TROSYD 2% Szampon

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1. TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF 2 % Shampoo
   1. What is TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF and what is it used for
   2. What you need to know before using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
2. TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is not recommended for use in newborns and
   1. How to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
   2. Possible side effects
   3. How to store TROSYD DERMATITE SEBORROICA E FORFORA
   4. Contents of the pack and other information
3. TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is available in HDPE bottles with a PP closure

TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF 2 % Shampoo

Generic medicine

Read this leaflet carefully before 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 want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 1. What TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is and what it is used for
• 2. What you need to know before using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
• 3. How to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
• 4. Possible side effects
• 5. How to store TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
• 6. Contents of the pack and other information

1. What is TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF and what is it used for

TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF contains the antifungal substance ketoconazole,
used to treat infections caused by fungi, including yeasts. Ketoconazole belongs to a group
of antifungal drugs called imidazoles. It works by interfering with the synthesis of ergosterol, a
component of fungal cell membranes.

TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is used to treat:
seborrheic dermatitis (a skin condition that affects the scalp causing scaling,
itching and redness of the skin);
dandruff (Pityriasis capitis).

2. What you need to know before using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF

DO NOT use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
if you are allergic to ketoconazole or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Consult your doctor or pharmacist before using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF.
If you are using a hair lotion or cream that contains a steroid, such as betamethasone or
hydrocortisone:

• you should gradually discontinue the lotion or cream during the first 2 or 3 weeks of treatment with ketoconazole shampoo.

If you have any questions about how to stop the steroid lotion or cream, consult your doctor or
pharmacist.
Seborrheic dermatitis and dandruff are often associated with hair loss. This has also been
reported with TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF, although rarely.
Avoid contact with eyes. If shampoo gets into your eyes, wash them immediately with plenty of water.

Children

TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is not recommended for use in newborns and

children.

Other medicines and TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The skin will absorb only a minimal amount of ketoconazole since the shampoo is only applied to the
scalp. Interactions with other medicines are therefore unlikely.
Sometimes you may be given TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF in combination with
a corticosteroid (e.g. a cream or lotion). Your doctor may tell you to start taking TROSYD
SEBORRHEIC DERMATITIS AND DANDRUFF and to gradually stop the treatment with the
corticosteroid over 2-3 weeks. If in doubt, contact your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
There are no adequate data on the use of ketoconazole in pregnant women. Animal studies
have shown adverse effects on reproduction after oral administration of high doses. It is therefore
possible that ketoconazole may cause harmful effects on the fetus. However, ketoconazole is not detected in
human blood after shampooing or application to the scalp. The risk to the fetus from using
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF Shampoo during pregnancy is therefore lower.

Breastfeeding
Ketoconazole is not detected in human blood after shampooing the scalp. It is therefore possible
to continue breastfeeding your baby during treatment.

Driving and operating machinery
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF has no, or negligible, effect on the
ability to drive vehicles or operate machinery.

TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF contains ponceau 4R (E124)
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF contains the dye ponceau 4R (E124) which may
cause allergic reactions. If you are allergic to certain dyes, tell your doctor before taking TROSYD
SEBORRHEIC DERMATITIS AND DANDRUFF.

3. How to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF

Use this medicine 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.
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF must be used exclusively on the skin.
Wet your hair with water. Apply sufficient shampoo to wash hair and scalp.
Massage the entire scalp and wash everything after 3-5 minutes.
Ketoconazole shampoo is used in adolescents and adults.

The recommended dose is…
Adults and adolescents
Use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF twice a week for 2-4 weeks.
To prevent recurrence of symptoms, continue to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
once a week or once every two weeks.
If you are using a topical corticosteroid (e.g., a cream or lotion) for a long time, your doctor
may tell you to start taking TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF and gradually stop
treatment with the corticosteroid over 2-3 weeks. This avoids
the onset of withdrawal symptoms (that is, rebound effects).

Children
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is not recommended for use in newborns and
children.

If you use more TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF than you should
Since the use of TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is limited to the scalp only, it is
unlikely that an overdose will occur.
In case of accidental ingestion, consult your doctor immediately or go to the nearest Emergency
Room.

If you forget to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
If you forget to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF, do so as soon as possible. If
however, it is almost time for the next dose, skip the missed dose and continue with your regular dose.
Do not double the dose to make up for the missed dose.

If you stop using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
Do not stop treatment with TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF without first
talking to your doctor.
If you have any doubts about 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 TROSYD DERMATITE SEBORROICA E FORFORA and tell your doctor immediately if you notice or suspect any of the following effects. You may need urgent medical attention.

• Allergic reaction (hypersensitivity), swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema);
• severe irritation or redness of the skin in the area treated with the shampoo, or other signs of allergy during the first few days of treatment;
• dryness or blisters of the skin.

The following side effects have also been reported:

Common(may affect up to 1 in 10 people):
local skin irritation;
dry and brittle hair;
hair loss.

Uncommon (may affect up to 1 in 100 people):
infection of the hair roots (folliculitis);
increased production of tears (increased lacrimation);
dry skin, rash, burning sensation of the skin;
redness of the skin, irritation and itching at the application site.

Rare (may affect up to 1 in 1000 people):
altered taste (dysgeusia);
eye irritation;
skin rash (acne);
hair discoloration;
skin peeling (exfoliation of the skin);
contact allergy (e.g. itching, rash);
allergic reaction at the application site;
pustules at the application site.

Not known (frequency cannot be estimated from available data):
urticaria;
swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or
breathing (angioedema).

Reporting of side effects
If you get 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 through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store TROSYD DERMATITE SEBORROICA E FORFORA

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

6. Contents of the pack and other information

What TROSYD DERMATITE SEBORROICA E FORFORA contains
The active ingredient is ketoconazole.
1 g of shampoo contains 20 mg of ketoconazole (2% w/w).

The other ingredients are:
Sodium lauryl ether sulfate
Disodium monolauryl ether succinate
Macrogol 120 methyl glucose dioleate
Macrogol-7-glyceryl cocoate
Imidurea
Lauryl dimethyl ammonium hydrolyzed animal collagen
Cocamide DEA
Sodium hydroxide
Sodium chloride
Ponceau 4R red (E124)
Concentrated hydrochloric acid (for pH adjustment)
Purified water.

Description of the appearance of TROSYD DERMATITE SEBORROICA E FORFORA and contents of the
pack
TROSYD DERMATITE SEBORROICA E FORFORA Shampoo is a clear, reddish solution.

TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is available in HDPE bottles with a PP closure

containing 60 ml, 80 ml or 120 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Giuliani Spa
Via Palagi, 2
20129 Milan

Manufacturer
LACHIFARMA SRL
S.S. 16 Zona Industriale
73010 Zollino (LE)