Terzolin 2% solution, 100 ml

Instructions for use for Terzolin 2% solution, 100 ml

Important notes (compulsory information):

Terzolin 2% solution. Active ingredient: ketoconazole. Application areas: For inflammatory skin changes with dandruff, redness and itching (Seborrheic dermatitis) and mushroom latches (Pityriasis versicolor).

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


LEAFLET: INFORMATION FOR THE USER

Terzolin 2% solution, for use in adolescents and adults
Active substance: ketoconazole

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 5 or 14 days (depending on the disease), contact your doctor.

What is in this leaflet

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

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

Terzoline is a fungal medicine for the external treatment of skin and scalp mushroom diseases (Antimycotic). Terzoline is used in inflammatory skin changes with dandruff, redness and itching (Seborrhoic dermatitis) and mushroom latches (PityRiasis versicolor.

2. What should you consider before using Terzoline?

Terzolin must not be used if they are allergic to ketoconazole or one of the other ingredients of this medicine referred to in section 6.

Warnings and Precautions:
Avoid contact of Terzolin with the eyes! Nevertheless, Terzolin gets in the eye, rinse them with plenty of water. If you are currently using outstanding cortisone-containing medicines at the same time as a result of their complaints, then consult their doctor or pharmacist. You can start using Terzoline immediately, but should not terminate the application of the cortisone-containing medicine from one on the other day. Your skin could react with redness or itching. Follow the treatment scheme: For a week, apply the cortisone-containing medicine in the same dose. For one to two more weeks, reduce the frequency of application of the cortisone-containing medicinal product. Then finish the application of the cortisone-containing medicine. Please talk to your doctor or pharmacist before applying Terzolin.

Application of Terzolin together with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently used other medicines / applied or intend to take / use other medicines. There is no evidence that Terzolin influences the effect of 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:
The drug of Terzoline is hardly received by the body after application on the head or body skin. Therefore, Terzolin may be applied after consultation with the doctor during pregnancy. In studies where the drug was fed by Terzoline to animals, fruit damage has occurred. Pregnant women must therefore be particularly careful when using Terzolin and avoid swallowing the solution.

Latving:
Terzolin can be used during breast-feeding. During lactation, however, Terzoline should not be used in the chest area. A contact of the infant with the treated body points should be avoided.

Driving and ability to operate machines:
There are no special precautions required.

3. How is Terzoline 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. The recommended dose is: Distribute the required amount of terzoline in the damp hair or on the dampened, affected body points. Massage the solution briefly and have them act for 3-5 minutes. Then rinse the solution with a lot of warm water or off (see also section "More information").

Treatment of complaints:

Illness	Single dose	Application frequency	Application
seborrhea dermatitis	walnut sized amount *	2 times a week at a distance of 3 or 4 days	2-4 Weeks
PityRiasis versicolor	walnut sized amount *	1-time a day	a maximum of 5 days

Further treatment to avoid recurrence of complaints:

Illness	Single dose	Application frequency	Application
seborrhea dermatitis	walnut sized amount *	1 times every 7 or 14 days	3-6 Months

*A walnut size equals approximately half a screw cap.

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 used a larger amount of Terzolin than you should:
Terzolin should not be taken. If you accidentally swallow Terzolin, talk to your doctor.

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. Possible side effects:

Occasionally (can concern up to 1 of 100 treated):

• Taste
• earth inflammation of a hair follicle
• Eye irritation, elevated tear flow
• Acne, hair loss, allergic skin reaction (Contact dermatitis)
• dry skin, altered surface structure of the hair
• Rash, burn
• Skinauers, skin shot
• Skin reactions at the administration site: Skinflug, skin irritation, sensitivity, itching, pustules

Rarely (can concern up to 1,000 treated):

• Hypersensitivity

Unknown (frequency based on the available data not estimable):

• Swelling of skin or mucous membranes due to fluid collection in the tissue, in the face and throat possibly with air note (angioedema)
• Huntering
• Discoloration of the hair

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 Medicinal Products and Medicinedutch, 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 is Terzoline to keep?

Keep this medicine inaccessible to children. You must not use this medicine after the date specified on the folding box and the container according to "usable until". The expiration date refers to the last day of the specified month. Do not store more than 25 ° C. Disposal of medicines should be carried out in accordance with the respective regional specifications. Therefore, ask your pharmacist as the medicine is to dispose of if you do not apply it anymore. You help to protect our environment.

6. Content of the pack and further information

What contains Terzolin:
The active ingredient is: ketoconazole. 1 ml solution contains 20 mg ketoconazole. The other ingredients are: Dodecylpoly (oxyethylene) -2-hydrogen sulfate, sodium salt; Dodecyl poly (oxyethylene) -3-hydrogen sulfosuccinate, disodium salt; N, N-B \ S- (2-hydroxyethyl) cocos fatty acid amide; Tridodecylammoniumpoly peptides (MMG 2000); Poly (oxyethylene) -120-methyl (D-glucopyra noside) Dioleat; 1.1 'Methylene BIS 3- (3Hydroxymethyl-2,5-dioxoimi-Dazolidine-4-YL) urea (Imidurea); Perfume bouquet (herbs); Erythrosine; Sodium hydroxide; Sodium chloride; Hydrochloric acid 36%; purified water.

How to look for Terzolin and content of the pack:
Terzoline is a reddish, clear, viscous solution. Terzoline is available in plastic bottles with 60 ml and 100 ml solution. Not all pack sizes may be placed on the market.

More information:

• The seborrheic dermatitis usually occurs on the scalp, face and hull. The signs are scattering skin, redness, itching, as well as sometimes moistens. It can also come to increased hair loss.
• The skin changes in the mushroom lens (PityRiasis versicolor) develop over months and rarely cause complaints. There is no itching. The infestation is to be sharply demarcated, round or oval spots. Mostly, back, shoulders or chest are infested, but the entire body can be affected. The changes are on bright skin pale red to brownish and a bit scaly. On dark skin, white spots show up. Often, the stains go into each other and form large interrupted surfaces that resemble a map.
• Ketoconazole, the active ingredient of Terzolin, has a wide range of active spectrum (against skin, yeast, mold and other mushrooms) and acts against the cause of seborrheic dermatitis and mushroom latches (PityRiasis versicolor), i. The infestation with yeast.
• A previous or subsequent hair linen with a commercially available shampoo is not required. Due to the special composition of Terzoline, the hair is cleaned during treatment at the same time.

Pharmaceutic entrepreneur:
Johnson & Johnson GmbH
Johnson & Johnson Place 2
41470 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer:
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
2340 BEERSE
Belgium

This leaflet was last revised in September 2015.

Source: Information of the leaflet
Status: 04/2017