Minoxidil doppelherz for men

Package leaflet: Information for the user

Minoxidil Doppelherz for men, 50 mg/g, topical foam
Minoxidilum
Please read the entire 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 patient leaflet or as directed by a
physician, pharmacist, or nurse.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
• If there is no improvement after 4 months of treatment, or if your condition worsens, contact your physician.

Table of contents

1. What Minoxidil Doppelherz for men is and what it is 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 Minoxidil Doppelherz for men is and what it is used for

The active substance in Minoxidil Doppelherz for men is minoxidil. Minoxidil promotes hair regrowth and slows down hair loss in men with a receding hairline and vertex baldness by stimulating hair follicles.
Minoxidil Doppelherz for men is used in the treatment of men aged 18 years and older with common hereditary hair loss (also known as androgenetic alopecia).
It is intended for topical application on the scalp only.

2. Important information before using Minoxidil Doppelherz for men

When not to use Minoxidil Doppelherz for men

• if the patient is 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, consult a doctor or
pharmacist:

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

After entering the bloodstream, minoxidil may cause adverse effects related to low blood pressure, such as 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 any of these adverse effects occur, stop using the medicine and consult a doctor.
When Minoxidil Doppelherz for men should not be used:

• if the pattern of hair loss differs from a receding hairline and balding on the crown of the head
• if there is no family history of hair loss
• if hair loss is sudden and (or) patchy
• 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, use of this medicine has caused changes in hair colour and texture.
During the first 2 to 6 weeks of treatment, increased hair loss may occur (old hairs fall out and are replaced by new ones). This indicates that the medicine is working and old hairs are being replaced by new ones.
This symptom should resolve after a few weeks. If hair loss continues, discontinue use of Minoxidil Doppelherz for men and contact a doctor.
Accidental ingestion may cause serious cardiovascular adverse effects. For this reason, the medicine should be stored out of the reach of children.
If the foam is accidentally applied to areas of the body other than the scalp, wash thoroughly with plenty of water to avoid unwanted hair growth.
Cases of excessive body hair growth in infants have been reported following skin contact with application sites of minoxidil in patients (caregivers) using topical minoxidil.
Hair growth returned to normal within a few months once the infant was no longer exposed to minoxidil. Care should be taken to ensure that children do not come into contact with areas of the body where minoxidil has been applied topically.
If excessive hair growth on a child's body is observed during use of topical products containing minoxidil, consult a doctor.
Children and adolescents
Minoxidil Doppelherz for men must not be used in children and adolescents under 18 years of age.
Minoxidil Doppelherz for men and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Minoxidil Doppelherz for men must not be used simultaneously with other medicines applied topically to the scalp (e.g. corticosteroids, tretinoin, dithranol).
Long-term use of low-dose oral aspirin may affect the effectiveness of minoxidil treatment.
Minoxidil Doppelherz for men and other hair cosmetic products
Using shampoo during treatment
During treatment with Minoxidil Doppelherz for men, use a mild shampoo. Minoxidil Doppelherz for men should be applied to dry scalp.
Using hair care products during treatment
To achieve the best results, wait until Minoxidil Doppelherz for men has been fully absorbed into the scalp before using any styling products. Apply Minoxidil Doppelherz for men first, then use your regular styling products. Do not mix Minoxidil Doppelherz for men with other products intended for application to the scalp.
Advice regarding hair colouring or permanent waving
There is no information available on the effect of these procedures on the action of Minoxidil Doppelherz for men. However, to avoid possible scalp irritation, ensure that Minoxidil Doppelherz for men has been rinsed off the hair and scalp before using chemical agents for these procedures. Also inform your hairdresser that you are using Minoxidil Doppelherz for men.
Pregnancy, breastfeeding and fertility
Minoxidil Doppelherz for men is not intended for use in women.
Do not use this medicine during pregnancy, breastfeeding, or when trying to become pregnant.
Driving and operating machinery
This medicine may cause dizziness or hypotension. If these symptoms occur, do not drive or operate machinery.
Minoxidil Doppelherz for men contains ethanol
This medicine contains 560 mg of alcohol (ethanol) per dose (1 g), equivalent to 560 mg alcohol/g of medicine (56% w/w). It may cause stinging on damaged skin. If applied to sensitive areas (e.g. eyes, mucous membranes or damaged skin), thoroughly and generously rinse with running water.
Minoxidil Doppelherz for men contains butylhydroxytoluene (E 321)
This medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of eyes and mucous membranes.
Minoxidil Doppelherz for men contains cetyl alcohol and stearyl alcohol
This 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 patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
To achieve and maintain the desired hair growth effect, use the foam twice daily.
The foam is intended for application only to healthy scalp skin. DO NOT use it on areas of the scalp affected by inflammation, infection, irritation, or pain. DO NOT apply the medicine to other parts of the body.
Apply the foam directly to the scalp skin.
Avoid contact of the medicine with the eyes. If the foam gets into the eyes, rinse them immediately with plenty of cold tap water.

