Package Insert: Information for the User

Fenivir 10 mg/g Cream

Penciclovir

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

Fenivir contains penciclovir and belongs to a group of medications called antivirals that inhibit 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 begins to multiply and then the lesion develops. This occurs, for example, when the defenses are weakened, when a cold or flu is present, or in cases where one has been exposed to strong sunlight. The virus causes painful blisters on the lips.

Fenivir is indicated for the treatment of fever blisters (Herpes labial). When applying Fenivir, it reduces the duration of pain from cold sores and accelerates their healing. Additionally, the period in which the cold sore is contagious also decreases, although applying Fenivir does not prevent you from being able to infect someone else.

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

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 fever blisters or around the mouth. It is not recommended to use it on mucous membranes (inside the mouth, nose, or genital areas).

Apply Fenivir away from the eyes.

Consult your doctor or pharmacist before using Fenivir:

• if you are unsure whether the lesion is a fever blister;
• if you have any disease or are receiving treatment that weakens your immune system (for example, HIV, bone marrow transplants, or cancer treatments).

Children

Do not recommend treatment with Fenivir cream in children under 12 years old.

Using Fenivir cream with other medications

No known interactions with other medications.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. No data is available on fertility.

Driving and operating machinery

No adverse effects have been observed that affect the ability to drive and operate machinery.

Important information about some of the components of Fenivir cream

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetoestearic alcohol.

Additionally, it contains 416 mg of propylene glycol per gram of cream, which may cause skin irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

However, the cream can be applied even if a fever has already appeared.

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 containers that contain clean single-use applicators, you can use the applicator instead of your finger if you prefer.

Fenivir must 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 must consult your doctor.

Use in children

The treatment with Fenivir cream is not recommended for children under 12 years old.

If you use more Fenivir cream than you should

Although it is unlikely to occur, the use of an excessive amount of Fenivir in a single application may cause skin irritation.

In case of accidental ingestion, mouth mucosa irritation may occur, but 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 Toxicological Information Service. Phone 91 562 04 20.

If you forgot 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 compensate for the missed doses.

General precautions to follow when you have a cold sore

Remember that cold sores are contagious.

To avoid infecting other parts of your body with the virus and to prevent infecting others, it is essential that when you have a cold sore:

• Avoid kissing, especially children.
• Avoid oral sex.
• Use your own towels and napkins and do not share utensils, glasses, cups, etc.
• Avoid breaking blisters or touching sores, as this will prolong healing time.
• Avoid touching your eyes, as the virus can cause a serious condition if it reaches your eye.

Do not give this cream to others, 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 medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Normally, the adverse effects produced by Fenivir are mild.

Some frequent adverse effects (which may affect up to 1 in 10 patients) are: burning, itching, or numbness when the cream is applied. However, these effects usually disappear quickly.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the tube and on the box after “Expiration Date”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Do not freeze.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fenivir cream

The active ingredient is penciclovir. 1 gram of Fenivir contains 10 mg of penciclovir.

The other components are: white soft paraffin, liquid paraffin, cetoestearic alcohol, propylene glycol, cetomacrogol 1000 and purified water.

Appearance of the product and content of the container

Fenivir is a white, fluid, homogeneous cream, presented in 2 g aluminum tubes.

They may be presented in a container that contains 20 single-use applicators.

Only some types of containers may be marketed.

Holder of the marketing authorization

Perrigo España, S.A.

Xavier Cugat Square, 2 - Building D, 1st floor

08174 Sant Cugat del Vallès (Barcelona)

Responsible for manufacturing

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 with the following names:

IrelandVectavir cold sore cream

BelgiumVectavir 1%, cream

FinlandVectavir 1% emulsiovoide

GreeceFenivir

LuxembourgVectavir 1%, cream

PortugalFenivir, 10 mg/g, cream

SpainFenivir 10 mg/g cream

United KingdomVectavir Cold Sore Cream

This leaflet was approved in November 2020.

Last revision of this leaflet: July 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es