Minoxidil medinfar

Package leaflet: Information for the user

Minoxidil Medinfar, 20 mg/mL, solution for topical use on the scalp
minoxidil
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• 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 doctor or pharmacist. See section 4.
• If there is no improvement after four months of treatment, or if your condition worsens, consult your doctor.

Table of 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, indicated for the symptomatic treatment of androgenetic alopecia in men and women aged 18 to 55 years.
Minoxidil Medinfar stabilizes androgen-dependent hair loss (androgenetic alopecia) on the scalp, particularly in the vertex region in men. In women, this condition is characterized by reduced hair density on the crown and front part of the scalp, with preservation of the anterior hairline. 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 scalp skin due to local vasodilation.
The onset and extent of response to this medicine may vary between individuals and cannot be predicted.
Minoxidil Medinfar is intended for external use only and should be applied exclusively to the hairy scalp.

2. Important 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);
• when using other medicines for the hairy 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 (an itchy inflammatory skin condition), sunburn, shaved scalp, or if the scalp is damaged by scars or burns, as hair follicles are absent in such areas;
• if the patient has any symptoms of cardiovascular disease or heart rhythm disorders, 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 effectiveness of this medicine in cases of hair loss in the temporal region (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.

Exercise particular caution if the patient has or has had cardiovascular disease or heart 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 applying minoxidil topically. Monitoring should be performed at the beginning of treatment and then at regular intervals.

Discontinue use of Minoxidil Medinfar and consult a doctor:

• 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 any of the following symptoms occur: 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 appear (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. 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 observed in a child during topical use of minoxidil-containing medicines, consult a doctor.

Isolated cases of slight 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 serious adverse cardiovascular effects. Therefore, keep the medicine 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 contacting sensitive areas (eyes, mucous membranes, abraded skin). In such cases, the affected area should be thoroughly rinsed with plenty of running tap water. If the burning sensation and/or irritation persists, seek medical advice.

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 any medicines you are currently using, have recently used, or plan to use.

Currently, there is 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 of Minoxidil Medinfar (minoxidil) may exacerbate orthostatic hypotension (a drop in blood pressure upon standing from a lying position) in patients also taking peripheral vasodilators (certain 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 absorption of active substances.

Pregnancy and breastfeeding

Data on the use of Minoxidil Medinfar in pregnant women are limited. Therefore, Minoxidil Medinfar must not be used during pregnancy.

If the 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 259 mg of propylene glycol in each mL of topical solution. Propylene glycol may cause skin irritation.

Minoxidil Medinfar contains ethanol

This medicine contains 466 mg of alcohol (ethanol) in each mL of topical solution. 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 plenty of water.

3. How to use Minoxidil Medinfar?

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.
Minoxidil Medinfar is intended for topical application to dry, hairy scalp skin.
Apply Minoxidil Medinfar only to healthy, intact scalp skin and always strictly follow the instructions below. Do not apply Minoxidil Medinfar to areas of the body other than the hairy scalp.

Recommended dose:
Unless otherwise prescribed by a 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 gently with fingertips to ensure even distribution of the medicine. 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, wash hands thoroughly.

Do not exceed the recommended daily dose of 2 mL of the 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 for external use only and solely on the hairy scalp.

Each package of Minoxidil Medinfar contains two different application devices:

• a pre-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 of the bottle.
3. Apply 1 mL of solution by pressing the pump dispenser 6 times and spread it gently with fingertips to ensure even distribution of the medicine.
4. Wash 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 of 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 gently with fingertips to ensure even distribution of the medicine.
5. Wash hands and any other areas that may have come into contact with Minoxidil Medinfar, except the scalp.

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

Other important information on use
After applying Minoxidil Medinfar, wash 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 twice daily for 2 to 4 months is required to achieve a therapeutic effect. To maintain the effect, continuous use twice daily without interruption is recommended.
Using Minoxidil Medinfar in larger amounts or more frequently than recommended will not provide better results.
Regarding potential therapeutic effect, sufficient clinical experience is available for treatment periods up to one year.
If no effects are observed after 4 months of treatment, therapy should be discontinued.

Use of more than the recommended dose of Minoxidil Medinfar
Using Minoxidil Medinfar in doses higher than recommended, over large body areas, or on areas other than the hairy scalp may lead to increased systemic absorption of minoxidil.
There have been no reported cases to date in which topical application of minoxidil solution caused symptoms of poisoning.
However, accidental ingestion of the concentrated active substance minoxidil in Minoxidil Medinfar may lead to effects on internal organs similar to those seen after ingestion of the active substance 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 has been 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 provides no benefit and may lead to adverse effects.

Discontinuation of Minoxidil Medinfar treatment
Continuation of 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 a 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
• Increased hair growth outside 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, flaking, folliculitis

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

• Dizziness, nausea

Frequency unknown (cannot be estimated from available data):

• Contact dermatitis (skin inflammation due to allergy)
• Depression
• Eye irritation
• Faster heartbeat, palpitations, low blood pressure
• Vomiting
• Application site reactions, which may also affect ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin, 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 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02 - 222 Warsaw
Phone: + 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 the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging or
bottle under "EXP". The expiry date refers to the last day of the specified month.
Do not store above 25°C. Do not store in a refrigerator and do not 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Minoxidil Medinfar contains

• The active substance is minoxidil. Each millilitre of topical solution contains 20 mg of minoxidil.
• The other ingredients are: propylene glycol, anhydrous ethanol and purified water.

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
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 countries under the following names:
Austria: Minoxidil Redcare 20 mg/mL Solution for topical application (scalp)
Belgium:
FR (French): Minoxidil Leman 20 mg/mL Solution for topical application
NL (Dutch): Minoxidil Leman 20 mg/mL Oplossing voor huidgebruik
DE (German): Minoxidil Leman 20 mg/mL Lösung zur Anwendung auf der Haut
Germany: Minoxidil Redcare 20 mg/mL Solution for topical application (scalp)
Italy: SCEVADIL
Luxembourg: Minoxidil Leman 20 mg/mL Solution for topical application
Portugal: Noage
Romania: Minoxidil Medinfar 20 mg/mL cutaneous solution