Minoxidil medinfar

Package leaflet: Information for the user

Minoxidil Medinfar, 50 mg/mL, solution for topical use
minoxidil
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet as you may need to read it again.
• 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 doctor or pharmacist. See section 4.
• If there is no improvement after four months of treatment, or if your condition worsens, consult your doctor.

Leaflet contents

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

1. What Minoxidil Medinfar is and what it is used for

Minoxidil Medinfar is a topical solution containing the active substance minoxidil, used for the symptomatic treatment of androgenetic alopecia in men aged 18 to 55 years.
Minoxidil Medinfar stabilizes androgen-dependent hair loss (androgenetic alopecia) on the scalp in the vertex area in men. Thus, treatment with Minoxidil Medinfar may help prevent the progression of androgenetic alopecia.
The mechanism by which topically applied minoxidil and (or) its metabolite stimulate hair growth is not yet fully understood. However, it is believed that minoxidil acts on hair follicles by increasing blood flow in the hairy scalp due to local vasodilation.
The onset and extent of effect of this medicine may vary between individuals and cannot be predicted.
Minoxidil Medinfar is intended for external use only and should be applied exclusively to hairy areas of the scalp.

2. Information before using Minoxidil Medinfar

When not to use Minoxidil Medinfar

• if the patient is allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• in women, because during treatment there may occur occasional, cosmetically undesirable, reversible facial hair growth;
• when using other medicines for the scalp;
• if there is any dressing or bandage on the scalp;
• in case of sudden or patchy hair loss;
• if there is any condition affecting the scalp, including psoriasis (itchy inflammatory skin condition), sunburn, shaved scalp, or if the scalp is scarred or burned, as hair follicles are absent in such areas;
• if the patient has any symptoms of cardiovascular disease or cardiac arrhythmia, such as coronary heart disease, arrhythmia, congestive heart failure, or valvulopathy;
• if the patient has high blood pressure (hypertension);
• if the patient is taking medicines used to treat high blood pressure.

Warnings and precautions
Minoxidil Medinfar should be applied only to intact, healthy, hairy scalp skin.
Do not use Minoxidil Medinfar if the cause of hair loss is unknown or if the scalp is red, inflamed, or painful.
There is currently no clinical experience regarding the efficacy of this medicine in temporal hair loss (receding hairline).
Minoxidil Medinfar is intended for external use only on the hairy scalp.
Do not apply Minoxidil Medinfar to other parts of the body.
Special caution is required if the patient has or has had cardiovascular disease or cardiac rhythm disorders such as tachycardia, chest pain, fainting, dizziness, unexplained weight gain, or symptoms of fluid retention (swelling of hands or feet). This medicine should not be used under such conditions (see section "When not to use Minoxidil Medinfar").
Patients with low blood pressure should consult a doctor before topical application of minoxidil, and monitoring should be performed at the beginning of treatment and then at regular intervals.
Minoxidil Medinfar should be discontinued and medical advice sought:

• if low blood pressure is observed;
• if the patient has high blood pressure;
• if the patient is taking medicines used to treat high blood pressure;
• if at least one of the following symptoms occurs: chest pain, rapid heartbeat, weakness or dizziness, sudden and unexplained weight gain, swelling of hands or feet, persistent redness or irritation of the scalp, or if any other unexpected new symptoms occur (see section "Use of more than the recommended dose of Minoxidil Medinfar").

Unwanted hair growth may result from transferring the medicine to areas other than the scalp.
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. The hair growth returned to normal within a few months after the infant was no longer exposed to minoxidil. Care should be taken to prevent children from coming into contact with areas of the body where minoxidil has been applied topically. If excessive hair growth is noticed on a child during topical use of minoxidil-containing medicines, medical advice should be sought.
Isolated cases of minor changes in hair color have been reported by patients with very light hair during simultaneous use of hair care products or after swimming in heavily chlorinated water.
Accidental ingestion may cause severe adverse cardiovascular effects. Therefore, the medicine should be stored out of reach of children.
Avoid inhaling the sprayed mist.
Due to the content of alcohol and propylene glycol, Minoxidil Medinfar may cause a burning sensation and/or irritation if accidentally comes into contact with sensitive areas (eyes, mucous membranes, abraded skin). In such cases, the affected area should be thoroughly rinsed with plenty of running water. If burning sensation and/or irritation persist, medical advice should be sought.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.
Minoxidil Medinfar and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
There is currently no information available on interactions between Minoxidil Medinfar and other medicines.
Although not clinically proven, there is a theoretical possibility that systemic absorption of the active substance in Minoxidil Medinfar (minoxidil) may exacerbate orthostatic hypotension (a drop in blood pressure upon standing from a lying position) in patients who are also taking peripheral vasodilating medicines (some antihypertensive medicines that dilate blood vessels).
Minoxidil Medinfar should not be used together with other dermatological products (topical products containing active substances such as corticosteroids, retinoids, or anthralin) or with agents that enhance skin penetration of active substances.
Pregnancy and breastfeeding
Minoxidil Medinfar is indicated for use in men only.
Data on the use of Minoxidil Medinfar in pregnant women are limited. Therefore, Minoxidil Medinfar must not be used in pregnant women.
If a patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Minoxidil, when absorbed into the body, may pass into breast milk. Therefore, Minoxidil Medinfar must not be used in breastfeeding women.
Driving and operating machinery
This medicine may cause dizziness or changes in blood pressure. In such cases, patients should not drive or operate machinery.
Minoxidil Medinfar contains propylene glycol
This medicine contains 350 mg of propylene glycol in each mL of solution for the skin. Propylene glycol may cause skin irritation.
Minoxidil Medinfar contains 96% ethanol
This medicine contains 510 mg of alcohol (ethanol) in each mL of solution for the skin. It may cause stinging of damaged skin.
Ethanol may cause stinging and irritation of the eyes. In case of accidental contact with sensitive areas (eyes, abraded skin, mucous membranes), rinse thoroughly with large amounts of water.
Repeated application of Minoxidil Medinfar to hair, rather than to the hairy scalp skin, may lead to increased dryness and/or stiffness of the hair due to the content of ethanol and propylene glycol in Minoxidil Medinfar.

