NOTICE
ANSM - Last updated: 20/02/2013
Name of the medicinal product
UNIPEXIL 5% solution for skin application
minoxidil
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist after 3 months, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. What is UNIPEXIL 5%, solution for dermal application and in which cases it is used?
2. What should be known before using UNIPEXIL 5% solution for dermal application ?
3. How to use UNIPEXIL 5% solution for skin application ?
4. What are the possible side effects?
5. How to store UNIPEXIL 5% solution for skin application ?
6. Additional information.
1. WHAT IS UNIPEXIL 5%, solution for dermal application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
OTHER DERMATOLOGICAL PREPARATION.
Therapeutic indications
This medication is indicated in case of moderate hair loss (androgenetic alopecia) in the male subject.
2. BEFORE YOU USE UNIPEXIL 5% solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use UNIPEXIL 5% solution for skin application in the following cases:
· allergy known to minoxidil or to any of the constituents of the product,
· lesions of the scalp,
· intolerance to the 2% form,
· subjects under the age of 18 or over 65,
· any alopecia (hair loss) of the woman.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with UNIPEXIL 5%, solution for skin application :
Special warnings
In subjects with lesions of the scalp, an increase in the passage of the active substance into the blood is possible (see Never use UNIPEXIL 5% solution for skin application). In some rare cases, there may be a drop in blood pressure, an acceleration of the pulse, edema: you must stop treatment immediately and notify your doctor.
The risk of hypertrichosis (abnormal development of the hair system) at a distance justifies not using this drug in women.
This medicine contains propylene glycol and may cause skin irritation.
Precautions for use
This treatment requires regular medical follow-up, particularly at the beginning of treatment.
· Tell your doctor if you have heart problems.
· Do not swallow.
· In case of contact with sensitive surfaces (eye, irritated skin, mucous membranes) rinse thoroughly with running water.
· A change in the color and / or texture of the hair has been observed in some patients.
In case of doubt do not hesitate to ask the advice of your doctor or pharmacist.
Interaction with other medicines
Use of other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable .
Interactions with Herbal Medicines or Alternative Therapies
Not applicable .
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication is contraindicated in women.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable .
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of UNIPEXIL 5%, solution for skin application:
List of excipients with a well-known effect: propylene glycol.
3. HOW TO USE UNIPEXIL 5% solution for skin application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Reserved for adults only.
Dosage
Apply a dose of 1 ml to the scalp twice a day, taking as the starting point the center of the area to be treated.
This dose must be respected regardless of the extent of the area concerned.
The total daily dose should not exceed 2 ml.
Extend the product with your fingertips so as to cover the entire area to be treated.
Wash hands thoroughly after use.
Do not apply to any part of the body.
Administration mode
Dermal.
Apply to perfectly dry hair and scalp.
The method of application varies depending on the delivery system used with the vial.
Sprayer : This system is suitable for application on extended surfaces.
1. Remove the cover from the bottle .
2. Direct the pump towards the center of the surface to be treated, press it once and extend the product with the fingertips so as to cover the entire area to be treated. Repeat the procedure 6 times to apply a 1 ml dose (7 sprays in total). Avoid inhaling the product .
3. Replace the cover on the bottle after use.
Sprayer with an applicator : This system is suitable for application on small surfaces or under the hair.
1. Remove the cover from the bottle .
2. Remove the top of the pump. Fit the applicator and press firmly.
3. Direct the pump towards the center of the surface to be treated, press it once and extend the product with the fingertips so as to cover the entire area to be treated. Repeat the procedure 6 times to apply a 1 ml dose (7 sprays in total). Avoid inhaling the product .
4. Lower the applicator tip.
5. Replace the cover on the bottle after use.
Frequency of Administration
1 application twice a day, morning and evening.
Duration of the treatment
A treatment lasting 2 months at the rate of 2 applications per day may be necessary before a stimulation of hair growth is demonstrated.
The beginning and the degree of the response vary according to the subjects.
Do not stop the applications at the risk of returning to the previous state after a delay of 3 or 4 months.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, UNIPEXIL 5%, solution for skin application is likely to have undesirable effects, although not everyone is subject to it.
