PACKAGE LEAFLET: INFORMATION FOR THE USER

KETONOVA 20 mg/g, shampoo

Ketoconazole
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:
1 – What KETONOVA is and what it is 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

1. WHAT KETONOVA IS AND WHAT IT IS USED FOR

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

2. WHAT YOU SHOULD KNOW BEFORE USING KETONOVA

Do not use KETONOVA

if you are allergic to ketoconazole or to any of the excipients of this medicinal product (listed in section 6).
in children and adolescents under 15 years of age.

Warnings and precautions

Consult your doctor or pharmacist before using KETONOVA.
Avoid contact with the eyes. If some of the product gets into your eyes, rinse them gently with cool water.

Other medicines and KETONOVA

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
If you are regularly using on your scalp a lotion or cream containing a corticosteroid (such as betamethasone or hydrocortisone), gradually reduce the use of this product over 2–3 weeks when starting to use KETONOVA. This will help control the acute phase of your condition while KETONOVA begins to take effect.

If you have any questions about discontinuing your treatment with the corticosteroid lotion or cream,
consult your doctor or pharmacist before using this medicinal product.

Pregnancy and breastfeeding

There are no known risks associated with the use of KETONOVA during pregnancy and breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before using this medicinal product.

Driving and using machines

KETONOVA does not impair the ability to drive vehicles or operate machinery.

3. HOW TO USE KETONOVA

Use KETONOVA exactly as described in this leaflet or as directed 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 symptoms from returning.
If your hair requires additional washing between treatments, you may use your regular shampoo.

Instructions for use

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

If you use more KETONOVA than you should
Overdose is not expected when KETONOVA is used externally.
If KETONOVA is accidentally ingested, it is generally harmless. However, as with all topical products, you should immediately consult your doctor.

If you forget to use KETONOVA
Do not worry if you miss an application of KETONOVA. Do not use a double dose or apply the shampoo twice in succession to make up for a missed dose. Resume your usual schedule.

If you stop using KETONOVA
Once your skin condition has cleared, you can keep it under control and help prevent recurrence by using KETONOVA regularly once every one or two weeks. If you stop treatment with KETONOVA, your skin condition may return.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, KETONOVA may cause adverse reactions, although not everybody experiences them. Adverse reactions may include:

Uncommon adverse reactions (occur in less than 1 in 100 people but more than 1 in 1,000): inflammation of the hair bulb, increased lacrimation, hair loss, dry skin, abnormal hair structure, skin rash, burning sensation of the skin, reactions at the application site (erythema, irritation, pruritus).

Rare adverse reactions (occur in less than 1 in 1,000 people but more than 1 in 10,000): hypersensitivity, altered taste sensation, eye irritation, acne, contact dermatitis, skin disorders, shedding of dead skin cells, hypersensitivity at the application site or pustules at the application site.

Adverse reactions with unknown frequency (cannot be estimated from the available clinical study data): angioedema (fluid infiltration into tissues), urticaria (intense itching with skin rash or raised red patches), changes in hair colour.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE KETONOVA

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

6. PACKAGING CONTENTS AND OTHER INFORMATION

What KETONOVA contains

The active substance is ketoconazole (20 mg per 1,000 mg of shampoo).
The excipients are: sodium laureth sulfate, disodium laureth monosuccinate, macrogol-120 methyl glucose dioleate, macrogol-7-glycerol cocoate, imidurea, 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-coloured 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 MILAN, ITALY

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

This medicinal product is authorised in the European Economic Area countries under the
following names:
Denmark: KETONOVA 20 mg/g, shampoo
Italy: KETONOVA 20 mg/g, shampoo

This Patient Information Leaflet was last approved on