Can I use Minoxidil 5?

Regaine men

Patient information for "Minoxidil"

1. What is "Minoxidil" and what is it used for?

1.1 What are the properties of the medicinal product?

"Minoxidil" contains the active substance minoxidil, a medicine in a group of drugs called dermatics (a medicine used to treat skin conditions). Minoxidil is a medicine used to treat male hair loss (androgenetic alopecia).

"Minoxidil" is only available in pharmacies and without a prescription.

1.2 What strengths and dosage forms are there?

Minoxidil for the treatment of male hair loss is available in the following strength and dosage form:

- Solution containing 50 mg minoxidil in ml.

Your doctor or your pharmacist will advise you whether this strength and dosage form are suitable for your treatment.

1.3. "Minoxidil" is used

"Minoxidil" stabilizes the course of congenital baldness (androgenetic alopecia) in the tonsure area of ​​the scalp with a diameter of 3 to 10 cm in men aged 18 to 49 years.

The onset of androgenetic alopecia in men is characterized by the receding of the forehead-hair border at the temples with the formation of receding hairlines. In the following, there is also increasing hair thinning in the crown region (tonsure area).

2. What should you watch out for before using "Minoxidil"?

2.1. "Minoxidil" must not be used

- if you are hypersensitive (allergic) to the active substance minoxidil or any of the other ingredients of the drug,

- in women, due to occasional indications of cosmetically disturbing reversible hair growth on the face during treatment,

- if you are using other medicines on the scalp,

- if you suffer from sudden or uneven hair loss.

2.2.Special care is required when using "Minoxidil"

Use "Minoxidil" only on normal, healthy scalp.

There is no clinical experience on the effectiveness of baldness in the temple area (receding hairline).

If effects on organ systems (systemic effects) or severe skin reactions occur, the preparation must be discontinued.

You should not use "Minoxidil"

- if you have any signs of cardiovascular disease

- if you have high blood pressure

- if you are using antihypertensive agents to treat high blood pressure.

Occasionally, patients with very light hair who used other hair care products at the same time or after swimming in water containing a lot of chlorine have reported minor changes in hair color (light blonde coloration).

If you repeatedly apply "Minoxidil" to the hair instead of the scalp, this could lead to increased dryness and / or stiffness of the hair due to the ethanol and propylene glycol content in "Minoxidil".

"Minoxidil" contains alcohol and can cause stinging and irritation of the eyes. In the event of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), you should rinse these areas with plenty of water.

If you use "Minoxidil" frequently on your skin, it may cause irritation or inflammation and dry skin due to the alcohol in "Minoxidil".

Avoid breathing in the spray fumes.

Propylene glycol can cause skin irritation.

2.2.a) Children

"Minoxidil" should 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.

2.2.b) Elderly patients

There are no special precautions; However, please read and observe section 3 ("How should the medicine be taken?") with particular care.

2.2.c) Pregnancy

"Minoxidil" is only indicated for use in male patients.

2.2.d) Breastfeeding

"Minoxidil" is only indicated for use in male patients.

2.2.e) Ability to drive and use machines

It is not to be expected that the ability to drive actively or use machines will be impaired.

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

There is currently no evidence of interactions between "Minoxidil" and other agents. Although this has not been clinically proven, there is theoretically the possibility that the active substance of "Minoxidil" ("Minoxidil") could cause orthostatic hypotension (drop in blood pressure when changing from Lying down for standing) may be strengthened in patients concomitantly taking peripheral vasodilators (a type of vasodilator used to lower blood pressure).

"Minoxidil" should not be used together with other dermatics (external preparations with active ingredients such as corticosteroids, retinoids, anthralin) or with agents that increase the absorption of active ingredients through the skin (skin absorption).

2.4.What should be considered when using "Minoxidil" together with food, beverages and tobacco?

There are no special precautions; however, please note the information in Section 3.1 ("Type and duration of use").

3. How should "Minoxidil" be used?

Always use "Minoxidil" exactly as instructed in the package insert. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

"Minoxidil" is to be applied to the dry tonsure area of ​​the scalp.

"Minoxidil" is not intended to be used on any other part of the body.

After applying "Minoxidil", hands should be washed carefully to avoid accidental contact with mucous membranes and eyes.

After using "Minoxidil" you should wait at least 4 hours before moistening the scalp or hair.

How long should you use "Minoxidil"?

The beginning and the extent of hair growth are different for each patient. The treatment should last at least 8 weeks in order to be able to expect an effect. If the desired treatment success in the form of slowing down the hair loss does not occur within 4 months, the therapy should be discontinued.

However, in order to ensure that the number of hairs that was present at the start of therapy is retained, the solution must continue to be applied twice a day. There is sufficient clinical experience with regard to a possible therapeutic effect for an application period of up to one year.

Please talk to your doctor or pharmacist if you have the impression that the effect of "Minoxidil" is too strong or too weak.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

Apply 1 ml of "Minoxidil" twice a day (morning and evening) to the affected areas in the tonsure area of ​​the scalp.

The daily applied amount of 2 times 1 ml solution should not be exceeded regardless of the size of the affected skin area.

Each "Minoxidil" pack contains 3 different applicators:

- Pump spray applicator for large-area application in the tonsure area

- Pump spray applicator with extended tip for small, bald areas in the tonsure area

- Contact applicator for direct application to the tonsure area of ​​the scalp (for largely bald areas).

