Aciclovir Stada 50 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aciclovir Stada 50 mg/g cream
Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
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What Aciclovir Stada is and what it is used for
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What you need to know before using Aciclovir Stada
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How to use Aciclovir Stada
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Possible adverse effects
- Storage of Aciclovir Stada
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Contents of the pack and other information
1. What Aciclovir Stada is and what it is used for
Aciclovir Stada is a medication used to treat 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 using Aciclovir Stada
DO NOT use Aciclovir Stada:
- if you are allergic to aciclovir, valaciclovir, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Aciclovir Stada if you have or have had any special medical condition or illness, 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 sexual intercourse while lesions are visible to prevent transmission of the infection to their partners.
- The severity of the infection is determined by several 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 the most effective treatment in your case; treatment may vary from patient to patient.
Other medicines and Aciclovir Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The cream must not be mixed with other substances.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 systemic effects of aciclovir are more than likely negligible due to its local application on the skin.
Breastfeeding
Aciclovir passes into breast milk. There is insufficient information available about its consequences. Therefore, consult your doctor or pharmacist if you are breastfeeding.
Driving and using machines
There is no available information regarding the effects on the ability to drive or operate machinery. However, no negative effects are 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 infants under 4 weeks of age 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 instructions for use of this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Dosage
Aciclovir should be applied to the infected skin area five times daily, every 4 hours, omitting the nighttime application.
Aciclovir should be applied to established or early lesions as soon as possible after the onset of 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 healing is not complete after 5 days, the 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 more Aciclovir 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 necessary measures.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.
If you forget to use Aciclovir Stada
If you have only just remembered, you may apply the cream at the recommended dose.
If you miss a dose, wait until the next scheduled dose at the usual time.
Do not use a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Uncommon (may affect up to 1 in 100 people):
Transient burning or itching sensation at the application site, mild form of dry skin or skin peeling, itching.
Rare (may affect up to 1 in 1,000 people):
Skin reactions such as erythema, contact dermatitis following administration.
Hypersensitivity test results 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 adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir Stada
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aciclovir Stada
- The active substance is aciclovir. One gram of cream contains 50 mg of aciclovir, equivalent to 5 g of aciclovir per 100 g of cream.
- The other components are macrogol stearate, dimethicone, cetostearyl alcohol, liquid paraffin, white soft paraffin, propylene glycol (E1520) and purified water.
Appearance of the product and contents of the pack
Aciclovir Stada 50 mg/g cream is a white or almost white cream.
Aciclovir Stada 50 mg/g cream is supplied in aluminium tubes with a polyethylene cap. The tubes contain 2, 3, 5, 10, 15 or 20 g of cream.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
STADA ARZNEIMITTEL AG
Stadastrasse, 2-18,
D-61118 Bad Vilbel
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Aciclovir EG 50 mg/g crème
Denmark: Aciclodan creme, 50 mg/g
Finland: Acyclostad 50 mg/g kräm
France: ACICLOVIR EG 5 POUR CENT, Crème
Spain: Aciclovir STADA 50 mg/g crema
Date of the most recent review of this leaflet: October 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/