MINOVIVAX 50 mg /Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Minovivax 5%, 50 mg/ml, solution for the skin
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Minovivax 5% and what is it used for
4. Important information before using Minovivax 5%
   1. When not to use Minovivax 5%
   2. Warnings and precautions
   3. Children and adolescents under 18 years and patients over 65 years
   4. Minovivax 5% and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Minovivax 5% contains propylene glycol
   8. Minovivax 5% contains ethanol 96% (alcohol)
5. How to use Minovivax 5%
   1. Recommended dose
   2. Instructions for use
   3. Cleaning the spray pump and applicator
   4. Duration of treatment
   5. Using more than the recommended dose of Minovivax 5%
   6. Missing a dose of Minovivax 5%
   7. Stopping use of Minovivax 5%
6. Possible side effects
   1. The patient should immediately contact their doctor if they experience any of the following symptoms, as they may require urgent medical attention (frequency not known, cannot be estimated from the available data):
   2. Very common (may affect more than 1 in 10 patients)
   3. Common (may affect up to 1 in 10 patients)
   4. Uncommon (may affect up to 1 in 100 patients)
   5. Frequency not known (frequency cannot be estimated from the available data)
   6. Reporting side effects
7. How to store Minovivax 5%
8. Contents of the packaging and other information
   1. What Minovivax 5% contains
   2. What Minovivax 5% looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer

Leaflet attached to the packaging: information for the user

Minovivax 5%, 50 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 this 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 4 months there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Minovivax 5% and what is it used for

The active substance of Minovivax 5% is minoxidil.
Minovivax 5% is indicated for the treatment of androgenetic alopecia (hair loss)
in men and women.
Minovivax 5% is a solution for the skin, intended for use only on the scalp.
Minoxidil dilates blood vessels, but the exact mechanism of its action to stimulate hair growth is unknown.
To achieve noticeable hair growth, it may be necessary to use Minovivax 5% for at least 4 months or longer.
The results of the treatment are largely dependent on systematic use and individual patient characteristics. Poorer effects of minoxidil occur in patients with advanced and long-lasting androgenetic alopecia.
The maximum effect of the medicine is achieved after about 12 months of systematic use.
If after 4 months there is no improvement or the patient feels worse, they should contact their doctor.
In cases where there is no family history of androgenetic alopecia or it is not possible to determine, the patient should consult a doctor before using the medicine.

2. Important information before using Minovivax 5%

When not to use Minovivax 5%

If the patient is allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).
Minovivax 5% is not indicated for use in the treatment of alopecia areata (e.g., round areas without hair) or in cases of (sudden or unexplained hair loss.
Minovivax 5% should not be used:

• during chemotherapy (anticancer treatment),
• in cases of hair loss caused by an improper diet,
• in cases of hair loss caused by the cessation of hormonal contraceptives,
• on damaged scalp skin (e.g., due to burns, ulcers, or scarring),
• if hair loss has been caused by improper hair care (e.g., too tight hair tying). In such cases, mechanical irritation should be addressed.

If the patient is unsure of the cause of hair loss, they should contact their doctor.

Warnings and precautions

Before starting to use Minovivax 5%, the patient should discuss it with their doctor or pharmacist.
Minovivax 5% should be applied to healthy, normal, and undamaged scalp skin.
Minoxidil should not be used on irritated, painful, or inflamed skin.
Minovivax 5% is intended for use only on the scalp skin.
Minovivax 5% should not be used on areas other than the balding areas on the scalp. If minoxidil is applied to other parts of the body or in case of accidental contamination of other skin areas with the medicine, unwanted hair growth may occur in these areas. Therefore, after applying the medicine to the scalp, the hands should be washed thoroughly.
Patients with heart problems, such as coronary heart disease, arrhythmias, congestive heart failure, or heart valve disease, should not use Minovivax 5% without prior consultation with their doctor, due to potential systemic side effects (see section 4).
The use of Minovivax 5% should be stopped and the doctor consulted in case of low blood pressure, chest pain, rapid heartbeat, fainting, dizziness, weight gain, sudden and unexplained breathing difficulties (especially at rest), limb swelling, and persistent redness or irritation of the scalp, as well as other unusual side effects.
In case of severe side effects (see section 4), the use of Minovivax 5% should be stopped.
Minovivax 5% should not be used with other medicines intended for use on the skin.
Using Minovivax 5% more frequently or in larger amounts does not improve treatment outcomes.
Patients should avoid inhaling the medicine during application.
The medicine should not be swallowed. Swallowing the medicine can lead to severe side effects related to the heart. The medicine should be stored out of sight and reach of children.
The use of minoxidil may lead to changes in hair color or texture.
After applying minoxidil (before the scalp skin dries), when in contact with delicate materials or clothing, such as pillows or headgear, discoloration may occur. If the medicine is applied to the scalp in the evening, it is essential to apply it at least 2 hours before going to bed (especially for women). This will help minimize the risk of unwanted hair growth on the face in women.
At the beginning of treatment (usually within 2-6 weeks of starting it), increased hair loss may occur. If increased hair loss persists for more than 2 weeks, the use of Minovivax 5% should be stopped, and the doctor consulted.

