Therapeutic indications
This medicine is indicated in cases of moderate hair loss (androgenetic alopecia) in males. It is intended to be used exclusively on the scalp.
ALOSTIL 5% foam for cutaneous application contains minoxidil.
Minoxidil helps to regrow hair and stabilize hair loss in men with balding of the temporal gulfs and slight balding at the crown of the head by revitalizing the hair follicles.
2. WHAT YOU SHOULD KNOW BEFORE USING ALOSTIL 5%, foam for cutaneous application in pressurised bottle
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use ALOSTIL 5%, foam for cutaneous application:
-ifyou are allergic (hypersensitive) to minoxidil or to any of the other components contained in ALOSTIL 5%, foam for cutaneous application (see section 6).
Precautions for use; special warnings
Be careful with ALOSTIL 5%, foam for cutaneous application:
Ask your doctor or pharmacist for advice before using ALOSTIL if you have heart disease (including abnormal heart rhythm or rate), angina, chest pain and/or circulatory disorders.
Changes in hair colour and texture have been observed in some patients taking this medication.
Increased hair loss (shedding of small layers of skin from the scalp) may occur during the first 2 to 6 weeks of treatment. This indicates that the treatment is working and new hair is replacing the old hair. This phenomenon stops within a few weeks. If hair loss persists, stop using ALOSTIL and consult a doctor.
Accidental ingestion of the product may cause serious adverse cardiac effects. For this reason, it should be kept out of the reach of children.
Do not use ALOSTIL 5%, foam for skin application if:
youralopecia is not characterized by baldness of the temporal gulfs and slight tonsure at the top of the head,
youdo not have a family history of baldness,
you have no family history of baldness, -yourhair loss is sudden and/or in patches,
youdo not know the reason for your hair loss,
yourscalp is red, inflamed, irritated or painful.
This medicine contains butylated hydroxytoluene (E320) and may cause local skin reactions (e.g. eczema) or irritation of the eyes and mucous membranes.
This medicine contains cetyl alcohol and stearyl alcohol and may cause local skin reactions (e.g. eczema).
This medicine contains ethanol (alcohol) and causes burns and irritation if it comes into contact with the eyes. If ALOSTIL comes into contact with the eyes, mouth or a cut or skin lesion, wash with plenty of cold running water.
Special warnings
ALOSTIL 5% foam for skin application is EXTREMELY FLAMMABLE.
Do not go near a fire or flame and do not smoke during or immediately after application.
Children and adolescents
ALOSTIL should not be used in children and adolescents under the age of 18.
Other hair products and ALOSTIL 5% foam for skin application
Use of shampoo during treatment
You should use a mild shampoo during treatment with ALOSTIL. Your scalp should be dry before applying ALOSTIL.
Use of styling products during treatment
For best results, ALOSTIL should be allowed to penetrate the scalp before using any styling products. Apply ALOSTIL first, then use your styling products in the usual way. Do not mix ALOSTIL with any other preparation before applying to the scalp.
Recommendations for colouring or perming
There is no information available regarding the use of hair dyes or perms with ALOSTIL. However, to avoid possible scalp irritation, you should ensure that ALOSTIL has been thoroughly removed from the hair and scalp before using these chemicals.
You should also inform your hairdresser that you are using ALOSTIL.
Interactions with other medicines
Use of 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.
ALOSTIL should not be used with any other medication applied topically to the scalp.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
ALOSTIL is not intended for use by women.
This medicine is not recommended during pregnancy, lactation or during the period of conception.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving and Use of Machinery
No effect of ALOSTIL on your ability to drive or use machines is expected.
List of excipients with a known effect
Important information on the ingredients of ALOSTIL 5% foam for skin application
List of excipients with a known effect: Ethanol (alcohol), butylated hydroxytoluene (E320), cetyl alcohol and stearyl alcohol
3. HOW TO USE ALOSTIL 5%, foam for cutaneous application in pressurised bottle?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Always use ALOSTIL exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Use this foam twice a day to achieve and maintain the desired effect on hair growth.
This mousse is intended for use on the scalp only. NEVER apply it to any other part of the body.
Be sure to apply the mousse directly to the scalp.
Avoid contact with the eyes. If the foam gets into the eyes, rinse them immediately with plenty of cold running water.
Method of administration
Apply to perfectly dry hair and scalp.
Apply a 1 g dose (equivalent to the volume of half a bottle) to the area of hair loss twice a day.
1. To open the container, place the arrow on the ring opposite the arrow on the cap. Remove the cap (Figure 1).
2. The foam may melt on hot skin. If your fingers are hot, rinse them with cold water first. Dry them thoroughly before handling the foam.
3. Hold the bottle upside down and press the button to apply the foam to your fingertips (Figure 2). The total amount of foam applied should not exceed 1 g (equivalent to the volume of half a cork).
