciclovir EG 200 mg tablets

Denmark: Aciclodan 200 mg

Spain: Aciclovir Stada 200 mg tablets EFG

Finland: Acyclostad 200 mg tablets

Netherlands: Aciclovir CF 200 mg, tablets

Portugal: Aciclovir Ciclum 200 mg tablets

Sweden: Aciklovir STADA 200 mg

Date of last revision of this leaflet:August 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/