Country: Malta
Language: English
Source: Medicines Authority
MINOXIDIL
Laboratoires Bailleul S.A. 10-12 Avenue Pasteur L-2310 Luxembourg, Luxembourg
D11AX01
MINOXIDIL 50 mg/ml
CUTANEOUS SOLUTION
MINOXIDIL 50 mg/ml
OTC
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2014-09-30
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 Read the complete document
Page 1 of 8 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 Page 2 of 8 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 Read the complete document