MINOXIDIL BIO-H-TIN

MINOXIDIL BIO-H-TIN Pharma 50 mg/ml spray solution.

Important notes (mandatory information)

Minoxidil BIO-H-TIN-Pharma 20 mg/ml Spray. Areas of application: prevents excessive hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair in areas of the scalp that are already thinning or bald and strengthens existing vellus hair.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Minoxidil BIO-H-TIN-Pharma 20 mg/ml Spray for application to the skin, solution for adults aged 18 to 65.
Active ingredient: Minoxidil

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT IS MINOXIDIL BIO–H–TIN–PHARMA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING MINOXIDIL BIO–H–TIN–PHARMA?
3. HOW IS MINOXIDIL BIO–H–TIN–PHARMA USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MINOXIDIL BIO–H–TIN–PHARMA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MINOXIDIL BIO-H-TIN-PHARMA AND WHAT IS IT USED FOR?

Minoxidil BIO-H-TIN-Pharma contains the active ingredient minoxidil. Minoxidil BIO-H-TIN-Pharma prevents excessive hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair in areas of the scalp that are already thinning or bald and strengthens existing vellus hair. Minoxidil BIO-H-TIN-Pharma penetrates the scalp after application and reaches the hair roots. The mechanism by which it stimulates hair growth has not yet been clarified. However, it takes at least four months before you can see a result. If hair roots are still present, fine, light vellus hairs may grow back, which over time become longer, thicker and darker. The speed at which hair growth begins and how much hair grows back varies from patient to patient. Large bald patches or hair loss that has lasted for more than 10 years respond less well to Minoxidil BIO-H-TIN-Pharma. Minoxidil BIO-H-TIN-Pharma is to be used in adults aged 18 to 65.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MINOXIDIL BIO–H–TIN–PHARMA?

Minoxidil BIO-H-TIN-Pharma must not be used:

• if you are allergic to minoxidil or any of the other ingredients of this medicine listed in section 6.
• if you are using other topical (local, external) medicines on your scalp at the same time.

Minoxidil BIO-H-TIN-Pharma must not be used in children and adolescents under 18 years of age. There are no sufficient data on the safety and efficacy of Minoxidil BIO-H-TIN-Pharma in patients over 65 years of age. Hair loss after childbirth is normal to a certain extent. Therefore, Minoxidil BIO-H-TIN-Pharma should not be used in this case. Certain forms of hair loss can be a sign of a physical illness. In this case, Minoxidil BIO-H-TIN-Pharma will not work and it is important for your health to see a doctor if:

• sudden, severe hair loss,
• patchy hair loss (e.g. circular bald patches).

Minoxidil BIO-H-TIN-Pharma will also not work if the hair loss is due to one of the following causes:

• Use or intake of certain medicines (e.g. for cancer). In this case, hair growth may only be accelerated.
• Severe nutritional problems (very low iron levels, vitamin A overdose).
• Stopping taking the "pill" (The hormonal change can lead to a short-term increase in hair loss. However, this normally does not require medical treatment.)
• Scalp damaged by scarring or burns, as there are no longer any hair roots.
• Hairstyles in which the hair is tied tightly together (e.g. ponytail). In this case, you must eliminate the mechanical irritation.
• Pregnancy.

If you are unsure about the cause of your hair loss, you should consult your doctor.

Warnings and precautions

Please talk to your doctor or pharmacist before using Minoxidil BIO-H-TIN-Pharma. Minoxidil BIO-H-TIN-Pharma should only be applied to a healthy, intact scalp. Only a very small proportion of the active ingredient in Minoxidil BIO-H-TIN-Pharma penetrates the skin. Particularly in hypersensitive or heart patients, side effects that do not affect the skin can never be completely ruled out. If you notice oedema (swelling of body parts, possibly including the face) or heart problems (e.g. a rapid heartbeat), please inform your doctor. If Minoxidil BIO-H-TIN-Pharma accidentally gets into your eyes, it can cause irritation and burning. This also applies to sensitive surfaces such as mucous membranes or abrasions. In such cases, rinse the medicine off with plenty of water. To prevent Minoxidil BIO-H-TIN-Pharma from accidentally coming into contact with other parts of the body, you should wash your hands after each application of the medicine. If you become pregnant, please stop treatment. Minoxidil BIO-H-TIN-Pharma must not be swallowed! Accidental ingestion can lead to serious adverse effects. The medicine must therefore be kept out of the sight and reach of children. Inhalation of minoxidil should be avoided. Once you stop using Minoxidil BIO-H-TIN-Pharma, hair loss will start again. Exposure to artificial UV light or sunlight should be avoided. In some patients, hair colour and texture changed after treatment with minoxidil. If you have heart disease, you should consult your doctor before using Minoxidil BIO-H-TIN-Pharma. You should stop using this medicine and see a doctor if your blood pressure drops, if you experience chest pain, rapid heartbeat, weakness or dizziness, sudden unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp. If your symptoms worsen or do not improve within 12 months, please see a doctor.

Children and adolescents

Minoxidil BIO-H-TIN-Pharma must not be used in children and adolescents under 18 years of age.

Use of Minoxidil BIO-H-TIN-Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. No interactions of other medicines with Minoxidil BIO-H-TIN-Pharma are known to date. To be on the safe side, you should not use Minoxidil BIO-H-TIN-Pharma at the same time as other medicines on your scalp. It cannot be completely ruled out that the effect of blood pressure-lowering medicines may be increased.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect 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 with the use of Minoxidil BIO-H-TIN-Pharma 20 mg/ml during pregnancy. Minoxidil absorbed into the body passes into breast milk. Minoxidil BIO-H-TIN-Pharma 20 mg/ml can be used during pregnancy and breast-feeding, provided that the maternal benefit outweighs the risk to the unborn child or infant.

