Minovivax 5%
Poland
Table of Contents
Package leaflet: Information for the user
Minovivax 5%, 50 mg/ml, solution for skin application
Minoxidil
Please read this entire leaflet carefully 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 a
physician or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 4 months of treatment, or if you feel worse, consult your doctor.
Table of contents
- What Minovivax 5% is and what it is used for
- Important information before using Minovivax 5%
- How to use Minovivax 5%
- Possible side effects
- How to store Minovivax 5%
- Contents of the pack and other information
1. What Minovivax 5% is and what it is used for
The active substance in Minovivax 5% is minoxidil.
Minovivax 5% is indicated for the treatment of androgenetic alopecia (hair loss)
in men and women.
Minovivax 5% is a topical solution intended for application to the scalp only.
Minoxidil dilates blood vessels, but the exact mechanism by which it stimulates hair growth is not known.
Noticeable hair growth may require treatment with Minovivax 5% for at least 4 months or longer.
Treatment outcomes largely depend on consistent use and individual patient characteristics.
Poorer treatment results with minoxidil are observed in patients with advanced androgenetic alopecia lasting longer than 10 years.
Maximum therapeutic effect is achieved after approximately 12 months of regular use.
If there is no improvement after 4 months of treatment, or if you feel worse, consult your doctor.
In cases where there is no family history of androgenetic alopecia or when it cannot be determined, consult a physician before using this medicine.
2. Important information before using Minovivax 5%
When not to use Minovivax 5%
Do not use Minovivax 5% if the patient is allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6).
Minovivax 5% is not indicated for the treatment of alopecia areata (characterized by, for example, round, hairless patches) or in cases of sudden or unexplained hair loss.
Minovivax 5% should not be used:
- during cytostatic (anticancer) therapy,
- in cases of hair loss caused by an improper diet,
- in cases of hair loss following discontinuation of hormonal contraceptives,
- on damaged scalp skin (e.g. due to burns, ulcers, 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 first.
If the patient is unsure about the cause of hair loss, they should consult a doctor.
Warnings and precautions
Before starting treatment with Minovivax 5%, discuss it with a doctor or pharmacist.
Minovivax 5% should be applied only to healthy, normal, and undamaged scalp skin.
Do not apply minoxidil to irritated, painful, or inflamed skin.
Minovivax 5% is intended for topical use on the scalp only.
Do not apply Minovivax 5% to areas other than balding areas on the scalp. If minoxidil is applied to other parts of the body or accidentally comes into contact with other areas of the skin, unwanted hair growth may occur in those areas. Therefore, hands should be thoroughly washed after applying the medicine to the scalp.
Patients with heart conditions, such as ischemic heart disease, cardiac arrhythmias, congestive heart failure, or heart valve disease, should not use Minovivax 5% without prior consultation with a doctor due to potential systemic adverse effects (see section 4).
Discontinue use of Minovivax 5% and consult a doctor if low blood pressure, chest pain, rapid heartbeat, fainting, dizziness, weight gain, sudden and unexplained breathing difficulties (especially during rest), limb swelling, persistent redness or irritation of the scalp, or other unusual adverse effects occur.
If serious adverse effects occur (see section 4), discontinue use of Minovivax 5% immediately.
Do not use Minovivax 5% together with other medicines intended for topical application.
Using Minovivax 5% more frequently or in larger amounts than recommended 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 may cause changes in hair color or texture.
After applying minoxidil (before the scalp is completely dry), contact with delicate materials or clothing items such as pillows or head coverings may cause discoloration (staining).
When applying Minovivax 5% in the evening, ensure that application to the scalp occurs at least 2 hours before going to bed (especially important for women). This helps minimize the risk of unwanted facial hair growth in women.
During the initial phase of treatment (usually within 2–6 weeks after starting), increased hair loss may occur. If excessive hair loss persists for longer than 2 weeks, discontinue use of Minovivax 5% and consult a doctor.
Cases of excessive body hair growth in infants have been reported following skin-to-skin contact with application sites of minoxidil in 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 prevent children from coming into contact with areas of the body where minoxidil has been applied.
If excessive hair growth is observed in a child during use of topical minoxidil-containing products, consult a doctor.
Children and adolescents under 18 years of age and patients over 65 years of age
Minovivax 5% should not be used in children and adolescents under 18 years of age or in patients over 65 years of age due to lack of data on safety and efficacy.
Minovivax 5% 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 5% and other medicines are not known.
Do not use Minovivax 5% simultaneously with other topical medicines such as tretinoin or dithranol, as they may increase the penetration of minoxidil through the skin into the bloodstream and thereby increase the risk of adverse effects.
