Leaflet: Information for the user

Aciclovir Stada800mgcomprimidos EFG

Read this leaflet carefully before you start taking this medicine, because 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

Contents of theleaflet

1.What is Aciclovir Stada and how is it used.

2.Things you need to know before starting to take Aciclovir Stada

3.How to take Aciclovir Stada

4.Possible side effects

5.Storage of Aciclovir Stada

6.Contents of the package and additional information

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

Aciclovir Stadaisusedfor

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

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.

How to take Aciclovir Stada with other medications

Inform your doctor or pharmacist if you are taking, have recently taken or may need 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 nervous system disorders (neuropathies), convulsions and drowsiness.
• 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 blood levels of both medications may be increased.

Embryo and lactation

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.

Lactation

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.

Conduction and use of machinery

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 nervous system effects have been reported on occasion. You should take this into account if you intend to drive or use machines 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 your 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:

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

Use in children

No data is available regarding the dose for the treatment of herpes zoster in children.

Patients with renal function impairment

Caution is recommended if renal function is impaired.

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

Patients of advanced age

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

Method of administration

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.

What to do if you take too much Aciclovir Stada

Consult your doctor or pharmacist immediately at the Toxicological Information Service telephone: 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.

Missed dose of 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 normal dosing schedule as prescribed. Do not take a double dose of aciclovir to compensate for the missed doses.

Discontinue treatment with Aciclovir Stada

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. These side effects usually disappear once treatment has ended. We show you a list of possible side effects below.

Frequent: may affect up to 1 in 10 people

• Confusion
• Hallucinations
• 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

Infrequent: may affect up to 1 in 100 people

• Lack of sleep
• Urticaria
• 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

Blood count changes (anemia, leukopenia, thrombocytopenia)

• Sensation of detachment (reversible after treatment interruption), agitation, psychotic symptoms
• Tremor, 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

• The active ingredient of Aciclovir Stada is aciclovir. One tablet contains 800 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.

Qualityof Aciclovir Stadaandcontents of thepackage

Aciclovir Stada 800 mg tablets are oblong, white, and scored on both sides.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Denmark:Aciclodan 800 mg

Finland:Acyclostad 800 mg tabletti

Netherlands:Aciclovir CF 800 mg tabletten

Portugal:Aciclovir Ciclum 800 mg comprimidos

Spain:Aciclovir Stada 800 mg comprimidos EFG

Sweden:Aciclovir STADA 800 mg

Last review date of thisleaflet:February 2021

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/