NOTICE
ANSM - Last updated: 18/07/2012
Name of the medicinal product
UNIPEXIL 2 PER CENT, 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.
· 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, 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 2 PER CENT, solution for dermal application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE UNIPEXIL 2 PER CENT, solution for skin application?
3. HOW TO USE UNIPEXIL 2 PER CENT, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE UNIPEXIL 2 PER CENT, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS UNIPEXIL 2 PER CENT, solution for dermal application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
MINOXIDIL FOR LOCAL USE
(D: dermatological drugs)
Therapeutic indications
This medication is indicated in case of moderate hair loss (androgenetic alopecia) of adult, male or female. It promotes hair growth and stabilizes the phenomenon of fall.
2. BEFORE YOU USE UNIPEXIL 2 PER CENT, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take UNIPEXIL 2 PER CENT, solution for skin application:
YOU MUST NOT TAKE THIS MEDICINE if you are allergic to minoxidil or to any of the other ingredients in the solution.
If in doubt, you should seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with UNIPEXIL 2 PER CENT, solution for skin application:
Special warnings
In case of even old heart disease, it is necessary to consult a doctor before the first use of minoxidil. |
Do not apply minoxidil:
· in the event of sudden hair loss, hair loss due to illness or medication, DO NOT USE THIS MEDICINE AND TAKE ADVICE OF YOUR DOCTOR. In fact, minoxidil would not be effective on this type of hair loss ( see Additional information.
· on another part of the body.
Stop treatment and see your doctor if redness or persistent irritation of the scalp occurs.
· It is important to respect the recommended dosage and mode of administration:
o do not increase the dose per application, do not increase the frequency of applications,
o only apply minoxidil to a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp,
o do not use minoxidil together with retinoic acid or anthralin (medications sometimes used in dermatology) or any other dermatologic irritant drug.
In the event of non-compliance with the recommended dosage and / or mode of administration, passage into the general circulation of minoxidil may be increased and may lead to adverse effects such as chest pain, decreased blood pressure, tachycardia (accelerated rhythm dizziness or feeling dizzy, sudden and unexplained weight gain, swelling of the hands and feet.
This medicine contains propylene glycol and may cause skin irritation.
If symptoms occur, stop treatment and see your doctor.
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
DO NOT SWALLOW.
DO NOT INHALE.
Use this medicine only with caution
In case of accidental contact with the eye, wound or mucous membrane, the solution (containing ethyl alcohol) may cause burning and irritation: rinse thoroughly with running water.
Do not expose the treated scalp to the sun: protection is necessary (hat).
Interaction with other medicines
Taking other medicines
If you are using or have recently used any other medicines, including medicines obtained without a prescription, talk to your pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
If you are pregnant or breastfeeding
Do not take this medicine without consulting your doctor or pharmacist. |
It is best not to use minoxidil during pregnancy.
Similarly, the use of minoxidil should be avoided.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: Propylene glycol.
3. HOW TO USE UNIPEXIL 2 PER CENT, 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
Use this medication only in adults. |
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.
The daily dose should not exceed 2 ml, regardless of the extent of the area to be treated. Spread the product with your fingertips so that it covers the entire area to be treated (see administration procedure).
Before and after applying the solution, wash your hands thoroughly.
Apply to perfectly dry hair and scalp.
Method and route of administration
Dermal.
External use.
The bottle is equipped with an adaptable tip that allows a rational use of the product.
Use of the Pump Tip :
Unscrew cap from bottle.
Screw on the bottle, the system of end-pump present in the box. During the first use, it may be necessary to press the tip several times to prime the pump. To remove the product, press on the pump by pointing the nozzle towards the center of the different areas to be treated.
7 sprays deliver 1 ml of product.
Avoid leaving the dosing system on the bottle: the constant immersion of the tubing in the solution is harmful to the preservation of the latter, which under these conditions can not exceed one month. After use, remove the system from the bottle, rinse it and close the bottle with the cap provided for this purpose.
Frequency and timing of administration of the drug
An application of 1 ml in the morning and 1 ml in the evening.
Do not increase doses or application frequencies.
Duration of treatment
The onset and degree of response to treatment varies depending on the subject.
The result is not immediate: stopping hair loss and / or hair growth can only occur some time after starting treatment (about 3 or 4 months).
Symptoms and Instructions for Overdose
If you have used more UNIPEXIL 2 PERCENT solution for skin application than you should:
The accidental ingestion may cause effects due to the cardiovascular action of minoxidil: QUICKLY CONSULT A DOCTOR .
Instructions for omission of one or more doses
If you forget to use UNIPEXIL 2 PER CENT, solution for skin application:
Do not increase doses.
Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, UNIPEXIL 2 PERCENT, solution for dermal application is likely to have undesirable effects, although not everyone is subject to it.
· possible local irritation with scaling, itching, redness of the skin, dry skin (especially due to the presence of alcohol), hypertrichosis (abnormal development of the hair system from the point of application), burning sensation ,
· more rarely, allergic reactions (rhinitis, localized or generalized skin rashes, generalized redness, swelling of the face), dizziness, tingling, headache, weakness, edema, taste impairment, ear infections, vision problems, eye irritation, neuritis (inflammation of a nerve),
· in a few cases, a decrease in blood pressure, an acceleration of the pulse, hair loss particularly at the beginning of treatment, chest pain, a change in liver function,
· due to the presence of propylene glycol, risk of eczema.
In all these cases you should stop your treatment and tell your doctor.
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 2 PER CENT, solution for skin application?
Keep out of the reach and sight of children.
Expiration date
Do not use UNIPEXIL 2 PERCENT, solution for skin application after the expiry date stated on the outer packaging
Storage conditions
This medication should be stored at a temperature below 25 ° C.
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 2 PERCENT, solution for skin application?
The active substance is :
Minoxidil ................................................. .................................................. ............................................. 2 g
For 100 ml.
1 ml contains 20 mg of minoxidil.
The other components are :
Ethanol 96 percent, propylene glycol, purified water.
Pharmaceutical form and content
What is UNIPEXIL 2 PER CENT, solution for skin application and contents of the outer packaging?
This medication is in the form of a solution for skin application. Box of 1 or 3 bottles of 60 ml.
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
LABORATOIRES GIFRER BARBEZAT
8-10, rue Paul Bert
BP 165
69151 Décines Cedex
exploiting
GIFRER BARBEZAT
8 - 10, rue Paul Bert
69151 DECINES CEDEX
Maker
GIFRER BARBEZAT
8 - 10, rue Paul Bert
69151 DECINES CEDEX
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
SANITARY EDUCATION COUNCILS
a / What is called androgenetic alopecia ?
Normally the hair has a lifetime 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 shock, 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 women: Androgenetic alopecia is diffuse: there is an overall decrease in capillary density. The hair gradually clears from the skate.
* In humans: androgenetic alopecia begins with a degeneration 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 after applying minoxidil preferably in warm position.
· 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.