Minoxidil oeparolmed

Package leaflet: Information for the user

Minoxidil Oeparolmed, 50 mg/g, topical foam
Minoxidilum
Please read all of this leaflet carefully before 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 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 or if you feel worse, contact your doctor.

Table of contents

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

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

Minoxidil Oeparolmed is a topical foam for application to the scalp skin. Minoxidil Oeparolmed contains the active substance minoxidil, which works by enhancing blood flow to the hair follicles in the scalp.
Minoxidil Oeparolmed is indicated for the treatment of androgenetic alopecia (hormonally-related hair loss) in adult men (who experience hair loss or thinning at the vertex of the scalp) and in adult women (with general hair thinning: characteristic diffuse thinning of female-pattern hair loss in the vertex area of the scalp). Minoxidil Oeparolmed stimulates hair growth and helps prevent further hair loss.

The onset of androgenetic alopecia (hair loss) in men is characterized by hair loss along the fronto-temporal hairline, resulting in a receding hairline. Later, progressive thinning occurs at the vertex (crown) of the scalp. The diagram below illustrates the symptoms of androgenetic alopecia in men.

In women, the onset of hair loss is characterized by reduced hair density at the crown of the scalp. Complete hair loss is very rare, but thinning occurs in the central part of the part line. The diagram below illustrates the symptoms of androgenetic alopecia in women.

2. Important information before using Minoxidil OeparolMed

When not to use Minoxidil OeparolMed

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• On the hairline (forehead, temples),
• If the patient is using other topical medicines on the scalp,
• If the patient experiences sudden or patchy hair loss,
• In women during pregnancy,
• In women who are breastfeeding.

Warnings and precautions
Before starting treatment with Minoxidil OeparolMed, consult a doctor or
pharmacist if:

• The cause of hair loss is unknown, if hair loss occurred after childbirth, or if the scalp is red, irritated, or painful.
• The patient has symptoms of cardiovascular diseases or heart rhythm disorders.
• The patient has high blood pressure.
• The patient is taking medicines for high blood pressure.

The doctor should rule out other possible causes of hair loss, including hormonal disorders, systemic diseases, or malnutrition.
Minoxidil OeparolMed foam for the skin is highly flammable; therefore, do not use it near open flames, electrical devices (e.g. hair dryers), or while smoking cigarettes during or immediately after application.
Minoxidil OeparolMed should be applied only to intact, healthy scalp skin.
Minoxidil OeparolMed is intended for external use on the scalp only and must not be applied to other parts of the body.
Treatment with Minoxidil OeparolMed should be discontinued and medical advice sought:

• In case of low blood pressure.
• If the patient experiences one or more of the following symptoms: chest pain, rapid heartbeat, weakness or dizziness, sudden weight gain, swelling of hands or feet, persistent redness or irritation of the scalp (see section "Use of more than the recommended dose of Minoxidil OeparolMed"), or any other unexpected symptoms.

Using larger amounts or applying the medicine more frequently than recommended does not enhance treatment effectiveness.
To maintain the treatment effect, continuous use is required. If treatment with minoxidil is stopped, hair loss may recur.

Notes regarding increased hair loss
The resting phase (telogen phase) of the hair growth cycle is shortened in hair follicles treated with minoxidil, and the transition to the growth phase (anagen phase) occurs more rapidly. This stimulates new hair growth but may temporarily give the impression of increased hair loss. This reaction has been observed in some patients during the first 2 to 6 weeks of minoxidil treatment. Accelerated hair shedding, accompanied by increased regrowth, resolves within several weeks and indicates proper minoxidil action.
If minoxidil is applied to areas other than the scalp, unwanted hair growth may occur at those sites.
Isolated cases of slight hair color changes have been reported by patients with very light hair when using minoxidil together with other hair care products or after swimming in heavily chlorinated water.
Repeated application of Minoxidil OeparolMed to hair rather than to the hairy scalp may lead to increased dryness and/or stiffness of hair.
In case of accidental contact with sensitive areas (eyes, damaged skin, mucous membranes), rinse the affected area thoroughly with large amounts of cold water.
Accidental ingestion may lead to serious adverse cardiovascular reactions.
Keep the medicine out of sight and reach of children.
Cases of excessive body hair growth in infants have occurred following skin contact with application sites of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returned to normal within several months once the infant was no longer exposed to minoxidil. Care should be taken to prevent children from contacting areas of the body where minoxidil has been applied topically.
If excessive hair growth is observed in a child during use of topical minoxidil products, consult a doctor.

