KETONOVA 2% Szampon

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1. KETONOVA 20 mg/g, shampoo
   1. WHAT IS KETONOVA AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING KETONOVA
   3. HOW TO USE KETONOVA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE KETONOVA
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

KETONOVA 20 mg/g, shampoo

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

• Keep this leaflet. You may need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

• 1 – What KETONOVA is and what it is used for
• 2 – What you need to know before you use KETONOVA
• 3 – How to use KETONOVA
• 4 – Possible side effects
• 5 – How to store KETONOVA
• 6 – Contents of the pack and other information

1. WHAT IS KETONOVA AND WHAT IS IT USED FOR

KETONOVA belongs to a group of medicines called “antifungals”. They are used to
treat infections caused by fungi, including yeasts.
KETONOVA is a medicated shampoo used to treat and prevent a skin condition that
affects the scalp (also known as seborrheic dermatitis). This condition is characterized by
scaling and itching. KETONOVA works by destroying the fungus that causes the scalp
infection.
This medicine is indicated for use by adults and adolescents over 15 years of age.

2. WHAT YOU NEED TO KNOW BEFORE USING KETONOVA

Do not use KETONOVA

• if you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in section 6).
• in children and adolescents under the age of 15 years. Warnings and precautionsTalk to your doctor or pharmacist before using KETONOVA. Avoid contact with the eyes .If some gets into your eyes, rinse them gently with cold water. Other medicines and KETONOVATell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are regularly using a lotion or cream containing a steroid on your scalp (such as betamethasone or hydrocortisone), gradually use less and less of it for 2-3 weeks when you start using KETONOVA. This will block the acute phase of your condition while KETONOVA begins to work.

If you have any questions about stopping your treatment with the lotion or cream steroid,
ask your doctor or pharmacist for advice before using this medicine.

Pregnancy and breastfeeding
No known risks are associated with the use of KETONOVA during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
KETONOVA does not impair the ability to drive vehicles or use machines.

3. HOW TO USE KETONOVA

Use KETONOVA following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
KETONOVA is a medicated shampoo. It is for external use only (hair, scalp).

Dosage
The usual dose is 2 applications per week for 2-4 weeks. Afterwards, use the shampoo once every 1-2 weeks to prevent the recurrence of symptoms.
If your hair requires further washing between treatments, you can use your usual shampoo.

Method of administration

• 1. Wash your hair with KETONOVA.
• 2. Leave on for 3-5 minutes before rinsing thoroughly.
• 3. To ensure the product's effectiveness, do not rinse until at least 3 minutes have passed.

If you use more KETONOVA than you should
An overdose is not expected if KETONOVA is used for external use.
If you accidentally ingest KETONOVA, this is generally harmless. But, as with all products for external use, tell your doctor immediately.

If you forget to use KETONOVA
Do not worry if you have forgotten an application of KETONOVA. Do not use a double dose of shampoo or the same dose twice in a row to compensate for missing the dose. Resume your usual frequency.

If you stop using KETONOVA
Once your skin condition has been eliminated, you can keep it under control and prevent it from recurring by using KETONOVA regularly once every one or two weeks. If you stop treatment with KETONOVA, your skin condition may return to be a problem.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, KETONOVA can cause side effects, although not everybody gets them.
Side effects may include:
Uncommon side effects (may affect less than 1 in 100 people but more than 1 in

• 1,000): inflammation of the capillary bulb, increased tearing, hair loss, dry skin, abnormal hair structure, rash, skin burning sensation, reactions at the application site (erythema, irritation, itching)

Rare side effects (may affect less than 1 in 1,000 people, but more than 1 in

• 10,000): hypersensitivity, altered sense of taste, eye irritation, acne, contact dermatitis, skin disorders, shedding of dead skin cells, hypersensitivity at the application site or pustules at the application site.

Side effects with unknown frequency (cannot be estimated from the available clinical trial data): angioedema (fluid accumulation in the tissues), urticaria (intense itching with a rash or raised red patches), changes in hair color.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE KETONOVA

Keep this medicine out of sight and reach of children.
Do not use KETONOVA after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What KETONOVA contains

• The active ingredient is ketoconazole (20 mg per 1,000 mg of shampoo)
• The excipients are: sodium lauryl ether sulfate, monolauryl ether succinate bisodium, macrogol-120 methylglucose dioleate, macrogol-7-glyceryl cocoate, imidurea, hydrolyzed animal collagen lauryldimonium hydroxypropyl, phenoxyethanol, potassium sorbate, diethanolamide of coconut fatty acids, sodium hydroxide, sodium chloride, ponceau 4R (E124), concentrated hydrochloric acid, purified water.

Description of the appearance of KETONOVA and contents of the pack
KETONOVA is a clear, reddish shampoo, supplied in a plastic bottle. Each
bottle contains 60, 100 or 120 ml of shampoo.

Marketing Authorisation Holder
SIFARMA S.P.A.
VIA FILIPPO BRUNELLESCHI, 12, 20146 MILANO

Manufacturer
Next Pharma
Pharbil Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark: KETONOVA 20 mg/g, shampoo
Italy: KETONOVA 20 mg/g, shampoo