Minovivax 2%

Patient Information Leaflet

Minovivax 2%, 20 mg/ml, solution for topical use on the scalp
Minoxidil
Please read all of this leaflet carefully before starting to use the medicine, as it contains
important information for you.
Always use this medicine 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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 12 months of treatment, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

1. What Minovivax 2% is and what it is used for

The active substance in Minovivax 2% is minoxidil.
Minoxidil dilates peripheral blood vessels, but its exact mechanism of action in promoting hair growth is not fully understood.
Minovivax 2% is indicated for the treatment of androgenetic (male-pattern) alopecia in men and women.
Minovivax 2% is a topical solution intended for use only on the scalp skin.
Noticeable hair growth may require treatment with Minovivax 2% for at least 4 months or longer.
Treatment outcomes largely depend on consistent use and individual patient characteristics.
Poorer treatment responses are observed in patients with advanced and long-standing androgenetic alopecia (lasting over 10 years).
Maximum therapeutic effect is usually achieved after approximately 12 months of regular use.
If there is no improvement after 12 months of treatment, or if your condition worsens, consult your doctor.

2. Important information before using Minovivax 2%

When not to use Minovivax 2%

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

Minovivax 2% is not indicated for the treatment of alopecia areata (characterized by, for example,
circular bald patches) or in cases of sudden or unexplained hair loss.
Minovivax 2% should not be used:

• during cytostatic (anticancer) treatment
• in hair loss caused by an improper diet
• in hair loss following discontinuation of hormonal contraceptives
• on damaged scalp skin (e.g. due to burns, ulceration, or presence of scar tissue)
• if hair loss is caused by improper hair care (e.g. excessively tight hairstyles). In such cases, the mechanical irritation should be eliminated.
• during pregnancy or breastfeeding
• in postpartum hair loss.

If the patient is unsure about the cause of hair loss, they should consult a doctor.
Warnings and precautions
Before starting treatment with Minovivax 2%, discuss this with your doctor or pharmacist.
Minovivax 2% should be applied only to healthy, normal, and undamaged scalp skin.
Do not apply minoxidil to irritated, painful, or inflamed skin.
Patients with heart conditions, such as ischemic heart disease, cardiac arrhythmias, congestive heart failure, or heart valve disease, should not use Minovivax 2% without prior consultation with a doctor due to potential systemic adverse effects.
Treatment with Minovivax 2% should be discontinued and medical advice sought if low blood pressure, chest pain, rapid heartbeat, fainting, dizziness, weight gain, limb swelling, persistent redness or irritation of the scalp, or any other unusual adverse effects occur.
In case of severe adverse reactions (see section 4), use of Minovivax 2% should be discontinued.
Minovivax 2% is intended for topical use on the scalp only.
Do not apply Minovivax 2% to other parts of the body. Applying minoxidil to areas other than the scalp may result in excessive hair growth in those areas.
Do not use Minovivax 2% together with other topical skin products.
More frequent application of minoxidil does not improve treatment outcomes.
Avoid inhaling the medicine during application.
Do not swallow the medicine. Ingestion may lead to serious cardiovascular adverse effects. Keep the medicine out of sight and reach of children.
Minoxidil use may cause changes in hair color or texture.
After application of minoxidil (before the scalp is completely dry), contact with delicate materials or clothing items such as pillows or head coverings may cause discoloration (staining).
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 after the infant was no longer exposed to minoxidil. Care should be taken to prevent children from coming into contact with areas of the body where minoxidil has been applied topically.
If excessive hair growth is observed on a child during topical minoxidil use, consult a doctor.
Children and adolescents under 18 years of age and patients over 65 years of age
Use of Minovivax 2% is not recommended in children and adolescents under 18 years of age or in patients over 65 years of age due to lack of safety and efficacy data.
Minovivax 2% and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Interactions between Minovivax 2% and other medicines are not known.
Do not use Minovivax 2% simultaneously with other topical skin medicines such as tretinoin or dithranol, as they may increase minoxidil penetration through the skin into the bloodstream and increase the risk of adverse effects.
Exercise caution when using blood pressure-lowering medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Minovivax 2% should not be used during pregnancy or breastfeeding.
Driving and operating machinery
Minovivax 2% may cause dizziness or low blood pressure.
If these symptoms occur, do not drive or operate machinery.
Minovivax 2% contains propylene glycol and anhydrous ethanol (alcohol)
Due to the presence of propylene glycol, the medicine may cause skin irritation.
Minovivax 2% contains alcohol (ethanol), which may cause a burning sensation and/or irritation if accidentally contacted with sensitive surfaces (eyes, mucous membranes, or damaged skin). In such cases, the affected area should be thoroughly and generously rinsed with running water. If burning and/or irritation persist, seek medical advice. Hands should be washed after each application to prevent Minovivax 2% from contacting other parts of the body.
If severe skin reactions occur, discontinue use of minoxidil (see section 4. "Possible adverse effects").

