Страна: Израиль
Язык: английский
Источник: Ministry of Health
MINOXIDIL
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD
D11AX01
SOLUTION
MINOXIDIL 5 %
TOPICAL- SCALP
Not required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
MINOXIDIL
MINOXIDIL
Androgenetic alopecia in males .
2023-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor’s prescription MINOXI 5 SCALP SOLUTION ACTIVE INGREDIENT: minoxidil 5% Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. You must use this medicine according to the instructions in the dosage section in this leaflet. Consult your pharmacist if you need further information. MINOXI 5 IS INTENDED FOR MEN AGED 18-65 YEARS IN CASES OF HEREDITARY HAIR LOSS ONLY. If you experience no improvement in your hair growth after one year of use, you should discontinue treatment. 1. WHAT IS THIS MEDICINE INTENDED FOR? Minoxi 5 is intended for scalp hair growth in healthy men aged 18-65 years, in cases of hereditary hair loss only. Consult your doctor to ensure that your type of hair loss is suitable for treatment with this medicine. THERAPEUTIC GROUP: vasodilators in local administration for treatment of hair loss. The medicine contains minoxidil, which is considered a substance that works by helping the blood flow to the scalp hair follicles. The medicine is intended for men aged 18-65 years. Minoxi 5 works best in men with hair loss or thinning at the top of the scalp. Those who are younger, have been losing hair for a short period of time or have a small area of baldness are likely to experience the best results. You are unlikely to benefit from Minoxi 5 if you have been bald for many years or have a large area of hair loss. HEREDITARY HAIR LOSS is recognisable according to the following signs: The pattern of hair loss (see diagrams). It starts gradually and progresses. You have a family history of hair loss. No other symptoms are present with your hair loss. WHAT YOU NEED Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minoxi 5 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minoxidil 5% w/v. Contains propylene glycol 514 mg/ml and alcohol 244 mg/ml. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous Solution (to be applied to the scalp) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Minoxi 5 is indicated for the treatment of alopecia androgenetica in men. Onset and degree of hair regrowth may be variable among users. Although trends in the data suggest that those users who are younger, who have been balding for a shorter period of time or who have a smaller area of baldness on the vertex are more likely to respond to Minoxi 5, individual responses cannot be predicted. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Men aged 18-65: Hair and scalp should be thoroughly dry prior to topical application of Minoxi 5. A dose of 1 ml Minoxi 5 cutaneous solution should be applied to the total affected areas of the scalp twice daily. The total dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards. It may take twice daily applications for 2 months or more before evidence of hair growth can be expected. If hair re-growth occurs, twice daily applications of Minoxi 5 are necessary for continued hair growth. Anecdotal reports indicate that re-grown hair may disappear three to four months after stopping minoxidil application and the balding process will continue. Users should discontinue treatment if there is no improvement after one year. SPECIAL POPULATIONS There are no specific recommendations for use in patients with renal or hepatic impairment. PAEDIATRIC AND ELDERLY POPULATIONS Not recommended. The safety and effectiveness of minoxidil in children and adolescents below the age of 18 years or adults over the age of 65 years has not been established. METHOD OF ADMINISTRATION For topical use only. The method of application varies according to the disposable applicator used: Aim the pump a Прочитать полный документ