Aciclovir Mabo 50 mg/g cream EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Aciclovir MABO 50 mg/g cream EFG
Read the entire leaflet carefully before starting to use 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, consult 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 adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Aciclovir MABO is and what it is used for
- What you need to know before using Aciclovir MABO
- How to use Aciclovir MABO
- Possible adverse effects
- Storage of Aciclovir MABO
- Package contents and additional information
1. What Aciclovir MABO is and what it is used for
This medicinal product belongs to a group of medicines called antivirals. It is indicated for the treatment of initial and recurrent genital herpes, herpes labialis, and localized mucocutaneous infections caused by herpes simplex virus in immunocompetent patients (patients with properly functioning immune systems).
You should consult a doctor if your condition worsens or does not improve after 10 days.
2. Before using Aciclovir MABO
Do not use Aciclovir MABO
- If you are allergic (hypersensitive) to aciclovir or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Aciclovir MABO:
- Do not apply on the mucous membranes of the mouth, eye, or vagina, as it may cause irritation. Take special care to avoid accidental introduction into the eye. If accidental contact with the eyes occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.
- Do not exceed the recommended frequency of applications or the duration of treatment.
- Immunocompromised patients (e.g., patients with HIV infection (AIDS), organ transplant recipients, or those undergoing radiotherapy or chemotherapy) should consult their doctor before starting treatment with this medicine.
- Since cold sores are recurrences of an infection acquired early in life, an initial medical diagnosis is necessary, especially in children, in whom symptoms of the primary infection may go unnoticed or be mistaken for teething problems or other oral conditions.
- Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting the infection to the partner. Aciclovir does not prevent transmission of herpes. The use of a condom may help prevent transmission. Do not exceed the recommended frequency of applications or duration of treatment.
- In cases of severe disease or frequent recurrences, your doctor should consider systemic treatment.
Children and adolescents
Application in children under 12 years of age should always be carried out under medical supervision.
Administration in adolescents over 12 years of age is the same as for adults; see below.
Using Aciclovir MABO with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
No interactions associated with this route of administration have been reported for aciclovir.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
There is insufficient information on the effects of the cream during pregnancy. Systemic administration of aciclovir in rats and rabbits has not produced teratogenic or embryotoxic effects.
Breastfeeding
There is no information available on aciclovir levels in breast milk following topical administration.
Driving and use of machines
The influence of this medicine on the ability to drive or operate machinery is none or negligible.
Aciclovir MABO contains cetyl alcohol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
3. How to use Aciclovir MABO
Follow exactly the instructions for administration of this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.
The medicine should be administered as soon as possible after diagnosis, once signs or symptoms of the condition have appeared.
Remember to use your medicine.
Your doctor will advise you on the duration of treatment with this medicine. Do not stop the treatment prematurely, as the infection caused by the virus may recur.
Adults and children over 12 years
Apply five times a day, approximately every four hours, excluding sleeping hours.
Apply a sufficient amount of the product to cover the affected area with a thin layer.
Continue treatment for 5 days. If complete healing has not occurred within 5 days, treatment may be extended for another 5 days, up to a total of 10 days.
Consult a doctor if your condition worsens or does not improve after 10 days.
After applying this medicine, wash your hands to prevent the spread of the lesion to other areas of the body or transmission to other people.
This medicine contains a specially formulated base and must not be diluted or used as a base for incorporating other medicines.
If you think that the effect of Aciclovir MABO is too strong or too weak, inform your doctor or pharmacist.
If you use more Aciclovir MABO than you should
Cases of intoxication are unlikely due to its external use; however, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Aciclovir MABO
Do not use a double dose to make up for missed doses. Simply continue with the usual treatment as soon as possible.
Do not exceed the recommended frequency of application or the recommended duration of treatment.
If you stop treatment with Aciclovir MABO
Do not interrupt treatment earlier than advised by your doctor, as healing may not be complete and your condition may recur.
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 after topical application of aciclovir
- Mild dryness or peeling of the skin
- Itching sensation
Rare (may affect up to 1 in 1,000 people):
- Skin redness
- Contact dermatitis (a type of local allergy) following application of the medicine. When sensitization tests have been performed, it has been shown that components of the cream, rather than aciclovir, are more frequently responsible for causing this reaction.
Very rare (may affect up to 1 in 10,000 people):
- Immediate hypersensitivity reactions including angioedema (an inflammatory condition affecting deep layers of the skin, manifesting as swelling of the throat or difficulty swallowing or breathing). If this effect is severe, seek immediate medical attention as it requires urgent measures.
Prolonged use of the cream may lead to sensitization phenomena; if this occurs, treatment should be discontinued and a doctor consulted.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir MABO
Keep this medicine out of sight and reach of children.
Store at room temperature.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aciclovir MABO
- The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
- The other components are polyethylene glycol fatty acid esters, decyl oleate, macrogol cetyl stearyl ether, cetyl alcohol, phenylethyl alcohol, sodium citrate (E-331), citric acid and purified water.
Appearance of the product and contents of the container
The cream is a uniform, white cream, free from air bubbles.
It is presented in aluminum tubes of 2 g and 15 g, packed in a cardboard box.
Marketing Authorization Holder
MABO-FARMA
Calle Vía de los Poblados, 3,
Edificio 6, 28033 Madrid,
Spain.
Manufacturer
LISAPHARMA, S.P.A
Via Licinio, 11
I-22036 Erba (Como), Italy
or
LABORATORIOS BOHM, S.A.
C/ Molinaseca, 23. Polígono Industrial Cobo Calleja,
Fuenlabrada, 28947 Madrid
Spain
This leaflet was approved in April 2015
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/