Klinge KETOconazole 20 mg/g Shampoo

Ketoconazole Klinge 20 mg/g Shampoo. Indications: For the prevention and treatment of scalp infections caused by the fungus Pityrosporum, such as seborrheic dermatitis – greasy, scaly inflammation of the scalp and other skin areas and/or dandruff (pityriasis capitis). Warning: Contains benzyl alcohol.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketoconazole Klinge 20 mg/g Shampoo
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 your symptoms worsen or do not improve after 1-2 weeks, you should definitely see a doctor.

What this leaflet contains:

1. WHAT IS KETOCONAZOLE BLADE 20 MG/G SHAMPOO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU KNOW BEFORE USING KETOCONAZOLE BLADE 20 MG/G SHAMPOO?
3. HOW IS KETOCONAZOLE BLADE 20 MG/G SHAMPOO TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KETOCONAZOLE BLADE 20 MG/G SHAMPOO BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS KETOCONAZOLE BLADE 20 MG/G SHAMPOO AND WHAT IS IT USED FOR?

Ketoconazole Blade 20 mg/g Shampoo is a medicated shampoo for the prevention and treatment of scalp infections caused by the fungus Pityrosporum, such as:

• Seborrheic dermatitis - a greasy, scaly inflammation of the scalp and other skin areas.
• Dandruff (Pityriasis capitis).

2. WHAT YOU SHOULD KNOW BEFORE USING KETOCONAZOLE KLINGE 20 MG/G SHAMPOO?

Do not use Ketoconazole Klinge 20 mg/g Shampoo if you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:
Please talk to your doctor or pharmacist before using Ketoconazole Klinge 20 mg/g Shampoo. Ketoconazole can irritate the mucous membranes of the eyes, so contact with the eyes should be avoided. If the shampoo does get into your eyes, rinse them thoroughly with clean, cold water. If you have been using glucocorticoids such as betamethasone or hydrocortisone for a long time, you should not stop treatment with these medicines immediately when you start using Ketoconazole Klinge 20 mg/g Shampoo, but rather reduce the frequency of their use gradually over 2 to 3 weeks. This will help to avoid an initial worsening of your condition during treatment with Ketoconazole Klinge 20 mg/g Shampoo.

If you have any further questions about stopping corticosteroid treatment, ask your doctor or pharmacist.

Using Ketoconazole Klinge 20 mg/g Shampoo with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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. In general, Ketoconazole Klinge 20 mg/g Shampoo can be used during pregnancy and breastfeeding.

Driving and using machines:
Ketoconazole Klinge 20 mg/g Shampoo has no or negligible influence on the ability to drive and use machines.

Ketoconazole Blade 20 mg/g Shampoo contains benzyl alcohol:
This medicine contains 5.00 mg of benzyl alcohol in 1 g of solution corresponding to 0.50% (w/w). Benzyl alcohol may cause allergic reactions and mild local irritation.

3. HOW TO USE KETOCONAZOLE BLADE 20 MG/G SHAMPOO?

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.

Method of administration:
Ketoconazole Blade 20 mg/g Shampoo is for external use only. Not for oral use! Do not swallow!

Recommended dose:
Adults, including the elderly, and adolescents: Wet hair and scalp thoroughly with water. Use a sufficient amount of shampoo (approx. 5 ml) to wash hair and scalp, creating a good lather. Gently massage the shampoo over the entire scalp and leave on for 3-5 minutes, then rinse thoroughly. Your regular shampoo can be used between applications of Ketoconazole Blade 20 mg/g Shampoo, if needed.

Frequency of use:

• Ketoconazole Blade 20 mg/g shampoo should be used twice a week for a period of 2-4 weeks.
• Prevention: Apply once every 1-2 weeks to prevent a recurrence of symptoms.

If you or someone else accidentally swallows Ketoconazole Klinge 20 mg/g Shampoo:
Contact your doctor or pharmacist (accidental swallowing of small amounts is usually harmless).

If you forget to use Ketoconazole Klinge 20 mg/g Shampoo:
Do not use a double dose to make up for a missed dose. Continue treatment as directed.

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. Stop using Ketoconazole Klinge 20 mg/g Shampoo and tell your doctor immediately if you notice or suspect any of the following side effects. You may need urgent medical attention.

• Allergic reaction, swelling of the face, lips, mouth, tongue or throat, causing difficulty swallowing or breathing. This affects less than 1 in 1,000 people treated.
• Severe irritation or redness of the treated areas, or other signs of an allergic reaction during the first few days of treatment. This affects fewer than 1 in 100 patients.
• Peeling or blistering of the skin. This affects less than 1 in 1,000 patients.

Inform your doctor or pharmacist if you notice or suspect any of the following side effects:
Occasional side effects (affect less than 1 in 100 people treated):

• Infection of the hair roots.
• Increased tear production.
• Unusual hair loss or thinning of the hair.
• Dry skin, rash, burning sensation.
• Changes in the way the hair feels.

Rare side effects (affect less than 1 in 1,000 patients):

• Impairment of the sense of taste.
• Eye irritation.
• Acne.
• Flaky skin.

The following side effects have been reported, however, no precise statements can be made about their frequency (frequency not known):

• Hives (also known as nettle rash or urticaria).
• Changes in hair color.

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 KETOCONAZOLE BLADE 20 MG/G SHAMPOO?

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 container and the outer carton after EXP. The expiry date refers to the last day of that month.

Storage conditions:
Do not store above 25°C. Store in the original packaging. Keep the bottle tightly closed.

Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer need it. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ketoconazole Blade 20 mg/g Shampoo contains:
The active ingredient is ketoconazole. 1 g of shampoo contains 20 mg of ketoconazole, 1 ml of shampoo contains 20.84 mg of ketoconazole. The other ingredients are: sodium dodecyl sulfate paste 70%, 3-dodecyloxycarbonyl-2/3-sulfopropanoic acid, disodium salt solution 40%, sodium chloride, citric acid monohydrate, benzyl alcohol, edetic acid, tetrasodium salt dihydrate,
1,1'-methylenebis[3-(3-hydroxymethyl-2,5-dioxoimidazolidin-4-yl)urea] (Imidurea), poly[dimethyl(prop-2-en-1-yl)prop-2-en-1-aminium chloride-co-prop-2-enamide], dexpanthenol, alpha-dodecyl-omega-hydroxypoly(oxyethylene)-2, sodium hydroxide, erythrosine (E 127), purified water.

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