Minovivax 2%

Package Leaflet: Information for the User

Minovivax 2%, 20 mg/ml, Solution for the Skin

Minoxidil

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, You May Need to Read it Again.
• If You Need Advice or Further Information, Consult a Pharmacist.
• If the Patient Experiences any Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Leaflet, They Should Inform their Doctor or Pharmacist. See Section 4.
• If After 12 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 2% and What is it Used for
• 2. Important Information Before Using Minovivax 2%
• 3. How to Use Minovivax 2%
• 4. Possible Undesirable Effects
• 5. How to Store Minovivax 2%
• 6. Contents of the Package and Other Information

1. What is Minovivax 2% and What is it Used for

The Active Substance of Minovivax 2% is Minoxidil.
Minoxidil Dilates Peripheral Blood Vessels, but the Exact Mechanism of its Action Stimulating Hair Growth is Unknown.
Minovivax 2% is Indicated for the Treatment of Androgenetic Alopecia (Male Pattern) in Men and Women.
Minovivax 2% is a Medication in the Form of a Solution for the Skin, Intended for Use Only on the Scalp.
To Achieve Noticeable Hair Growth, it May be Necessary to Use Minovivax 2% 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 Medication is Achieved After About 12 Months of Systematic Use.
If After 12 Months There is no Improvement or the Patient Feels Worse, They Should Contact their 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 Components of this Medication (Listed in Section 6).

Minovivax 2% is Not Indicated for Use in the Treatment of Alopecia Areata (e.g., Round Areas Without Hair) or in the Case of Sudden or Unexplained Hair Loss.
Minovivax 2% Should Not be Used:

• During Chemotherapy (Anticancer Treatment)
• In the Case of Hair Loss Caused by an Improper Diet
• In the Case of Hair Loss Caused by the Discontinuation of Hormonal Contraceptives
• On Damaged Scalp Skin (e.g., Due to Burns, Ulcers, or the Presence of Scar Tissue)
• If Hair Loss is Caused by Improper Hair Care (e.g., Too Tight Hair Tying). In Such a Case, Mechanical Irritation Should be Addressed.
• During Pregnancy and Breastfeeding
• In the Case of Hair Loss After Childbirth.

If the Patient is Uncertain About the Cause of Hair Loss, They Should Consult a Doctor.

Warnings and Precautions

Before Starting to Use Minovivax 2%, the Patient Should Discuss it with their Doctor or Pharmacist.
Minovivax 2% Should be Applied to Healthy, Normal, and Undamaged Scalp Skin.
Minoxidil Should Not be Used on Irritated, Painful, or Inflamed Skin.
Patients with Heart Disorders, Such as Ischemic Heart Disease, Heart Rhythm Disorders, Congestive Heart Failure, or Heart Valve Disease, Should Not Use Minovivax 2% Without Prior Consultation with a Doctor, Due to Potential Systemic Undesirable Effects.
The Use of Minovivax 2% Should be Discontinued and a Doctor Consulted in the Event of Low Blood Pressure, Chest Pain, Rapid Heart Rate, Fainting, Dizziness, Weight Gain, Swelling of the Limbs, and Persistent Redness of the Scalp or its Irritation, as well as Other Unusual Undesirable Effects.
In the Event of Severe Undesirable Effects (See Section 4), the Use of Minovivax 2% Should be Discontinued.
Minovivax 2% is Intended for Local Use on the Scalp Only.
Minovivax 2% Should Not be Applied to Other Parts of the Body. In the Event of Minoxidil Application to Other Parts of the Body than the Scalp, Excessive Hair Growth may Occur in those Areas.
Minovivax 2% Should Not be Used with Other Medications Intended for Local Application to the Skin.
More Frequent Use of Minoxidil Does Not Affect the Improvement of Treatment Effects.
One Should Avoid Inhaling the Medication During Application.
The Medication Should Not be Swallowed. Swallowing the Medication can Lead to Severe Undesirable Effects Related to the Heart. The Medication Should be Stored in a Place Invisible and Inaccessible to Children.
The Use of Minoxidil may Cause a Change in Hair Color or Structure.
After Applying Minoxidil (Before the Scalp Skin Dries), During Contact with Delicate Materials or Clothing, Such as Pillows or Headgear, Discoloration may Occur.
There have been Cases of Excessive Hair Growth on the Body of Infants Following Contact with Minoxidil Application Sites in Patients (Caregivers) Using Minoxidil Locally. Hair Growth Returned to Normal Within a Few Months When the Infant was no Longer Exposed to Minoxidil. One Should be Careful that Children do not Come into Contact with Areas of the Body where Minoxidil has been Applied Locally.
If During Local Use of Products Containing Minoxidil, Excessive Hair Growth on the Child's Body is Observed, a Doctor Should be Consulted.