Children and adolescents
Minoxidil OeparolMed should not be used in children and adolescents under 18 years of age due to lack of data on efficacy and safety in this patient group.

Minoxidil OeparolMed and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Currently, there is no evidence of any interactions between Minoxidil OeparolMed and other medicines.
Changing position from lying down to standing may cause a drop in blood pressure. Although not clinically confirmed, there is a theoretical possibility that minoxidil absorbed into the bloodstream may exacerbate this effect, particularly in patients taking vasodilating medicines simultaneously.
Do not use Minoxidil OeparolMed concurrently with other topical medicines applied to the scalp (medicines containing corticosteroids, dithranol, or tretinoin as active ingredients) or with medicines that enhance skin absorption of active substances.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Minoxidil OeparolMed must not be used during pregnancy or breastfeeding, as no studies have been conducted on minoxidil use in pregnant women, and systemically absorbed minoxidil passes into human milk.

Driving and operating machinery
Minoxidil OeparolMed is not expected to affect the ability to drive or operate machinery.

Minoxidil OeparolMed contains stearyl alcohol, cetyl alcohol, and 96% ethanol.
Stearyl alcohol and cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Minoxidil OeparolMed contains 598.8 mg of 96% ethanol per administered dose (1 g), which may cause stinging on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or electrical devices such as hair dryers.

Minoxidil OeparolMed contains polysorbates.
Polysorbates may cause allergic reactions.

3. How to use Minoxidil OeparolMed

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.

Application to the scalp

Recommended dose:

• Men: 1 g (corresponding to the size of a hazelnut or a teaspoon) twice daily (morning and evening)
• Women: 1 g (corresponding to the size of a hazelnut or a teaspoon) once daily

Do not use higher doses than those recommended above, regardless of the size of the affected skin area.

• There is no need to wash the hair before applying Minoxidil OeparolMed. Hair and scalp must be dry before using Minoxidil OeparolMed. Wash your hands thoroughly before applying the medicine.
• The foam may quickly dissolve upon contact with warm skin. If your fingers are warm, rinse them with cold water and dry them thoroughly before use. Apply the foam to the balding areas and gently massage it into the scalp.
• For long hair, it may be necessary to part the hair several times to ensure the foam reaches the scalp. For this reason, it may be helpful to dispense the entire dose into a separate container. Parting the hair in the thinning area allows the foam to be distributed over as large a surface area of the scalp as possible. Using fingertips, spread the appropriate amount of foam over the affected areas of the scalp and gently massage it in, starting from the back of the head and moving forward. Part the hair at least two more times on each side of the head, and apply the remaining foam as described above until the entire dose has been used.
• Minoxidil OeparolMed does not have hair styling properties. After applying Minoxidil OeparolMed, hair may be styled as usual. However, do not wet the hairy scalp for approximately 4 hours to prevent washing out the medicine.
• After application, wash your hands and any used containers thoroughly to avoid accidental contact with eyes or mucous membranes.

To protect children from accessing the medicine, close the container and replace the cap after each use.

Method of administration

Hold the container vertically with the spray head pointing downward. Pressing the spray head releases an amount of foam equivalent to half the cap's volume onto the palm of the hand or onto a smooth, flat dish or saucer. The amount of foam should correspond to the size of a hazelnut or a teaspoon (see illustrations).

Duration of treatment

It is important not to interrupt regular use of the medicine at the recommended dose in order to maintain or improve the achieved effects.

Men
Treatment should last from 2 to 4 months with twice-daily application before noticeable therapeutic effects are observed.
Continuing treatment with twice-daily application is necessary to maintain the therapeutic effect. Using larger amounts or applying the medicine more frequently than recommended does not improve treatment outcomes.
If you feel the medicine's effect is too strong or too weak, consult your doctor or pharmacist.
There is sufficient clinical experience regarding the efficacy of the foam applied to the scalp in men for up to 4 months and safety data for up to 12 months.
If no expected improvement is observed after 4 months of using Minoxidil OeparolMed, treatment with this medicine should be discontinued.

Women
Treatment should last 3 months with once-daily application before noticeable therapeutic effects are observed.
Continuing treatment (applying the foam once daily) is necessary to maintain the therapeutic effect. Using larger amounts or applying the medicine more frequently than recommended does not improve treatment outcomes.
If you feel the medicine's effect is too strong or too weak, consult your doctor or pharmacist.
There is sufficient clinical experience regarding the therapeutic effect of the foam applied to the scalp in women for up to 12 months.
If no expected improvement is observed after 6 months of using Minoxidil OeparolMed, treatment with this medicine should be discontinued.

