Leaflet: information for the user

Aciclovir Stada 50 mg/g cream

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to otherseven 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 is Aciclovir Stada and what it is used for

2.What you need to know before starting touse Aciclovir Stada

3.How to use Aciclovir Stada

4.Possible side effects

1. Storage of Aciclovir Stada

6. Contents of the pack and additional information

Aciclovir Stadais an antiviral medication against viral infections.

Aciclovir is used for

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

Do not use Aciclovir Stada:

• if you are allergic toaciclovir, valaciclovir,any of the othercomponents of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aciclovir Stadasif you have or have had any medical condition or disease, especially,

•severe immune system deficiency, for example:

-patients with AIDS

-individuals who have received a bone marrow transplant.

Your doctor may decide to prescribe tablets in this case.

• Do not use aciclovir on mucous membranes (e.g., mouth, eyes, or vagina) to avoid local irritation. Also, avoid accidental eye contact.
• Patients with genital herpes should abstain from sexual intercourse during the time that lesions are visible to avoid transmitting the infection to their partners.
• The severity of the infection is determined by several factors, for example, 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 degree to which the virus is causing infections in other parts of the body. Therefore, your doctor will decide on the most effective treatment for you, and treatment may vary from patient to patient.

Other medications and Aciclovir Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The cream should not be mixed with other substances.

Pregnancy and breastfeeding

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

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

Breastfeeding

Aciclovir passes into breast milk. Not enough is known about the consequences of this. Therefore, consult your doctor or pharmacist if you are breastfeeding.

Driving and operating machinery

No information is available on the effects on the ability to drive or operate machinery. However, no negative effects are anticipated.

Aciclovir Stada contains propylene glycol (E1520) and cetyl alcohol

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

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

Follow exactly the administration instructions for this medication as indicated 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 nighttime application.

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

Administration Form

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

Treatment Duration

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

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

If you use moreAciclovir Stada than you should

If you have used more aciclovir than recommended or suspect overdose or misuse, you should consult your doctor, who will decide on the necessary measures.

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

If you forgot to use Aciclovir Stada

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

If you forgot an application, wait for the next scheduled application at the corresponding hour.

Do not use a double dose to compensate for missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rarely (may affect up to 1 in 100 people)

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

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

Dermatological reactions such as erythema, contact dermatitis after administration.

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 CAD. The expiration date is the last day of the month indicated.

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 of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofAciclovir Stada

-The active ingredient 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 components are stearate of macrogol, dimethicone, cetyl alcohol, liquid paraffin, white vaseline, propylene glycol (E1520) and purified water.

Appearance of the product and contents of the packaging

Aciclovir Stada 50 mg/g cream is a white or off-white medicinal product in the form of a cream.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA ARZNEIMITTEL AG

Stadastrasse, 2-18,

D-61118 BadVilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area with 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 PERCENT, Cream

Spain:Aciclovir STADA 50 mg/g cream

Date of the last review of this leaflet:October 2019

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