3. How to use Minovivax 2%

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.

Recommended dose
Apply 1 ml of Minovivax 2% solution to the scalp twice daily (morning and evening).
Do not exceed a daily dose of 2 ml, regardless of the size of the affected skin area.
Minovivax 2% is intended for topical use on the scalp only.
Do not apply Minovivax 2% to any parts of the body other than the scalp.
Before applying Minovivax 2% topically, ensure that the hair and scalp are completely dry.

Instructions for use
The method of using Minovivax 2% depends on the type of dispenser used.

1. Spray pump – for application to larger areas of the scalp

• Remove the protective cap from the spray pump.
• Direct the spray pump toward the affected area of the scalp.
• Press the spray pump 6 times to deliver a 1 ml dose.
• Apply the solution to the central part of the affected area and spread gently with fingertips, ensuring even distribution.
• After use, replace the protective cap.

2. Applicator – for application to small areas of the scalp or areas covered with hair
   For more precise local application, use the applicator provided in the package.

• Replace the spray pump with the applicator supplied in the package.
• Direct the applicator toward the affected area of the scalp.
• Press the applicator 6 times to deliver a 1 ml dose.
• Spread the solution gently with fingertips, ensuring even distribution.

After application, always wash your hands thoroughly.
Accidental contact of the medicine with the eyes, mucous membranes, or broken skin may cause a burning sensation and/or irritation. In such cases, rinse the affected area thoroughly and abundantly with running water. If burning and/or irritation persists, consult your doctor.

Cleaning the spray pump and applicator
To remove residual medicine and prevent clogging of the spray pump or applicator, unscrew these parts after each use and rinse them thoroughly with alcohol.

Duration of treatment
To achieve the desired effect, it is important to use Minovivax 2% regularly at the recommended dose twice daily without interruption.
Clinical studies have shown that noticeable hair growth may require treatment with minoxidil for at least 4 months or longer.
Discontinuation of treatment may result in recurrence of hair loss, returning to the pre-treatment condition within 3 to 4 months.
If there is no improvement after 12 months of treatment, or if the patient feels worse, consult your doctor.

Use of a higher than recommended dose of Minovivax 2%
There are no known cases of overdose with topically applied minoxidil.
Accidental ingestion of the medicine may cause symptoms related to systemic effects of minoxidil.
The most common symptoms include: tachycardia (increased heart rate), fluid retention, hypotension, and somnolence.
If such symptoms occur, seek immediate medical advice.

Missed dose of Minovivax 2%
Do not use a double dose to make up for a missed dose.

Discontinuation of Minovivax 2%
Maintenance of hair growth requires continuous use of Minovivax 2% at the recommended dose. After stopping treatment, cessation of new hair growth and return to the pre-treatment condition have been observed within 3 to 4 months.

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

4. Possible adverse reactions

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

• Swelling of the face, lips or throat, causing difficulty in swallowing or breathing (these may be symptoms of a severe allergic reaction)
• Generalised itching
• Generalised rash
• Feeling of tightness in the throat.

The following adverse reactions have been observed:
Very common (may affect more than 1 in 10 people)

• headache.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• dizziness,
• nausea.

Frequency unknown (frequency cannot be estimated from the available data)

• low blood pressure,

• angioedema (including swelling of the lips and tongue, swelling of the oral cavity and throat, swelling of the mucous membranes of the oral cavity and throat), hypersensitivity (including facial swelling, erythema multiforme, itching, sensation of tightness in the throat), contact dermatitis,

• depressive mood,

• eye irritation,

• tachycardia (increased heart rate), palpitations,

• vomiting,

• application site reactions, including ears and face (such as skin irritation and redness, itching, pain, swelling, dry skin, erythema), skin desquamation, skin inflammation,
  blisters, bleeding and ulceration, sometimes severe, transient hair loss,
  change in hair colour and change in hair texture,

• chest pain.

Some patients using minoxidil at the beginning of treatment have noticed increased hair loss.
This temporarily increased hair loss usually occurs within 2 to 6 weeks after starting minoxidil treatment and resolves spontaneously within a few weeks.
If this condition persists for more than two weeks without any improvement, the use of the medicine should be discontinued and medical advice sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Minovivax 2%

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Keep 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 following: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Minovivax 2% contains

• The active substance is minoxidil (1 ml of topical solution contains 20 mg of minoxidil).
• The other components are: propylene glycol, anhydrous ethanol and purified water.

What Minovivax 2% looks like and contents of the pack
A clear, homogeneous solution, colourless to pinkish.
Pack: bottle with a spray pump containing 100 ml of solution, with an applicator, in a cardboard box.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw
Manufacturer
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5
Condeixa-a-Nova
3150-194 Sebal
Portugal