ACICLOVIR AL

ACICLOVIR AL Cream

Important notes (mandatory information)

Aciclovir AL Cream Areas of application: for the soothing treatment of pain and itching in frequently recurring herpes infections with blistering in the lip area (recurrent herpes labialis).

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


Patient information: Information for the user
Aciclovir AL Cream
Active ingredient: Aciclovir 50 mg/g cream

Read all of this leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.
o Keep this leaflet. You may need to read it again later.
o Ask your pharmacist if you need more information or advice.
o If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
o If you do not feel better or if you feel worse after 10 days, contact your doctor.

What this leaflet contains

1. WHAT IS ACICLOVIR AL CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ACICLOVIR AL CREAM?
3. HOW TO USE ACICLOVIR AL CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ACICLOVIR AL CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ACICLOVIR AL CREAM AND WHAT IS IT USED FOR?
The active ingredient in Aciclovir AL Cream inhibits the multiplication of herpes viruses (virustatic). Aciclovir AL Cream is used for the soothing treatment of pain and itching in frequently recurring herpes infections with blistering in the lip area (recurrent herpes labialis).

2. WHAT SHOULD YOU CONSIDER BEFORE USING ACICLOVIR AL CREAM?
Aciclovir AL Cream must NOT be used if you are allergic to aciclovir, valaciclovir, propylene glycol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please note the following warnings before and during treatment with Aciclovir AL Cream

o The cream must not be applied to mucous membranes (e.g. in the oral cavity, on the eye or in the vagina), as local irritation can otherwise be expected. In particular, accidental contact of the cream with the eyes must be avoided.
o If you have a severe disorder of the body's immune system (e.g. AIDS or after bone marrow transplants), you must talk to a doctor before starting treatment. In this case, he or she may prescribe aciclovir in tablet form.

Use of Aciclovir AL Cream together with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. No clinically significant interactions have been identified to date.

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 or pharmacist for advice before using this medicine.
Pregnancy
Aciclovir AL Cream should only be used during pregnancy after careful consideration of the benefits and risks. Therefore, please talk to a doctor before using Aciclovir AL Cream.
Breast-feeding
Aciclovir is hardly absorbed by the body after external application to healthy skin. The dose that a child would absorb through breast-feeding after application of Aciclovir AL Cream to the mother is therefore low. If Aciclovir AL Cream is used during breast-feeding, contact between the breast-fed child and the treated areas of the body should be avoided.

Driving and using machines
So far, no effects on the ability to drive and use machines have become known.

Aciclovir AL Cream contains cetyl alcohol and propylene glycol. Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation.

3. HOW TO USE ACICLOVIR AL CREAM?
Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is: The cream is applied thinly to the infected skin areas 5 times a day every 4 hours during the day.

Type of application
Aciclovir AL Cream should be applied using a cotton swab by coating it with the 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 the cream is applied by hand, it should be washed thoroughly before and afterwards to prevent additional infection of the damaged skin areas, e.g. by bacteria or transmission of the viruses to mucous membranes and skin areas that are not yet infected.

Duration of use
The duration of treatment is generally 5 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, treatment should be discontinued and a doctor should be consulted. The attending physician decides on the duration of use. Please adhere to these times even if you are already feeling better.

If you forget to use Aciclovir AL Cream
If you forget to use it once, continue using it as prescribed afterwards (e.g. do not apply the cream more often or more thickly).

If you stop using Aciclovir AL Cream
It is important to use Aciclovir AL Cream for a sufficient period of time for successful treatment.

If you have any further questions about 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.

Occasional side effects (affect 1 to 10 in 1000 people)

o temporary burning or stinging on the treated skin areas
o drying and flaking of the skin treated with the cream
o itching.

Rare side effects (affect 1 to 10 in 10000 people)

o redness
o allergic skin reaction (contact dermatitis). If allergological tests were carried out, in most cases the other components of the cream base and not the active ingredient aciclovir proved to be the cause of the skin reaction. Contact dermatitis can be recognised by the fact that skin reactions occur more frequently and extend beyond the skin areas treated with cream. In such cases, please talk to your doctor.

Very rare side effects (affect less than 1 in 10000 people)

o immediate hypersensitivity reactions including angioedema (swelling of the skin or mucous membrane e.g. of the face, lips or tongue with difficulty swallowing or breathing) and hives (urticaria).

In the event of severe hypersensitivity reactions, inform a doctor immediately!

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 leaflet. You can also report side effects directly

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 TO STORE ACICLOVIR AL CREAM?
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 after "Use by". The expiry date refers to the last day of the month indicated. Do not store above + 25°C. After opening, Aciclovir AL Cream can be stored for 12 months if stored properly.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Aciclovir AL Cream contains
The active ingredient is aciclovir. 1 g of cream contains 50 mg of aciclovir. The other ingredients are: cetyl alcohol (Ph. Eur.), dimethicone 350cSt, macrogolglycerol stearate (Ph.Eur.), liquid paraffin, propylene glycol, white petrolatum, purified water.

What Aciclovir AL Cream looks like and contents of the pack
White to almost white homogeneous cream. Aciclovir AL Cream is available in packs of 2 g cream.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel

This leaflet was last revised in January 2014.

Source: Information from the package leaflet
Status: 11/2014
Areas of application: for the soothing treatment of pain and itching in frequently recurring herpes infections with blistering in the lip area (recurrent herpes labialis).