Minorga

Leaflet attached to the packaging: information for the user

Minorga 20 mg/ml, solution for the skin

Minoxidil

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 4 months there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

1. What is Minorga and what is it used for

Minorga contains minoxidil at a concentration of 20 mg in 1 ml. Minorga is a liquid medicine for direct application to the scalp. It is used to treat hair loss, not as a cure. Minoxidil is a vasodilator, and its exact mechanism of action, which causes hair regrowth, is unknown. Minorga is indicated for use in adults aged 18 to 65 years with gradual thinning or hair loss on the vertex of the scalp. Thinning or hair loss is a slow process that may become noticeable after several years of gradual loss. Minorga is particularly indicated for men with hair loss or thinning on the vertex of the scalp and for women with overall thinning of hair. If after 4 months there is no improvement or worsening, you should contact your doctor.

2. Important information before using Minorga

When not to use Minorga:

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

Minorga is not indicated for use in cases of patchy baldness (sudden or unexplained hair loss) or scarring baldness (characterized by scarring or scabbing). Additionally, Minorga should not be used if hair loss is associated with pregnancy, childbirth, or severe diseases, such as thyroid dysfunction, lupus, or hair loss from a specific area of the scalp due to inflammation or other diseases.

Warnings and precautions

Since baldness can also be a symptom of a serious ovarian, pituitary, or adrenal disease, women should consult a doctor before starting Minorga if they have any of the following symptoms: rapid weight gain, especially in the trunk and face, sparing the limbs (central obesity); excessive hair growth on the face, similar to that in men (hirsutism); menstrual irregularities; high blood pressure; muscle weakness; back pain; osteoporosis; skin stretch marks; acne. Before starting Minorga, you should discuss it with your doctor or pharmacist. You should not start using Minorga if hair loss is sudden or unexplained, or if it occurs after an illness or treatment. If you have any further doubts about hair loss, you should consult your doctor before starting Minorga. If you have or have had heart or blood vessel disease, including irregular heartbeat, you should consult your doctor before starting Minorga. You should not use Minorga if the area affected by hair loss is red, inflamed, irritated, or painful, such as in the case of severe sunburn or seborrheic dermatitis. You should also not apply Minorga to other parts of the body or at the same time as other topical medicines on the skin. If you experience unusual symptoms after using Minorga, you should stop using it and consult your doctor. It is especially important to stop using Minorga in case of rapid heartbeat (palpitations), swelling of the hands and feet, sudden weight gain without obvious reason, chest pain, weakness, and (or) dizziness. You should also stop using Minorga in case of redness or irritation of the scalp. Systemic symptoms (e.g., rapid heartbeat or fluid retention) occur more frequently in patients with known or suspected coronary heart disease and in patients with risk factors for myocardial infarction. In case of decision to use Minorga, patients with such diseases and doctors should be aware of the risk. Minorga is intended for use only on the scalp, as minoxidil may be absorbed more from other areas of the body, which increases the frequency of side effects. You should not use Minorga if the scalp is irritated or sunburned. Additionally, Minorga should not be used on the scalp if another topical medicine is being used on the skin at the same time. There have been cases of excessive hair growth on the body of infants following contact with areas of application of minoxidil in 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 to avoid contact between children and 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. Do not swallow. Do not inhale. Minorga contains alcohol, which may cause a burning sensation and irritation of the eyes. In case of accidental contact with sensitive surfaces (eye, skin abrasions, mucous membranes), the area of contact should be rinsed thoroughly with cold tap water.

Children and adolescents

Minorga should not be used in patients under 18 years of age.

Minorga and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking, or have recently taken, and about medicines you plan to take. Although not clinically confirmed, it is theoretically possible that minoxidil absorbed through the skin may enhance orthostatic hypotension in patients taking vasodilators at the same time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

Minorga should not affect your ability to drive or use machines.

Minorga contains propylene glycol.

It may cause skin irritation.

3. How to use Minorga

Minorga is for treatment, but not a cure. It is essential not to interrupt regular use of Minorga in the recommended dose, twice a day, to maintain or improve the effects achieved. You should apply one dose of Minorga (1 ml) directly to the area of the scalp where hair loss occurs, TWICE A DAY, for example, in the morning and evening. You should spread the dose over the entire area, rubbing the solution with your fingertips. Each bottle of Minorga contains enough for 30 days of use. Clinical trials have shown that the response to treatment is quite variable, and the effects are not immediate. Usually, new hair growth is gradual, and it is necessary to continue using the medicine twice a day for at least 4 months to become noticeable. Since the action of Minorga starts from the hair follicles, about 2-6 weeks after starting treatment, there may be a temporary acceleration of hair loss. If, at the time of starting treatment with Minorga, you have little hair and respond to treatment, new growing hair will be soft and fine, and initially difficult to notice. As you continue treatment, new hair will take on a color and texture similar to your other hair. If, at the time of starting treatment, hair loss is not very pronounced, new growing hair will have a color and texture similar to your other hair. If you wash your head before using Minorga, you should use a mild shampoo. There is no need to change your standard hair care routine during Minorga treatment. However, you should first apply Minorga, wait until the hair is dry, and then apply hair products (e.g., coloring shampoo, permanent hair dyes). If you swim or get your hair wet for other reasons, it is best to apply Minorga to dry scalp after swimming or wait two hours after application. You should allow Minorga to act on the scalp for at least two hours.

How to apply Minorga

Minorga is for external use only. Apply one dose (1 ml) to the area affected by hair loss, twice a day. Do not apply a dose larger than recommended. Do not apply the medicine to areas other than the scalp. If you wash your head before using Minorga, you should use a mild shampoo. To administer one dose (1 ml) of Minorga, seven sprays are necessary. Rub the administered volume into the entire area affected by hair loss. After each application, wash your hands.

