Package leaflet: Information for the user

Transcription

1 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 1 Package leaflet: Information for the user Minoxidil BIO-H-TIN-Pharma 20 mg/ml cutaneous spray, solution Minoxidil For women aged over 18 years. 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 has 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. See Section 4. What is in this leaflet 1. What Minoxidil BIO-H-TIN-Pharma 20 mg/ml is and what it is used for 2. What you need to know before you use Minoxidil BIO-H-TIN-Pharma 20 mg/ml 3. How to use Minoxidil BIO-H-TIN-Pharma 20 mg/ml 4. Possible side effects 5. How to store Minoxidil BIO-H-TIN-Pharma 20 mg/ml 6. Contents of the pack and other information

2 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 2 1. What Minoxidil BIO-H-TIN-Pharma 20 mg/ml is and what it is used for Minoxidil BIO-H-TIN-Pharma 20 mg/ml contains the active ingredient minoxidil. Minoxidil BIO-H-TIN-Pharma 20 mg/ml prevents excessive hair loss in women and stimulates hair growth. It also promotes regrowth of new hairs on areas of the scalp which are already thinning or bald, and strengthens downy hair. Following application, Minoxidil BIO-H-TIN-Pharma 20 mg/ml penetrates the scalp and reaches the hair roots. The mechanism by which hair growth is stimulated has not yet been clarified. It takes at least four months until success can be seen. If hair roots are present, fine, lightcoloured downy hair can regrow which becomes longer, thicker and darker over time. How quickly hair growth begins and how much hair grows back differs between patients. Large bald areas or pre-existing hair loss for more than 10 years are less responsive to Minoxidil BIO-H-TIN-Pharma 20 mg/ml. Minoxidil BIO-H-TIN-Pharma 20 mg/ml is for use in women aged over 18 years old. 2. What you need to know before you use Minoxidil BIO-H-TIN-Pharma 20 mg/ml Do not use Minoxidil BIO-H-TIN-Pharma 20 mg/ml if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6) if you concurrently use other topical medical preparations on the scalp Minoxidil BIO-H-TIN-Pharma 20 mg/ml must not be used in children and adolescents under 18 years. The safety and efficacy of Minoxidil BIO-H-TIN-Pharma 20 mg/ml in patients over 65 years of age have not been established. Hair loss after giving birth is normal to a certain extent, therefore Minoxidil BIO-H-TIN- Pharma 20 mg/ml should not be used in this case. Certain types of hair loss could be signs of a physical illness. In this case, Minoxidil BIO-H- TIN-Pharma 20 mg/ml will have no effect and it is important for your health that you consult a doctor in the case of: sudden onset of excessive hair loss patchy hair loss (for example, formation of round patches of hair loss) Minoxidil BIO-H-TIN-Pharma 20 mg/ml will also have no effect if the hair loss is due to one of the following reasons: use of certain medicines (e.g. for cancer). A more rapid regrowth of hair may however possibly be promoted. serious nutritional problems (very low iron levels, vitamin A overdose) stopping taking the pill (due to hormonal changes, a temporary increase in hair loss can occur. This does not usually require medical treatment) damaged scalp due to scarring or burns as hair roots are no longer present hair styles which pull the hair tightly from the scalp (e.g. ponytail). In these cases the mechanical stimulation should be eliminated pregnancy