Use in children and adolescents
Due to lack of data on safety and efficacy, Minoxidil OeparolMed should not be used in children and adolescents under 18 years of age.

Overdose of Minoxidil OeparolMed
There is no evidence that topically applied minoxidil is absorbed in amounts sufficient to cause systemic effects. When used as directed, overdose is unlikely.
Increased absorption of minoxidil into the bloodstream may affect the whole body and may occur due to:

• improper application (using higher doses than recommended or applying to large body surface areas or to body parts other than the scalp),
• individual patient characteristics,
• unusual sensitivity or skin disorders caused by inflammatory conditions or scalp diseases (e.g. abrasions or psoriasis of the scalp).

Accidental ingestion or application of Minoxidil OeparolMed to diseased skin areas may affect the entire body (systemic effects). This may cause the following adverse effects: rapid heartbeat, decreased blood pressure, fluid retention, sudden weight gain, dizziness, drowsiness.
In case of ingestion or symptoms of overdose, consult a doctor. In the event of minoxidil overdose, the doctor may initiate symptomatic and supportive treatment.

Missed dose of Minoxidil OeparolMed
Do not use a double dose to make up for a missed dose. Continue treatment with the recommended dose.

Discontinuation of Minoxidil OeparolMed
Sometimes, after stopping minoxidil treatment, cessation of hair growth and, occasionally, return to the previous condition within 3 to 4 months after stopping treatment have been observed.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
You should stop using Minoxidil OeparolMed and contact your doctor immediately
if you experience any of the following symptoms, as urgent medical attention may be required (frequency unknown, cannot be estimated from available data):

• swelling of the face, lips or throat causing difficulty in swallowing or breathing. These may be signs of a severe allergic reaction,
• hypersensitivity reactions with symptoms such as generalised itching, widespread skin rash and sensation of tightness in the throat.

The following adverse effects may occur:
Very common (may affect more than 1 in 10 people):

• headache.

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

• weight gain,
• excessive facial hair growth,
• itching, redness and rash, dermatitis, acneiform dermatitis, hypertrichosis,
• shortness of breath,
• swelling of hands and feet,
• high blood pressure,
• scalp irritation including: stinging/burning, dryness/itching/flaking of the scalp, folliculitis.

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

• dizziness,
• nausea.

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

• contact dermatitis,
• depressive mood,
• eye irritation,
• increased heart rate, palpitations, low blood pressure,
• vomiting,
• application site reactions affecting also ears and face, including: itching, skin irritation, pain, redness, swelling, dryness of the skin, inflammatory skin rash up to skin peeling, dermatitis, blisters, bleeding and skin ulceration,
• transient hair loss, change in hair colour, change in hair texture,
• chest pain.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Minoxidil OeparolMed

The medicinal product is flammable.
Store in the original packaging to protect from light. Store in an upright position.
Do not store above 30°C. Do not store in the refrigerator or freeze.
Keep this medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging following: Expiry date (EXP). The expiry date refers to the last day of the stated month.
Shelf-life after first use: 1 year.
Medicinal products should 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 pack and other information

What Minoxidil OeparolMed contains
The active substance is minoxidil.
1 g of topical foam contains 50 mg of minoxidil.
The other ingredients are: all-rac-α-Tocopheryl acetate, monohydrate citric acid, polysorbate 60,
stearyl alcohol, cetyl alcohol, lactic acid, glycerol, 96% ethanol, purified water,
gas mixture: propane/n-butane/i-butane.

What Minoxidil OeparolMed looks like and contents of the pack
Minoxidil Oeparolmed is a white to yellowish topical foam.
The pressurized container is made of aluminium internally coated with a polyamide-imide lacquer,
closed with a valve, equipped with a dip tube and cap, and presented in a cardboard box. Each container holds 100 g of topical foam. Pressurized container.
Minoxidil Oeparolmed is available in packs containing 1, 2, 3 or 4 containers, each containing 100 g of topical foam.
Not all pack sizes may be marketed.
Minoxidil Oeparolmed does not contain propylene glycol or butylhydroxytoluene (BHT).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Medicair Bioscience Laboratories S.A.
Athinon-Lamias National Road 61st Km
320 09 Schimatari
Greece