Aciclovir Pensa 50 mg/g cream EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Aciclovir pensa 50 mg/g cream EFG
Read all of this 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 you should not give it to others, 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
- What Aciclovir Pensa is and what it is used for
- What you need to know before using Aciclovir Pensa
- How to use Aciclovir Pensa
- Possible side effects
- How to store Aciclovir Pensa
- Contents of the pack and other information
1. What Aciclovir Pensa is and what it is used for
This medicine belongs to a group of medicines called antivirals. It is indicated for the treatment of initial and recurrent genital herpes, cold sores, and localized mucocutaneous infections caused by the herpes simplex virus in immunocompetent patients (those with a properly functioning immune system).
You should consult a doctor if your condition worsens or does not improve after 10 days.
2. What you need to know before using Aciclovir Pensa
Do not use Aciclovir Pensa
- 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 Pensa.
- Do not apply on mucous membranes of the mouth, eye, or vagina, as this may cause irritation. Care must be taken to avoid accidental introduction into the eye. If contact with the eyes occurs accidentally, rinse thoroughly with water and consult an ophthalmologist if necessary.
- Do not exceed the recommended frequency of applications or the recommended duration of treatment.
- Immunocompromised patients (e.g. patients with HIV infection (AIDS), 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 earlier in life, usually at a young age, an initial medical diagnosis is necessary, especially in children, in whom symptoms of the primary infection may go unnoticed or be mistaken for teething disorders or other oral conditions.
- Avoid sexual contact in patients with genital herpes, as there is a risk of transmitting the infection to their 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 the 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 children over 12 years of age is the same as for adults; see below.
Use of Aciclovir Pensa with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
No interactions have been reported with aciclovir administered by this route (topical).
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, 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 cream administration during pregnancy. Systemic administration of aciclovir to rats and rabbits has not produced teratogenic or embryotoxic effects.
Breastfeeding
There is no information available on the levels of aciclovir in breast milk following topical administration.
Driving and use of machines
The influence of this medicine on the ability to drive and operate machinery is none or negligible.
Aciclovir Pensa contains cetostearyl alcohol and propylene glycol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
This medicine may cause skin irritation because it contains propylene glycol.
3. How to use Aciclovir Pensa
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The medicine should be applied 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 how long to take this medicine. Do not stop treatment early, as the viral infection may recur.
Adults and children over 12 years of age:
Apply five times a day, approximately every four hours, except during sleeping hours. Apply a sufficient amount of 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 avoid spreading the lesion to other areas of the body or transmitting it to other people.
This medicine contains a specially formulated base and should not be diluted or used as a base for incorporating other medicines.
If you think that the effect of Aciclovir Pensa is too strong or too weak, inform your doctor or pharmacist.
If you use more Aciclovir Pensa 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.
If you forget to use Aciclovir Pensa
Do not use a double dose to make up for missed doses. Simply continue your regular treatment as soon as possible.
Do not exceed the recommended frequency of application or duration of treatment.
If you stop using Aciclovir Pensa
Do not interrupt treatment earlier than advised by your doctor, as healing may not be complete and your condition may recur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Uncommon (may affect up to 1 in 100 people):
- Transient burning or itching after cutaneous 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. In sensitization tests, substances causing this reaction have more frequently been found to be components of the cream rather than aciclovir itself
Very rare (may affect up to 1 in 10,000 people):
- Immediate hypersensitivity reactions including angioedema (an inflammatory process affecting deep layers of the skin, manifested as swelling of the throat or difficulty swallowing or breathing). If this effect is severe, seek medical attention immediately, as emergency measures may be required.
Prolonged use of the cream may lead to sensitivity phenomena; if these occur, 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 it is an effect not listed in this leaflet. You may also report them directly via 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 Pensa
This medicine does not require special storage conditions. Keep this medicine out of the sight and reach of children.
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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aciclovir Pensa
- The active substance is aciclovir. Each gram of cream contains 50 mg of aciclovir.
- The other components are: propylene glycol, emulsifying cetostearyl alcohol (Type B), liquid paraffin, filant vaseline, poloxamer 407, and purified water.
Appearance of the medicine and contents of the pack
White or yellowish cream.
It is presented in cardboard boxes containing tubes with 2 and 15 grams of cream, packed in aluminum tubes.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
Towa Pharmaceutical Europe, S.L.
C/ de Sant Martí 75-97
08107 Martorelles (Barcelona)
Spain
or
Kern Pharma, S.L.
Polígon Industrial Colón II, Venus, 72
08228 Terrassa – Barcelona (Spain)
Date of the most recent review of this leaflet: May 2015
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