ACICLOVIR STADA 50 MG/G CREAM

Introduction

Package Leaflet: Information for the User

Aciclovir Stada 50 mg/g Cream

Read all of this leaflet carefully before you start using 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 is Aciclovir Stada and what is it used for
2. What you need to know before you use Aciclovir Stada
3. How to use Aciclovir Stada
4. Possible side effects
   1. Storage of Aciclovir Stada

1. Contents of the pack and further information

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

Aciclovir Stada is a medicine against viral infections (antiviral agents).

Aciclovir is used for

• treatment of immunocompetent patients with skin infections caused by the herpes simplex virus.

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

Do not use 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 using Aciclovir Stada ifyou have or have had any special medical condition or disease, especially,

• severe immune system deficiency, e.g.:
  • patients with AIDS
  • people who have received a bone marrow transplant.

In this case, your doctor may decide to prescribe tablets.

• Do not use aciclovir on mucous membranes (e.g., mouth, eyes, or vagina) to avoid local irritation. Accidental eye contact should also be avoided.
• Patients with genital herpes should abstain from having sexual intercourse during the time the lesions are visible to avoid transmitting the infection to their partners.
• The severity of the infection is determined by various factors, e.g., the degree of your body's immune response to the infection, the number of times the infection has occurred, the duration of these infections, and the extent to which the virus is causing infections in other parts of the body. Therefore, your doctor will decide on the most effective treatment in your case, and the treatment may vary from patient to patient.

Other medicines and Aciclovir Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

The cream should not be mixed with other substances.

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.

The use of aciclovir should only be considered when the potential benefits outweigh the possibility of unknown risks. It should be noted that the effects of aciclovir on the whole body are likely to be insignificant due to local application to the skin.

Breastfeeding

Aciclovir passes into breast milk. The consequences are not well known. Therefore, consult your doctor or pharmacist if you are breastfeeding.

Driving and using machines

There is no information available on the effects on the ability to drive or use machines. However, no negative effect is expected.

Aciclovir Stada contains propylene glycol(E1520)and cetyl alcohol

This medicine contains 150 mg of propylene glycol in each gram of cream.

Propylene glycol may cause skin irritation. Do not use this medicine in babies under 4 weeks with open wounds or large areas of damaged skin (such as burns) without consulting your doctor or pharmacist first.

3. How to use Aciclovir Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

Aciclovir should be applied to the infected skin area, five times a day, every 4 hours, omitting the night application.

Aciclovir should be applied to established or initial lesions as soon as possible after the onset of an infection.

Method of administration

Apply a thin layer of cream to the affected areas of the skin.

Duration of treatment

This treatment should be carried out for 5 days. If after 5 days the healing is not complete, the treatment may be continued for another 5 days.

If you feel that the effect of aciclovir is too strong or too weak, talk to your doctor or pharmacist.

If you use moreAciclovir Stada than you should

If you have used more aciclovir than recommended or in case of suspected overdose or misuse, you should consult your doctor, who will decide on the measures to be taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to use Aciclovir Stada

If the forgetfulness is recent, you can apply the cream at the recommended dose.

If you missed an application, you should wait for the next application at the corresponding time.

Do not use a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people)

Transient burning or itching sensation at the application site, mild dryness or flaking of the skin, itching.

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

Skin reactions such as erythema, contact dermatitis after administration.

The results of hypersensitivity tests have shown that the reactive substances were mostly components of the cream and not aciclovir itself.

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

Severe immediate allergic reactions including angioedema (swelling of the tongue and/or face) and urticaria (hives).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofAciclovir Stada

• The active substance is aciclovir. One gram of cream contains 50 mg of aciclovir, which is equivalent to 5 g of aciclovir per 100 grams of cream.
• The other ingredients are macrogol stearate, dimethicone, cetyl alcohol, liquid paraffin, white petrolatum, propylene glycol (E1520), and purified water.

Appearance and packaging

Aciclovir Stada 50 mg/g cream is a white or off-white cream.

Aciclovir Stada 50 mg/g cream is available in aluminum tubes with a polyethylene cap. The tubes contain 2, 3, 5, 10, 15, or 20 grams of cream.

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

info@stada.es

Manufacturer

STADA ARZNEIMITTEL AG

Stadastrasse, 2-18,

D-61118 Bad Vilbel

Germany

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

Belgium: Aciclovir EG 50 mg/g cream

Denmark: Aciclodan cream, 50 mg/g

Finland: Acyclostad 50 mg/g cream

France: ACICLOVIR EG 5 POUR CENT, Cream

Spain: Aciclovir STADA 50 mg/g cream

Date of last revision of this leaflet:October 2019

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