Instructions for use

The instructions for use depend on the type of dispenser used.

• A. Dispenser with a nozzle for applying the solution to larger areas of the scalp.
• B. Dispenser with an applicator for applying the solution to small areas of the scalp or areas with hair.
• A. Dispenser with a nozzle Recommended for use on large areas of the scalp.
• 1) Remove the cap from the bottle.
• 2) Direct the nozzle towards the area without hair, press once, and spread the solution over the entire area with your fingertips. Repeat this procedure six times until the required dose of 1 ml is administered (i.e., a total of 7 sprays). Avoid inhaling the solution during application.
• 3) After use, rinse the nozzle and close the bottle with the cap to avoid evaporation of alcohol.
• B. Dispenser with an applicator Recommended for use on small or hairy areas of the scalp.
• 1) Remove the cap from the bottle.
• 2) Pull the top part of the dispenser, removing it. Place the applicator on the dispenser and press to the end.
• 3) Direct the applicator towards the area without hair, press once, and spread the solution over the entire area with your fingertips. Repeat this procedure six times until the required dose of 1 ml is administered (i.e., a total of 7 sprays). Avoid inhaling the solution during application.
• 4) After use, rinse the applicator and close the bottle with the cap to avoid evaporation of alcohol.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should contact your doctor or pharmacist.

Using more than the recommended dose of Minorga

No cases of minoxidil overdose due to Minorga application have been reported. Do not take Minorga orally. In case of accidental ingestion, you should consult your doctor or a poison control center. Possible symptoms and signs of minoxidil overdose are mainly symptoms related to the cardiovascular system, associated with fluid retention and tachycardia. In case of fluid retention, appropriate diuretic treatment can be used. Tachycardia can be controlled by using an appropriate beta-adrenergic blocker. Symptomatic hypotension should be treated by intravenous administration of electrolyte solutions. You should avoid using sympathomimetic drugs, such as adrenaline and noradrenaline, as these may cause excessive cardiac stimulation. If you experience other, unlisted Minorga effects, you should immediately inform your doctor or pharmacist. Clinical trials have determined the exact dose of Minorga to be used to achieve satisfactory effects. It is not recommended to use the medicine in a dose larger than recommended (1 ml) or more frequently than twice a day. More frequent administration will not increase the rate or amount of new hair growth but may increase the frequency of side effects.

Missing a dose of Minorga

If you miss one or two doses of Minorga, you should return to your normal schedule of using the medicine twice a day. You should not use a larger dose of the medicine to make up for the missed dose.

Stopping Minorga treatment

Maintenance of hair growth requires continuous use of Minorga in the recommended dose. Three to four months after stopping Minorga treatment, new hair growth will stop, and the process will return to the state before treatment. If you have any further doubts about using this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

You should immediately contact your doctor if you experience any of the following symptoms, as you may need urgent medical attention:

• Swelling of the face, lips, or throat, which makes swallowing or breathing difficult. These may be symptoms of a severe allergic reaction (frequency not known, cannot be estimated from available data).

Like all medicines, Minorga can cause side effects, although not everybody gets them. Side effects are listed in order of decreasing frequency. Very common (may affect more than 1 in 10 people):

• Headache

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

• Depression
• Shortness of breath
• Itching, excessive hair growth, rash, acne-like rash, skin inflammation, skin irritation
• Musculoskeletal pain
• Peripheral edema
• Pain

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

• Dry skin, skin peeling, temporary hair loss, change in hair texture, change in hair color
• Irritation at the application site

Rare (may affect up to 1 in 1,000 people):

• Rapid heartbeat, increased heart rate, chest pain
• Redness at the application site

Very rare (may affect up to 1 in 10,000 people):

• Hypotension

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 Minorga

The medicine should be stored out of sight and reach of children. The product is flammable. Protect from heat. Store the bottle tightly closed. Do not use this medicine after the expiry date stated on the bottle after "EXP". The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Minorga contains

The active substance of Minorga is minoxidil. The other ingredients are propylene glycol, ethanol, and purified water.

What Minorga looks like and contents of the pack

Minorga is a clear and colorless or slightly yellowish solution with an alcohol smell, available in the following packaging: HDPE bottle with a spray pump/applicator containing 60 ml of solution. Pack size: 1 bottle of 60 ml with 1 detachable dispenser with a nozzle and cap, and 1 detachable dispenser with a tubular applicator. 3 bottles of 60 ml with 3 detachable dispensers with a nozzle and cap, and 3 detachable dispensers with a tubular applicator.

Marketing authorization holder and manufacturer

Marketing authorization holder Laboratoires Bailleul S.A. 14-16 Avenue Pasteur L-2310 Luxembourg Manufacturer DELPHARM HUNINGUE SAS 26 rue de la Chapelle 68330 Huningue France Lichtenheldt GmbH Pharmazeutische Fabrik Industriestrasse 7-11 23812 Wahlstedt Germany

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

Cyprus Androxil 2%, δερματικό διάλυμα Greece Androxil 2%, δερματικό διάλυμα Spain Minoxidil Biorga 20 mg/mL solución cutánea Malta Minorga 2%, taħlita likwida għall-ġilda Poland Minorga 20 mg/mL, roztwór na skórę Portugal Minoxidil Biorga 2%, solução cutânea Czech Republic Minorga 20 mg/ml, kožní roztok Slovakia Minorga 2%, dermálny roztok Romania Minorga 20 mg/mL, soluƫie cutanată Italy Minoxidil Biorga 2%, soluzione cutanea

Date of last revision of the leaflet: 09/2024