ACICLOVIR STADA 800 mg TABLETS

Introduction

Leaflet: Information for the user

Aciclovir Stada800mgcomprimidos EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Aciclovir Stada belongs to a class of effective drugs against viral infections (antivirals).

Aciclovir Stada is used

• for the treatment of varicella-zoster virus (herpes) of the skin and mucous membranes in immunocompetent patients, in whom a severe course can be predicted.

2. What you need to know before taking Aciclovir Stada

Do not take Aciclovir Stada

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Aciclovir Stada.

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.
• mycophenolate mofetil(a medicine used in transplant patients). You should be careful 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 plan to become pregnant, consult your doctor or pharmacist before using 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 plan 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, which 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:

One tablet of aciclovir 800 mg, 5 times a day, every 4 hours. The dose is omitted during the night. Treatment should be started 48 hours after the infection appears. The duration of treatment should be 7 days.

Use in children

There is no data available on the dose for the treatment of herpes zoster in children.

Patients with reduced kidney function

Caution is recommended if kidney function is impaired.

The dose should be reduced to one tablet of aciclovir 800 mg, 3 times a day, at intervals of approximately 8 hours in patients with moderate renal impairment (creatinine clearance in the range of 10-25 ml/minute). If renal impairment is severe (creatinine clearance below 10 ml/minute), a dose of one tablet of aciclovir 800 mg, twice a day, at intervals of 12 hours is recommended.

Elderly patients

In principle, no dose adjustment is required in elderly patients. Only in cases of renal impairment may the 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 problems or elderly patients, make sure to drink plenty of liquid during treatment with aciclovir. It is also important that patients treated with high doses of aciclovir drink enough 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 forgotten dose. Wait until it is time for the next dose and continue with your normal dosing schedule as prescribed. Do not take a double dose of aciclovir to make up for forgotten doses.

If you stop taking Aciclovir Stada

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

If you have any further questions about the use of this medicine, 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, drowsiness
• The reversible side effects mentioned above 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

Uncommon: may affect up to 1 in 100 people

• Insomnia
• Hives
• Diffuse hair loss (its relationship to 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
• Increased blood urea and creatinine

Very rare: affects less than 1 in 10,000 people

Changes in blood counts (anemia, leukopenia, thrombocytopenia)

• Feeling of detachment (reversible after treatment discontinuation), agitation, psychotic symptoms
• Tremors, ataxia, dysarthria, seizures, encephalopathy, changes in consciousness up to coma
• The reversible side effects mentioned above 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them through 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. Storage of 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 packaging after "Do not use after" or "EXP".

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 further information

• The active substance of Aciclovir Stada is aciclovir. One tablet contains 800 mg of aciclovir.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (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 800 mg tablets are oblong, white, and scored on both sides.

Each pack of Aciclovir Stada 800 mg tablets contains 35, 50, or 500 tablets in blister strips. The blister strips contain 5 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

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

Denmark: Aciclodan 800 mg

Finland: Acyclostad 800 mg tablets

Netherlands: Aciclovir CF 800 mg tablets

Portugal: Aciclovir Ciclum 800 mg tablets

Spain: Aciclovir Stada 800 mg tablets EFG

Sweden: Aciclovir STADA 800 mg

Date of last revision of this leaflet:February 2021

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/