Exercise caution when using antihypertensive medicines.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Minovivax 5% should not be used during pregnancy or breastfeeding.
Driving and operating machinery
Minovivax 5% may cause dizziness or low blood pressure.
If these symptoms occur, do not drive or operate machinery.
Minovivax 5% contains propylene glycol
This medicine contains 350 mg of propylene glycol per ml of topical solution.
Propylene glycol may cause skin irritation.
Minovivax 5% contains 96% ethanol (alcohol)
This medicine contains 510 mg of alcohol (ethanol) per ml of topical solution.
Minovivax 5% contains alcohol (ethanol), which may cause a burning sensation and/or irritation upon accidental contact 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. After each application, hands should be washed to prevent Minovivax 5% from coming into contact with 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 5%
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
Men
Apply 1 ml of Minovivax 5% solution to the scalp twice daily (morning and evening).
Women
Apply 1 ml of Minovivax 5% solution to the scalp once or twice daily.
Do not exceed a daily dose of 2 ml, regardless of the size of the affected skin area.
Minovivax 5% is intended for topical use on the scalp only.
Do not apply Minovivax 5% to areas of the body other than the scalp.
Before applying Minovivax 5% topically, ensure that the hair and scalp are completely dry.
Instructions for use
The instructions for using Minovivax 5% depend on the type of dispenser used.
- Spray pump – for applying the solution 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 pump 6 times to deliver a 1 ml dose.
- Apply the solution to the central part of the affected area and spread it gently with the fingertips, ensuring even distribution.
- After application, replace the protective cap.
- Applicator – for applying the solution to small areas of the scalp or areas covered with hair
For more precise topical 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 with the fingertips, ensuring even coverage.
After applying the solution, always wash your hands thoroughly.
This medicine is for topical use only. Minovivax 5% should be used according to the instructions, exclusively on the scalp. Before application, the hair and scalp must be completely dry. Apply 1 ml of the solution to the balding areas and massage gently into the scalp (typically the crown and frontal hairline).
If applying Minovivax 5% in the evening, ensure that the application to the scalp is performed at least 2 hours before going to bed (especially important for women). This helps minimize the risk of unwanted facial hair growth in women.
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 persist, 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 not to interrupt regular use of Minovivax 5% at the recommended dose—twice daily for men and once or twice daily for women.
Clinical studies have shown that noticeable hair growth may require treatment for at least 4 months or longer.
Discontinuation of treatment may result in recurrence of hair loss and return to the pre-treatment condition within 3 to 4 months.
If there is no improvement after 4 months of treatment, or if the patient feels worse, consult your doctor.
Use of a higher than recommended dose of Minovivax 5%
Accidental ingestion or application of larger than recommended doses (e.g., to large body areas or areas other than the scalp) may cause systemic effects of minoxidil. The most common symptoms include: tachycardia (rapid heart rate), fluid retention, hypotension, and drowsiness.
If such symptoms occur, contact your doctor immediately.
Missed dose of Minovivax 5%
Do not apply a double dose to make up for a missed dose.
Stopping Minovivax 5%
Maintenance of hair growth requires continuous use of Minovivax 5% at the recommended dose. After stopping treatment, cessation of new hair growth and return to the pre-treatment condition may occur 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 everybody will experience them.
You should contact a doctor immediately if any of the following symptoms occur,
as urgent medical attention may be required (frequency unknown, cannot be estimated
from available data):
- Swelling of the face, lips or throat, which makes swallowing or breathing difficult (these may be symptoms of a severe allergic reaction)
- Generalised itching
- Generalised rash
- Sensation of tightness in the throat.
The following adverse reactions have been reported:
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 available data)
- Low blood pressure,
- Angioedema (including: swelling of 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,
- Depressed 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, rash), skin desquamation, dermatitis, blistering, bleeding and ulceration, sometimes severe, transient hair loss, change in hair colour and change in hair texture,
- Chest pain.
Some patients have noticed increased hair loss at the beginning of minoxidil treatment.
This temporarily intensified hair loss most commonly occurs within 2 to 6 weeks after starting
minoxidil use 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 should be 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 Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 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 Minovivax 5% medicine
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Store the bottle tightly closed.
Shelf life after first opening of 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. This will help protect the environment.
6. Contents of the pack and other information
What Minovivax 5% contains
- The active substance is minoxidil (1 ml of topical solution contains 50 mg of minoxidil).
- The other ingredients are: propylene glycol, 96% ethanol.
What Minovivax 5% looks like and contents of the pack
A clear, homogeneous solution, colourless to pale pinkish.
Pack: bottle with a spray pump containing 100 ml of solution, with an attached applicator, in a cardboard box.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Tel. +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