ALOPEXY 5% Lösung zur Anwendung auf der Haut

For moderate hereditary hair loss in men Brochure Alopexy Active ingredients 50 mg minoxidil Excipients Water, purified 240 mg propylene glycol 520 mg ethanol 96% (v/v) Source: Avoxa/ABDATA Pharma Data Service Indication The preparation is a solution for use on the skin that contains minoxidil, an active ingredient that stimulates hair growth. This medicine is used to treat certain moderate cases of a condition called androgenetic alopecia (excessive hair loss) in men. This medicine is not recommended for use in women because abnormal hair growth (hypertrichosis) is often expected. Contraindications The medicine must not be used if you are allergic to minoxidil or any of the other ingredients of this medicine. if you have already had an intolerance reaction to the solution containing 20 mg/ml minoxidil. if you have an illness or injury to your scalp. Children and young people Safety and effectiveness in children under 18 years have not been established. No data is available. Therefore, the medicine is not recommended for children under 18 years of age. Elderly patients This medicine should not be used by people over 65 years of age because its effectiveness and safety have not been established in these patient groups. Dosage Always use this medicine exactly as described or exactly as discussed with your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure. The recommended dose is to apply 1 ml twice daily to the scalp area to be treated. The amount applied daily should not exceed 2 ml, regardless of the size of the area to be treated. Frequency of application Use 1 ml of the solution in the morning and evening. The amount of application and the frequency of applications must not be increased. Under no circumstances should you change the recommended dose on your own. Duration of application A treatment result is not immediately visible. A stop to hair loss and/or new hair growth can only be expected a certain time after the start of treatment. Consistent treatment is required to increase and maintain hair regrowth. First results can be expected after 2 to 4 months of twice daily use. The response to treatment and the degree of response varies from person to person. If treatment is stopped, a return to baseline is likely within 3 to 4 months. If you have used more than you should When used as directed, an overdose is unlikely. When used on damaged scalp, absorption of the active ingredient may be increased and side effects may occur. If you forget to use it Do not use a double dose if you forget the previous dose. Continue normal use: 1 application in the morning, 1 application in the evening. If you cancel the application Not applicable. Side effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Contact a doctor immediately if you notice any of the following symptoms - you may need urgent medical treatment: Swelling of the face, lips, or throat that makes it difficult to swallow or breathe. This could be a sign of a serious allergic reaction (frequency not known and cannot be estimated from the available data). The most commonly observed reactions were minor skin reactions. Frequent use on the skin can cause irritation and dry skin due to the alcohol it contains. The following reported side effects have been classified by frequency: Very common: may affect more than 1 in 10 people: Abnormal hair growth (hypertrichosis) beyond the application site, especially when the medicine is used by women. Headache. Common: may affect up to 1 in 10 people: Local skin reactions at the application site, e.g. B. Irritation with shedding of dead skin cells (desquamation), itching, redness of the skin, skin inflammation, dry skin, allergic skin reaction, inflammatory skin diseases, acne-like pustules, pain in the musculoskeletal system, fluid accumulation in the tissue (peripheral edema), breathing difficulties and depression. Not known: Frequency cannot be estimated from the available data Ear infections, inflammation of the outer ear, inflammation of the nasal mucosa, hypersensitivity, nerve inflammation, tingling sensation, impaired taste sensation, burning sensation on the skin, visual disturbances, eye irritation, dizziness, drop in blood pressure, increased pulse rate, heart palpitations, chest pain, weakness, swelling in the facial area (facial oedema), skin redness (erythema), skin rash, hair loss, irregular hair growth, change in hair color, change in hair texture, Inflammation of the liver (hepatitis) and kidney stones. In all cases mentioned, treatment should be stopped and your doctor should be contacted immediately. If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects that are not specified. Patient information Warnings and precautions Please talk to your doctor or pharmacist before using the medicine. Particular caution is required if you have cardiovascular disease or heart rhythm disorders such as low blood pressure (hypotension), tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or signs of water retention (swelling of the hands or feet). Under these circumstances, you should consult a doctor before using this medicine. Monitoring should occur at the start of treatment and periodically thereafter. The recommendation that this medicine should not be used by women is due to the risk of abnormal hair growth (hypertrichosis). You should not use this medicine in the following cases: if there is no family history of hair loss, sudden and/or uneven hair loss, pregnancy-related hair loss or hair loss of unknown cause. In these cases, you should consult a doctor before use as the treatment may be ineffective for these types of hair loss. if your scalp is red, inflamed, infected, irritated or painful. This medicine should only be used on healthy scalp. If the scalp is damaged, the active ingredient (minoxidil) can pass more into the blood. Do not use this medicine on the scalp at the same time as other skin preparations. Do not use this medicine on other parts of the body. During application This medicine, which contains ethanol (alcohol), may cause burning or irritation if accidental contact with eyes, wounds, irritated skin, or mucous membranes occurs. Rinse the affected area with plenty of cold tap water. If symptoms persist, consult a doctor. A temporary increase in hair loss may occur during the first 2 to 6 weeks of treatment. If hair loss persists or worsens after 6 weeks, you should stop using the product and consult your doctor. The treated scalp should not be exposed to sunlight: wear head protection (hat). Do not swallow. Accidental ingestion may result in adverse effects due to minoxidil's effects on the cardiovascular system. Therefore, keep this medicine out of the reach and reach of children. See a doctor immediately! Do not inhale spray mist. Some patients have experienced changes in hair color and/or texture. Stop use immediately and consult a doctor if you experience any of the following symptoms: low blood pressure, chest pain, increased pulse rate, attacks of weakness or dizziness, sudden unexplained weight gain, swollen hands or feet (edema), persistent redness or irritation of the scalp. Ability to drive and use machines The medicine has no or negligible influence on the ability to drive and use machines. Pregnancy and breastfeeding This medicine is not recommended for women. Avoid use during pregnancy or breastfeeding. If you are pregnant or breast-feeding, may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Application For use on the skin. For external use. Wash your hands thoroughly before and after applying the solution. Before application, hair and scalp must be completely dry. Using your fingertips, spread the medicine over the entire scalp area to be treated. Start in the middle of the area to be treated. You must not use the medicine on other parts of the body. Instructions for use For further information see instructions for use! Interactions Use together with other medicines Do not use this medicine at the same time as other skin products such as tretinoin, anthralin, or betamethasone dipropionate because these products may change the amount of minoxidil in the blood. Please inform your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines, even if they are non-prescription medicines. Use with food and drinks Not applicable. Medicine service Package leaflet ALOPEXY 5% solution for use on the skin 3X60 ml against hereditary hair loss ( Source: Avoxa/ABDATA Pharma Data Service )