Leaflet: Information for the User

Aciclovir Stada 200 mg Tablets EFG

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

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

2.What you need to knowbefore starting totake Aciclovir Stada

3.How to take Aciclovir Stada

4.Possible side effects

5.Storage of Aciclovir Stada

6.Contents of the pack and additional information

Aciclovir Stada belongs to a class of effective medications 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 progression, such as primary genital herpes (excluding herpes simplex virus infections in newborns and herpes simplex virus infections in children with reduced immune system function).

-for the prophylaxis of severe recurrent genital herpes infections in immunocompetent patients.

-for the prophylaxis of herpes simplex infections that occur after bone marrow or organ transplantation and during periods of remission after acute leukemia treatment.

Do not take Aciclovir Stada

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

Warnings and precautions

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

-If your kidney function is impaired or you are an elderly person. The dose should be adjusted as follows, and also drink a sufficient amount of liquid during treatment (see also section 3 “How to take Aciclovir Stada”).

-If you have a nervous disorder.

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

Taking Aciclovir Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication.

Particularly, inform your doctor if you are taking any of the following medications:

• interferon(medication used in the treatment of multiple sclerosis), may increase the effects of both medications.
• zidovudine(medication used in the treatment of AIDS), may cause neurological disorders (neuropathies), convulsions 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(medication used in transplant patients). Be careful if you are taking high doses of aciclovir, as the levels of both medications in the blood may be increased.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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, there is not enough information available on its consequences. Therefore, consult your doctor or pharmacist if you are breastfeeding.

Driving and operating machinery

It is not yet known if aciclovir affects the ability to drive or operate machinery. Although the properties of aciclovir make such an effect unlikely, fatigue, headache and neurological effects have occasionally been reported. You should take this into account if you intend to drive or operate machinery during treatment with aciclovir.

Aciclovir Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

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

Take this medicine exactly as your doctor has told you to. In some cases, the dose may be different from the recommended dose. Consult your doctor if you are unsure.

The recommended dose is:

• Treatment of simple herpes virus infections in immunocompetent patients:

One tablet ofaciclovir5 times a day, every 4 hours for 5 days. Do not take any dose at night. If the infection is severe, the doctor may decide to treat you for a longer period. The first dose should be taken as soon as symptoms appear.

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

Two tablets ofaciclovir, twice a day, every 12 hours.

• Prophylaxis of simple herpes infections, after bone marrow or organ transplants and during periods of remission after acute leukemia treatment:

One tablet ofaciclovir, 4 times a day, every 6 hours.

In patients whose immune system deteriorates severely, the dose may be increased to 2 tablets ofaciclovir, 4 times a day.

Aciclovir prophylaxis therapy should start simultaneously at the beginning of the risk period, therefore, when the immune system is depressed.

Use in children

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

Patients with reduced renal function

Caution is recommended if renal function is impaired.

Simple herpes virus infections:

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

Older patients

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

Administration method

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

Patients with renal impairment or elderly patients should ensure they drink plenty of liquid during aciclovir treatment. It is also important for patients treated with high doses of aciclovir to drink enough liquid.

If you take more Aciclovir Stada than you should

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

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

If you forgot to take Aciclovir Stada

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

If you interrupt the treatment with Aciclovir Stada

Your doctor has indicated the time you should continue taking aciclovir. Do not stop treatment before the recommended time without consulting your doctor first.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, althoughnot everyone will experience them.These side effects usually disappear once the treatment has ended. The following is a list of possible side effects.

Frequent: may affect up to 1 in 10 people

• Dizziness
• Alucinations
• Headache, dizziness, drowsiness

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

•Nausea
•Vomiting
•Diarrhea
•Abdominal pain

•Itching
•Skin rash (including photosensitivity)

•Fatigue
•Fever
•Weakness

Less frequent: may affect up to 1 in 100 people

•Lack of sleep

•Hives
•Diffuse 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
•Increased blood urea and creatinine

Very rare: affects up to 1 in 10,000 people

•Changes in blood count (anemia, leukopenia, thrombocytopenia)

•Sensation of detachment (reversible after treatment interruption), agitation, psychotic symptomsShaking, ataxia, dysarthria, seizures, encephalopathy, alterations in consciousness up to coma

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

•Hepatitis, jaundice

•Acute renal failure, renal pain

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https:/www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging, after "Do not use after" or "CAD".

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

• The active ingredient of Aciclovir Stada is aciclovir. A tablet contains 200 mg of aciclovir.
• The other components are: microcrystalline cellulose, sodium carboxymethyl starch (type A) (derived from potato starch), copovidone, 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 tablets.

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

Only some pack sizes may be marketed.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG,

Stadastrasse 2- 18

61118 Bad Vilbel (Germany)

or

LAMP San Prospero S.p.A

Via della Pace 25/A

41030 SanProspero, 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 medicinal product is authorized in the Member States of the European Economic Area with 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

Last review date of this leaflet:August 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/