ACYCLOVIR STADA KRĒMS 5% 5G

ATC code: D06BB03 

Active substances: Aciclovirum

Vendor, principal: Stada Arzneimittel Ag. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ACYCLOVIR STADA 50MG/1G 5G

Package leaflet: Information for the user

Acyclovir STADA, 50 mg/g 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 or advice.
-   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 10 days.

What is in this leaflet

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

1.   What Acyclovir STADA is and what it is used for

Acyclovir STADA is an anti-viral medicine.
Acyclovir STADA is used for treating frequently recurring herpes on facial skin and lips. Early treatment with Acyclovir STADA cream can prevent the full breakout of herpes. If herpes has already developed on the skin, using aciclovir cream can accelerate the healing process.

2.   What you need to know before you use Acyclovir STADA Do not use Acyclovir STADA

-   if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6);
-   to prevent local irritation, Acyclovir STADA should not be applied onto mucous membranes (e.g. mouth, vaginal mucous membrane or the eye).

Warnings and precautions

Talk to your doctor or pharmacist before using Acyclovir STADA. If you have severe immunodeficiency (i.e. severe immune system damage), be sure to talk to your doctor before beginning treatment.

Other medicines and Acyclovir STADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions with any other medicines have currently been reported.

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 taking this medicine.
Pregnancy
Limited experience with using aciclovir tablets during pregnancy has shown no aciclovir-related effects on pregnancy or the health of the foetus/newborn. Acyclovir STADA can be used during pregnancy only after careful evaluation of the risks and benefits.
Breast-feeding
The amount of aciclovir absorbed into the organism after external use on healthy skin is negligible. Thus, if the mother has used Acyclovir STADA, the amount passed on to the baby while breastfeeding is low. If Acyclovir STADA is used while breast-feeding, care should be taken to prevent the baby from coming into contact with the treated areas.

Driving and using machines

No effects on the ability to drive or use machines have been reported.
Acyclovir STADA contains cetyl alcohol and propylene glycol.
Cetyl alcohol may cause local skin irritation (so-called contact dermatitis). Propylene glycol may cause skin irritation.

3. How to use Acyclovir STADA

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.

The recommended dose is:

Apply a thin layer of cream onto the infected area of skin 5 times a day, every 4 hours. Instructions of use
Use a cotton bud to take enough cream to cover the infected area/areas. When applying Acyclovir STADA, make sure to cover not only areas with visible symptoms of a herpes infection (blisters, swelling, redness), but also the surrounding areas. In case you use your hand(s) to apply Acyclostad STADA, make sure to wash your hands thoroughly both before and after applying the cream to prevent the infection from spreading to the damaged areas of skin (e.g. by bacteria or other micro organisms), as well as to other uninfected mucous membranes or areas of skin.
Attention!
For the best results, treatment with Acyclovir STADA should begin as early as possible, i.e. as soon as you notice the first signs of herpes (burning sensation, itchiness, discomfort, redness). If the blisters have already scabbed or healed, anti-viral treatment with Acyclovir STADA will no longer have any effect.
Duration of use
The treatment usually lasts for 5 days, but the duration may vary in different individuals and the treatment may continue until the blisters have scabbed or completely healed. However, the treament should not last for longer than 10 days.
If you feel that the effect of Acyclovir STADA is too strong or too weak, talk to your doctor or pharmacist.

If you forget to use Acyclovir STADA

If you are unable to treat the herpes in time, do so at the first opportunity and continue the treatment as before (do not apply the cream more frequently or in a thicker layer than usual).

If you stop using Acyclovir STADA

To ensure successful treatment, it is important to use Acyclovir STADA for a sufficiently long period of time (see also: How to use Acyclovir STADA
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following classifications are used for evaluating the frequency of side effects:

Very common:	more than 1 patient in 10
Common:	less than 1 patient in 10, but more than 1 in 100
Uncommon:	less than 1 patient in 100, but more than 1 in 1,000
Rare:	less than 1 patient in 1,000, but more than 1 in 10,000
Very rare:	at most 1 patient in 10,000
Unknown:	cannot be estimated from available data

Skin and subcutaneous tissue disorders
Uncommon: Acyclovir STADA can cause transient burning or prickling sensation in the treated area of skin. Occasionally, redness, dryness and flakiness of the skin treated with Acyclovir STADA has been observed.
Rare: redness, allergic skin reactions (contact dermatitis). In most cases when allergologic testing was carried out, the skin reaction was determined to be more likely caused by the pharmaceutical excipients used in the cream, rather than the active substance aciclovir. If the side effects listed above are clearly expressed and involve areas not treated with the cream, you may have contact dermatitis. In this case, talk to your doctor.
Immune system disorders
Very rare: Early hypersensitivity reactions, incl. angioedema (severe allergic reaction causing swollen face or throat).

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 alsoreport side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Acyclovir STADA

5.

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
After the initial opening of the tube, use within 12 months.
Do not use this medicine after the expiry date which is stated on the tube and 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 Acyclovir STADA contains

The active substance is aciclovir.
1 g of cream contains 50 mg of aciclovir.
The other ingredients are:
dimeticone, macrogol glycerol stearate, cetyl alcohol, liquid paraffin, propylene glycol, white vaseline, purified water.

What Acyclovir STADA looks like and contents of the pack

White homogenic cream
One original package contains 5 g of cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Almar Sehver Tartu mnt 16 10117 Tallinn Phone 6605910 [email protected].

This leaflet was last revised in November 2016