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Package leaflet: Information for the user
Minoxidil BIO-H-TIN-Pharma 50 mg/ml cutaneous spray, solution
Minoxidil
For male adults aged 18 to 65 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 50 mg/ml is and what it is used for
2. What you need to know before you use Minoxidil BIO-H-TIN-Pharma 50 mg/ml
3. How to use Minoxidil BIO-H-TIN-Pharma 50 mg/ml
4. Possible side effects
5. How to store Minoxidil BIO-H-TIN-Pharma 50 mg/ml
6. Contents of the pack and other information
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1. What Minoxidil BIO-H-TIN-Pharma 50 mg/ml is and what it is used for
Minoxidil BIO-H-TIN-Pharma 50 mg/ml contains the active ingredient minoxidil.
Minoxidil BIO-H-TIN-Pharma 50 mg/ml prevents hereditary hair loss in men 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 50 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 50 mg/ml.
Minoxidil BIO-H-TIN-Pharma 50 mg/ml is for use in male adults aged 18 to 65 years.
2. What you need to know before you use Minoxidil BIO-H-TIN-Pharma 50 mg/ml
Do not use Minoxidil BIO-H-TIN-Pharma 50 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 50 mg/ml must not be used in children and adolescents under
18 years.
Safety and efficacy of Minoxidil BIO-H-TIN-Pharma 50 mg/ml in patients over 65 years of age
have not been established.
Certain types of hair loss could be signs of a physical illness. In this case, Minoxidil BIO-HTIN-Pharma 50 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 50 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
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 50 mg/ml.
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Minoxidil BIO-H-TIN-Pharma 50 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 50
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 50 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 BIOH-TIN-Pharma 50 mg/ml unintentionally comes in contact with other parts of the body, you
should wash your hands after each use of the medicine.
Minoxidil BIO-H-TIN-Pharma 50 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 50 mg/ml, hair loss will start again.
Minoxidil BIO-H-TIN-Pharma 50 mg/ml is not intended for use by women.
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-TINPharma 50 mg/ml.
You should stop using this product and see a doctor if low blood pressure is detected or 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 50 mg/ml must not be used in patients under 18 years.
Other medicines and Minoxidil BIO-H-TIN-Pharma 50 mg/ml
Tell your doctor or pharmacist if you are taking / using, have recently taken/used or might
take/use any other medicines.
No interactions with other medicines are known to date with Minoxidil BIO-H-TIN-Pharma 50
mg/ml. For your safety, Minoxidil BIO-H-TIN-Pharma 50 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.
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Pregnancy, breast-feeding and fertility
Minoxidil BIO-H-TIN-Pharma 50 mg/ml is intended for use by males only.
Driving and using machines
No effects on the ability to drive and use machines are expected.
Minoxidil BIO-H-TIN-Pharma 50 mg/ml contains propylene glycol
Propylene glycol can cause skin irritation.
3. How to use Minoxidil BIO-H-TIN-Pharma 50 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 50 mg/ml on the healthy, intact scalp and
follow carefully the application information. Do not apply Minoxidil BIO-H-TIN-Pharma 50
mg/ml to other parts of the body.
The recommended dose is:
Spread 1 millilitre (seven pushes on the spray applicator) of Minoxidil BIO-H-TINPharma 50 mg/ml in the morning and evening onto the thinning or bald areas of the scalp.
Minoxidil BIO-H-TIN-Pharma 50 mg/ml can be very easily spread – 1 ml is enough for a large
area. In no case should you use more.
Pump spray applicator with extended tip – for smaller application areas


picture 1
picture 2
picture 4
picture 5
picture 3
Remove the cap from the bottle (picture 1). Remove the small spray head (picture 2)
and place the spray head with the extended tip down firmly (picture 3).
Turn the extended tip into a 90 ° position (picture 4) so that the applicator can be used
comfortably on the affected area.
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
Spray directly onto the scalp in the area of the hair loss (picture 5). After each pumping
process, spread the solution with the finger tips onto the affected area. Avoid breathing
in spray.
Pump spray applicator – for larger application areas
picture 1


picture 2
Remove the cap from the pump spray applicator (picture 1) and spray directly onto the
scalp in the area of the hair loss (picture 2). 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.
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 50 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 50 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

slight inflammatory reactions on the scalp
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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 50 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-HTIN-Pharma 50 mg/ml. This is probably due to the effect of minoxdil 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 50 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 to protect the
environment.
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6. Contents of the pack and other information
What Minoxidil BIO-H-TIN-Pharma 50 mg/ml contains:

The active substance is minoxidil. 1 ml solution contains 50 mg minoxidil.

The other ingredients are ethanol 96% (v/v), propylene glycol and water (purified).
What Minoxodil BIO-H-TIN-Pharma 50 mg/ml looks like and contents of the pack:
Minoxidil BIO-H-TIN-Pharma 50 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: pump spray applicator with extended tip and a
pump spray 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 50 mg/ml Spray zur Anwendung auf der Haut,
Lösung
Minoxidil BIO-H-TIN-Pharma 50 mg/ml Spray zur Anwendung auf der Haut,
Lösung
This leaflet was last revised in {MM/YYYY}.