3. How to use Minoxidil Medinfar?

This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Minoxidil Medinfar is intended for topical application to dry, hairy scalp skin.
Apply Minoxidil Medinfar only to healthy, intact scalp skin and always follow the instructions below. Do not apply Minoxidil Medinfar to areas of the body other than the hairy scalp.
The recommended dose is:
Unless otherwise advised by your doctor, Minoxidil Medinfar should be used as follows:
Apply 1 mL of Minoxidil Medinfar solution by pressing the pump dispenser 6 times, twice daily, every 12
hours (morning and evening), to the affected area of the scalp.
Apply the solution to the center of the affected area and spread it evenly with fingertips to ensure uniform distribution. For application to smaller areas, use the applicator provided in the package. To do this, remove the upper part of the spray head and insert the applicator. Then press the applicator 6 times, as indicated above for the pump dispenser. After each application, thoroughly wash your hands.
Do not exceed the recommended daily dose of 2 mL of medicine (i.e. 2 x 1 mL solution), regardless of the size of the affected scalp area.

Use in children and adolescents
Minoxidil Medinfar must not be used in children and adolescents under 18 years of age, as controlled studies on efficacy and safety in these age groups are not available.

Method of administration
Topical application (to the scalp). Minoxidil Medinfar is intended solely for external use and only on the hairy scalp.
Each package of Minoxidil Medinfar contains two different application devices:

• a factory-assembled pump dispenser for application to large areas
• a separate applicator with an extended tip for smaller areas

Both applicators can be used interchangeably by detaching one and replacing it with the other.
Six sprays are required to deliver a 1 mL dose.

Instructions for use/application
Method 1 – pump dispenser

1. This device works best when applying the solution to large areas of the scalp.
2. Remove the outer cap from the bottle.
3. Apply 1 mL of solution by pressing the pump dispenser 6 times, and spread it with fingertips to ensure even distribution of the medicine.
4. Wash your hands and any other areas that may have come into contact with Minoxidil Medinfar, except the scalp.

Method 2 – applicator with extended tip

1. This applicator is best suited for applying the solution to small areas of the scalp or under the hair.
2. Remove the outer cap from the bottle.
3. Remove the upper part of the spray head (the packaging component with the opening) by pulling it upward, and insert the applicator.
4. Apply 1 mL of solution by pressing the applicator 6 times, and spread it with fingertips to ensure even distribution of the medicine.
5. Wash your hands and any other areas that may have come into contact with Minoxidil Medinfar, except the scalp.

Cleaning the pump dispenser and applicator
After each use, remove the upper part of the spray head or the applicator and rinse with 70% isopropyl alcohol to remove any residual medicine and prevent clogging.

Additional important information on use
After applying Minoxidil Medinfar, wash your hands thoroughly to avoid accidental contact with mucous membranes and eyes.
After applying Minoxidil Medinfar, you may style your hair as usual. However, do not wet the scalp for approximately 4 hours to prevent washing out the medicine.

Duration of treatment
The onset and extent of hair regrowth vary among individual patients. Generally, treatment must be applied twice daily for 2 to 4 months to achieve a therapeutic effect. To maintain the effect, continuous twice-daily use without interruption is recommended.
Using Minoxidil Medinfar in larger amounts or more frequently will not provide better results.
Regarding potential therapeutic effect, sufficient clinical experience exists for treatment periods up to one year.
If no effects are observed after 4 months of treatment, therapy should be discontinued.

