PENCIVIR

PENCIVIR for cold sores cream

Important notes (mandatory information)

Pencivir for cold sores. Active ingredient: Penciclovir. Areas of application: for the palliative treatment of pain and itching and to accelerate crust formation during the natural healing process of acute episodes of mild forms of recurrent cold sores (recurrent herpes labialis).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Pencivir for cold sores
Active ingredient: Penciclovir 10 mg/g cream

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in the package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you do not feel better or if you feel worse after 4 days, contact your doctor.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What this package leaflet contains

1. WHAT IS PENCIVIR FOR COLD SORES AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING PENCIVIR FOR COLD SORES?
3. HOW SHOULD PENCIVIR FOR COLD SORES BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PENCIVIR FOR COLD SORES BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PENCIVIR FOR COLD SORES AND WHAT IS IT USED FOR?

Pencivir for cold sores is a medicine whose active ingredient inhibits the growth of certain viruses (virostatic). If you do not feel better or if you feel worse after 4 days, contact your doctor. Area of application: for the palliative treatment of pain and itching and to accelerate crust formation during the natural healing process of acute episodes of mild forms of recurrent cold sores (recurrent herpes labialis).

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING PENCIVIR FOR COLD SORES?

Pencivir for cold sores must not be used if you have previously experienced a contact allergy after using creams containing aciclovir or Pencivir for cold sores or if you are known to be allergic to penciclovir or any of the other ingredients of Pencivir for cold sores listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Pencivir for cold sores. Pencivir for cold sores should only be used on cold sores on the lip and around the mouth. Application to mucous membranes (e.g. in the eyes, mouth, nose or genitals) is not recommended. Immunocompromised patients in particular (e.g. AIDS patients or bone marrow transplant recipients) should be advised to see a doctor in case oral therapy is indicated. No other special precautions are necessary during the use of Pencivir for cold sores. If you are not sure whether you have cold sores (herpes labialis), ask your doctor for advice.

Children

No studies have been conducted in children under 12 years of age.

Use of Pencivir for cold sores with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. There is no evidence of interactions between Pencivir for cold sores and other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor for advice before using this medicine. Since the systemic availability of penciclovir after topical application is minimal, a risk to pregnant and breast-feeding mothers when using Pencivir for cold sores is unlikely. There is no information on whether penciclovir passes into breast milk. Since there is insufficient experience to date, Pencivir for cold sores should only be used during pregnancy and breast-feeding under the supervision of a doctor and after careful consideration of the benefits and risks.

Driving and using machines

No effects are known.

Pencivir for cold sores contains cetyl stearyl alcohol and propylene glycol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation.

3. HOW SHOULD PENCIVIR FOR COLD SORES BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is:

Adults (including the elderly) and adolescents over 12 years of age

Please use Pencivir for cold sores as soon as possible after the first symptoms of the disease appear (e.g. burning, itching). However, if blisters have already formed, you can still start using Pencivir for cold sores, as even later use accelerates the healing process and shortens the duration of pain. You should apply Pencivir for cold sores thinly to the infected skin areas with a clean finger at 2-hour intervals (at least 6 times a day) while you are awake. Alternatively, you can also use a cotton swab that has been coated with the amount of cream required for the size of the affected skin area. If you apply Pencivir for cold sores with your finger, please wash your hands thoroughly before and after applying the cream. You should apply the cream after eating. If you have accidentally rubbed off the cream within one hour of application, you should apply an additional application.

Use in children under 12 years of age

No studies have been conducted in children under 12 years of age.

Method of administration

For application to the skin.

Duration of use

You should continue treatment with Pencivir for cold sores for a total of 4 days (corresponding to 96 hours). Please adhere to this time even if you feel better earlier. Please do not discontinue treatment even if there is no significant improvement immediately. If the skin condition worsens during treatment with Pencivir for cold sores, please discontinue treatment and consult your doctor. You should also talk to your doctor if your cold sores do not heal properly after treatment with Pencivir for cold sores.

Please talk to your doctor or pharmacist if you have the impression that the effect of Pencivir for cold sores is too strong or too weak.

If you have used more Pencivir for cold sores than you should

If you have applied more than you should, remove the excess cream from the skin with a cloth. If you have applied a large amount of Pencivir for cold sores to the skin at once, no harmful effects are to be expected other than mild skin irritation (see "Side effects"). If Pencivir for cold sores has been accidentally swallowed once, no harmful effects are to be expected other than irritation in the area of the oral mucosa. In both cases, no special treatment is necessary. If you are still concerned, please contact your doctor or pharmacist.

If you forget to use Pencivir for cold sores

If you have forgotten to apply your Pencivir for cold sores once or twice at the intended time, do so as soon as possible (longer breaks may affect the effect). The next applications should then be made every 2 hours again.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

General disorders and administration site conditions

Commonly, reactions may occur at the treated skin areas (including burning and pain on the skin, numbness).

Immune system disorders

Frequency not known: Hypersensitivity reactions, hives.

Skin and subcutaneous tissue disorders

Frequency not known: Allergic dermatitis (including rash, itching, blisters and oedema).

If you notice any side effects, please inform your doctor or pharmacist immediately so that they can determine the severity and decide on any necessary further measures or advise you.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD PENCIVIR FOR COLD SORES BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and tube. Note on shelf life after first opening: Shelf life after first opening: 12 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pencivir for cold sores contains

The active substance is: 10 mg penciclovir in 1 g cream. The other ingredients are: Propylene glycol; purified water; white petrolatum; cetyl stearyl alcohol; liquid paraffin; cetomacrogol 1000.

What Pencivir for cold sores looks like and contents of the pack

Pencivir for cold sores is a white cream and is available in packs of 2 g cream.

Pharmaceutical entrepreneur

Omega Pharma Deutschland GmbH
Benzstraße 25
71083 Herrenberg

Manufacturer

Omega Pharma International NV
Venecoweg 26
9810 Nazareth
Belgium

Medgenix Benelux NV
Vliegveld 21
8560 Wevelgem
Belgium

This package leaflet was last revised in September 2016.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Penciclovir. Areas of application: for the palliative treatment of pain and itching and to accelerate crust formation during the natural healing process of acute episodes of mild forms of recurrent cold sores (recurrent herpes labialis).