Minoxidil Doppelhezh dla memzhhizn

Package Leaflet: Information for the User

Minoxidil Doppelherz For Men, 50 mg/g, Foam for Cutaneous Use

Minoxidil

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor, pharmacist, or nurse.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.
• If after 4 months no improvement has occurred, or if you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Minoxidil Doppelherz For Men and what is it used for
• 2. Important information before using Minoxidil Doppelherz For Men
• 3. How to use Minoxidil Doppelherz For Men
• 4. Possible side effects
• 5. How to store Minoxidil Doppelherz For Men
• 6. Contents of the pack and other information

1. What is Minoxidil Doppelherz For Men and what is it used for

The active substance of Minoxidil Doppelherz For Men is minoxidil. Minoxidil causes hair growth and prevents hair loss in men with receding hairline and baldness on the vertex of the head by rebuilding hair follicles.

Minoxidil Doppelherz For Men is used to treat common hereditary hair loss (also known as androgenetic alopecia) in men aged 18 years and older.

2. Important information before using Minoxidil Doppelherz For Men

When not to use Minoxidil Doppelherz For Men

• if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Minoxidil Doppelherz For Men, you should consult your doctor or pharmacist:

• if you have heart disease, including arrhythmia or disturbances in heart rate, angina pectoris, or chest pain and (or) circulatory disorders.

After absorption into the bloodstream, minoxidil may cause side effects related to low blood pressure, including chest pain, rapid heartbeat, fainting, dizziness, sudden unexplained weight gain, or swelling of hands and feet. It may also cause prolonged redness or irritation of the scalp.

If you experience any of these side effects, you should stop using the medicine and consult your doctor.

When not to use Minoxidil Doppelherz For Men:

• if the pattern of hair loss is different from receding hairline and baldness on the vertex of the head
• if there is no family history of hair loss
• if hair loss is sudden and (or) uneven
• if the cause of hair loss is unknown
• if there is inflammation, infection, irritation, or pain on the scalp.

Minoxidil Doppelherz For Men is HIGHLY FLAMMABLE! Avoid fire, flames, and smoking during and immediately after application.

In some patients, the use of this medicine has caused changes in hair color and texture.

Within the first 2 to 6 weeks of treatment, increased hair shedding may occur (old hair falls out and new hair grows in its place). This means that the medicine is working and old hair is making way for new hair.

This symptom should disappear after a few weeks. If hair continues to fall out, you should stop using Minoxidil Doppelherz For Men and consult your doctor.

Accidental ingestion may cause serious side effects in the circulatory system. For this reason, the medicine should be kept out of the reach of children.

If the foam is accidentally applied to areas of the body other than the scalp, it should be thoroughly rinsed off with plenty of water to avoid unwanted hair growth.

There have been cases of excessive hair growth on the body of infants following contact with the skin of patients (caregivers) using topical minoxidil.

Hair growth returned to normal within a few months when the infant was no longer exposed to minoxidil. You should be careful not to let children come into contact with areas of the body where minoxidil has been applied topically.

If excessive hair growth on the body of a child is observed during the use of topical minoxidil products, you should consult a doctor.

Children and Adolescents

Minoxidil Doppelherz For Men should not be used in children and adolescents under 18 years of age.

Minoxidil Doppelherz For Men and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Minoxidil Doppelherz For Men should not be used at the same time as other medicines applied topically to the scalp (e.g., corticosteroids, tretinoin, ditranol).

Prolonged use of aspirin in small doses after oral administration may affect the efficacy of minoxidil treatment.

Minoxidil Doppelherz For Men and other hair care products

Using shampoo during treatment

During the use of Minoxidil Doppelherz For Men, you should use a mild shampoo. Minoxidil Doppelherz For Men should be applied to a dry scalp.

Using styling products during treatment

To achieve the best results, you should wait until Minoxidil Doppelherz For Men has been absorbed into the scalp before using any styling products. First, apply Minoxidil Doppelherz For Men, then your regular styling products.

Do not mix Minoxidil Doppelherz For Men with other products intended for application to the scalp.

