Minorga

Package leaflet: Information for the user

Minorga, 50 mg/ml, solution for topical use
Minoxidilum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Minorga is and what it is 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 Minorga is and what it is used for

Minorga contains minoxidil at a concentration of 50 mg in 1 ml.
Minorga is a liquid medicine intended for direct application to the scalp.
It is used in the treatment of hair loss, but not as a cure. Minoxidil is a peripheral vasodilator, and its exact mechanism of action leading to hair regrowth is unknown.
Minorga is indicated for use in adults aged 18 to 65 years with progressive thinning or hair loss on the crown of the head. Thinning or hair loss is a gradual process, which may become noticeable after several years of progressive hair loss.
Minorga is particularly indicated in men with hair loss or thinning on the crown of the head, and in women with general hair thinning.
If there is no improvement or if your condition worsens after 4 months of treatment, consult your doctor.

2. Important information before using Minorga

When not to use Minorga:

• if the patient is 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 hair loss (sudden or unexplained hair loss) or scarring alopecia (characterized by healing with ulcers or scar tissue). Furthermore, Minorga should not be used if hair loss is associated with pregnancy, childbirth, or serious illnesses such as thyroid disorders, systemic lupus erythematosus, hair loss from a specific area of the scalp due to inflammatory conditions, or other diseases.

Warnings and precautions

Since hair loss may also be a symptom of a serious disease of the ovaries, pituitary gland, or adrenal glands, women should consult a doctor before starting treatment with Minorga if they have any of the following symptoms: rapid weight gain, especially in the trunk and face while sparing the limbs (central obesity); facial hair growth resembling that in men (hirsutism); menstrual irregularities; hypertension; muscle weakness; back pain; osteoporosis; skin striae; acne.

Before starting treatment with Minorga, discuss this with your doctor or pharmacist.
Do not start using Minorga if hair loss is sudden or unexplained, or if it occurred after an illness or medical treatment. If you have any further doubts regarding hair loss, consult your doctor before starting Minorga.

Patients using Minorga should first undergo a medical examination. The doctor should assess whether the patient has healthy scalp skin.

If the patient has ever had heart or vascular disease, including irregular heartbeat, consult a doctor before starting Minorga.

Do not use Minorga if the area affected by hair loss is red and inflamed, irritated, or painful, such as in the case of severe sunburn or seborrheic dermatitis. Also, do not apply Minorga to other parts of the body or simultaneously with other topical skin medications.

If unusual symptoms occur after applying Minorga, stop using it and consult your doctor. It is particularly important to discontinue use if you experience rapid heartbeat (palpitations), swelling of hands and feet, sudden unexplained weight gain, chest pain, weakness, and/or dizziness.

Discontinue use also if scalp skin becomes red or irritated.

In patients with a history of heart disease, the condition may worsen during treatment with Minorga.

There have been cases of excessive body hair growth in infants 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 ensure that children do not come into contact with body areas where minoxidil has been applied topically. If excessive hair growth is observed on a child during use of topical minoxidil products, consult a doctor.

Do not swallow.
Do not inhale.

Minorga contains alcohol, which may cause a burning sensation and eye irritation. In case of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), wash the affected area thoroughly with plenty of cold tap water.

Inform your doctor or pharmacist if the patient:
* has heart disease;
* has previously experienced allergic reactions;
* is 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 the patient is currently using or has recently used, as well as any medicines the patient plans to use.

Although not clinically confirmed, it is theoretically possible that minoxidil absorbed through the skin may exacerbate orthostatic hypotension in patients concurrently taking peripheral vasodilator drugs.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Minorga is not expected to affect the patient's ability to drive or operate machinery.

Minorga contains propylene glycol.
It may cause skin irritation.

3. How to use Minorga

Minorga is used for treatment but does not provide a cure. It is important not to interrupt regular use of the medication at the dose prescribed by the doctor for the specific medical condition, in order to maintain or improve the effects achieved.
Apply one dose of Minorga (1 ml) directly to the area of the scalp affected by hair loss TWICE DAILY, for example in the morning and evening (or according to another comparable schedule). Spread the dose evenly over the entire area, massaging the solution into the scalp with fingertips. Each bottle of Minorga contains enough medication for 30 days of use.
This medication should not be used in patients under 18 years of age.
Clinical studies have shown that the response to treatment varies considerably and effects are not immediate. Typically, new hair growth is gradual, and continuous use of the medication twice daily for at least four months is necessary before improvement becomes noticeable.
Since the action of Minorga begins at the hair follicles, a temporary acceleration of hair loss may occur approximately 2–6 weeks after starting treatment.
If a patient has little hair at the beginning of treatment and responds to therapy, the newly growing hair will initially be soft and fine, and difficult to notice.
With continued treatment, the new hair will gradually acquire color and texture similar to the patient’s existing hair. If hair loss is not extensive at the beginning of treatment, the newly growing hair will have color and texture similar to the patient’s remaining hair.
Using an inappropriate medication or incorrect dosage may be harmful. Therefore, this medication should never be used to treat other diseases or given to other patients.
There is no need to change your usual hair care routine during treatment with Minorga. However, Minorga should be applied first; wait until the hair is dry before applying hair sprays, conditioners, gels, or other products (e.g. coloring shampoos, permanent hair dyes). If the patient swims or wets the hair for other reasons, it is optimal to apply Minorga to dry scalp after swimming or wait two hours after application of the medication. 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 daily. Do not apply more than the recommended dose. Do not apply the medication to areas other than the scalp. If the patient washes their hair before applying Minorga, use a gentle and effective shampoo.
Seven sprays are required to deliver one dose (1 ml) of Minorga.
Massage the applied volume of medication into the entire affected area. Wash hands after each application.