For the dose of 1 ml, 6 puffs (pump sprays) or a chamber filling (contact applicator) are required.

Pump spray applicator:

- Remove the large and small caps from the bottle.

- Place the spray applicator on the bottle and screw it tight.

- Press the pump six times. After each pumping process, distribute the liquid over the affected area with your fingertips. Avoid inhaling spray vapors.

- Close the bottle with the large cap after use. Throw away the small cap.

- Wash hands thoroughly after use.

Pump spray applicator with extended tip:

- First screw the pump spray applicator onto the bottle (see above).

- Remove the small spray head and attach the extended tip firmly. Remove the small cap at the tip end.

- Press the pump six times. After each pumping process, distribute the liquid over the affected area with your fingertips. Avoid inhaling spray vapors.

- After use, the small cap should be put back on the tip.

- Wash hands thoroughly after use.

Contact applicator:

- Remove the large and small caps from the bottle.

- Instead, insert the contact applicator and screw it tight.

- Hold the bottle upright and squeeze it once so that the upper chamber fills up to the black mark. The chamber now contains 1 ml of solution.

- Turn the bottle upside down and apply the solution evenly to the affected area until the chamber is completely empty.

- After use, close the bottle with the large cap again.

- Wash hands thoroughly after use.

3.3.If you use more "Minoxidil" than you should

If you experience any side effects when using too high a dose of the drug, contact your doctor immediately. When treating the overdose, he will be guided by the clinical picture.

Use of "Minoxidil" in higher doses than recommended and on larger areas of the body or areas other than the scalp can possibly lead to an increased absorption of "Minoxidil" into the body. So far, no cases have been reported in which the external application of "Minoxidil" solution would have resulted in symptoms of poisoning.

After accidental ingestion, the concentration of "Minoxidil" in "Minoxidil" can lead to systemic effects corresponding to the pharmacological action of the active ingredient. Signs and symptoms of a "Minoxidil" overdose would probably appear as effects on the cardiovascular system in connection with increased water retention in the tissues (salt and water retention), accelerated heartbeat (tachycardia), drop in blood pressure (hypotension), sudden Expressing weight gain, drowsiness, dizziness.

In the event of accidental ingestion or if symptoms of an overdose occur, please notify a doctor immediately so that he can decide how to proceed! Please have the pack of the drug ready so that the doctor can find out about the active substance that has been absorbed.

3.4.If you forget to use "Minoxidil"

Next time do not apply about double the amount, but continue the treatment with the recommended dose. It does not make sense to make up for the omitted application and could lead to undesirable effects.

3.5.Effects if treatment with "Minoxidil" is stopped

If the treatment is interrupted, a state occurs within 3 to 4 months that would have been achieved without therapy with "Minoxidil".

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

4. What are the possible side effects?

Like all medicines, "Minoxidil" can have side effects.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

4.1 Which side effects can occur in detail?

Apart from side effects that affect the skin, such as itching (pruritus), peeling of the skin, acute skin inflammation (dermatitis) and volatile skin rashes (rash), no side effects occurred significantly more frequently than in the group treated with "Minoxidil" in clinical trials in patients who received a drug-free preparation as a control (placebo).

Although no causal relationship with the use of "Minoxidil" was found in clinical studies, the following effects on organ systems (systemic effects) should possibly be taken into account: increased water retention in tissues (salt and water retention), accelerated heartbeat (tachycardia) ), Dizziness, aggravation of pre-existing angina pectoris (disease of the coronary arteries with a typical feeling of constriction) or the triggering of angina pectoris symptoms in patients with previously undiagnosed coronary artery disease (coronary heart disease).

The following adverse events were reported in clinical trials:

Side effects in the skin area (e.g. itching, peeling of the skin, local skin inflammation, rash, contact dermatitis, inflammatory reddening of the skin) and headaches occasionally occurred.

Side effects in the cardiovascular area ("palpitations", accelerated or slowed heartbeat) occurred rarely. Rare cases of low blood pressure (hypothonia) have been observed.

In rare cases, ear infections (otitis externa), increased hair growth (hypertrichosis) outside the hairy head or increased hair loss can occur.

In individual cases, side effects of the psyche (tiredness, excessive movement activity), the metabolism (water accumulation in the tissue) as well as the gastrointestinal tract (nausea, diarrhea) and occasionally the nervous system (dizziness, headache, abnormal sensations, fainting) have been reported.

A transient increase in the number of hairs that have fallen out has been seen in some patients two to six weeks after starting treatment. This effect is based on the fact that "Minoxidil" shortens the resting phase (telogen phase) of the hair cycle, so that more hair can temporarily fall out. At the same time, the growth phase (anagen phase) is reached more quickly and the growth of new hair is stimulated Accompanied by increased hair regrowth, it decreases within a few weeks and can be interpreted as the first sign of the "Minoxidil" effect.

The propylene glycol contained in "Minoxidil" can cause intolerance symptoms in patients who are sensitive to this substance.

Because of the ethanol in "Minoxidil", frequent use of the drug may cause irritation and dry skin.

Please inform your doctor or pharmacist if you become seriously affected by any of the side effects listed, or if you notice any side effects not listed in this leaflet.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you have a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can have serious consequences under certain circumstances. In such cases, do not continue to take the medicine without doctor's advice.

5. How should "Minoxidil" be stored?

Store "Minoxidil" at normal room temperature and keep the medicine in the original packaging away from light and moisture.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; February 2011