Mycohaug C 3 vaginal cream, 20 g

Upute za korištenje Mycohaug C 3 vaginal cream, 20 g

Important notes (compulsory information):

Mycohaug C3 20 mg / g, vaginal cream. Active substance: Clotrimazole. Areas of application: In infectious discharge, caused by yeast fibroids; Inflammation of the vagina by mushrooms - mostly yeast fifles of the genus Candida - as well as overlapping infections (Superinfectations) with clotimazole-sensitive bacteria.

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


LEAFLET: INFORMATION FOR THE USER

Mycohaug C3 20 mg / g, vaginal cream
Active substance: Clotrimazole

Read the entire leaflet carefully before starting using this medicine, because it contains important information for you. 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 feel better or even worse after 4 days, contact your doctor.

What is in this leaflet:

1. What is Mycohaug C3 and what is it used for?
2. What should you be used before using Mycohaug C3 NOTE?
3. How is mycohaug C3 to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep mycohaug C3?
6. Content of the pack and more information

1. What is Mycohaug C3 and what is it used for?

Mycohaug C3 is a medicine for the treatment of fungal infections of the vagina. The drug clotimazole inhibits growth and proliferation of fungal cells, e.g. Spros mushrooms (yeasts) and a number of other fungi and some bacteria. Mycohaug C3 is applied to infectious discharge caused by yeast fibroids; Inflammation of the vagina by fungi - mostly yeast fuses of the genus Candida - as well as superimposed infections (superinfectures) with clotimazole-sensitive bacteria. If you feel better or even worse after 4 days, contact your doctor.

2. What should you consider before using Mycohaug C3?

Mycohaug C3 must not be used if they are allergic to clotrimazole or one of the other ingredients of this medicine mentioned in section 6.

Warnings and Precautions:
Please talk to your doctor or pharmacist before using Mykohaug C3: at fever (temperatures of 38 ° C and above), abdominal pain, back pain, poorly smelling vaginal outflow, nausea, vaginal bleeding and / or combined with shoulder pain you should consult a doctor.

Please consult your doctor:

• for the first appearance of the disease;
• if more than four such fungal infections occurred during the past 12 months.

Application of Mycohaug C3 together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / applied other medicines. With simultaneous treatment of vaginal applied clotimazole and oral tacrolimus (FK-506 Immunosuppressive) can lead to the increase in Tacrolimus and equally Sirolimus plasma levels. Patients should therefore be monitored carefully on symptoms of Tacrolimus or Sirolimus overdose; if necessary by determining the respective plasma concentration level.

Pregnancy, lactation and reproductive capability:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to be pregnant to become, ask your doctor or pharmacist for advice before applying this medicine. You can apply Mycohaug C3 during pregnancy and lactation, but only according to a physician's instructions. Studies on the influence of clotimazole on the propagatability of man are not available.

Driving and ability to operate machines:
Mycohaug C3 has no or a negligible influence on the ability to drive and the ability to operate machines.

Mycohaug C3 contains cetylstearyl alcohol:
Cetylstearyl alcohol can locally limited skin irritation (eg. B. Contact dermatitis). With simultaneous use with latex products (e.g., condoms, diaphragms), it may occur because of the auxiliaries contained (in particular stearates) to reduce the functionality and thus to impair the safety of these products. The effect is temporary and occurs only during treatment.

3. How is Mycohaug C3 to apply?

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. You should once daily - in the evening - on 3 consecutive days 1 Applicator filling (approx. 5 g) As described below, insert and empty as low as possible in the vagina.

Application of Mycohaug C3 with applicator:

1. Pull out the white piston from about 1 cm out of the pipe, and put it on the opened tube.
2. Fill the tube by careful pressing the tube until the piston is almost completely pushed out.
3. Take the applicator from the tube, insert it as low as possible in the vagina (best in supine), and empty it through pressure on the white piston.
4. Remove the applicator after use, and throw it away.

The treatment should not expediently not be carried out during menstruation or be completed before the beginning.

Duration of application:
A treatment at three consecutive days is usually sufficient to eliminate a fungal infection. If necessary, a second treatment cycle can be connected. In general, the signs of vaginal inflammation caused by fungi (such as itching, discharge, burning), significantly returned within the first four days after the start of treatment. If no significant improvement in the symptoms occurs after 4 days, please contact your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Mycohaug C3 is too strong or too weak.

If you forget the application of Mycohaug C3:
If you have forgotten the application in the evening, you can make up the application over the following morning. Next time, do not apply a larger amount of vaginal cream, but continue the treatment as recommended.

If you cancel the application of Mycohaug C3:
In order to achieve a complete healing of the infection and to prevent a relapse, you should not terminate or interrupt the treatment prematurely without consultation with your doctor. If you do this, a recurrence of the discomfort is to be feared, as your fungal infection is probably not healed correctly yet. The treatment should therefore not cancel after the decay of complaints, but consistently continue over 3 days.

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. As part of the application of clotimazole after approval, the following side effects were identified. Since these reactions voluntarily reported in an indefinite size of patient groups, an indication of the frequency based on the available data is not estimated.

Significantly side effects or characters to which you should pay attention and measures, whomn They are affected:
If you are affected by one of the side effects below, mycohaug C3 will not apply and look for your doctor as soon as possible.

• Allergic reactions (respiratory distress, powerlessness)
• Rash, genital skin release, edema, discomfort, pelvic pain, vaginal bleeding
• Abdominal pain

Other possible side effects:

• Allergic reactions (hives, hypotension)
• Itching, burning, skin smooth, skin irritation

At hypersensitivity to cetylstearyl alcohol, locally limited irritation of skin or mucosal can occur.

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 effectively over the Federal Institute for Medicinal Products and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, 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 mycohaug C3?

Keep this medicine inaccessible to children. You may follow this medicine after the on the folding box / tube "Usable until" stated expiry date no longer use. The expiry date refers to the last day of the specified month. This medicinal product does not require special storage conditions. The vaginal cream is stable after a break for 4 weeks. The medicine must not be in wastewater (to be disposed of over toilet or washbasin. No longer needed medicine can be given to household waste. You help to protect our environment.

6. Content of the pack and further information

What Mykohaug C3 contains:
The active ingredient is cletrimazole. 1 g of vaginal cream contains 20 mg clotrimazole. The other ingredients are: benzyl alcohol, cetyl palmitate (ph.eur.), Cetylstearyl alcohol (Ph.eur.), Diffluent paraffin, polysorbate 60, sorbitan stearate, purified water.

How Mycohaug C3 looks like and content of the pack:
White, shiny vaginal cream in packs of 20 g with 3 Applicators.

Pharmaceutic entrepreneur:
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Telephone 0821 74881-0
Fax 0821 74881420
E-Mail: [email protected]

Manufacturer:
C.P.M. Contractpharma GmbH & Co. KG
Spring road 7
83620 Feldkirchen-Westerham

This leaflet was last revised in May 2016.

Source: Information of the leaflet
Status: 12/2016