Therapeutic indications
This medicine is indicated in cases of moderate hair loss (androgenetic alopecia) in males.
It is not recommended for women because of the high incidence of hypertrichosis (abnormal development of the hair system) at a distance from the application sites.
2. WHAT YOU SHOULD KNOW BEFORE USING ALOPEXY 5%, solution for cutaneous application
List of information needed before taking the medicine
Not applicable.
Contraindications
Never use ALOPEXY 5%, solution for cutaneous application:
If you are allergic to the active substance (minoxidil) or to any of the other components contained in ALOPEXY 5%.
If you have experienced intolerance when using minoxidil 2% solution.
If you have scalp lesions.
Children and the Elderly:
The efficacy and safety of this drug have not been studied in subjects under 18 years of age or over 65 years of age.
Precautions; special warnings
Use caution with ALOPEXY 5%, solution for cutaneous application:
If you have, or have had, heart disease (even old heart disease), you should consult a doctor before using this drug for the first time.
The risk of hypertrichosis (abnormal development of the hair system) justifies that this medicine is not recommended for women.
You should not apply this product:
If you have no family history of alopecia, if you have sudden and/or patchy hair loss, hair loss following childbirth, or hair loss of unknown cause. In these cases, you should consult your doctor before taking this medication as this treatment may not be effective for these types of hair loss.
If your scalp is red, inflamed, infected, irritated or painful. This medicine should only be applied to a healthy scalp (see section: "How to use ALOPEXY 5%"). In patients with scalp lesions, there may be an increased transfer of the active substance (minoxidil) into the bloodstream (see section: "Never use ALOPEXY5%").
Do not apply this medicine at the same time as other medicines applied to the scalp.
During treatment
In the event of accidental contact with the eye, a wound, irritated skin or a mucous membrane, the solution containing alcohol may cause a burning sensation or irritation: rinse thoroughly with cold running water. In case of persistent signs, consult a doctor.
Do not expose the treated scalp to the sun, protection is necessary (hat).
Do not swallow. Accidental ingestion may cause effects due to the cardiovascular action of minoxidil. Therefore, the product should be kept out of sight and reach of children. SEEK PROMPT MEDICAL ATTENTION.
- ·Do not inhale.
A change in hair color and/or texture has been observed in some patients.
This treatment requires regular medical monitoring, especially at the beginning of treatment.
You should stop treatment immediately and consult a doctor:
If you experience a drop in blood pressure, chest pain or a rapid pulse
If you feel weak or dizzy
Sudden unexplained weight gain, swelling of the hands or feet (edema)
Persistent redness or irritation of the scalp
Interactions with other medicines
Use of other medications
Do not apply this medication at the same time as other products intended for application to the scalp, such as anthralin, tretinoin, betamethasone dipropionate, as these products may affect the amount of minoxidil in the blood.
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
The use of this medicine is not recommended in women.
Do not take this medicine during pregnancy or while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving and using machines
Effects are unlikely.
List of excipients with a known effect
Important information about some of the ingredients of ALOPEXY 5%, solution for cutaneous application:
This medicine contains propylene glycol and may induce skin irritation.
This medicine contains ethanol and is therefore flammable.
3. HOW TO USE ALOPEXY 5%, solution for cutaneous application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Always follow the dosage indicated by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is 1 ml to be applied twice a day to the scalp area to be treated.
The daily dose should not exceed 2 ml, regardless of the size of the area to be treated.
Frequency of administration
One application of 1 ml in the morning and 1 ml in the evening.
Do not increase the dose or frequency of application.
In all cases, strictly adhere to the dose.
Duration of treatment
The result is not immediate: the stopping of hair loss and/or hair growth requires a certain amount of time after the beginning of the treatment. A 2-month treatment with 2 applications per day may be necessary before hair growth is stimulated. The time required and the degree of response vary according to the individual.
If the treatment is stopped, according to some observations, a return to the initial state would appear in 3 to 4 months.
Method of administration
Dermal route. External use.
Before and after application of the solution, wash hands thoroughly.
Apply to perfectly dry hair and scalp.
Spread the product with the fingertips so as to cover the entire area to be treated, starting from the centre of the area to be treated.
Do not apply the product to any other part of the body.
Method of application
Depending on the delivery system used: dosing pipette or sprayer
Dosing pipette
Sprayer with applicator
This system is suitable for application to small areas or under the hair.
Rinse the cannula with warm water after each use.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
Symptoms and instructions in case of overdose
If you have used more ALOPEXY 5%, solution for skin application than you should have:
Overdose is unlikely if used as directed. If applied to an injured scalp, the absorption of the active substance may be increased and adverse reactions may occur (see section 2 WHAT YOU SHOULD KNOW BEFORE USING ALOPEXY 5%, solution for cutaneous application).
Instructions in case of missed dose(s)
If you forget to use ALOPEXY 5%, solution for cutaneous application :
Do not apply a double dose to make up for the dose you forgot to apply.
Resume the usual frequency: 1 application in the morning and 1 application in the evening.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, ALOPEXY 5%, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.
Very common: may occur in more than 1 in 10 people
Hypertrichosis (excessive hair growth) at a distance from the application site, especially when used on women.
Headache.
Common: may occur in more than 1 in 100 people
Local skin reactions at the product application site: local irritation with desquamation (removal of dead skin cells), itching, redness of the skin, dermatitis, dryness of the skin, allergic skin reaction due to the presence of propylene glycol, inflammatory skin reaction, acne-like skin rash, muscle and joint pain, peripheral oedema (fluid in the tissues), difficulty in breathing and depression.
Unknown (cannot be estimated on the basis of available data)
Ear infection, otitis externa, rhinitis, hypersensitivity, neuritis (nerve damage), tingling, taste alteration, burning sensation, blurred vision, eye irritation, dizziness, low blood pressure, increased pulse rate, chest pain, weakness, facial swelling (fluid in the tissues), irritation, redness, hair loss and irregular hair, change in hair color or texture, hepatitis, and kidney stones.
In all these cases, you should stop your treatment and tell your doctor promptly.
Reporting side effects
If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (Ansm) and the network of Regional Pharmacovigilance Centres. By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.
5. HOW TO CONSERVE ALOPEXY 5%, solution for cutaneous application?
Keep this medicine out of the reach and sight of children.
Expiry date
Do not use ALOPEXY 5%, solution for cutaneous application after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
Storage conditions
Flammable product.
The solution must be used within 1 month after first opening.
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
Full list of active ingredients and excipients
What does ALOPEXY 5% solution for skin application contain?
The active substance is:
Minoxidil ................................................................................................................................................ 5 g
Per 100 ml.
The other ingredients are:
Propylene glycol, 96% ethanol, purified water.
Pharmaceutical form and content
What is ALOPEXY 5% solution for skin application and what does it contain?
This medicine is presented as a solution for cutaneous application.
60 ml bottle with graduated pipette. Box of 1 or 3 bottles.
60 ml bottle with graduated pipette and dosing pump with applicator. Box of 1 or 3 bottles.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
PIERRE FABRE DERMATOLOGIE
45 place Abel Gance
92100 BOULOGNE
Français
English