Children and adolescents under 18 years and patients over 65 years

Minovivax 5% should not be used in children and adolescents under 18 years and in patients over 65 years, due to the lack of data on safety and efficacy.

Minovivax 5% and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Interactions between Minovivax 5% and other medicines are not known.
Minovivax 5% should not be used at the same time as other medicines used on the skin, such as tretinoin and ditranol, as they may increase the absorption of minoxidil through the skin into the blood and increase the risk of side effects.
Caution should be exercised when using medicines that lower blood pressure.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Minovivax 5% should not be used during pregnancy and breastfeeding.

Driving and using machines

Minovivax 5% may cause dizziness or low blood pressure.
In case of symptoms, the patient should not drive or operate machines.

Minovivax 5% contains propylene glycol

This medicine contains 350 mg of propylene glycol in each ml of the solution for the skin.
Propylene glycol may cause skin irritation.

Minovivax 5% contains ethanol 96% (alcohol)

This medicine contains 510 mg of alcohol (ethanol) in each ml of the solution for the skin.
Minovivax 5% contains alcohol (ethanol), which, in case of accidental contact with sensitive surfaces (eyes, mucous membranes, and damaged skin), may cause a burning sensation and (or) irritation. In such cases, the affected surface should be thoroughly rinsed with running water. If burning and (or) irritation persist, the patient should consult their doctor. After each application of the medicine, the hands should be washed so that Minovivax 5% does not come into contact with other parts of the body. In case of severe skin reactions, the use of minoxidil should be stopped (see section 4, "Possible side effects").

3. How to use Minovivax 5%

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Men
A dose of 1 ml of Minovivax 5% should be applied to the scalp skin 2 times a day (morning and evening).
Women
A dose of 1 ml of Minovivax 5% should be applied to the scalp skin 1 to 2 times a day.
The daily dose should not exceed 2 ml, regardless of the size of the affected skin area.
Minovivax 5% is intended for use only on the scalp skin.
Minovivax 5% should not be used on parts of the body other than the scalp skin.
Before applying Minovivax 5% locally, the hair and scalp skin should be completely dry.

Instructions for use

The instructions for using Minovivax 5% depend on the type of dispenser used.

• 1) Spray pump – for applying the solution to larger areas of the scalp skin
• Remove the protective cap from the spray pump.
• Direct the spray pump towards the surface of the scalp skin affected by the condition.
• Press the spray pump 6 times to deliver a dose of 1 ml.
• Apply the solution to the central part of the affected scalp skin area and spread it with the fingertips, making sure the medicine is applied evenly.

• After finishing, put the protective cap back on.
• 2) Applicator – for applying the solution to small areas of the scalp skin or areas with hair

To ensure more precise local application, the applicator included in the packaging should be used.

• Replace the spray pump with the applicator included in the packaging.
• Direct the applicator towards the surface of the scalp skin affected by the condition.

• Press the applicator 6 times to deliver a dose of 1 ml.
• Spread the solution with the fingertips, making sure the medicine is applied evenly.

