FENIVIR 10 mg/g CREAM

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 administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 4 days.

Contents of the Package Leaflet:

1. What is Fenivir cream and what is it used for
2. What you need to know before you start using Fenivir cream
3. How to use Fenivir cream
4. Possible side effects
5. Storage of Fenivir cream
6. Contents of the pack and further information

1. What is Fenivir cream and what is it used for

Fenivir contains penciclovir and belongs to a group of medicines called antivirals that slow down the multiplication of viruses, such as the one that causes cold sores.

This virus can remain inactive for long periods of time, but when it becomes active, it starts to multiply and then the lesion develops. This happens, for example, when the defenses are weakened, when you have a cold or flu, or in cases where you have been exposed to strong sunlight. The virus causes painful blisters on the lips.

Fenivir is indicated for the treatment of cold sores (Herpes labialis). When applying Fenivir, it reduces the duration of the pain of the cold sore and accelerates its healing. Additionally, the period during which the cold sore is contagious also decreases, although applying Fenivir does not prevent you from infecting another person.

You should consult a doctor if it worsens or does not improve after 4 days.

2. What you need to know before you start 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 on cold sores on the lips or around the mouth. It is not recommended to use it on mucous membranes (inside the mouth, nose, or genital areas).

You should avoid applying Fenivir inside or around the eyes.

Consult your doctor or pharmacist before using Fenivir:

• if you are not sure that the lesion is a cold sore;
• if you have any disease or are receiving any treatment that weakens your immune system (e.g., AIDS, bone marrow transplant, or cancer treatment).

Children

Treatment with Fenivir cream is not recommended in children under 12 years of age.

Using 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 take any other medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. No data are available on fertility.

Driving and using machines

No adverse effects have been observed that affect the ability to drive and use machines.

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 stearyl alcohol.

Additionally, 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 of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Use the cream as soon as possible after the appearance of the first symptoms (itching and tingling).

However, the cream can be applied when the cold sore has already appeared.

Always wash your hands before and after applying Fenivir. Apply a small amount of product with the tip of your finger to the affected area. Optionally, for packs that contain single-use clean applicators, you can use the applicator instead of your finger if you wish.

Fenivir should be applied every 2 hours during the day (approximately 8 times a day) for 4 consecutive days.

If your symptoms persist or worsen at any time or if you do not observe 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 it is unlikely that adverse effects will occur, using an excessive amount of Fenivir in a single application may cause skin irritation.

In case of accidental ingestion, it may cause irritation of the oral mucosa, although no treatment is necessary. Contact your doctor or pharmacist if this happens.

In case of accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to use Fenivir cream

Apply the dose as soon as you remember and the next dose at the usual time.

Do not apply a double dose to make up for forgotten doses.

What general precautions should you follow when you have a cold sore

Remember that cold sores are contagious.

To avoid infecting other parts of your body with the virus, as well as infecting 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 wounds, as this will prolong the healing time.
• Avoid touching your eyes, as the virus can cause a very 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 further questions about the use of this product, ask your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Normally, the side effects produced by Fenivir are mild.

Some frequent side effects (may affect up to 1 in 10 patients) are: burning, stinging, or numbness when applying the cream. However, these effects usually disappear quickly.

Other possible side effects are allergic reactions such as allergic dermatitis, rash, urticaria, itching, and edema.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System. Website: www.notificaRAM.es. By reporting side 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 carton after "EXP". The expiry date is the last day of the month indicated.

Do not store above 30°C.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further 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 stearyl 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, presented in aluminum tubes of 2 g.

It may be presented in a pack that contains 20 single-use applicators.

Only some pack sizes may be marketed.

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Ireland Vectavir cold sore cream

Belgium Vectavir 1%, cream

Finland Vectavir 1% emulsion

Greece Fenivir

Luxembourg Vectavir 1%, cream

Portugal Fenivir, 10 mg/g, cream

Spain Fenivir 10 mg/g cream

United Kingdom Vectavir Cold Sore Cream

This leaflet was approved in November 2020.

Last revision of this leaflet: July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es