TERZOLIN

TERZOLIN 2% solution

Important notes (mandatory information)

Terzolin 2% solution. Active ingredient: Ketoconazole. Areas of application: for inflammatory skin changes with scales, redness and itching (seborrheic dermatitis) and pityriasis versicolor.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Terzolin 2% solution for use in adolescents and adults
Active ingredient: Ketoconazole

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 5 or 14 days (depending on the condition), talk to your doctor.

What this package leaflet contains

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

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

Terzolin is an antifungal medicine for external treatment of fungal infections of the skin and scalp (antimycotic). Terzolin is used for inflammatory skin changes with scales, redness and itching (seborrheic dermatitis) and pityriasis versicolor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING TERZOLIN?

Terzolin must not be used if you are allergic to ketoconazole or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Avoid contact of Terzolin with the eyes! If Terzolin gets into your eyes, rinse them with plenty of water. If you are currently using topical corticosteroids for your symptoms, consult your doctor or pharmacist. You can start using Terzolin immediately, but you should not stop using the corticosteroid from one day to the next. Your skin may react with redness or itching. Follow the treatment plan:

• Apply the corticosteroid in the same dose for one week.
• Reduce the frequency of application of the corticosteroid for one to two more weeks.
• Then stop using the corticosteroid.

Please talk to your doctor or pharmacist before using Terzolin.

Use of Terzolin with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. There is no evidence that Terzolin affects the action of other medicines.

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

The active ingredient of Terzolin is hardly absorbed by the body after application to the scalp or skin. Therefore, Terzolin may be used during pregnancy after consultation with a doctor. In studies in which the active ingredient of Terzolin was fed to animals, fetal damage occurred. Pregnant women must therefore be particularly careful when using Terzolin and avoid swallowing the solution.

Breastfeeding

Terzolin can be used during breastfeeding. However, Terzolin should not be used in the breast area during breastfeeding. Contact of the infant with the treated areas of the body should be avoided.

Driving and using machines

No special precautions are required.

3. HOW TO USE TERZOLIN?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. This medicine is intended for external use on the skin and scalp only!

The recommended dose for adults and adolescents is

Distribute the required amount of Terzolin in damp hair or on the damp affected areas of the body. Massage the solution in briefly and leave it on for 3 - 5 minutes. Then rinse the solution off with plenty of warm water (see also section "Further information").

Treatment of symptoms

Condition	Single dose	Frequency of application	Duration of application
seborrheic dermatitis	a handful	2 times per week at intervals of 3 or 4 days	2 - 4 weeks
Pityriasis versicolor	a handful	1 time per day	1 - 5 days

Further treatment to prevent recurrence of symptoms

Condition	Single dose	Frequency of application	Duration of application
seborrheic dermatitis	a handful	1 time every 7 or 14 days	3 - 6 months

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

If you have accidentally swallowed Terzolin

Terzolin must not be taken orally. If you accidentally swallow Terzolin, talk to your doctor.

If you have any further questions on 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.

Possible side effects

Occasionally (may affect up to 1 in 100 people):

• Taste disturbance.
• purulent inflammation of a hair follicle.
• Eye irritation, increased tear flow.
• Acne, hair loss, allergic skin reaction (contact dermatitis).
• dry skin, altered surface structure of the hair.
• Rash, burning.
• Skin abnormalities, skin scaling.
• Skin reactions at the site of administration: skin redness, skin irritation, sensitivity, itching, pustules.

Rarely (may affect up to 1 in 1,000 people):

• Hypersensitivity.

Not known (frequency cannot be estimated from the available data):

• Swelling of the skin or mucous membranes due to fluid accumulation in the tissue, in the face and throat possibly with shortness of breath (angioedema).
• Hives.
• Discoloration of the hair.

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 TERZOLIN?

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 the label of the plastic bottle after "use by:". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Terzolin 2%

solution contains

The active ingredient is: Ketoconazole. 1 ml solution contains 20 mg ketoconazole. The other ingredients are dodecylpoly(oxyethylene)-2-hydrogen sulfate, sodium salt; dodecylpoly(oxyethylene)-3-hydrogen sulfosuccinate, disodium salt; N,N-Bis(2-hydroxyethyl)coconut fatty acid amide; tridodecylammonium polypeptides (MMG 2000); poly(oxyethylene)-120-methyl(D-glucopyranosid)dioleate; 1,1'-methylenebis[3-(3hydroxymethyl-2,5-dioxoimidazolidin-4-yl)urea] (imidurea); perfume bouquet (herbs); erythrosine; sodium hydroxide; sodium chloride; hydrochloric acid 36 %; purified water.

What Terzolin 2%

solution looks like and contents of the pack

Terzolin is a reddish, clear, viscous solution. Terzolin 2% solution is available in plastic bottles containing 60 ml and 100 ml solution.

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 September 2019.

Source: Information from the package leaflet
Status: 10/2020
Active ingredient: Ketoconazole. Areas of application: for inflammatory skin changes with scales, redness and itching (seborrheic dermatitis) and pityriasis versicolor.