ZOVIRAX

ZOVIRAX Cold Sore Cream

Important notes (mandatory information)

Zovirax Cold Sore Cream. Active ingredient: Aciclovir. Areas of application: for the symptomatic treatment of pain and itching and to accelerate crust formation during the natural healing process of acute episodes 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

Zovirax Cold Sore Cream
Active ingredient: Aciclovir

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Zovirax Cold Sore Cream must be used as directed to ensure the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 10 days, you must see a 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.

1. WHAT IS ZOVIRAX COLD SORE CREAM AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING ZOVIRAX COLD SORE CREAM?
3. HOW TO USE ZOVIRAX COLD SORE CREAM? WHAT SIDE EFFECTS ARE POSSIBLE?
4. HOW TO STORE ZOVIRAX COLD SORE CREAM?
5. FURTHER INFORMATION

1. WHAT IS ZOVIRAX COLD SORE CREAM AND WHAT IS IT USED FOR?

Zovirax Cold Sore Cream is a topical medicine that inhibits the growth of certain viruses (virostatic, virus-DNA polymerase inhibitor). Area of application: Zovirax Cold Sore Cream is used for the symptomatic treatment of pain and itching and to accelerate crust formation during the natural healing process of acute episodes of recurrent cold sores (recurrent herpes labialis).

2. WHAT YOU NEED TO KNOW BEFORE USING ZOVIRAX COLD SORE CREAM?

Zovirax Cold Sore Cream must not be used:

• if you are hypersensitive (allergic) to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of Zovirax Cold Sore Cream.
• for a skin infection other than cold sores, e.g. genital herpes or inflammation in the mouth or nose.

Special care must be taken when using Zovirax Cold Sore Cream:

• if you are not sure whether you have cold sores. Ask your doctor for advice.
• if the blisters have not crusted over or healed after 10 days of treatment at the latest or if your herpes infection even gets worse, please see a doctor.
• in case of contact with the eye. If you accidentally get cream in your eye, rinse it thoroughly with warm water and consult your doctor if you have any concerns.
• if the disease progresses more severely. In this case, please consult your doctor.
• in patients who are acutely suffering from cold sores. They should avoid spreading the virus, especially if the wound is open.
• when applied to mucous membranes (e.g. in the oral cavity, on the eye or in the vagina), as local irritation can otherwise be expected.
• if you have severe disorders of the body's own immune system (e.g. in the case of a bone marrow transplant or AIDS) or severe forms of recurrent herpes labialis. Please consult a doctor before starting treatment.

When using Zovirax Cold Sore Cream with other medicines

No interactions are known. Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines.

When using Zovirax Cold Sore Cream with food and drink

No interactions are known.

Pregnancy

If you are pregnant or think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using Zovirax Cold Sore Cream. Use during pregnancy should be after weighing the benefits and possible risks.

Breastfeeding

Aciclovir passes into breast milk. However, the dose that a child would receive after application of Zovirax Cold Sore Cream through breastfeeding is negligible. Zovirax Cold Sore Cream should only be used during breastfeeding after consulting your doctor or pharmacist.

Driving and using machines

No impairments are known.

Important information about certain other ingredients of Zovirax Cold Sore Cream

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

3. HOW TO USE ZOVIRAX COLD SORE CREAM?

Always use Zovirax Cold Sore Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Apply Zovirax Cold Sore Cream at the first signs of herpes (burning, itching, tension, redness, swelling or blisters). To achieve the greatest possible treatment success, Zovirax Cold Sore Cream should be used before and during the blister phase. Unless otherwise prescribed by your doctor, the cream is applied thinly to the infected and adjacent skin areas 5 times a day every 4 hours during the day.

Type of application

Zovirax Cold Sore Cream can be applied either with a clean finger or with a cotton swab by spreading it with an amount necessary for the size of the infected skin areas. When applying, care should be taken to ensure that not only the already visible signs of herpes (blisters, swelling, redness) are covered with the cream, but that adjacent areas are also included in the treatment. If applied by hand, it should be washed thoroughly before and afterwards to prevent additional infection of the damaged skin area or transmission to other people.

Duration of application

The duration of treatment is generally 4 days. If the skin symptoms worsen during treatment or if the blisters have not crusted over or healed after 10 days of treatment at the latest, please discontinue treatment and consult a doctor.

If you have used more Zovirax Cold Sore Cream than you should

If you accidentally apply too much or swallow cream, no negative effects are to be expected. However, if you have swallowed a large amount of cream, please talk to your doctor or pharmacist.

If you forget to use Zovirax Cold Sore Cream

Continue the application as described as soon as you remember. Do not use double the amount of Zovirax Cold Sore Cream.

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, Zovirax Cold Sore Cream can have 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.

If you are affected by any of the following side effects, stop using Zovirax Cold Sore Cream and see your doctor immediately.

Skin and subcutaneous tissue disorders

Uncommon:

• temporary burning or stinging on the treated skin areas
• drying, itching and flaking of the treated skin

Rare:

• redness
• occurrence of contact dermatitis. Contact dermatitis can be recognized by the fact that the above-mentioned side effects occur more frequently and extend beyond the skin areas treated with the cream.

Immune system disorders
Very rare:

• sudden hypersensitivity reactions including angioedema (Quincke's edema, pale swelling of the skin, especially in the facial area).

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, Department 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 TO STORE ZOVIRAX COLD SORE CREAM?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the tube and folding box after "Use by". The expiry date refers to the last day of the month. Storage conditions: Do not refrigerate or store.

6. FURTHER INFORMATION

What Zovirax Cold Sore Cream contains

The active ingredient is: Aciclovir. 1 g of cream contains 50 mg of aciclovir. The other ingredients are: propylene glycol, white petrolatum, cetyl stearyl alcohol (Ph. Eur.), liquid paraffin, glycerol monostearate, macrogol stearate 100, poloxamer 407, sodium dodecyl sulfate, dimethicone 20, purified water.

Available pack sizes

Packs of 2 g cream.

Pharmaceutical entrepreneur

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich

Address:
Barthstraße 4
80339 Munich
Tel.: (089) 78 77-209
Fax: (089) 78 77-304
E-mail: medical.contactcenter@gsk.com

Manufacturer

Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)
Harmire Road, Barnard Castle
Durham, DL12 8DT
United Kingdom

This package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Aciclovir. Areas of application: for the symptomatic treatment of pain and itching and to accelerate crust formation during the natural healing process of acute episodes of recurrent cold sores (recurrent herpes labialis).