Information about increased hair shedding
During treatment with the active substance minoxidil, the resting phase (telogen phase) of the hair cycle is shortened, and the growth phase (anagen phase) is reached more quickly. This stimulates new hair growth, causing old, inactive hairs to shed from the scalp. This may give the initial impression of increased hair loss. Some patients have experienced this reaction 2 to 6 weeks after starting minoxidil treatment. However, this should not be a cause for concern, as it is accompanied by increased hair regrowth. This effect resolves within a few weeks and may be interpreted as the first sign of minoxidil’s action.

Use of a higher than recommended dose of Minoxidil Medinfar
Using Minoxidil Medinfar in higher than recommended doses, over large body surface areas, or on areas other than the hairy scalp may lead to increased systemic absorption of minoxidil.
To date, there have been no reported cases in which topical application of minoxidil solution caused symptoms of poisoning.
In case of accidental ingestion, the concentration of the active substance minoxidil in Minoxidil Medinfar may lead to effects on internal organs similar to those observed after oral intake of the active substance, e.g. in tablet form. This may cause the following adverse effects: rapid heartbeat, decreased blood pressure, fluid retention, and consequently sudden weight gain, dizziness.
In case of accidental ingestion or symptoms of overdose, contact a doctor immediately. The doctor will decide on further management. Show the doctor the medicine packaging so that the doctor knows which active substance was ingested.

Missed dose of Minoxidil Medinfar
Do not use a double dose to make up for a missed dose; continue treatment with the recommended dose. Making up for a missed dose will not provide any benefit and may lead to adverse effects.

Discontinuation of Minoxidil Medinfar treatment
Continuous treatment is necessary to improve and maintain hair growth. Otherwise, hair loss will recur.
Discontinuing treatment with Minoxidil Medinfar may result in a return to the initial state of hair loss within 3 to 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 medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately if the patient notices any of the following symptoms:

• the patient may need urgent medical help:
• swelling of the face, lips or throat causing difficulty in swallowing or breathing. This may be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from available data);
• generalized redness of the skin (frequency unknown, cannot be estimated from available data);
• generalized itching (frequency unknown, cannot be estimated from available data);
• tightness in the throat (frequency unknown, cannot be estimated from available data).

Very common (may affect more than 1 in 10 people):

• Headache

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

• Itching
• Excessive hair growth in areas other than the scalp (including facial hair growth in women), skin inflammatory reaction (including acneiform rash, skin rash)
• Shortness of breath, breathing difficulties
• Swelling of hands and feet
• Weight gain
• High blood pressure
• Irritation of the hairy scalp, such as stinging, burning, dryness, itching, scaling, folliculitis

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

• Dizziness, nausea

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

• Allergic contact dermatitis (skin inflammation due to allergy)
• Depression
• Eye irritation
• Fast heartbeat, palpitations, low blood pressure
• Vomiting
• Application site reactions, which may also affect ears and face, such as itching, skin irritation, pain, redness, swelling, dryness, inflammatory rash, up to possible skin peeling, dermatitis, blistering, bleeding and ulceration
• Temporary hair loss, changes in hair color, altered hair texture
• Chest pain

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring of Adverse Drug Reactions
of 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 21 309
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 the medicine.

5. How to store Minoxidil Medinfar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and bottle after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Do not store in a refrigerator or freeze.
Keep the bottle tightly closed.
Shelf-life after first use: 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Minoxidil Medinfar contains

• The active substance is minoxidil. Each millilitre of the topical solution contains 50 mg of minoxidil.
• The other ingredients are: propylene glycol and ethanol 96%.

What Minoxidil Medinfar looks like and contents of the pack
A clear, colourless to slightly yellowish homogeneous solution, free from suspended particles.
Minoxidil Medinfar is available in bottles containing 60 mL of topical solution (bottle with a dosing pump) with an applicator.
Pack sizes:
1 x 60 mL and 3 x 60 mL of topical solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratório Medinfar - Produtos Farmacêuticos, S.A.
Rua Henrique Paiva Couceiro, 29, Venda Nova
2700-451 Amadora
Portugal
Email: [email protected]

Manufacturer
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5
3150-194 Condeixa-a-Nova
Portugal

This medicinal product is authorised in the European Economic Area (EEA) countries under the following names:
Austria: Minoxidil Redcare 50 mg/mL Lösung zur Anwendung auf der Haut (Kopfhaut)
Belgium: FR (French): Minoxidil Leman 50 mg/mL Solution pour application cutanée
NL (Dutch): Minoxidil Leman 50 mg/mL Oplossing voor cutaan gebruik
DE (German): Minoxidil Leman 50 mg/mL Lösung zur Anwendung auf der Haut
Germany: Minoxidil Redcare 50 mg/mL Lösung zur Anwendung auf der Haut (Kopfhaut)
Italy: SCEVADIL
Luxembourg: Minoxidil Leman 50 mg/mL Solution pour application cutanée
Portugal: Noage
Spain: Minoxidil GalenicumDerma 50 mg/mL solución cutánea
Romania: Minoxidil Medinfar 50 mg/mL soluţie cutanată