After applying the solution, the hands should always be washed thoroughly.
The medicine is for local use only. Minovivax 5% should be used according to the instructions, only on the scalp skin. Before using Minovivax 5%, the hair and scalp skin should be completely dry. 1 ml of the solution should be spread in the balding areas and massaged into the skin (most often the top of the head and the frontal area).
If Minovivax 5% is used in the evening, it is essential to apply it at least 2 hours before going to bed (especially for women). This will help minimize the risk of unwanted hair growth on the face in women.
Accidental contact of the medicine with the eyes, mucous membranes, or damaged skin may cause a burning sensation and (or) irritation. In such cases, the affected skin surface should be thoroughly rinsed with running water. If burning and (or) irritation persist, the patient should consult their doctor.

Cleaning the spray pump and applicator

To remove any remaining medicine and prevent clogging of the upper part of the spray pump or applicator, after each use, these parts should be unscrewed and thoroughly rinsed with alcohol.

Duration of treatment

To achieve the desired effect of the medicine, it is essential not to interrupt regular use of Minovivax 5% in the recommended dose of 2 times a day for men and 1 to 2 times a day for women.
Clinical trials have shown that to achieve noticeable hair growth, it may be necessary to use the medicine for at least 4 months or longer.
Stopping treatment may cause a relapse of hair loss and a return to the pre-treatment state within 3 to 4 months.
If after 4 months there is no improvement or the patient feels worse, they should contact their doctor.

Using more than the recommended dose of Minovivax 5%

Accidental ingestion of the medicine or use of larger doses than recommended (e.g., on large areas of the body or on areas other than the scalp skin) may cause symptoms related to the systemic action of minoxidil. The most common symptoms include: tachycardia (rapid heart rate), fluid retention, low blood pressure, and drowsiness.
In case of similar symptoms, the patient should immediately contact their doctor.

Missing a dose of Minovivax 5%

A double dose should not be used to make up for a missed dose.

Stopping use of Minovivax 5%

Maintaining hair growth requires continuous use of Minovivax 5% in the recommended dose. After stopping treatment, a cessation of new hair growth and a return to the pre-treatment state have been observed within 3 to 4 months.
In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor if they experience any of the following symptoms, as they may require urgent medical attention (frequency not known, cannot be estimated from the available data):

• Swelling of the face, lips, or throat, which makes swallowing or breathing difficult (these may be symptoms of a severe allergic reaction)
• Generalized itching
• Generalized redness
• Sensation of pressure in the throat.

The following side effects have been observed:

Very common (may affect more than 1 in 10 patients)

• Headache.

Common (may affect up to 1 in 10 patients)

• Shortness of breath,
• itching, excessive hair growth (in women also on the face), skin inflammation, acne-like rash, rash,
• peripheral edema,
• weight gain.

Uncommon (may affect up to 1 in 100 patients)

• Dizziness,
• nausea.

Frequency not known (frequency cannot be estimated from the available data)

• Low blood pressure,
• angioedema (including: lip and tongue swelling, oral and throat swelling, swelling of the mucous membranes of the mouth and throat), hypersensitivity (including: facial swelling, erythema multiforme, itching, sensation of pressure in the throat), contact dermatitis,
• depressive mood,
• eye irritation,
• tachycardia (rapid heart rate), palpitations,
• vomiting,
• local reactions at the application site, including the ears and face (including: skin irritation and redness, itching, pain, swelling, dryness of the skin, redness), skin peeling, skin inflammation, blisters, bleeding, and ulcers, sometimes severe, temporary hair loss, changes in hair color and texture,
• chest pain.

Some patients at the beginning of minoxidil treatment have noticed increased hair loss.
This temporarily increased hair loss usually occurs within 2-6 weeks of starting treatment and resolves on its own within a few weeks.
If this condition persists for more than 2 weeks without any improvement, the use of the medicine should be stopped, and the doctor consulted.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Minovivax 5%

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store the bottle tightly closed.
Shelf life after first opening the bottle: 12 months.
Do not use this medicine after the expiry date stated on the packaging or label after EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Minovivax 5% contains

• The active substance of the medicine is minoxidil (1 ml of the solution for the skin contains 50 mg of minoxidil).
• The other ingredients are: propylene glycol, ethanol 96%.

What Minovivax 5% looks like and what the packaging contains

Clear, homogeneous solution, colorless to light pink.
Packaging: bottle with a spray pump containing 100 ml of the solution, with an applicator included, in a cardboard box.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Phone: +48 22 855 40 93

Manufacturer

Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5
Condeixa-a-Nova
3150-194 Sebal
Portugal
Date of last revision of the leaflet:October 2024