ACIC KRĒMS 5% 2G

ATC code: D06BB03 

Active substances: Aciclovirum

Vendor, principal: Hexal Ag/salutas Pharma Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ACIC 50MG/1G 2G

Package leaflet: Information for the user

Acic 5% cream

Aciclovir

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

1.   What Acic 5 % cream is and what it is used for
2.   What you need to know before you use Acic 5% cream
3.   How to use Acic 5% cream
4.   Possible side effects
5.   How to store Acic 5% cream
6.   Contents of the pack and other information

1.   What Acic 5 % cream is and what it is used for

Aciclovir is an anti-viral agent. Acic cream is used to treat Herpes simplex infections on the skin and lips (recurrent cold sores).
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2.   What you need to know before you use Acic 5% cream Do not use Acic cream:

-   if you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

-   It is not recommended to apply Acic cream on mucous membranes (e.g. mouth, eye, vagina), as this may cause irritation. Special care should be taken in order to prevent the cream from getting in the eye.
-   In the case of severe immunodeficiency (e.g. AIDS patients or after a bone marrow transplantation) and necessary oral tablet treatment, talk to your doctor before starting the treatment.
-   The excipient propylene glycol may cause skin irritation and the excipient cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
In the case of lesions, patients with cold sores should avoid transmitting the disease. To avoid the transmission of the infection, do not allow others to touch the infected area on your skin. Do not share your drinking vessels or dishes with others. The virus is also capable of infecting other areas of the body.
If your hands have come into contact with herpes, avoid touching your eyes, as the herpes virus can cause severe corneal ulcers.
In the case of very slowly healing and frequently recurring herpes, ask your doctor for advice for further actions.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

3. How to use Acic 5% cream

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For the best possible results, start using the medicine when you see the first signs of herpes (burning, itching, tension and redness).
Anti-viral treatment with Acic cream is no longer effective if the skin rash has already become covered with a scab.
Instructions for a single dose and daily doses
The cream should be applied onto the infected skin area in a thin layer five times a day, every four hours (except at night).
Method and duration of application
The Acic cream should be applied by using a cotton bud; the amount of cream on the cotton bud should correspond to the size of the infected area of skin.
When applying the cream, make sure to apply the cream not only onto the areas with visible signs of herpes (blisters, swelling, redness), but also to the surrounding areas.
If you use your fingers to apply the cream, wash your hands thoroughly before and after using the medicine in order to prevent the infection from spreading to other damaged areas of skin (e.g. by bacteria), as well as to uninfected mucous membranes and areas of skin.
The duration of the treatment is usually 4-5 days; if necessary, it can be used for up to 10 days. If the lesion has not disappeared after 10 days of treatment, talk to your doctor.
The treatment must continue until the blisters have scabbed or healed.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are grouped based on their incidence:
very common ≥ 1/10, common ≥ 1/100 and < 1/10, uncommon ≥ 1/1,000 and < 1/100, rare ≥ 1/10,000 and <1/1,000, very rare <1/10,000.
Skin and subcutaneous tissue disorders
Uncommon:   temporary burning or stinging sensation after applying the aciclovir cream.
Slight dryness or flaking of the skin.
Itchiness.
Rare:   redness of the skin. Post-application contact dermatitis. The reactions are more frequently
caused by the excipients, rather than aciclovir.
Immune system disorders
Very rare: hypersensitivity reactions, incl. angioedema and urticaria.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Acic 5% cream

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Acic 5% cream contains

-   The active substance is aciclovir. 1 g of cream contains 50 mg of aciclovir.
-   The other ingredients are: ICI - Arlaton 983 S Pharma; dimethicone 350; cetyl alcohol; liquid paraffin; white vaseline; propylene glycol; purified water.

What Acic 5% cream looks like and contents of the pack

The original package contains 2 g of cream.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Sandoz d.d.
Verovškova 57 1000 Ljubljana Slovenia
Manufacturer:
Salutas Pharma GmbH Otto-von Guericke-Allee 1 D-39179 Barleben Germany
or
Salutas Pharma GmbH Lange Göhren 3 D-39171 Osterweddingen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Sandoz d.d. Estonian branch Pärnu mnt 105 11312 Tallinn
Phone 6652 400
This leaflet was last revised in May 2014