Before applying the foam to the skin
Your hair and scalp should be dry.

How to apply the foam to the skin
Apply a dose of 1 g (corresponding to the volume of half the protective cap) to the area of hair loss twice daily (once in the morning and once in the evening).
Remove the protective cap (Figure 1).
The foam may begin to melt upon contact with warm skin. If your fingers are warm, rinse them first with cold water and 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 the volume of half the protective cap), regardless of the size of the treated area.
Gently massage the foam into the areas of the scalp requiring treatment using your fingertips (Figure 3), then wash your hands immediately after applying the foam.
After each use, close the container by replacing the protective cap.

Figure 1 Figure 2 Figure 3

Duration of treatment with Minoxidil Doppelherz for Men
Hair regrowth takes time. Results may become noticeable after 2 months of using the medicine twice daily. In some men, results may only be visible after at least 4 months of treatment.

What to expect during treatment with Minoxidil Doppelherz for Men
During the first few months after starting the foam, some patients may experience increased hair loss. This may indicate that Minoxidil Doppelherz for Men is working. This temporary increase in hair shedding usually occurs within 2 to 6 weeks after starting treatment and then subsides.
If excessive hair loss persists beyond 6 weeks, consult your doctor.
Initially, new hairs are typically soft, fine, and colorless. With continued use, new hairs should gradually match the color and thickness of the surrounding scalp hair. Since hair grows slowly, the effect of Minoxidil Doppelherz for Men becomes noticeable after some time—usually after 2–4 months of twice-daily application.
If no hair regrowth is observed after 4 months, discontinue use of Minoxidil Doppelherz for Men.

The extent of hair regrowth varies individually. The medicine will not work the same way in all men. Continued use is necessary to increase and maintain hair growth. Otherwise, hair loss will resume.

Use of more than the recommended dose of Minoxidil Doppelherz for Men
If you accidentally apply more medicine than recommended, consult your doctor. Follow the instructions carefully. Do not use more than 2 g (corresponding to the volume of one protective cap) per day, and do not apply more than twice daily. Applying a larger amount or using it more frequently will not make hair grow faster or improve results.
If a child accidentally swallows Minoxidil Doppelherz for Men, take the child to the hospital immediately (if possible, bring the Minoxidil Doppelherz for Men container, as the doctor may need to know how much medicine was ingested).

Missed dose of Minoxidil Doppelherz for Men
Do not be concerned if you miss one or two doses. Continue using the medicine as usual. Do not apply a double dose to the scalp if you miss a dose, as excessive use may cause low blood pressure, rapid heartbeat, drowsiness, or fatigue.

Stopping treatment with Minoxidil Doppelherz for Men
If you stop using the foam, the hair that has regrown may be lost, and the scalp will likely return to its previous condition within 3–4 months.

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

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
You should STOP using the foam and contact your doctor immediately if any of the following symptoms occur –
the patient may require immediate medical attention:

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

Other adverse reactions may occur as described below:
Common (may affect up to 1 in 10 users):

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

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

• Nausea

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Minoxidil Doppelherz dla mężczyzn

Keep the medicine out of the sight and reach of children.
Warning: Extremely flammable aerosol. Pressurised container: May burst if heated. Store away from heat sources, hot surfaces, sparking devices, open flames, and other sources of ignition. Do not smoke. Do not spray near open flame or other sources of ignition. Do not pierce or burn, even after use. Store the container in the outer packaging to protect from light. Do not expose to temperatures exceeding 50°C.
Do not use this medicine after the expiry date stated on the cardboard box and pressurised container following: EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Minoxidil Doppelherz for Men contains

• The active substance is minoxidil. One gram of the topical 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 cream foam for topical application.
The carton contains one or three aluminum pressurized containers with a metering valve and a white polypropylene dispenser with a transparent polypropylene protective cap, containing 60 grams of the medicinal product, together with the package leaflet.
Not all pack sizes may be marketed.
Minoxidil Doppelherz for Men contains 60 grams of foam for topical use, which is sufficient for one month of treatment.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Queisser Pharma Poland Sp. z o.o.
ul. Domaniewska 39
02-672 Warsaw, Poland
Tel.: (22) 487 52 54
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries 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 for Men