3 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 3 If you are not sure of the reasons for your hair loss, you should consult a doctor. Warnings and precautions Talk to your doctor or pharmacist before using Minoxidil BIO-H-TIN-Pharma 20 mg/ml. Minoxidil BIO-H-TIN-Pharma 20 mg/ml must only be applied to healthy, intact scalp skin. Only a very small amount of the active ingredient from Minoxidil BIO-H-TIN-Pharma 20 mg/ml penetrates the skin. The occurrence of side effects which do not involve the skin can never fully be excluded especially in sensitive patients or those with heart disease. Should you notice oedema (swelling of parts of the body due to increased water retention, possibly also in the face) or heart problems (e.g. increased heart rate), please inform your doctor. Irritation and burning can occur if Minoxidil BIO-H-TIN-Pharma 20 mg/ml accidently gets into the eyes. This also applies to sensitive surfaces such as mucous membranes or grazed areas. In such cases, wash the medicine off with plenty of water. To avoid that Minoxidil BIO- H-TIN-Pharma 20 mg/ml unintentionally comes in contact with other parts of the body, you should wash your hands after each use of the medicine. If you should become pregnant please discontinue the treatment. Minoxidil BIO-H-TIN-Pharma 20 mg/ml must not be swallowed. Accidental ingestion can lead to serious undesirable effects. This medicine must therefore be kept out of the sight and reach of children. Inhalation of minoxidil should be avoided. As soon as you stop using Minoxidil BIO-H-TIN-Pharma 20 mg/ml, hair loss will start again. Solar irradiation should be avoided. Some patients have experienced changes in hair colour/texture after therapy with minoxidil. If you have a heart condition you should contact a doctor before using Minoxidil BIO-H-TIN- Pharma 20 mg/ml. You should stop using this product and see a doctor if low blood pressure is detected or if you experience chest pain, a rapid heartbeat, feeling faint or dizzy, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp. If your symptoms get worse or do not improve after 12 months, please consult a doctor. Children and adolescents Minoxidil BIO-H-TIN-Pharma 20 mg/ml must not be used in patients under 18 years. Other medicines and Minoxidil BIO-H-TIN-Pharma 20 mg/ml Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

4 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 4 No interactions with other medicines are known to date with Minoxidil BIO-H-TIN-Pharma 20 mg/ml. For your safety, Minoxidil BIO-H-TIN-Pharma 20 mg/ml should not be used together with other medications on the scalp. It cannot be fully excluded that the effect of blood pressure reducing medicines can be enhanced. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is little experience regarding the use of Minoxidil BIO-H-TIN-Pharma 20 mg/ml during pregnancy. Minoxidil which has been absorbed in the body passes into the breast milk. Minoxidil BIO-H-TIN-Pharma 20 mg/ml can be used during pregnancy and breast-feeding providing the benefits to the mother outweigh the risks to the unborn baby or nursing infant. Driving and using machines No effects on the ability to drive and use machines are expected. This medicine contains 208 mg propylene glycol per millilitre (ml). Propylene glycol can cause skin irritation. 3. How to use Minoxidil BIO-H-TIN-Pharma 20 mg/ml Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Please only use Minoxidil BIO-H-TIN-Pharma 20 mg/ml on the healthy, intact scalp and follow carefully the application information. Do not apply Minoxidil BIO-H-TIN-Pharma 20 mg/ml to other parts of the body. The recommended dose is: Spread 1 millilitre (seven pushes on the spray pump applicator) of Minoxidil BIO-H- TIN-Pharma 20 mg/ml in the morning and evening onto the thinning or bald areas of the scalp. Minoxidil BIO-H-TIN-Pharma 20 mg/ml can be very easily spread 1 ml is enough for a large area. In no case should you use more. pump applicator for larger application areas picture 1 picture 2 Remove the cap from the spray pump applicator (picture 1) and spray directly onto the scalp in the area of the hair loss (picture 2). Seven pushes on the spray pump