Children and Adolescents Under 18 Years of Age and Patients Over 65 Years of Age

The Use of Minovivax 2% is Not Recommended in Children and Adolescents Under 18 Years of Age and Patients Over 65 Years of Age, Due to the Lack of Data on Safety and Efficacy.

Minovivax 2% and Other Medications

The Patient Should Inform their Doctor or Pharmacist About all Medications Currently Being Used, as well as Those Planned for Use.
Interactions Between Minovivax 2% and Other Medications are Not Known.
Minovivax 2% Should Not be Used Simultaneously with Other Medications Intended for Local Application to the Skin, Such as Tretinoin and Ditranol, as they may Increase the Penetration of Minoxidil Through the Skin into the Blood and Enhance the Risk of Undesirable Effects.
Care Should be Taken When Using Blood Pressure-Lowering Medications.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, Suspects they may be Pregnant, or Plans to Have a Child, They Should Consult a Doctor or Pharmacist Before Using this Medication.
Minovivax 2% Should Not be Used During Pregnancy and Breastfeeding.

Driving and Operating Machines

Minovivax 2% may Cause Dizziness or Low Blood Pressure.
In the Event of these Symptoms, the Patient Should Not Drive or Operate Machines.

Minovivax 2% Contains Propylene Glycol and Anhydrous Ethanol (Alcohol)

Due to the Presence of Propylene Glycol, the Medication may Cause Skin Irritation.
Minovivax 2% Contains Alcohol (Ethanol), Which in the Event 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 Rinsed Thoroughly with Running Water. If the Burning Sensation and (or) Irritation Persist, a Doctor Should be Consulted. After Each Application of the Medication, Hands Should be Washed so that Minovivax 2% Does not Come into Contact with Other Parts of the Body.
In the Event of Severe Skin Reactions, the Use of Minoxidil Should be Discontinued (See Section 4, "Possible Undesirable Effects").

3. How to Use Minovivax 2%

This Medication Should Always be Used Exactly as Described in the Patient Information Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, a Doctor or Pharmacist Should be Consulted.

Recommended Dose

A Dose of 1 ml of Minovivax 2% Should be Applied to the Scalp Twice a Day (Morning and Evening).
The Daily Dose Should Not Exceed 2 ml, Regardless of the Size of the Affected Skin Area.
Minovivax 2% is Intended for Local Use on the Scalp Only.
Minovivax 2% Should Not be Applied to Parts of the Body Other than the Scalp.
Before Local Application of Minovivax 2%, the Hair and Scalp Should be Completely Dry.

Instructions for Use

The Instructions for Using Minovivax 2% Depend on the Type of Dispenser Used.

• 1) Spray Pump – for Applying the Solution to Larger Areas of the Scalp
• Remove the Protective Cap from the Spray Pump.
• Direct the Spray Pump Towards the Surface of the Scalp Affected by the Condition.
• Press the Pump 6 Times to Deliver a Dose of 1 ml.
• Apply the Solution to the Central Part of the Affected Scalp Area and Spread it with the Fingertips, Ensuring the Medication is Applied Evenly.
• After Completion, Replace the Protective Cap.
• 2) Applicator – for Applying the Solution to Small Areas of the Scalp or Areas Covered with Hair For More Precise Local Application, the Applicator Provided with the Package Should be Used.
• Replace the Spray Pump with the Provided Applicator.
• Direct the Applicator Towards the Surface of the Scalp Affected by the Condition.
• Press the Applicator 6 Times to Deliver a Dose of 1 ml.
• Spread the Solution with the Fingertips, Ensuring the Medication is Applied Evenly.

After Applying the Solution, Hands Should Always be Washed Thoroughly.
Accidental Contact of the Medication 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 Rinsed Thoroughly with Running Water. If the Burning Sensation and (or) Irritation Persist, a Doctor Should be Consulted.

Cleaning the Spray Pump and Applicator

To Remove Residual Medication and Prevent Clogging of the Upper Part of the Spray Pump or Applicator, After Each Use, these Parts Should be Unscrewed and Rinsed Thoroughly with Alcohol.

