Kataval

PACKAGE LEAFLET: INFORMATION FOR THE USER

Kataval 1 mg/g + 5 mg/g cream

Triamcinolone, Neomycin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What Kataval is and what it is used for
2 What you need to know before using Kataval
3 How to use Kataval
4 Possible side effects
5 How to store Kataval
6 Contents of the pack and other information

1. What Kataval is and what it is used for

Kataval contains two active substances: triamcinolone, which belongs to the class of corticosteroid anti-inflammatory medicines, and neomycin, which belongs to the class of antibiotics.
This medicine is indicated for the treatment of: certain inflammatory skin diseases (atopic dermatitis, eczematous dermatitis, nummular eczema, contact dermatitis, seborrheic dermatitis, neurodermatitis, generalized erythroderma), itching in the anal region or on the external female genital organs, haemorrhoids, external otitis, eczematized psoriasis (a chronic inflammatory skin disease).

2. What you need to know before using Kataval

Do not use Kataval
if you are allergic to triamcinolone, neomycin, or any of the other ingredients of this
medicine (listed in section 6);
if you have a form of skin tuberculosis;
if you have a skin infection caused by a virus called Herpes Simplex;
if you have other skin diseases caused by viruses.

Warnings and precautions
Talk to your doctor or pharmacist before using Kataval.
Prolonged use of topical products such as Kataval may cause your skin to become excessively sensitive.
Your doctor should periodically monitor your condition, as this type of treatment requires careful supervision.
If you apply the cream over large areas of the body, for prolonged periods, or under occlusive dressings—including a child's diaper—active ingredients may pass through the skin and affect the entire body. Excessive absorption of the antibiotic contained in this medicine may cause adverse effects such as ototoxicity and kidney problems.
In addition, prolonged use of the antibiotic may lead to the development of resistant microorganisms, including fungi.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
Your doctor will recommend using this medicine in very young infants only if strictly necessary and under their direct supervision.

Other medicines and Kataval
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, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
You may use Kataval during pregnancy only if your doctor has instructed you to do so and under their direct supervision.

Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

Kataval contains methyl p -hydroxybenzoate, propyl p -hydroxybenzoate, and cetostearyl alcohol
These may cause allergic reactions (including delayed-type reactions).
They may cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE KATAVAL

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the cream to the affected area 3-4 times a day, for a maximum of 10 consecutive days.
If you use more Kataval than you should
If you use an excessive amount of this medicine, contact your doctor.
If you forget to use Kataval
If you forget to use Kataval, you may apply it immediately. Then continue with the applications as usual.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The use of this medicine may cause you local skin reactions, burning sensation, itching, irritation, dry skin, skin thinning, acne, skin discoloration, appearance of stretch marks (striae), blurred vision.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system at the following website: 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 KATAVAL

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 packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Kataval contains

• The active substances are triamcinolone acetonide and neomycin sulfate. 100 g of cream contain 0.1 g of triamcinolone acetonide and 0.5 g of neomycin sulfate.
• The other components are: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, condensed cetylstearyl alcohol with ethylene oxide, liquid paraffin, squalane, potassium sorbate, sorbitol, purified water.

Description of the appearance of Kataval and contents of the pack
Cream.
The pack contains one 30 g tube of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
FARMA GROUP S.r.l.
Via Strampelli, 18
63074 San Benedetto del Tronto (AP)
Manufacturer responsible for batch release:
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe 1
29016 Cortemaggiore (PC)