Advice on hair coloring or permanent waving

There is no information on the effect of these treatments on the action of Minoxidil Doppelherz For Men.

However, to avoid potential scalp irritation before using chemical treatments, you should ensure that Minoxidil Doppelherz For Men has been washed out of your hair and scalp. You should also inform your hairdresser that you are using Minoxidil Doppelherz For Men.

Pregnancy, Breast-feeding, and Fertility

Minoxidil Doppelherz For Men is not intended for women.

This medicine should not be used during pregnancy, breast-feeding, or while trying to conceive.

Driving and Using Machines

This medicine may cause dizziness or hypotension. If you experience these symptoms, you should not drive or operate machinery.

Minoxidil Doppelherz For Men contains ethanol

This medicine contains 560 mg of alcohol (ethanol) per dose (1 g), which corresponds to 560 mg of alcohol/g of medicine (56% w/w). It may cause burning of damaged skin. If the medicine is applied to sensitive skin surfaces (i.e., eyes, mucous membranes, or damaged skin), it should be thoroughly rinsed with plenty of running water.

Minoxidil Doppelherz For Men contains butylhydroxytoluene (E 321)

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

Minoxidil Doppelherz For Men contains cetyl alcohol and stearyl alcohol

The medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Minoxidil Doppelherz For Men

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

To achieve and maintain the desired effect of hair growth, the foam should be used twice a day.

The foam is intended for use on the scalp only. DO NOT apply it to the scalp if there is inflammation, infection, irritation, or pain. DO NOT apply the medicine to other parts of the body.

Apply the foam directly to the scalp.

Avoid contact with the eyes. If the foam gets into your eyes, rinse them immediately with plenty of cold water from the tap.

Before applying the foam to the scalp

Your hair and scalp should be dry.

How to apply the foam to the scalp

Apply 1 g (corresponding to half of the protective cap) to the area of hair loss twice a day (once in the morning and once in the evening).

Remove the protective cap (Figure 1).

When in contact with warm skin, the foam may start to melt. If your fingers are warm, first rinse them with cold water. Dry them thoroughly before applying the foam.

Turn the container upside down and press the nozzle to dispense the foam onto your fingertips (Figure 2).

The total amount of foam applied should not exceed 1 g (corresponding to half of the protective cap), regardless of the size of the treated area.

Gently massage the foam into the scalp areas that need treatment (Figure 3), then wash your hands immediately after applying the foam.

After each use, replace the protective cap on the container.

Figure 1 Figure 2 Figure 3

Duration of treatment with Minoxidil Doppelherz For Men

Hair growth requires time. Effects may be noticeable after 2 months, when using the medicine twice a day. In some men, effects may be visible after at least 4 months of using the medicine.

What to expect when using Minoxidil Doppelherz For Men

During the first few months after starting to use the foam, some patients may experience increased hair shedding. This may mean that Minoxidil Doppelherz For Men is working. This temporary increase in hair shedding usually occurs within 2 to 6 weeks of starting treatment and then subsides.

If increased hair shedding does not subside after 6 weeks, you should consult your doctor.

Hair is usually soft, fluffy, and colorless. With longer use, new hair should have the same color and thickness as the rest of the hair on the head. Since hair grows slowly, the effect of Minoxidil Doppelherz For Men may only be noticeable after some time. It may be noticeable after 2-4 months, when using the medicine twice a day.

If after 4 months your hair has not started to grow, you should stop using Minoxidil Doppelherz For Men.

The degree of hair growth is individual. The medicine will not work in the same way for all men. Continued use is necessary to increase and maintain hair growth. Otherwise, hair will start to fall out again.

Using more than the recommended dose of Minoxidil Doppelherz For Men

If you have accidentally used more of the medicine than recommended, you should consult your doctor.

Follow the instructions. Do not use more than 2 g (corresponding to one protective cap) per day and do not use more frequently than twice a day. Hair will not grow faster and you will not get a better effect if you use more of the medicine or use it more often.

If a child has ingested Minoxidil Doppelherz For Men, you should take the child to the hospital (if possible, take the Minoxidil Doppelherz For Men container with you, as the doctor may ask how much of the medicine the child has ingested).

