Minorga 5% Cutaneous Solution 50mg/ml

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

MINOXIDIL

Tillgänglig från:

Laboratoires Bailleul S.A. 10-12 Avenue Pasteur L-2310 Luxembourg, Luxembourg

ATC-kod:

D11AX01

INN (International namn):

MINOXIDIL 50 mg/ml

Läkemedelsform:

CUTANEOUS SOLUTION

Sammansättning:

MINOXIDIL 50 mg/ml

Receptbelagda typ:

OTC

Terapiområde:

OTHER DERMATOLOGICAL PREPARATIONS

Bemyndigande status:

Authorised

Tillstånd datum:

2014-09-30

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MINORGA 5%, CUTANEOUS SOLUTION
Minoxidil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
ALWAYS USE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS
YOUR DOCTOR OR PHARMACIST HAVE TOLD YOU.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 4 months.
WHAT IS IN THIS LEAFLET
1.
What Minorga 5%, cutaneous solution is and what it is used for
2.
What you need to know before you use Minorga 5%, cutaneous solution
3.
How to use Minorga 5%, cutaneous solution
4.
Possible side effects
5.
How to store Minorga 5%, cutaneous solution
6.
Contents of the pack and other information
1.
WHAT MINORGA 5%, CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR
Minorga 5%, cutaneous solution contains minoxidil, at the
concentration of 50 mg per ml.
Minorga 5%, cutaneous solution is a medicine in a liquid form, for
direct application on the scalp. It is used as a
treatment for hair loss and not as a cure. Minoxidil is a peripheral
vasodilator, whose exact mechanism to renew
hair growth is unknown.
Minorga 5%, cutaneous solution is indicated for use in adults aged
from 18 to 65 years with a gradual
weakening or loss of hair on top of the head. Weakening or loss of
hair is a slow process that may become
obvious after several years of gradual loss.
Minorga 5%, cutaneous solution is particularly indicated in men who
suffer from hair loss or weakening on top
of the head and in women with generalized hair weakening.
You must talk to a doctor if you do not feel better or if you feel
worse after 4 months.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MINORGA 5%, CUTANEOUS SOLUTION
DO NOT USE MINORGA 5%, CUTANEOUS SOLUTION :
-
if you are allergic to minoxid

Produktens egenskaper

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Minorga 5%, cutaneous solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 50 mg/ml (5% w/v).
One spray of Minorga 5% cutaneous solution contains 7 mg of minoxidil.
Seven sprays are required to apply approximately 1 ml of solution
containing 50 mg of
minoxidil.
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cutaneous solution.
Clear and colorless or slightly yellow solution with an alcohol odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Minorga 5%, cutaneous solution is indicated for the treatment of
alopecia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of 1 ml of Minorga 5%, cutaneous solution should be applied
on the scalp twice
daily (once in the morning, once at night). This dose should be
administered regardless of the
affected area size. The total daily dose should not exceed 2 ml.
_Paediatric and elderly population _
It is not recommended below 18 years old and over 65 years old due to
a lack of data on
safety and efficacy.
Method of administration
Minorga 5%, cutaneous solution is for external use only. It is not
recommended below 18
years and over 65 years due to a lack of data on safety and efficacy.
Minorga 5%, cutaneous solution should be applied in accordance with
the instructions and
only on the scalp. Minorga 5%, cutaneous solution should be applied
only on dry hair and
scalp. After applying Minorga 5%, cutaneous solution, hands should be
washed thoroughly.
The application of the product may be required twice daily, for four
months or more. In all
cases, physician should consider discontinuing treatment if no results
are observed within 4
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months. If hair growth occurs, it is necessary to continue the
administration of Minorga 5%,
cutaneous solution, twice daily, in order to maintain its effect.
After treatment discontinuation
with minoxidil topical lotion, hair growth arrest and, sometimes, the
return