4. Using your fingers, lightly massage the foam into the affected areas of the scalp (Figure 3), then wash your hands immediately after applying the foam.
5. After each use, close the container by pushing the cap back on to the bottle.
1 application twice daily.
Duration of treatment
Hair regrowth takes time. Results can be seen after 2 months of twice daily use. For some men, at least 4 months of application may be required before results are visible.
What can I expect during the use of ALOSTIL?
When using this foam for the first time, some users observe an increase in hair loss during the first few months of application. This may indicate that ALOSTIL is working. This temporary increase in hair loss usually occurs between 2 and 6 weeks after starting the treatment and then disappears.
If hair loss persists after 6 weeks, consult your doctor.
The hair is usually soft, fluffy and colourless. With each application, the new hair is normally the same colour and thickness as the other hair. Because hair growth is slow, ALOSTIL takes time to work.
Results can be seen in 2 to 4 months of twice daily use.
If hair does not grow back after 4 months, stop using ALOSTIL.
The amount of hair regrowth varies from user to user. This product does not work for all men.
Symptoms and instructions in case of overdose
If you have used more ALOSTIL 5%, foam for skin application than you should have:
Follow the directions for use.
Do not use more than 2 g (equivalent to the volume of one capful) per day and do not apply more than twice a day. Your hair will not grow back faster and the effect will not be better if you use it more often.
If a child swallows ALOSTIL, take him or her to hospital immediately (with the bottle of ALOSTIL if possible, so that the doctor has an idea of how much the child has swallowed).
Instructions in case of missed doses
If you forget to use ALOSTIL 5%, foam for skin application:
Do not worry if you miss one or two applications, just continue to use the product as if you had not missed any doses.
Do not apply a double amount of ALOSTIL to your scalp if you miss an application.
Risk of withdrawal syndrome
If you stop using ALOSTIL 5% foam for skin application :
If you stop using the foam, hair that has grown back may fall out and it is likely that your scalp will return to its original condition in 3 to 4 months.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, ALOSTIL 5% foam for skin application is likely to have side effects, although not everyone is susceptible.
If you experience any of the following infrequent side effects (less than 1 in 100 patients), STOP using the foam and tell your doctor as soon as possible:
Chest pain.
Low blood pressure.
Increased heart rate.
Faintness with impending unconsciousness or dizziness.
Swelling of the hands or feet, shortness of breath, high blood pressure.
Sudden unexplained weight gain.
Persistent local redness or rash.
Other possible side effects:
Common (less than 1 in 10 patients) possible adverse reaction: headache.
Uncommon side effect (less than 1 in 100 patients) possible:
Itching, excessive hair growth, acne, skin irritation, inflammatory skin conditions causing redness and itching, breathing discomfort or difficulty.
Scalp irritation, such as local redness, itching, dryness, scaling. It may be due to other components of the product: hydroxybutyl toluene, cetyl alcohol and/or stearyl alcohol. This effect is usually temporary; if it persists, discontinue use of this product.
Unwanted hair growth outside the scalp has occasionally been reported. Always wash your hands thoroughly after application and, in case of accidental contact of the foam with parts of the body other than the scalp, rinse thoroughly with water.
Temporary hair loss may occur during the first 2 to 6 weeks of use. This is probably related to a change in the growth cycle and usually stops within a few weeks. If hair loss continues beyond 2 weeks, stop using the product and talk to your doctor.
A change in hair color and/or texture is possible. In this case, stop using ALOSTIL.
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%, foam for cutaneous application in pressurised bottle
Keep out of the reach and sight of children.
Expiry date
Do not use ALOSTIL 5% foam for dermal application after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
Storage conditions
Caution Extremely flammable:
Pressurized container. Protect from sunlight and do not expose to temperatures exceeding 50 C. Do not pierce, do not throw into fire, even after use. Do not spray on an open flame or any incandescent substance. Keep away from sources of ignition - Do not smoke. Do not use near or place container on polished or painted surfaces.
If necessary, warn against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household garbage. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does ALOSTIL 5% foam for skin application in a pressurised bottle contain?
The active substance is:
Minoxidil............................................................................................................................................ 50 mg
Per 1 g of foam for skin application.
The other components are:
Ethanol anhydrous, purified water, butylated hydroxytoluene (E321), lactic acid, citric acid anhydrous, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60, propane/ butane/ isobutene (propellant)
Pharmaceutical form and content
What is ALOSTIL 5% foam for skin application in a pressurised bottle and what does it contain?
This medicinal product is in the form of a foam for dermal application in a pressurised bottle.
The foam is white to off-white. The medicine is packaged in an aerosol bottle containing 60 g of foam (corresponding to 73 ml). The bottle contains enough product for one month of treatment. Box of 1 or 3 pressurized bottles.
Not all presentations may be marketed.
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
