ACICLOSTAD

ACICLOSTAD cream for cold sores

Important notes (mandatory information)

Aciclostad for cold sores. Active ingredient: Aciclovir. Areas of application: for the symptomatic 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 consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Aciclostad, for the symptomatic treatment of pain and itching in the lip area
Active ingredient: Aciclovir

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.

• Keep the leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• 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.
• If you do not feel better or if you feel worse after 10 days, contact your doctor.

What this leaflet contains

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

1. WHAT IS ACICLOSTAD AND WHAT IS IT USED FOR?

Aciclostad is a medicine for the treatment of viral infections (virostatic).

Aciclostad is used:

• for the symptomatic 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 ACICLOSTAD?

Aciclostad must NOT be used:

• if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine.

Warnings and precautions

Please note the following warnings before and during treatment with Aciclostad:

• The cream must not be applied to mucous membranes (e.g. in the oral cavity, on the eye or in the vagina), as otherwise local irritation can be expected.

In particular, accidental contact of the cream with the eyes should be avoided.

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 Aciclostad 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

breastfeeding

If you are pregnant or breastfeeding, 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

Aciclostad should only be used during pregnancy after careful consideration of the benefits and risks. Therefore, please talk to a doctor before using Aciclostad.

Breastfeeding

Aciclovir is hardly absorbed by the body after external application to healthy skin. The dose that a child would absorb through breastfeeding after application of Aciclostad cream to the mother is therefore low. If Aciclostad cream is used during breastfeeding, contact between the breastfed 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.

Aciclostad contains cetyl alcohol and propylene glycol Cetyl alcohol can cause local skin irritation (e.g. contact dermatitis).

This medicine contains 150 mg propylene glycol per 1 g cream. Propylene glycol can cause skin irritation. Do not use this medicine on babies under 4 weeks of age with open wounds or extensive skin injuries or damage (such as burns) without consulting your doctor or pharmacist.

3. HOW TO USE ACICLOSTAD?

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

You should apply the cream thinly to the affected skin areas 5 times a day at 4-hour intervals during the day.

Type of application

When applying Aciclostad, you must observe the following:

• You should apply Aciclostad using a cotton swab by coating it with the amount necessary for the size of the affected skin areas.
• When applying, you should make sure that you not only cover the already visible signs of herpes (blisters, swelling, redness) with the cream, but that you also include adjacent areas in the treatment.
• If you apply the cream by hand, you should clean your hands thoroughly before and afterwards to prevent additional infection of the damaged skin area (e.g. by bacteria) or transmission of the viruses to mucous membrane and skin areas that are not yet infected.

Special note

To achieve the greatest possible treatment success, Aciclostad should be used at the first signs of herpes (burning, itching, tension and redness). If the blisters are crusted or healed, antiviral treatment with Aciclostad is no longer useful.

Duration of use

The duration of treatment is generally 5 days. In individual cases, treatment should be continued until the blisters are crusted or healed. However, a treatment period of 10 days should not be exceeded.

If you forget to use Aciclostad

Continue treatment as prescribed (e.g. do not apply the cream more frequently or more thickly).

If you stop using Aciclostad:
For successful treatment, it is important to use Aciclostad for a sufficient period of time.

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 1,000 people treated):

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

Rare side effects (affect 1 to 10 in 10,000 people treated):

• redness
• Allergic skin reaction (contact dermatitis). If allergological tests were carried out, in most cases the other ingredients 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 10,000 people treated):

• 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 urticaria (hives).

In the case 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 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 about the safety of this medicine.

5. HOW TO STORE ACICLOSTAD?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "use by" or "exp". The expiry date refers to the last day of the month indicated.

Do not store above +25ºC. The medicine can be stored for 12 months after opening the container.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Aciclostad for cold sores 50 mg per 1 g cream contains: 1 g cream contains 50 mg aciclovir.

The active ingredient is:
Aciclovir. 1 g cream contains 50 mg aciclovir.

The other ingredients are

Cetyl alcohol (Ph.Eur.), dimethicone 350cSt, macrogolglycerolstearates (Ph.Eur.) (1500 g/mol), liquid paraffin, propylene glycol, white petrolatum, purified water.

What Aciclostad for cold sores 50 mg per 1 g cream looks like and contents of the pack

White to almost white homogeneous cream.

Aciclostad for cold sores 50 mg per 1 g cream is available in packs of 2 g cream.

Pharmaceutical entrepreneur

STADA Consumer Health Deutschland GmbH
Stadastraße 2-18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel

This leaflet was last revised in August 2020.

Source: Information from the package leaflet
Status: 01/2025
Active ingredient: Aciclovir. Areas of application: for the symptomatic treatment of pain and itching in frequently recurring herpes infections with blistering in the lip area (recurrent herpes labialis).