Fenivir 10 mg/g cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fenivir 10 mg/g cream
Penciclovir
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 4 days.
Contents of the leaflet:
- What Fenivir cream is and what it is used for
- What you need to know before using Fenivir cream
- How to use Fenivir cream
- Possible side effects
- How to store Fenivir cream
- Contents of the pack and other information
1. What Fenivir cream is and what it is used for
Fenivir contains penciclovir and belongs to a group of medicines called antivirals, which inhibit the multiplication of viruses, such as the one that causes cold sores.
This virus may remain inactive for long periods of time, but when it becomes activated, it starts multiplying and then the lesion develops. This occurs, for example, when the immune defenses are weakened, during a cold or flu, or in cases of prolonged exposure to strong sunlight. The virus causes painful blisters on the lips.
Fenivir is indicated for the treatment of cold sores (Herpes labialis). When Fenivir is applied, the duration of pain caused by cold sores is reduced and healing is accelerated. In addition, the period during which the herpes infection is contagious is also shortened, although applying Fenivir does not prevent you from transmitting it to another person.
You should consult a doctor if your condition worsens or does not improve after 4 days.
2. What you need to know before using Fenivir cream
Do not use Fenivir cream
- if you are allergic to penciclovir, famciclovir, or any of the other components of Fenivir (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Fenivir cream.
Fenivir should be used for cold sores on the lips or around the mouth. It is not recommended for use on mucous membranes (inside the mouth, nose, or genital areas).
Application of Fenivir inside or around the eyes should be avoided.
Consult your doctor or pharmacist before using Fenivir:
- if you are unsure whether the lesion is a cold sore;
- if you have any illness or are receiving any treatment that weakens your immune system (for example, AIDS, bone marrow transplant recipients, or cancer treatments).
Children
Treatment with Fenivir cream is not recommended in children under 12 years of age.
Use of Fenivir cream with other medicines
No interactions with other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. There are no available data on fertility.
Driving and using machines
No adverse effects affecting the ability to drive or operate machinery have been observed.
Important information about some of the components of Fenivir cream
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol and stearyl alcohol.
In addition, it contains 416 mg of propylene glycol per gram of cream, which may cause skin irritation.
3. How to use Fenivir cream
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Apply the cream as soon as possible after the first symptoms appear (itching and tingling).
Nevertheless, the cream may still be applied once the lesion has already developed.
Always wash your hands before and after applying Fenivir. Apply a small amount of the product with the fingertip to the affected area. Optionally, for packages containing clean single-use applicators, you may use the provided applicator instead of your finger, if desired.
Fenivir should be applied every 2 hours during the day (approximately 8 times daily) for 4 consecutive days.
If your symptoms persist or worsen at any time, or if you do not notice any improvement after 4 days of treatment, you should consult your doctor.
Use in children
Treatment with Fenivir cream is not recommended in children under 12 years of age.
If you use more Fenivir cream than you should
Although adverse effects are unlikely, excessive use of Fenivir in a single application may cause skin irritation.
In case of accidental ingestion, irritation of the oral mucosa may occur, although no treatment is usually necessary. Contact your doctor or pharmacist if this happens.
In case of accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.
If you forget to use Fenivir cream
Apply the missed dose as soon as you remember, and then take the next dose at the usual time.
Do not apply a double amount to make up for forgotten doses.
General precautions to follow when you have a cold sore
Remember that cold sores are contagious.
To avoid spreading the virus to other parts of your body or to other people, it is important that when you have a cold sore:
- Avoid kissing, especially children.
- Avoid oral sex.
- Use your own towels and napkins and do not share cutlery, glasses, cups, etc.
- Avoid breaking the blisters or touching the sores, as this will prolong healing time.
- Avoid touching your eyes, as the virus can cause a serious condition if it reaches the eye.
Do not give this cream to other people, even if their symptoms are the same as yours.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
If you have any other 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 experiences them.
Usually, the adverse effects caused by Fenivir are mild.
Some common adverse effects (may affect up to 1 in every 10 patients) are: burning, stinging, or numbness at the site of cream application. However, these effects usually disappear quickly.
Other possible adverse effects include allergic-type reactions such as allergic dermatitis, rash, urticaria, itching, and edema.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fenivir cream
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton after “Expiry”. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Do not freeze.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Fenivir cream
The active substance is penciclovir. 1 gram of Fenivir contains 10 mg of penciclovir.
The other components are: white soft paraffin, liquid paraffin, cetyl alcohol, propylene glycol, cetomacrogol 1000, and purified water.
Appearance of the product and contents of the pack
Fenivir is a white, fluid cream with a homogeneous appearance, supplied in 2 g aluminium tubes.
A pack may contain 20 single-use applicators.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Perrigo España, S.A.
Pza. Xavier Cugat, 2 - Edif. D, Pl. 1ª
08174 Sant Cugat del Vallès (Barcelona)
Manufacturer
Omega Pharma International NV
Venecoweg 26
B-9810 Nazareth
Belgium
Medgenix Benelux NV
Vliegveld 21
Wevelgem, 8560
Belgium
This medicinal product is authorised in the European Economic Area member states under the following names:
Ireland Vectavir cold sore cream
Belgium Vectavir 1%, crème
Finland Vectavir 1% emulsiovoide
Greece Fenivir
Luxembourg Vectavir 1%, crème
Portugal Fenivir, 10 mg/g, Creme
Spain Fenivir 10 mg/g cream
United Kingdom Vectavir Cold Sore Cream
This leaflet was approved in November 2020.
Latest revision of this leaflet: July 2022
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.es