Terbinafin HCL ACIS 10 mg / g cream, 15 g

Instructions for use for Terbinafin HCL ACIS 10 mg / g cream, 15 g

Important notes (compulsory information):

Terbinafin HCL ACIS 10 mg / g cream. Active substance: Terbinafinhydrochloride Applications: for the external treatment of mushroom or yeast infections of the skin, such as e.g. Foot mushroom.

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


LEAFLET: INFORMATION FOR THE USER

Terbinafin HCL ACIS 10 mg / g cream - Tube with 15 g cream
Active substance: Terbinafinhydrochloride

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 specified in this packing book. See section 4.
• If you do not feel better or even worse after 14 days, contact your doctor.

What is in this leaflet

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

1. What is Terbinain HCL ACIS and what is it used for?

Terbinafin HCL ACIS is a white cream containing 10 mg / g terbinafin hydrochloride as a drug. Terbinafin HCL ACIS is used for the external treatment of mushroom or yeast infections of the skin, e.g. Foot mushroom applied.

2. What should you pay attention to HCL ACIS before using Terbinafin?

Terbinafin HCL ACIS must not be used if they are allergic to terbinafine hydrochloride or one of the section 6. mentioned other ingredients of this medicinal product are. An overlap can be recognized, for example, at red stains and swelling of the skin and / or itching.

Warnings and Precautions:
Please talk to your doctor or pharmacist before using Terbinafin HCL ACIS. Terbinafin HCL ACIS is only externally applied. Contact with the eyes can cause irritation and is therefore to be avoided. If the cream accidentally advised against the eyes, they should be thoroughly rinsed under lying water.

Children:
The use of Terbinafin HCL ACIS is under 12 children under 12 Not recommended years ago. The experiences in children are limited.

Application of Terbinafin HCL ACIS together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied / applied other medicines. There is no evidence that TERBINAIN HCL ACIS affects other medicines.

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:
You should not apply this medicine during pregnancy, except this is absolutely necessary.

Latving:
Since Terbinain goes into breast milk, Terbinain HCL ACIS should not apply if you breastfeed a child. Toddlers and infants must not come into contact with the treated skin areas, including the breasts.

Driving and ability to operate machines:
This medicine has no impact on the ability to drive and the ability to serve machinery.

Terbinafin HCL ACIS containt Cetylstearylalcohol:
Cetylstearyl alcohol can locally limited skin reactions (eg Contact dermatitis.

3. How to use TERBINAIN HCL ACIS?

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.

Type of application:
The opening of the tube is sealed with aluminum. This seal can be opened with the upturned tube cover under light pressure.

For application on the skin.
Before applying the cream, the skin must be carefully cleaned and dried. Wear the cream in a thin layer on the inflamed skin and slightly beyond and rub it easily. Please wash your hands afterwards, unless your hands are the place to be treated.

Adults and adolescents over 12 years

• Footpush (Tennea Pedis): 1 times a day for 1 week.
• Lichen (Tennea Corporis, Tinea Cruris): 1 times a day for 1 Week.
• Skin mushroom (cutaneous candidiasis): 1 times a day for 1 to 2 Weeks.
• Clamp (PityRiasis versicolor): 1 - 2 times a day for 2 Weeks.

In general, after a few days, it comes to improving the symptoms. An irregular application or premature cancellation of treatment increases the likelihood that the symptoms occur again. If you find no improvement after two weeks, please inform your doctor or pharmacist.

Elderly patients:
There are no indications that other dosages are required for older patients or other side effects occur than younger patients.

Children:
Since there are only limited experiences with the use of Terbinain HCL ACIS in children under 12 years, the application of this medicine in this age group is not recommended.

If you have used a larger amount of Terbinafin HCL ACIS than you should:
Cases of overdose of Terbinain HCL ACIS have not become known in external application. With uncertainty, however, ask your doctor or pharmacist. However, if Terbinain Cream is accidentally taken, such side effects can be expected, as can occur when overdosed with Terbinain tablets (eg headaches, nausea, pain in upper abdomen and dizziness). In this case, a doctor or emergency doctor should be notified. If the cream accidentally gets into the eyes, you should rinse them thoroughly under lying water.

If you forget the application of Terbinafin HCL ACIS:
Continue treatment without tetrinain HCL ACIS to apply an additional time or to apply a larger amount than usual.

If you cancel the application of Terbinafin HCL ACIS:
If you cancel the application of TERBINAIN HCL ACIS prematurely, the original symptoms can occur again.

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. Exit application of the cream and take immediate medical help if you have one of the following very rare allergic reaction:

• Heavy itching with red rash, hives, bubbles or bubble formation
• Breathing NOT or swelling of mouth, face, lips, tongue or neck

The skin with which these allergic reactions occur is not known (based on the available data).

The following side effects were also reported:

• Oust (concerned 1 of 10 treated): skin shot, itching
• Occasionally (concerns 1 of 100 treated): skin compensation, scab, skin changes, skin discoloration, redness, burning, pain or irritation at the application site
• Rarely (affects 1 of 1,000 Treated): dry skin, eczema, contact dermatitis, aggravation of the underlying fungal infection
• Unknown (skin on the basis of the available data not estimable): overlap, rash
• If Terbinain HCL ACIS accidentally reaches the eyes, an eye irritation can occur in rare cases.

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 share effects directly
Federal Institute for Medicinal Products and Medical Devices, Dept. Pharmacovigilance,
Kurt-Georg-Kiesinger-Allee 3, D-53175
Bonn, website: http://www.bfarm.de
Show. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep TERBINAIN HCL ACIS?

Keep this medicine inaccessible to children. You must not use the medicinal product after the expiry date specified on the container and the folding box according to "until". The expiry date refers to the last day of the specified month. This medicinal product does not require special storage conditions.

Note on durability after a break:
After opening the tube, Terbinain HCL ACIS is stable for 6 months.

6. Content of the pack and further information

What Terbinafin HCL ACIS contains:
The active ingredient is: TerbinainHydrochloride. 1 g cream contains 10 mg terbinain hydrochloride. The other ingredients are: purified water, cetylstearyl alcohol, isopropyl myristate, cetyl palmitate, sorbitan stearate, benzyl alcohol, polysorbate 60, sodium hydroxide.

How Terbinafin HCL ACIS looks like and content of the pack:
TERBINAIN HCL ACIS 10 mg / g cream is a white cream. TERBINAIN HCL ACIS 10 mg / g cream is available in aluminum tubes with 15 g and 30 g. Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur:
acis Arzneimittel GmbH
Lil-Dagover ring 7
82031 green forest
Telephone: 089/44 23 246 0
Fax: 089/44 23 246 66
E-Mail: [email protected]

Manufacturer:
MIBE GmbH medicine
Munich Straße 15
06796 Brehna

This leaflet was last revised in March 2015.

Source: www. acis. de
Status: 07/2015