Missing a dose of Minoxidil Doppelherz For Men

Do not worry if you miss one or two doses. Continue to use the medicine as you always do. Do not apply a double dose of the medicine to the scalp if you miss a dose, as excessive use may cause low blood pressure, rapid heartbeat, and drowsiness or fatigue.

Stopping use of Minoxidil Doppelherz For Men

If you stop using the foam, the hair that has regrown may fall out, and the scalp will likely return to its previous state within 3-4 months.

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

4. Possible side effects

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

STOP using the foam and consult your doctor if you experience any of the following symptoms - you may need urgent medical attention:

• Swelling of hands or feet (common)
• Swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing. This may be a sign of a severe allergic reaction (frequency not known)
• Hypersensitivity or increased sensitivity. This may include redness of the skin, itching, swelling of the face, pressure in the throat, and may be life-threatening (frequency not known)
• Dizziness (uncommon)
• Fast or irregular heartbeat (rare)
• Chest pain (rare)
• Low blood pressure (frequency not known)
• Sudden unexplained weight gain (common)

Other side effects that may occur:

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

• Headache
• Shortness of breath, difficulty breathing
• Excessive hair growth in women, possible increase in hair on the beard/soft fine hair on the face, body, arms, and legs
• Rash or skin irritation/eczema (dermatitis), acne-like rash (acneiform dermatitis)/itching

Uncommon (may affect up to 1 in 100 people):

• Nausea

Frequency not known (cannot be estimated from the available data):

• Eye irritation
• Vomiting
• Temporary hair loss
• Change in hair color and texture
• Local reactions at the site of application, such as itching, skin irritation, pain, rash, swelling, dryness of the skin, redness of the scalp, ears, or face, sometimes severe, such as peeling, dermatitis, blisters, bleeding, and ulceration
• Contact dermatitis

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Minoxidil Doppelherz For Men

Keep the medicine out of the sight and reach of children.

Danger: highly flammable aerosol. Pressurized container: Do not expose to heat or flames. Keep away from heat sources, hot surfaces, sparks, open flames, and other ignition sources. Do not smoke. Do not spray near open flames or other ignition sources. Do not pierce or burn, even after use. Store the container in the outer packaging to protect it from light. Do not expose to temperatures above 50°C.

Do not use this medicine after the expiry date stated on the carton and pressurized container after: EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Minoxidil Doppelherz For Men contains

• The active substance is minoxidil. One gram of foam contains 50 mg of minoxidil (5% w/w).
• The other ingredients are: anhydrous ethanol, purified water, butylhydroxytoluene (E 321), lactic acid (E 270), citric acid (E 330), glycerol (E 422), cetyl alcohol, stearyl alcohol, polysorbate 60, propellant: propane/isobutane/n-butane.

What Minoxidil Doppelherz For Men looks like and contents of the pack

Minoxidil Doppelherz For Men is a white to yellowish creamy foam for cutaneous use.

The carton contains one or three aluminum pressurized containers with a valve and a white polypropylene dispenser with a transparent polypropylene protective cap, containing 60 grams of the medicine, together with the package leaflet.

Not all pack sizes may be marketed.

Minoxidil Doppelherz For Men contains 60 grams of foam, which is sufficient for one month of treatment.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Doppelherz Pharma GmbH

Schleswiger Straße 74

24941 Flensburg

Germany

Manufacturer:

Ioulia and Irene Tseti Pharmaceutical Laboratories S.A. (Intermed S.A.)

Kaliftaki 27

145 64 Kifisia, Attiki

Greece

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Queisser Pharma Poland Sp. z o.o.

ul. Domaniewska 39

02-672 Warsaw, Poland

Tel.: (22) 487 52 54

Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:

Minoxidil Intermed

Austria:

Minoxidil DoppelherzPharma Männer 50 mg/g Schaum zur Anwendung auf der Kopfhaut

Germany:

Minoxidil DoppelherzPharma Männer 50 mg/g Schaum zur Anwendung auf der Haut (Kopfhaut)

Poland:

Minoxidil Doppelherz Dla mężczyzn

Date of last revision of the package leaflet: 10/2024