1. WHAT IS ALOSTIL 5 PER CENT, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic Class
OTHER DERMATOLOGICAL PREPARATIONS
Therapeutic indications
This drug is indicated for the treatment of moderate hair loss (androgenetic alopecia) in males.
2. WHAT YOU SHOULD KNOW BEFORE USING ALOSTIL 5 PER CENT, solution for cutaneous application
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use ALOSTIL 5 PER CENT, solution for cutaneous application in the following cases:
knownallergyto minoxidil or any of the components of the product,
scalplesions,
intoleranceto the 2% form,
subjectsunder 18 years of age or over 65 years of age,
anyalopecia (hair loss) in women.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special care with ALOSTIL 5 PER CENT, solution for cutaneous application:
Special Warnings
In patients with scalp lesions, there may be an increase in the passage of the active ingredient into the bloodstream (see Never use ALOSTIL 5 PER CENT, solution for cutaneous application). In rare cases, a drop in blood pressure, increased pulse rate, and edema may occur: stop treatment immediately and notify your physician.
The risk of hypertrichosis (abnormal development of the hair system) at a distance justifies not using this medicine in women.
This medicine contains propylene glycol and may cause skin irritation.
Precautions for use
This treatment requires regular medical monitoring, especially at the beginning of treatment.
Inform your doctor in case of heart problems.
Do not swallow.
In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes) rinse thoroughly with running water.
A change in hair colour and/or texture has been observed in some patients.
In case of doubt, do not hesitate to ask your doctor or pharmacist for advice.
PHARMACIST.
Interactions with other drugs
Taking or using other medications
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 breastfeeding
Pregnancy and lactation
This medicine is contraindicated in women.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: propylene glycol, 96% ethanol.
3. HOW TO USE ALOSTIL 5 PER CENT, solution for skin application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
For adult use only.
Dosage
Apply twice daily a dose of 1 ml on the scalp, starting from the centre of the area to be treated.
This dose must be respected regardless of the size of the area concerned.
The total daily dose should not exceed 2 ml.
Spread the product with the fingertips so that the entire area to be treated is covered.
Wash your hands thoroughly after use.
Do not apply the product to any other part of the body.
Method of administration
Dermal route.
Apply to thoroughly dry hair and scalp.
The method of application will vary depending on the delivery system used with the bottle:
Sprayer
This system is suitable for treating large areas of the scalp.
1. Remove the outer cap of the bottle.
2. Unscrew and remove the inner cap.
3. Insert the sprayer into the bottle, screw it on tightly and remove the small transparent cap.
4. Point the sprayer towards the centre of the surface to be treated, press once and spread the product with your fingertips. Repeat 6 times to apply a 1 ml dose.
Avoid inhaling the spray. Replace cap on bottle after use.
Sprayer with applicator
This system is suitable for treating small areas or under the hair.
1. Remove the outer cap from the bottle.
2. Unscrew and remove the inner cap.
3. Insert the sprayer into the bottle, screw it on tightly and remove the small transparent cap.
4. Pull firmly upwards to remove the "head" (marked with an arrow) from the sprayer.
5. Insert the applicator onto the spray wand (now without the head) and push it all the way in. Finally, remove the small cap (clear plastic) from the end of the applicator.
6. Point the sprayer at the center of the area to be treated or under the hair, squeeze once and spread the solution with your fingertips. Repeat this process six times to apply the required 1 ml dose.
Avoid inhaling the product. Replace the small clear cap on the end of the applicator after use.
Frequency of administration
1 application twice a day, morning and evening.
Duration of treatment
It may take up to 2 months of treatment with 2 applications per day before a stimulation of hair growth is evident.
The onset and degree of response will vary from subject to subject.
Do not discontinue applications as this may lead to a return to the previous state after 3 or 4 months.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all drugs, ALOSTIL 5 PER CENT, solution for cutaneous application is susceptible to adverse reactions, although not everyone is susceptible.
Local irritation with scaling (removal of dead skin cells), itching, erythema (redness of the skin), dry skin, acne, burning and hypertrichosis (abnormal growth of hair at a distance) or more rarely allergic reactions may occur. Breathing difficulties have also been reported. Your doctor should be informed.
In some rare cases, a drop in blood pressure, rapid pulse, palpitations, hair loss, irregular hair growth, chest pain, hepatitis or kidney stones may occur: stop the treatment immediately and inform your doctor.
More rarely, other reactions have been described, such as allergy (rhinitis, skin rash, generalized redness, facial swelling), dizziness, tingling, headache, weakness, edema (liquid infiltration in the tissues), alteration of taste, ear infection, vision problems, eye irritation, neuritis (nerve damage).
It should be noted, however, that these effects, especially those that have been reported less frequently, have been reported without any definite evidence of treatment-induced effects.
Due to the presence of propylene glycol, eczema may occur.
Due to the presence of ethanol, frequent application to the skin may cause skin irritation and dryness.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE ALOSTIL 5 PER CENT, solution for cutaneous application
Keep out of the reach and sight of children.
Expiry date
Do not use ALOSTIL 5 PER CENT, solution for dermal application after the expiry date stated on the bottle.
Storage conditions
Flammable product.
This drug should be stored below 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does ALOSTIL 5 PER CENT, solution for cutaneous application contain?
The active substance is:
Minoxidil ................................................................................................................................................ 5 g
Per 100 ml of solution.
The other ingredients are:
Propylene glycol, 96 per cent ethanol, purified water
Pharmaceutical form and contents
What is ALOSTIL 5 PER CENT, solution for skin application and what does it contain?
This medicine is available as a solution for skin application in a bottle. Box of 1 or 3.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY LES MOULINEAUX
Français
English