5 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 5 applicator provide 1 ml solution. After each pumping process, spread the solution with the finger tips onto the affected area. Avoid breathing in spray. Close the bottle with the lid after each use. Extended spray-tip applicator for smaller application areas picture 4 picture 5 Take the cap off the bottle (picture 1). Remove the spray head by pulling upwards (picture 2), place the extended spray-tip applicator on the top and click it into place using slight pressure (picture 3). The minoxidil-solution is now ready for use. The extended spray-tip applicator is suitable for spraying directly onto the scalp in the area of the hair loss (picture 4). After each pumping process, spread the solution with the finger tips onto the affected area. Avoid breathing in spray. For convenient storage, the applicator can simply be swivelled downwards (picture 5). Method of use Apply the solution from the middle of the affected area by means of gentle massage. Your scalp and hair must be completely dry. After use, please wash your hands so that the medicine does not accidentally come into contact with the eyes or mucous membranes. Duration of use When you regularly use Minoxidil BIO-H-TIN-Pharma 20 mg/ml twice a day, you should see new hairs after approximately four months. The hair loss will be stopped sooner. If you use more Minoxidil BIO-H-TIN-Pharma 20 mg/ml than you should Every accidental ingestion or excessive use can cause serious side effects. This is related to the vasodilatory effect of Minoxidil. Signs of an overdose are mostly manifest in the cardiovascular area (increased heart rate with low blood pressure and reduced fluid excretion). Treatment must definitely be carried out by a doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor right away if you notice any of the following symptoms you may need urgent medical treatment. Swelling of the face, lips or throat which makes it difficult to swallow or breathe. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data). Other side effects Common: may affect up to 1 in 10 people

6 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 6 slight inflammatory reactions on the scalp Rare: may affect up to 1 in 1,000 people local skin irritation including skin reddening, itching, formation of dandruff and burning, skin irritation, skin rash, inflammation of the skin (dermatitis), allergic reactions such as nettle rash, facial swelling headache, nerve inflammation, dizziness, drowsiness allergic rhinitis shortness of breath, swollen hands or feet (oedema caused by water retention in the tissues), pain in the chest changes in blood pressure or heart rate, abnormal heart beats (palpitations) Very rare: may affect up to 1 in 10,000 people fall in blood pressure increased hair growth on areas not treated with Minoxidil BIO-H-TIN-Pharma 20 mg/ml (in women also on the face), allergic inflammation of the skin (dermatitis), inflammation of the hair follicules (folliculitis), loss of hair (alopecia), increased secretion from the sebaceous glands (seborrhoea). Some patients observed increased hair loss after starting treatment with Minoxidil BIO-H- TIN-Pharma 20 mg/ml. This is probably due to the effect of minoxidil which causes the hair to come out of the resting phase and move into the growth phase (old hairs fall out and make space for the newly growing ones). This temporarily increased hair loss usually occurs 2 to 6 weeks after starting treatment and disappears of its own accord after several weeks. Should it occur for more than 2 weeks without evidence of improvement, you should discontinue use and consult a doctor. Very rare cases with the simultaneous appearance of muscle and joint pain, tiredness, weakness or weight loss as well as abnormal liver function values have been described. These changes disappeared on their own after ending treatment. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Minoxidil BIO-H-TIN-Pharma 20 mg/ml Keep this medicine out of the sight and reach of children. Do not store above 25 C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Minoxidil BIO-H-TIN-Pharma 20 mg/ml contains: The active substance is minoxidil. 1 ml solution contains 20 mg minoxidil.

7 Text draft from Minoxidil BIO-H-TIN-Pharma 20 mg/ml Page 7 The other ingredients are ethanol 96% (v/v), propylene glycol and water (purified). What Minoxidil BIO-H-TIN-Pharma 20 mg/ml looks like and contents of the pack: Minoxidil BIO-H-TIN-Pharma 20 mg/ml is a clear, slightly yellow to slightly pink coloured solution. Packs with 1 x 60 ml solution or 3 x 60 ml solution. Not all pack sizes may be marketed. Each pack contains two different applicators: Extended spraytip applicator and a spray pump applicator. Marketing Authorisation Holder <[To be completed nationally]> Manufacturer <[To be completed nationally]> This medicinal product is authorised in the Member States of the EEA under the following names: Austria Germany Minoxidil BIO-H-TIN-Pharma 20 mg/ml zur Anwendung auf der Haut, Lösung Minoxidil BIO-H-TIN-Pharma 20 mg/ml zur Anwendung auf der Haut, Lösung This leaflet was last revised in {MM/YYYY}.