CLABIN

CLABIN plus solution

Important notes (mandatory information)

Clabin plus, solution. Areas of application: for external treatment of warts.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Clabin plus, solution for application to the skin
Active ingredients: salicylic acid, lactic acid

Read the entire package leaflet carefully because it contains important information for you. This medicine is also available without a prescription. However, in order to achieve the best possible treatment results, Clabin plus must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If your condition worsens or does not improve after 4 – 6 weeks, you must see a doctor in any case.
• If any of the listed side effects affect you significantly or if you notice side effects that are not listed in this package leaflet, please inform your doctor or pharmacist.

The package leaflet contains

1. WHAT IS CLABIN PLUS AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING CLABIN PLUS?
3. HOW TO USE CLABIN PLUS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CLABIN PLUS?
6. FURTHER INFORMATION

1. WHAT IS CLABIN PLUS AND WHAT IS IT USED FOR?

Clabin plus is a medicine for the external treatment of warts.

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING CLABIN PLUS?

Clabin plus must not be used:

• if you are hypersensitive to the active ingredients salicylic acid or lactic acid as well as salicylates or any of the other ingredients of Clabin plus.
• in infants.
• in patients with renal insufficiency.
• in nursing mothers if large areas of skin are to be treated regularly.

Special care is required when using Clabin plus

Clabin plus should not be used on the face or genital area. Do not bring into contact with eyes and mucous membranes. In case of doubt, a doctor should be consulted. Warts are contagious! To prevent the spread of infection, your own towel should never be shared with others. Do not walk barefoot if you have foot warts.

When using Clabin plus with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken other medicines, even if they are non-prescription medicines. Salicylic acid can increase the absorption of other topically applied medicines through the skin. The absorbed salicylic acid delays the breakdown of methotrexate and enhances the effect of sulfonylureas.

Pregnancy and breast-feeding

Clabin plus may only be used on a small area (area less than 5 cm2) during pregnancy. Clabin plus must not be used on the nursing breast. Accidental ingestion of Clabin plus by the infant through contact with the treated area of the body must be avoided. Should the doctor consider regular treatment of large areas of skin with Clabin plus to be necessary, breastfeeding should be stopped early, as risks due to insufficient detoxification in newborns cannot be ruled out. Ask your doctor or pharmacist for advice before using any medicine.

3. HOW TO USE CLABIN PLUS?

Always use Clabin plus exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Clabin plus is intended for application to the skin.

Unless otherwise prescribed by your doctor, the usual dose is

Apply Clabin plus 2 to 4 times daily to the wart(s). Clabin plus solution should not come into contact with the healthy skin surrounding the wart. You can protect it with a greasy cream. Allow the treated areas of skin to dry. Before reapplying, the existing film should be removed by peeling or rubbing off. With regular use, the softened horny layer can be easily removed after a few days, if necessary after a hot soapy bath. This process is repeated until the wart is removed or falls off.

The use of Clabin plus over a period of 4 to 6 weeks is normally sufficient. Do not use Clabin plus for longer than 1 week without medical advice. The maximum daily dose for adults of 2 g must not be used for longer than 1 week. For children, the daily dose of 0.2 g must not be exceeded.

Please talk to your doctor or pharmacist if you have the impression that the effect of Clabin plus is too strong or too weak.

If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Clabin plus can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of 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.

Clabin plus occasionally causes slight burning and, with more frequent applications, also more severe burning, especially on the skin surrounding the wart. Furthermore, the following have been described in very rare cases: hypersensitivity reactions on the skin (allergic contact dermatitis), dilation of small, superficial skin vessels (telangiectasias), brown spots, photosensitivity with the occurrence of skin reactions after exposure to sunlight (photosensitization), skin inflammation (dermatitis), thinning of the upper skin layers, pigmentation, depigmentation. In case of excessive irritation, treatment should be interrupted in the meantime and resumed after the reaction has subsided. In the case of more serious side effects than irritation, please consult a doctor.

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, 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 CLABIN PLUS?

Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the bottle and the folding box. The expiry date refers to the last day of the month. Do not store above 25°C. Caution, highly flammable! Keep away from naked flames. Close Clabin plus tightly after use and make sure that there is no more solution on the neck of the bottle. This prevents Clabin plus from crystallizing and the opening from sticking together. Note on shelf life after opening: Clabin plus has a shelf life of 4 months after opening.

6. FURTHER INFORMATION

10 g Clabin plus solution for application to the skin contains

Active ingredients: lactic acid (Ph. Eur.) 1.67 g, salicylic acid (Ph.Eur.) 1.67 g. The other ingredients are: elastic collodion (consisting of ethanol, ether, pyroxylin, rosin, castor oil).

Clabin plus is available in packs of 15 ml solution.

Pharmaceutical entrepreneur:
Omega Pharma Deutschland GmbH
Benzstraße 25
71083 Herrenberg

Manufacturer

Famar Nederland B.V.
Industrieweg 1
5531 AD Bladel
Netherlands

This package leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 02/2021
Areas of application: for external treatment of warts.