Vobamyk cream, 20 g

Instructions for use for Vobamyk cream, 20 g

Important notes (compulsory information):

Vobamyk cream. Active substance: Miconazol nitrate. Application areas: For the treatment of superficial mushroom diseases of the skin and by gram-positive bacteria infected skin diseases caused by Miconazole sensitive pathogens.

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


LEAFLET: INFORMATION FOR THE USER

Vobamyk cream
Active substance: Miconazol nitrate

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet or exactly as your doctor's or pharmacist instructions.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse after 4 to 6 weeks, contact your doctor.

What is in this leaflet

1. What is Vobamyk and what is it used for?
2. What should you consider before using Vobamyk?
3. How is vobamyk to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Vobamyk?
6. Content of the pack and further information

1. What is Vobamyk and what is it used for?

Vobamyk is an imidazole antimycotic with antibacterial effect. Vobamyk is used to treat superficial fungal diseases of the skin and by gram-positive bacteria infected skin diseases caused by Miconazole sensitive pathogens.

2. What should you consider before using Vobamyk?

Vobamyk must not be used if they allergic to miconazole nitrate, related fungal-picking drugs (other imidazole derivatives such as cletrimazole) or one of the section 6. other ingredients of this medicine are.

Warnings and Precautions:
Please talk to your doctor or pharmacist before applying Vobamyk. Avoid contact with eyes, mucous membranes and open wounds.

Application of Vobamyk together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / use other medicines. With simultaneous use of Vobamyk in the genital or anal range and latex products (e.g., condoms, diaphragms), it may be due to the ingredient included "White Vaselin" to reduce the functionality and thus to impair the security of these products. In the simultaneous use of vobamyk and the intake of blood clotting inhibitors containing warfarin, it can cause interactions in rare cases. Therefore, blood clotting should be monitored.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before applying this medicine.

Pregnancy:
Since there is no sufficient experience in pregnant women about the use of Vobamyk, pregnancy caution is required in the first 12 weeks.

Latving:
During lactation, Vobamyk should not be used in the chest area.

Driving and ability to operate machines:
There are no special precautions required. Vobamyk contains stearyl alcohol and propylene glycol stearyl alcohol and propylene glycol can locally limited skin irritation (e.g., Contact dermatitis.

3. How to use Vobamyk?

Always use this medicine as described in this leaflet or exactly after the arrangement made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: Wear Vobamyk twice daily thinly on the affected skin districts.

Duration of application:
The application time of local antimycotics with the skin of the skin is individually different. Basically, Vobamyk should be applied beyond the healing at least one week. The average application time is - depending on the localization of skin disease - 4 to 6 weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of Vobamyk is too strong or too weak.

If you have used a larger amount of Vobamyk than you should:
The excessive application of Vobamyk can lead to skin irritations. A brief interruption of therapy or a reduced frequency of applications can be solved.

If you forget the application of Vobamyk:
Get a forgotten application, and continue the therapy in the usual way. Do not turn twice the amount if you forget the previous application.

If you cancel the application of Vobamyk:
With insufficiently long treatment, the fungal disease can replace or occur again (relapse). Always contact your doctor if you want to cancel the treatment.

If you have further questions about the application of this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. If you notice one of the following side effects, finish the application of Vobamyk and contact your doctor immediately: swelling of face, tongue or neck; Difficulties while swallowing; Hives and breathing difficulties (angioedema, anaphylactic reactions).

Possible side effects:
Rarely (1 to 10 treated from 10,000):
Hives (urticaria), contact dermatitis, rash, redness, itching (pruritus), burning on the skin.

Very rare (less than 1 treated from 10,000):
Anaphylactic reaction, hypersensitivity reaction, angioedema.

If side effects occur, you should discontinue Vobamyk and consult a doctor so that this is about the severity and possibly can decide on required further measures.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Vobamyk?

Keep this medicine inaccessible to children. You may not use this medicine after the expirable date specified on the outer carton and the tube after "usable until". The expiry date refers to the last day of the specified month. Storage conditions: Do not store more than 25 ° C. Note on durability after breaking: Do not use Vobamyk for more than 6 months after opening the tube.

6. Content of the pack and more information

What Vobamyk contains:
The active ingredient is: Miconazol nitrate. 1 g cream contains 20 mg miconazole nitrate. The other ingredients are: medium-chain triglycerides; Glycerol monostearate 40-55; Stearyl alcohol (ph.eur.); Glycerol monostearate macrogol stearate 5000 (1: 1); Dimeticon 100; Propylene glycol; White vaseline; Purified water.

Like Vobamyk looks and content of the pack:
Vobamyk is a white to broken white cream. Vobamyk is available in packs with 20 g and 50 g cream.

Pharmaceutical entrepreneur and manufacturer:
Almirall Hermal GmbH
Scholtzstraße 3, 21465 Reinbek
Telephone: (040) 727 04 0
Fax: (040) 7229296
[email protected], www.almirall.de

This leaflet was last revised in September 2015.

Source: Information of the leaflet
Status: 12/2016