Minoxidil BIO-H-TIN-Pharma 20 mg/ml Spray zur Anwendung auf der Haut (Kopfhaut), Lösung

Minoxidil BIO-H-TIN-Pharma contains the active ingredient minoxidil.

Application

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. How quickly hair growth begins and how much hair grows back varies from patient to patient. Large bald patches or hair loss that has existed 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.

How is it used?

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 20 mg/ml prevents excessive hair loss in women 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. How quickly hair growth begins and how much hair grows back varies from patient to patient. Large bald patches or hair loss that has existed for more than 10 years respond less well to Minoxidil BIO-H-TIN-Pharma.

Minoxidil BIO-H-TIN-Pharma is approved for use in women over 18 years of age.

What should you consider before taking it?

What should you consider before using Minoxidil BIO-H-TIN-Pharma?

Minoxidil BIO-H-TIN-Pharma 20 mg/ml 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.
• if you suffer from sudden or uneven hair loss.
• if you are pregnant.
• if you are breastfeeding your child.

Warnings and precautions

Please talk to your doctor or pharmacist before using Minoxidil BIO-H-TIN-Pharma.

• Hormonal causes, underlying diseases or malnutrition must be ruled out. In these cases, you must receive targeted treatment.
• You should not use Minoxidil BIO-H-TIN Pharma if the cause of the
  hair loss is unknown, if you have hair loss after childbirth, or if your scalp is red, inflamed or painful.
• Only apply Minoxidil BIO-H-TIN Pharma to a normal, healthy scalp.
• Minoxidil BIO-H-TIN Pharma is only intended for external use on the scalp. Do not apply Minoxidil BIO-H-TIN Pharma to other parts of the body.

You should not use Minoxidil BIO-H-TIN Pharma,

• if you have signs of cardiovascular disease or
  heart rhythm disorders
• if you have high blood pressure
• if you are taking medicines to treat high blood pressure (antihypertensives).

You should stop using Minoxidil BIO-H-TIN Pharma and see a doctor,

• if your blood pressure drops, or
• if one or more of the following symptoms occur: chest pain,
  rapid heartbeat, feeling faint or dizzy, sudden and unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp (see section "If you have used more Minoxidil BIO-H-TIN Pharma than you should") or other unexpected new symptoms.

You will not achieve a better result if you use Minoxidil BIO-H-TIN Pharma in larger amounts or more often.

To maintain the effect, it is recommended to continue the twice-daily application continuously. If you stop using Minoxidil, hair loss will occur again.

Notes on increased hair loss

When treating hair follicles with the active ingredient minoxidil, the resting phase (telogen phase) of the hair cycle is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair. This pushes the "old" inactive hair out of the scalp. Initially, this gives the impression of increased hair loss. This reaction has been observed in some patients two to six
weeks after starting treatment with the active ingredient minoxidil. This accelerated hair loss, which is accompanied by increased hair regrowth, subsides within a few weeks and can be an early sign of the effect of minoxidil.

Notes

If you apply Minoxidil to areas of the body other than the scalp, it may cause unwanted hair growth there.

In rare cases, patients with very light hair have reported slight changes in hair colour (slight blonding) when using hair care products at the same time or after swimming in heavily chlorinated water.

If you repeatedly spray Minoxidil BIO-H-TIN Pharma onto your hair instead of your scalp, this could lead to increased dryness and/or stiffness of the hair due to the ingredients in Minoxidil BIO-H-TIN Pharma.

In case of accidental contact with sensitive areas (eyes, abrasions, mucous membranes), rinse these areas with plenty of cold water.

Avoid inhaling the spray vapours.
Accidental ingestion can cause serious cardiovascular side effects. Therefore, you must keep this medicine out of the reach of children.

Children and adolescents

Minoxidil BIO-H-TIN-Pharma must not be used in children and adolescents under 18 years of age, as there are no results on efficacy and safety from controlled clinical studies for this patient group.

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

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

• No interactions of other medicines with Minoxidil BIO-H-TIN- Pharma are known to date.
• Changing from lying or sitting to standing (change of position) can cause a drop in blood pressure. Although not clinically proven, there is a theoretical possibility that this effect may be increased by absorption of the active ingredient minoxidil into the bloodstream.
• This can occur especially in patients who are taking
  vasodilatory medicines at the same time.
• You should not use Minoxidil BIO-H-TIN Pharma together with other dermatological preparations
  (external preparations containing active ingredients such as corticosteroids, retinoids, dithranol) or with agents that enhance the absorption of active ingredients through the skin
  increase.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Minoxidil BIO-H-TIN Pharma must not be used by pregnant or breastfeeding women, as there are no studies in pregnant women and minoxidil can pass into breast milk.

