Trosyd for seborrheic dermatitis and dandruff
Italy
Table of Contents
Package leaflet: Information for the user
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF 2% Shampoo
Equivalent medicine
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 would like more information or advice, consult your pharmacist.
- If you experience any of the 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 you notice a worsening of symptoms.
Contents of this leaflet:
- What TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is and what it is used for
- What you need to know before using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
- How to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
- Possible side effects
- How to store TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
- Contents of the pack and other information
1. What TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is and what it is 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 medicines 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 disorder affecting the scalp which causes skin flaking,
itching and redness);
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 to any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF.
If you are using a lotion or cream for the hair containing 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 steroid lotions or creams, talk to 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 the eyes. If the shampoo gets into the eyes, rinse 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 medicines.
Only a minimal amount of ketoconazole is absorbed through the skin, as the shampoo is applied only to the
scalp. Interactions with other medicines are therefore unlikely.
Sometimes you may be prescribed TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF in combination with
a corticosteroid (e.g. a cream or lotion). Your doctor may instruct you to start using TROSYD
SEBORRHEIC DERMATITIS AND DANDRUFF and to gradually discontinue the corticosteroid treatment over a
2-3 week period. If in doubt, contact your doctor.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient data on the use of ketoconazole in pregnant women. Animal studies have shown adverse reproductive effects after oral administration of high doses. Therefore, 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 low.
Breastfeeding
Ketoconazole is not detected in human blood after shampooing the scalp. Therefore,
breastfeeding may be continued during treatment.
Driving and using machines
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF has no effect or negligible effect on the
ability to drive or operate machinery.
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF contains ponceau 4R (E124)
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF contains the colouring agent ponceau 4R (E124), which may
cause allergic reactions. If you are allergic to certain dyes, discuss this with your doctor before taking TROSYD
SEBORRHEIC DERMATITIS AND DANDRUFF.
3. How to use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is for external use on the skin only.
Wet your hair with water. Apply enough shampoo to wash your hair and scalp.
Massage the shampoo into the entire scalp and rinse thoroughly after 3–5 minutes.
Ketoconazole shampoo is intended for use in adolescents and adults.
Recommended dose
Adults and adolescents
Use TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF twice a week for 2–4 weeks.
To prevent recurrence of symptoms, continue using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF once a week or once every two weeks.
If you have been using a topical corticosteroid (e.g. a cream or lotion) for a long time, your doctor may advise you to start using TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF and gradually discontinue the corticosteroid over a period of 2–3 weeks. This helps prevent withdrawal symptoms (i.e. rebound effects).
Children
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is not recommended for use in infants and children.
If you use more TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF than you should
Since TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is applied only to the scalp, overdose is unlikely.
In case of accidental ingestion, contact 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, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
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 questions about how to use 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 SEBORRHEIC DERMATITIS AND DANDRUFF and contact your doctor immediately if you notice or suspect any of the following side effects. You may need urgent medical treatment.
- Allergic reaction (hypersensitivity), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
- severe irritation or redness of the skin in the treated area, or other signs of allergy during the first days of treatment;
- dryness or blistering 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 tear production (increased lacrimation);
dry skin, skin rash, sensation of burning of the skin;
redness, irritation and itching at the application site.
Rare (may affect up to 1 in 1,000 people):
taste disturbance (dysgeusia);
eye irritation;
skin eruption (acne);
discoloration of hair;
skin peeling (skin exfoliation);
contact allergy (e.g. itching, skin rash);
allergic reaction at the application site;
pustules at the application site.
Not known (frequency cannot be estimated from the available data):
urticaria;
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 SEBORRHEIC DERMATITIS AND DANDRUFF
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the bottle after the word “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 you no longer use. This will help protect the environment.
6. Package contents and other information
What TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF contains
The active substance is ketoconazole.
20 mg of ketoconazole (2% w/w) are contained in 1 g of shampoo.
The other components are:
Sodium laureth sulfate
Disodium laureth monosuccinate
Macrogol 120 methyl glucose dioleate
Polyoxyethylenglycol-7-glyceril cocoate
Imidurea
Lauric diimmonium hydroxypropyl hydrolyzed animal collagen
Coco fatty acid diethanolamide
Sodium hydroxide
Sodium chloride
Ponceau 4R red (E124)
Concentrated hydrochloric acid (for pH adjustment)
Purified water.
Description of the appearance of TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF and contents of the pack
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF Shampoo is a clear, reddish solution.
TROSYD SEBORRHEIC DERMATITIS AND DANDRUFF is available in HDPE bottles with PP closure containing 60 ml, 80 ml or 120 ml of solution.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Giuliani Spa
Via Palagi, 2
20129 Milan
Manufacturer
LACHIFARMA SRL
S.S. 16 Zona Industriale
73010 Zollino (LE)