1. WHAT IS SEBIPROX 1.5% Shampoo AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Sebiprox shampoo contains a compound called ciclopirox olamine. It belongs to a group of medicines called "antifungals".
Therapeutic indications
Sebiprox shampoo is recommended for scaly, red and itchy scalps (called seborrheic dermatitis).
2. WHAT DO YOU NEED TO KNOW BEFORE USING SEBIPROX 1.5% Shampoo?
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use SEBIPROX 1.5% shampoo:
If you are allergic (hypersensitive) to ciclopirox olamine or any of the other components contained in Sebiprox shampoo (listed in paragraph 6).
If you are in doubt, ask your doctor or pharmacist before using Sebiprox Shampoo.
Precautions for use; special warnings
Be careful with SEBIPROX 1.5% shampoo:
- - SEBIPROX Shampoo is for external use only.
- - SEBIPROX Shampoo may, in rare cases, change the colour of your hair if you have grey, white or chemically damaged hair (e.g. due to hair colouring). Check with your doctor or pharmacist before using SEBIPROX Shampoo if this is the case. Your doctor or pharmacist will tell you if SEBIPROX shampoo is suitable for you.
- - SEBIPROX is not recommended for use in children under 12 years of age as safety and efficacy are not known in this age group.
- - Try to avoid contact of SEBIPROX shampoo with your eyes. It may cause stinging and irritation. In case of accidental contact with your eyes, rinse the affected area with water.
Interactions with other medicines
Taking or using other medicines
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
There is no information on the safety of SEBIPROX shampoo in pregnant women.
- - If you are pregnant or planning to become pregnant, talk to your doctor.
- - If you become pregnant while using SEBIPROX shampoo, talk to your doctor.
It has not been determined whether the ingredients of SEBIPROX shampoo can be excreted in breast milk. If you are breastfeeding, ask your doctor before using SEBIPROX shampoo.
If you are using SEBIPROX shampoo while breastfeeding, make sure that all traces of SEBIPROX shampoo have been completely rinsed from your chest after bathing/showering before you start breastfeeding your child.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving and using machines:
There are no restrictions on driving or operating machinery when using Sebiprox Shampoo.
List of excipients with a known effect
Important information about certain ingredients of SEBIPROX 1.5% shampoo
Sebiprox shampoo contains dipropylene glycol (contained in fragrance AF 17050). This may cause skin irritation in some people.
3. HOW TO USE SEBIPROX 1.5% Shampoo
Instructions for proper use
Not applicable.
Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment
Dosage
- - Use SEBIPROX shampoo 2 to 3 times a week for 4 weeks.
- - Use SEBIPROX Shampoo only on your hair, scalp and adjacent areas if they need it.
- - You can use a mild shampoo on days when you are not using SEBIPROX shampoo.
How to use SEBIPROX shampoo
1. Wet the hair.
2. Use enough SEBIPROX shampoo so that it covers your scalp and hair and adjacent areas, if they are also affected.
3. Massage the scalp and adjacent areas if necessary, using your fingertips.
4. Rinse your scalp and hair thoroughly.
5. Repeat from step 2 to step 4. SEBIPROX shampoo should be in contact with your scalp for a total of three to five minutes for both applications.
Be careful not to get SEBIPROX shampoo in your eyes. If this happens, rinse well with clean water.
Symptoms and instructions in case of overdose
If you accidentally swallow SEBIPROX 1.5% Shampoo :
The ingredients in SEBIPROX shampoo are not known to be harmful if swallowed in small amounts. If you accidentally get SEBIPROX shampoo in your mouth, rinse it out immediately with water. If you accidentally swallow a large amount of SEBIPROX Shampoo, ask your doctor or pharmacist for advice.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, SEBIPROX 1.5% shampoo is likely to have undesirable effects, although not everyone is subject to them.
Undesirable effects may occur at different frequencies, which are defined as follows:
- - very common: may affect more than 1 in 10 people.
- - common: may affect up to 1 in 10 people.
- - indeterminate: frequency that cannot be estimated from the available data.
The following adverse reactions have been observed with SEBIPROX Shampoo:
Very common:
- - skin irritation*,
- - itching*.
Common:
- - Skin rash*,
- - burning sensation,
- - redness at the application site.
Undetermined frequency:
- - allergic reaction,
- - scaling of the skin*,
- - eczema (itchy skin rash)*,
- - hair loss,
- - hair color changes.
Some of these effects (marked with an "*") may also be symptoms of the disease you are treating. However, if you notice these side effects for the first time after using SEBIPROX Shampoo, or if the irritation, redness or itching gets worse, stop using SEBIPROX Shampoo and tell your doctor or pharmacist.
If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet.
5. HOW TO USE SEBIPROX 1.5% shampoo
Keep out of the reach and sight of children.
Expiry date
Do not use SEBIPROX 1.5% shampoo after the expiry date stated on the bottle and outer packaging. The expiry date refers to the last day of the month.
Conditions of storage
There are no special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be thrown down the drain or put in the household garbage. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does SEBIPROX 1.5% shampoo contain?
The active substance is: ciclopiroxolamine 1,5 g per 100 g.
The other components are:
70% sodium lauryl ether sulphate, cocamidopropyl betaine, disodium phosphate dodecahydrate, citric acid monohydrate, coconut oil fatty acid diethanolamide, hexylene glycol, oleic alcohol, polysorbate 80, polyquaternium 10, perfume AF17050 (containing dipropylene glycol), sodium hydroxide, purified water.
Pharmaceutical form and content
What is SEBIPROX 1.5% shampoo and what does it contain?
Sebiprox shampoo is a straw-yellow to orange shampoo in bottles of 60 ml, 100 ml, 125 ml, 150 ml, 250 ml, 350 ml or 500 ml. Not all bottle sizes may be marketed.
Name and address of the marketing authorisation holder and manufacturing authorisation holder responsible for batch release, if different
Holder
STIEFEL LABORATORIES (IRELAND) LTD
FINISKLIN BUSINESS PARK
SLIGO
IRELAND
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