Driving and using machines

As a side effect of Minoxidil BIO-H-TIN Pharma, dizziness or low blood pressure may occur. If this is the case for you, do not drive or operate machinery.This medicine contains 208 mg propylene glycol per millilitre (ml).

Propylene glycol can cause skin irritation.

How should the medicine be taken?

How to use Minoxidil BIO-H-TIN-Pharma?

Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

In the morning and evening, spread 1 millilitre (ml) (press the pump seven times) of Minoxidil BIO-H-TIN-Pharma 20 mg/ml on the thinning or bald areas of the scalp. 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 - for large-area application

• Remove the cap from the spray head (Figure 1) and spray directly onto the scalp in the area of hair loss (Figure 2). Seven pumps deliver 1 ml of solution. After each pumping process, distribute the liquid with your fingertips over the affected area. Avoid inhaling spray vapours.
• Close the bottle with the cap after each use.

Pump spray applicator with extended tip - for small-area application
Remove the cap from the bottle (Figure 1). Pull the spray head upwards (Figure 2), place the applicator with the extended tip on top and lock it in place with light pressure (Figure 3). The Minoxidil solution is now ready for use.

The extended tip now allows you to spray directly onto the scalp in the area of hair loss (Figure 4). After each pumping process, distribute the liquid with your fingertips over the affected area. Avoid inhaling spray vapours.

For space-saving storage, the applicator can simply be turned downwards after use (Figure 5).

Type of application

Apply the solution starting from the centre of the affected areas by gently spreading it. 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.

After applying Minoxidil BIO-H-TIN Pharma, the hair can be styled as usual. However, the scalp should not be moistened for about 4 hours to avoid washing off Minoxidil BIO-H-TIN Pharma.

Duration of application

If you use Minoxidil BIO-H-TIN-Pharma regularly twice a day, you should see new hair after about four months.

To maintain the effect, it is recommended to continue the twice-daily application continuously. You will not achieve a better result if you use Minoxidil BIO-H-TIN Pharma in larger amounts or more often than twice a day. Sufficient clinical experience is available for a duration of use of up to 48 weeks with regard to a possible therapeutic effect.

Discontinue therapy if the desired treatment success does not occur within 8 months.
If you have used more Minoxidil BIO-H-TIN-Pharma than you should

The use of Minoxidil BIO-H-TIN Pharma has given no indication of a correspondingly large absorption of the active ingredient minoxidil into the bloodstream, which could lead to an effect on the whole body. If you follow the instructions for use, an overdose is unlikely.

A larger absorption of the active ingredient contained in Minoxidil BIO-H-TIN Pharma into the bloodstream can have effects on the whole body, e.g. through:

• incorrect use (in a higher dosage than recommended and on larger
  areas of the body or areas of the body other than the scalp),
• patient-specific differences,
• an unusual sensitivity or impairment of the skin due to inflammation or pathological skin changes on the scalp (e.g.
  skin abrasions or psoriasis on the scalp).

After accidental ingestion or after application of Minoxidil BIO-H-TIN Pharma to impaired or pathologically altered skin areas, effects on the whole body (systemic effects) may occur. This can lead to the following
side effects: rapid heartbeat, drop in blood pressure, fluid retention and consequent sudden weight gain, dizziness, sluggishness.

In case of accidental ingestion or signs of an overdose, you should consult a doctor. The doctor can initiate symptomatic and supportive treatment in the event of an overdose of the active ingredient minoxidil.

If you forget to use Minoxidil BIO-H-TIN-Pharma

Do not apply double the amount next time, but continue treatment with the recommended dose. It does not make sense to make up for the missed
application and could lead to undesirable effects.

If you stop using Minoxidil BIO-H-TIN-Pharma

If treatment is interrupted, a condition will develop within 3 to 4 months

as would have been achieved without therapy with Minoxidil BIO-H-TIN Pharma.

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

What side effects are possible?

How should Minoxidil BIO-H-TIN-Pharma be stored?

Keep this medicine out of the reach of children.

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 store above 25°C.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

Special storage instructions

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.
Never dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Minoxidil BIO-H-TIN-Pharma contains

The active ingredient is minoxidil. 1ml 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 pump spray applicator with extended tip and a spray head.