· It is possible that local irritation with desquamation (elimination of dead skin cells), itching, erythema (redness of the skin), dry skin, acne, burning sensation and hypertrichosis (abnormal development of the hair system at a distance) more rarely allergic reactions. Respiratory difficulties have also been reported. Tell your doctor.
· In some rare cases, there may be a decrease in blood pressure, an acceleration of the pulse, palpitations, hair loss, irregular hair, chest pain, hepatitis or kidney stones: the treatment should be discontinued immediately and tell your doctor.
· More rarely, other allergic reactions (rhinitis, rash, generalized redness, swelling of the face), dizziness, tingling, headache, weakness, edema (fluid infiltration in the tissues) , taste disturbance, ear infection, visual disturbances, eye irritation, neuritis (nerve damage).
· It should be noted, however, that these effects, especially those which have been most rarely reported, have been without it being formally established that they were caused by the treatment.
· Due to the presence of propylene glycol, risk of eczema.
· Due to the presence of ethanol, frequent applications on the skin can cause irritation and dryness of the skin.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE UNIPEXIL 5% solution for dermal application?
Keep out of the reach and sight of children.
Expiration date
Do not use UNIPEXIL 5% after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding + 25 ° C.
Flammable product.
Keep container tightly closed.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does UNIPEXIL contain 5%, solution for skin application?
The active substance is :
Minoxidil ................................................. .................................................. .............................................. 5 g
For 100 ml of solution.
The other components are :
Ethanol 96 percent, propylene glycol, purified water.
Pharmaceutical form and content
What is UNIPEXIL 5%, solution for skin application and contents of the outer packaging?
This medication is in the form of a 60 ml spray application solution with an applicator. Box of 1 or 3 vials.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
GIFRER BARBEZAT
8-10 RUE PAUL BERT
69150 DECINES CHARPIEU
exploiting
GIFRER BARBEZAT
8-10 RUE PAUL BERT
69150 DECINES CHARPIEU
Maker
GIFRER BARBEZAT
8-10 RUE PAUL BERT
69150 DECINES CHARPIEU
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
SANITARY EDUCATION COUNCILS
a) What is called androgenetic alopecia ?
Normally the hair has a lifespan of 3 to 6 years and it drops 50 to 100 hair per day.
A greater fall in hair may occur seasonally (in the fall) or after delivery: this fall is normal, transient and there is no need to start treatment.
Alopecia is defined as hair loss greater than 100 hairs per day.
There are two types of alopecia:
· acute alopecia,
· chronic alopecia.
Acute alopecia (sudden hair loss over a short period of time) may be diffuse or patchy (alopecia areata) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, psychic, stress ...).
These acute alopecia should not be treated with this medication.
Chronic (long-term) alopecia are almost always diffuse.
They are sometimes due to a specific disease (thyroid, metabolic ...) and they should not be treated with this drug.
In the vast majority, these chronic alopecia are of poorly known origin, usually of hereditary nature: it is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
b) How to recognize androgenetic alopecia in the male subject ?
Androgenetic alopecia begins with a dislocation of the temporal gulfs.
Then a slight tonsure appears at the top of the skull.
These two hairless areas will gradually increase: the androgenetic alopecia is gradually evolving towards baldness.
c) Some tips for use
· Use a slightly aggressive shampoo (preferably without silicone).
If you do your shampoo after the application of minoxidil, respect a period of 4 hours after this.
If you apply minoxidil after shampooing, it is recommended to do it on a dry scalp.
You can use a hair dryer preferably in a warm position after applying minoxidil.
· You can use styling foams, gels or sprays within a minimum of 1 hour between applications.
· There is no interaction between your treatment with minoxidil and your permanent or coloring care but it is better to limit them because of their aggressiveness on the hair.
· If you plan to expose yourself to the sun after applying minoxidil, it is recommended to cover your hair.
d) Some additional information
· At the beginning of treatment, over a short period, it is possible that an increase in hair loss occurs. These hair were destined to fall and do it more quickly. This is a normal phenomenon, continue treatment.
· The first hair that grows will be soft, fluffy and not very visible. As you continue your treatment, they can change and thicken.