Driving and using machines

The ability to actively participate in road traffic or to operate machines is not expected to be impaired.

Minoxidil BIO-H-TIN-Pharma contains propylene glycol

Propylene glycol can cause skin irritation.

3. HOW IS MINOXIDIL BIO-H-TIN-PHARMA USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Please only apply Minoxidil BIO-H-TIN-Pharma to a healthy, intact scalp and follow the instructions for use below exactly. Do not apply Minoxidil BIO-H-TIN-Pharma to other parts of the body. The recommended dose is: Apply 1 millilitre (ml) (press the pump seven times) of Minoxidil BIO-H-TIN-Pharma to the thinning or bald areas of the scalp in the morning and evening. Minoxidil BIO-H-TIN-Pharma is very easy to spread - 1 ml is sufficient even for large areas. Under no circumstances should you use more.

Spray head with extended tip - for small-area application:

• remove the cap from the bottle. remove the small spray head and firmly attach the extended tip.
• Turn the extended tip to a 90° position so that the applicator can be conveniently applied to the area to be treated.
• spray directly onto the scalp in the area of hair loss. after each pumping action, spread the liquid over the affected area with your fingertips. Avoid inhaling the spray mist.

Pump spray applicator - for large-area application:

• remove the cap from the spray applicator and spray directly onto the scalp in the area of hair loss. after each pumping action, spread the liquid over the affected area with your fingertips. Avoid inhaling the spray mist.
• close the bottle with the cap after each use.

Method of application

Apply the solution by gently spreading it from the centre of the affected areas. Your scalp and hair must be completely dry. After application, please wash your hands so that the medicine does not accidentally come into contact with your eyes or mucous membranes.

Duration of use

If you use Minoxidil BIO-H-TIN-Pharma regularly twice a day, you should see new hair after about four months. Hair loss will be stopped even earlier.

If you have used more Minoxidil BIO-H-TIN-Pharma than you should

Any accidental ingestion or excessive use can trigger serious side effects. This is related to the vasodilatory effect of minoxidil. Signs of overdose usually manifest themselves in the cardiovascular system (rapid heartbeat with low blood pressure and reduced fluid excretion). Treatment must be carried out by a doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• mild inflammatory reactions of the scalp.

Rare side effects (may affect up to 1 in 1,000 people):

• Local skin irritation including redness, itching, scaling and burning, skin irritation, rash, dermatitis, allergic reactions such as hives, facial swelling,
• headache, neuritis, dizziness, drowsiness,
• Allergic rhinitis,
• shortness of breath, swollen hands or feet (due to fluid retention in the tissue), chest pain,
• changes in blood pressure or heart rate, palpitations.

Very rare side effects (may affect up to 1 in 10,000 people):

• drop in blood pressure,
• Increased hair growth in areas not treated with Minoxidil BIO–H–TIN–Pharma (in women also on the face), allergic inflammation of the skin, hair follicle inflammation (folliculitis), hair loss (alopecia), increased secretion of the sebaceous glands in the skin

Some patients observed an increase in hair loss after starting treatment with Minoxidil BIO-H-TIN-Pharma. This is probably due to the minoxidil effect, which transfers the hair from the resting phase to the growth phase (old hair falls out and makes way for new hair). This temporarily increased hair loss usually starts 2 - 6 weeks after the start of application and disappears by itself within a few weeks. If this persists for more than two weeks without any improvement, please stop using the product and consult a doctor.

Individual cases of concomitant muscle or joint pain, fatigue, weakness or weight loss as well as abnormal liver function values have been described. These changes resolved spontaneously after discontinuation of treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly in Austria to the Federal Office for Safety in Health Care, Institute of Pharmacovigilance, Traisengasse 5, AT-1200 Vienna, Fax: + 43 (0) 50 555 36207, Website: www.basg.gv.at or in Germany directly to the Federal Institute for Drugs and Medical Devices, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD MINOXIDIL BIO-H-TIN-PHARMA BE STORED?

Keep this medicine out of the reach of children. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the bottle and carton after "Use by". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Minoxidil BIO-H-TIN-Pharma contains

The active ingredient is minoxidil. 1 ml solution contains 20 mg minoxidil. The other ingredients are ethanol 96% (V/V), propylene glycol and purified water.

What Minoxidil BIO-H-TIN-Pharma looks like and contents of the pack

Minoxidil BIO-H-TIN-Pharma is a clear, slightly yellowish to slightly pinkish solution. Packs of 1 x 60 ml solution or 3 x 60 ml solution. Not all pack sizes may be marketed. Each pack contains 2 different applicators: a spray applicator with extended tip and a spray head.

Pharmaceutical entrepreneur

BIO-H-TIN Pharma GmbH & Co. KG
Emil-Kemmer-Straße 33
D-96103 Hallstadt,
Telephone: 0951/6043-0
Telefax: 0951/604329

Manufacturer

Laboratoires Chemineau
93 Route de Monnaie
37210 Vouvray
France

This leaflet was last revised in April 2014.

Source: Information from the package leaflet
Status: 04/2016
Areas of application: prevents excessive hair loss in women and men and stimulates hair growth. It also promotes the regrowth of new hair in areas of the scalp that are already thinning or bald and strengthens existing vellus hair.