Minorga

Package Leaflet: Information for the User

Minorga, 50 mg/ml, Cutaneous Solution

Minoxidil

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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 pack and other information

1. What is Minorga and what is it used for

Minorga contains minoxidil at a concentration of 50 mg in 1 ml.
Minorga is a liquid medicine for direct application to the scalp.
It is used to treat hair loss, and not as a cure. Minoxidil is a peripheral vasodilator, the exact mechanism of which, causing 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 the hair.
If there is no improvement or worsening after 4 months, you should contact your doctor.

2. Important information before using Minorga

When not to use Minorga:

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

Warnings and precautions

Since baldness can also be a symptom of a severe 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 torso and face, sparing the limbs (central obesity); hair growth on the face similar to that in men (hirsutism); menstrual disorders; hypertension; muscle weakness; back pain; osteoporosis; skin stretch marks; acne.
Before starting Minorga, you should discuss it with your doctor or pharmacist.
Do not start using Minorga if hair loss is sudden or unexplained, or if it occurs after illness or treatment. If you have any further doubts about hair loss, you should consult your doctor before starting Minorga.
Patient using Minorga should first undergo a medical examination. The doctor should assess whether the patient has a healthy scalp.
If the patient has or has had heart or blood vessel disease, including irregular heartbeat, they should consult their doctor before starting Minorga.
Minorga should not be used if the area affected by hair loss is red, inflamed, irritated, or painful, such as in the case of severe sunburn or seborrheic dermatitis. Minorga should not be applied to other parts of the body or at the same time as other topical medicines on the skin.
If unusual symptoms occur 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.
In patients with a history of heart disease, Minorga may worsen their condition.
There have been cases of excessive hair growth on the body of infants following skin contact with minoxidil application sites 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 children coming into contact with areas of the body where minoxidil has been applied topically. If excessive hair growth on the child's body is noticed 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 to the eyes. In case of accidental contact with sensitive surfaces (eye, skin abrasions, mucous membranes), rinse the area of contact thoroughly with cold tap water.
You should inform your doctor or pharmacist if you:
* have heart disease;
* have had allergic reactions in the past;
* are taking other medicines.

Children and adolescents

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

Minorga and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Although not clinically confirmed, it is theoretically possible that minoxidil absorbed through the skin may enhance orthostatic hypotension in patients taking vasodilating medicines at the same time.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Minorga is unlikely to affect your ability to drive or use machines.

Minorga contains propylene glycol.

This may cause skin irritation.

3. How to use Minorga

Minorga is for treatment, but not a cure. It is important not to stop regular use of the medicine in the prescribed dose for the given disease state to maintain or improve the achieved effects.
Apply one dose of Minorga (1 ml) directly to the scalp area where hair loss occurs TWICE DAILY, for example in the morning and evening (or according to another comparable scheme). Spread the dose over the entire area, rubbing the solution in with your fingertips. Each bottle of Minorga contains enough for 30 days of use.
This medicine should not be used by patients under 18 years of age.
Clinical studies have shown that the response to treatment is quite variable, and the effects are not immediate. Usually, new hair growth is gradual and requires continuous use of the medicine twice a day for at least 4 months to become noticeable.
Since Minorga works on hair follicles, about 2-6 weeks after starting treatment, there may be a temporary acceleration of hair loss rate.
If, at the start of treatment with Minorga, the patient has little hair and responds to treatment, new growing hair will be soft and fine, and initially difficult to notice.
As treatment continues, new hair will take on color and texture similar to the patient's other hair.
If, at the start of treatment, hair loss is not very pronounced, new growing hair will have color and texture similar to the patient's other hair.
Using the wrong medicine or the wrong dose may be harmful. Therefore, never use this medicine to treat other diseases or other patients.
There is no need to change the standard hair care during Minorga use. However, apply Minorga first, wait until the hair is dry, and then apply other hair products (e.g., coloring shampoo, permanent hair dyes). If you swim or wet your hair for other reasons, it is best to apply Minorga to dry scalp after swimming or wait two hours after application. Allow Minorga to work 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 more than the recommended dose. Do not apply the medicine to areas other than the scalp. If you wash your head before applying Minorga, use a gentle and effective shampoo.
To administer one dose (1 ml) of Minorga, seven sprays are required.
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. Sprayer for applying the solution to larger areas of the scalp.
• B. Applicator for applying the solution to small areas of the scalp or hairy areas.
• A. Sprayer Recommended for use on large areas of the scalp.
• 1) Remove the cap from the bottle.
• 2) Direct the sprayer towards the bald area, 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 sprayer and close the bottle with the cap to prevent alcohol evaporation.
• B. 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 bald area, 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 prevent alcohol evaporation.

This medicine should always be used in accordance with the recommendations of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Using more than the recommended dose of Minorga

Do not take Minorga orally. In case of accidental ingestion, consult your doctor or a poison control center.
Accidental ingestion may cause systemic symptoms related to the vasodilating effect of minoxidil.
Possible symptoms and signs of minoxidil overdose include mainly cardiovascular symptoms related to fluid retention and tachycardia. In case of fluid retention, appropriate diuretic treatment can be used. Tachycardia can be controlled with a suitable beta-adrenergic blocker. Symptomatic hypotension should be treated with 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 any other, unlisted effects of Minorga, you should immediately inform your doctor or pharmacist.
In clinical studies, the exact dose of Minorga to be used to achieve satisfactory effects has been determined. It is not recommended to use the medicine in a dose higher 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. Do 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.
About three to four months after stopping Minorga, new hair growth will stop, and the process will return to the normal state that existed before treatment began.
If you have any further doubts about using this medicine, you should consult 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 the 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 (dyspnea)
• 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):

• Palpitations, rapid heartbeat, 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 any not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Adverse Reaction Monitoring 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.
Side effects can also be reported 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

Keep the medicine out of the 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 pack and other information

What Minorga contains

• The active substance 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 alcoholic odor, available in the following packaging:
HDPE bottle with a pump/sprayer containing 60 ml of solution.
Pack size:
1 bottle of 60 ml with 1 detachable sprayer and cap, and 1 detachable applicator.
3 bottles of 60 ml with 3 detachable sprayers and caps, and 3 detachable applicators.

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 5%, cutaneous solution
Greece
Androxil 5%, cutaneous solution
Spain
Minoxidil Biorga 50 mg/mL cutaneous solution
Malta
Minorga 5%, liquid mixture for the skin
Poland
Minorga 50 mg/mL, cutaneous solution
Portugal
Minoxidil Biorga 5%, cutaneous solution
Czech Republic
Minorga 50 mg/ml, cutaneous solution
Slovakia
Minorga 5%, cutaneous solution
Romania
Minorga 50 mg/mL, cutaneous solution
Italy
Minoxidil Biorga 5%, cutaneous solution

Date of last revision of the leaflet: 09/2024