Ketozoline 2% Shampoo for seborrheic dermatitis, 60 ml

Ketozolin 2% Shampoo. Active ingredient: Ketoconazole. Indications: Treatment and prophylaxis of seborrheic dermatitis of the scalp and pityriasis versicolor in adults and adolescents. Warning: Contains potassium sorbate.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketozolin 2% Shampoo, for use in adults and adolescents.
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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse after 5 or 14 days (depending on the illness), consult your doctor.

What this leaflet contains:

1. WHAT IS KETOZOLIN 2% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING KETOZOLIN 2%?
3. HOW IS KETOZOLIN 2% TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KETOZOLIN 2% BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION.

1. WHAT IS KETOZOLINE 2% AND WHAT IS IT USED FOR?

Mechanism of action:
Ketozoline 2% belongs to the group of medicines used to treat skin diseases caused by fungal infections (antifungal). Ketozoline 2% is effective against a broad spectrum of fungi, including yeasts. Its action is based on altering the cell membranes of the fungus. Ketozoline 2% acts superficially (topically) in the outermost layer of skin and does not enter the body.

Uses:
Ketozoline 2% is used in adults and adolescents to treat and prevent the following types of fungal skin diseases:
dandruff on the scalp (seborrheic dermatitis) - scaly brownish patches on the skin (pityriasis versicolor).

Your doctor may have prescribed a different use for you. Please follow your doctor's instructions.

2. WHAT YOU SHOULD KNOW BEFORE USING KETOZOLINE 2%

Do not use Ketozolin 2%
if you are allergic (hypersensitive) to ketoconazole or any of the other ingredients of this medicine listed in section 6. The use of Ketozolin 2% in children is not recommended, as there are no data on its efficacy and safety in this age group.

Warnings and precautions:
Please talk to your doctor or pharmacist before using Ketozolin 2%. In rare cases, an increase in the hair loss normally associated with dandruff has been observed during the use of Ketozolin 2%. Avoid contact with the eyes. If the shampoo gets into your eyes, rinse them thoroughly with cold water. If you are currently using topical cortisone-containing products for your condition, consult your doctor or pharmacist. You can start using Ketozoline 2% immediately, but you should not stop using the cortisone-containing medication abruptly. Your skin may react with redness or itching.

Follow the treatment regimen:

• Use the same dose of the cortisone-containing medication for one week.
• Reduce the frequency of use of the cortisone-containing medication for another one to two weeks.
• Then stop using the cortisone-containing medicine.

Using Ketozolin 2% with other medicines:
Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is not known whether using Ketozolin 2% affects other medicines.

Using Ketozolin 2% with food and drink:
No restrictions.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine .

Pregnancy:
The active ingredient in Ketozolin 2% is hardly absorbed by the body after application to the scalp or body. Therefore, Ketozolin 2% may be used during pregnancy after consulting a doctor. In studies where the active ingredient in Ketozolin 2% was fed to animals, harm to the fetuses occurred. Pregnant women must therefore be particularly careful when using Ketozolin 2% and avoid swallowing the solution.

Breastfeeding:
Ketozolin 2% can be used during breastfeeding. However, Ketozolin 2% should not be applied to the breast area during breastfeeding. Contact of the infant with the treated areas should be avoided.

Driving and operating machinery:
Ketozolin 2% has no influence on occupational safety or the ability to safely participate in road traffic.

Ketozolin 2% contains potassium sorbate:
Potassium sorbate may cause localized skin irritation (e.g., contact dermatitis).

3. HOW TO USE KETOZOLIN 2%?

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is for external use only!

The recommended dose is:
Adults and adolescents:
Scaly brownish patches on the skin (pityriasis versicolor):
Treatment: once daily for a maximum of five days. Prevention: once daily for a maximum of three days before summer.

Dandruff (seborrheic dermatitis):
Treatment: twice weekly, 3-4 days apart, for two to four weeks.
Prevention: once weekly or every two weeks for three to six months.

Wash the affected areas with the shampoo. Rinse the shampoo out after three to five minutes. Always use this medicine exactly as your doctor has told you. Individual needs vary. Treatment should only be changed or stopped on the advice of a doctor. Please talk to your doctor or pharmacist if you feel that the effect of Ketozolin 2% is too strong or too weak.

If you have used more Ketozolin 2% than you should:
Do not swallow Ketozolin 2%. In case of accidental ingestion of Ketozolin 2%, contact your doctor, the emergency room, or a pharmacy immediately. To avoid aspiration, do not induce vomiting.

If you forget to use Ketozolin 2%:
Continue the treatment as prescribed by your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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 disorder
• purulent inflammation of a hair follicle
• Eye irritation, increased tear production
• Acne, hair loss, allergic skin reaction (contact dermatitis)
• dry skin, altered surface structure of the hair
• Rash, burning
• Skin abnormalities, skin peeling
• Skin reactions at the application site: skin redness, skin irritation, sensitivity, itching, pustules

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

• Hypersensitivity

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

• Swelling of the skin or mucous membranes due to fluid accumulation in the tissue, in the face and throat, possibly accompanied by shortness of breath (angioedema)
• hives
• Hair discoloration

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE KETOZOLINE 2%?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tube and outer carton after "EXP". The expiry date refers to the last day of that month. Once the tube is first opened, the medicine can be used for 6 months. Do not store above 25°C.

Never dispose of medicines via wastewater (e.g., down the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer need it. This will help protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Ketozolin 2% contains:
The active ingredient is ketoconazole. 1 g of shampoo contains 20 mg of ketoconazole (2%).

The other ingredients are:
Dodecyl poly(oxyethylene)-2-hydrogen sulfate, sodium salt; Dodecyl poly(oxyethylene)-3-hydrogen; Sulfosuccinate, disodium salt; Poly(oxyethylene)-120-methyl(D-glucopyranoside) dioleate; Macrogolglycerol cocoate (Ph. Eur.) [7 EO units]; 1,1-Methylenebis[3-(3-hydroxymethyl-2,5-di-oxoimidazolidin-4-yl)urea]; Tridodecylammonium polypeptide (MMG 2000); N,N-Bis(2-hydroxyethyl)coco fatty acid amide; Sodium hydroxide; Sodium chloride; Ponceau 4R (E124); Hydrochloric acid 10% (in small amounts for pH adjustment); Potassium sorbate; Sodium sulfate; Phenoxyethanol; Citric acid; Purified water.

What Ketozolin 2% looks like and contents of the pack: Appearance:
Clear reddish solution.

(Apo) Usually ship out within 3-5 business days