Instructions for use
The method of use depends on the type of dispenser being used.
A. Dispenser with spray nozzle for applying the solution to larger areas of the scalp.
B. Dispenser with applicator for applying the solution to small areas of the scalp or areas covered with hair.

A. Dispenser with spray nozzle
Recommended for use on large areas of the scalp.

1. Remove the cap from the bottle.
2. Direct the nozzle toward the hairless area, press once, and spread the solution over the entire area with fingertips. Repeat this procedure six times until the required dose of 1 ml is delivered (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 prevent evaporation of alcohol.

B. Dispenser with applicator
Recommended for use on small or hairy areas of the scalp.

1. Remove the cap from the bottle.
2. Pull the upper part of the dispenser to remove it. Attach the applicator to the dispenser and press firmly until fully secured.
3. Direct the applicator toward the hairless area, press once, and spread the solution over the entire area with fingertips. Repeat this procedure six times until the required dose of 1 ml is delivered (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 evaporation of alcohol.

This medication should always be used according to the instructions of the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Use of a higher than recommended dose of Minorga
Do not take Minorga orally. In case of accidental ingestion, consult a doctor or a toxicology information center immediately.
Accidental ingestion may cause systemic symptoms related to minoxidil’s vasodilatory effects.
Possible symptoms and signs of minoxidil overdose include primarily cardiovascular effects related to fluid retention and tachycardia. In case of fluid retention, appropriate diuretic treatment may be administered. Tachycardia can be controlled using an appropriate beta-blocker. Symptomatic hypotension should be treated with intravenous electrolyte solutions. Avoid sympathomimetic drugs such as adrenaline and noradrenaline, as these may cause excessive cardiac stimulation.

If any other side effects not described in this leaflet occur, inform your doctor or pharmacist immediately.
Clinical studies have established the exact dose of Minorga required to achieve satisfactory results. Use of a higher dose than recommended (1 ml) or more frequently than twice daily is not advised. Increased frequency of application will not enhance the rate or amount of new hair growth, but may increase the frequency of adverse reactions.

Missed dose of Minorga
If one or two doses of Minorga are missed, resume the normal twice-daily regimen. Do not use a higher dose to make up for the missed dose.

Stopping use of Minorga
Maintaining hair growth requires continuous use of Minorga at the recommended dose. Approximately three to four months after discontinuing Minorga, new hair growth will stop and the process will return to the normal state observed before starting treatment.

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

4. Possible adverse reactions

Contact your doctor immediately if any of the following symptoms occur,
as urgent medical attention may be required:

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

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The adverse reactions listed below are arranged in decreasing order of frequency.
Very common (may affect more than 1 in 10 patients):

• Headache

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

• Depression
• Shortness of breath (dyspnoea)
• Itching, excessive hair growth, rash, acneiform rash, skin inflammation, inflammatory skin conditions
• Musculoskeletal pain
• Peripheral oedema
• Pain

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

• Dry skin, skin peeling, transient hair loss, change in hair structure, change in hair colour
• Application site irritation

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

• Palpitations, increased heart rate, chest pain
• Erythema at the site of administration

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

• Hypotension

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 Adverse Drug Reactions of the Office for 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Minorga medicine

Keep the medicine 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 following "EXP". The expiry date refers to the last day of the stated month.

6. Contents of the packaging 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, colourless or slightly yellowish solution with an alcoholic odour, available in the following packaging:
HDPE bottle with pump/sprayer containing 60 ml of solution.
Pack sizes:
1 bottle of 60 ml with 1 detachable dosing device with nozzle and cap, and 1 detachable dosing device with tubular applicator.
3 bottles of 60 ml with 3 detachable dosing devices with nozzle and cap, and 3 detachable dosing devices with tubular applicator.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires Bailleul S.A.
14-16 Avenue Pasteur
L-2310 Luxembourg

Manufacturers
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 authorised in the European Economic Area countries under the following names:
Cyprus Androxil 5%, δερματικό διάλυμα
Greece Androxil 5%, δερματικό διάλυμα
Spain Minoxidil Biorga 50 mg/mL solución cutánea
Malta Minorga 5%, taħlita likwida għall-ġilda
Poland Minorga 50 mg/mL, roztwór na skórę
Portugal Minoxidil Biorga 5%, solução cutânea
Czech Republic Minorga 50 mg/ml, kožní roztok
Slovakia Minorga 5%, dermálny roztok
Romania Minorga 50 mg/mL, soluție cutanată
Italy Minoxidil Biorga 5%, soluzione cutanea