Duration of Treatment

To Achieve the Desired Effect of the Medication, it is Essential Not to Interrupt Regular Use of Minovivax 2% in the Recommended Dose Twice a Day.
Clinical Trials have Shown that to Achieve Noticeable Hair Growth, it may be Necessary to Use Minoxidil for at Least 4 Months or Longer.
Discontinuation of Treatment may Cause a Relapse of Alopecia and a Return to the Pre-Treatment State Within 3 to 4 Months.
If After 12 Months There is no Improvement or the Patient Feels Worse, They Should Contact their Doctor.

Use of a Higher than Recommended Dose of Minovivax 2%

There are no Known Cases of Minoxidil Overdose When Used Locally.
Accidental Ingestion of the Medication may Cause Symptoms Related to its Systemic Action.
The Most Common Symptoms Include: Tachycardia (Rapid Heart Rate), Fluid Retention, Hypotension, and Lethargy.
In the Event of Observing Similar Symptoms, a Doctor Should be Consulted Immediately.

Missing a Dose of Minovivax 2%

A Double Dose Should Not be Used to Make up for a Missed Dose.

Discontinuation of Minovivax 2% Use

Maintenance of Hair Growth Requires Continuous Use of Minovivax 2% in the Recommended Dose. After Discontinuation of Treatment, a Stop in the Growth of New Hair and a Return to the Pre-Treatment State have been Observed Within 3 to 4 Months.
In Case of any Further Doubts Regarding the Use of the Medication, a Doctor or Pharmacist Should be Consulted.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, Although they may not Occur in Everyone.

The Patient Should Immediately Consult a Doctor if they Experience any of the Following Symptoms, as Urgent Medical Attention may be Required (Frequency Unknown, Cannot be Determined from Available Data):

• Swelling of the Face, Lips, or Throat, which Makes Swallowing or Breathing Difficult (May be Symptoms of a Severe Allergic Reaction)
• Generalized Itching
• Generalized Redness
• Sensation of Tightness in the Throat.

The Following Undesirable Effects have been Observed:

Very Common (May Affect More than 1 in 10 Patients)

• Headache.

Common (May Affect up to 1 in 10 Patients)

• Dyspnea,
• Itching, Excessive Hair Growth (in Women also on the Face), Dermatitis, Acne-like Rash, Rash,
• Peripheral Edema,
• Weight Gain.

Uncommon (May Affect up to 1 in 100 Patients)

• Dizziness,
• Nausea.

Frequency Unknown (Frequency Cannot be Determined from Available Data)

• Low Blood Pressure,
• Angioedema (Including: Lip and Tongue Swelling, Mouth and Throat Swelling, Swelling of the Mucous Membranes of the Mouth and Throat), Hypersensitivity (Including: Face Swelling, Erythema Multiforme, Itching, Sensation of Tightness in the Throat), Contact Dermatitis,
• Depressive Mood,
• Eye Irritation,
• Tachycardia (Rapid Heart Rate), Palpitations,
• Vomiting,
• Local Reaction at the Application Site, Including the Ears and Face (Including: Skin Irritation and Redness, Itching, Pain, Swelling, Dryness of the Skin, Redness), Desquamation, Dermatitis, Blisters, Bleeding, and Ulcers, Sometimes Severe,

Some Patients at the Beginning of Minoxidil Treatment Observed Increased Hair Loss.
This Temporarily Enhanced Process of Hair Loss Usually Occurs Within 2-6 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 Medication Should be Discontinued and a Doctor Consulted.

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including any Undesirable Effects not Listed in the Leaflet, the Patient Should Inform their Doctor or Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Phone: 22 49-21-301, Fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Minovivax 2%

The Medication Should be Stored in a Place Invisible and Inaccessible to 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 Medication After the Expiration Date Stated on the Packaging or Label After: EXP. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should Not be Disposed of in Sewers or Household Waste Containers. A Pharmacist Should be Asked How to Dispose of Unused Medications. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Minovivax 2% Contains

• The Active Substance of the Medication is Minoxidil (1 ml of the Solution for the Skin Contains 20 mg of Minoxidil).
• Other Ingredients are: Propylene Glycol, Anhydrous Ethanol, and Purified Water.

What Minovivax 2% Looks Like and What the Package Contains

A Clear, Homogeneous Solution, Colorless to Pinkish.
Packaging: Bottle with a Spray Pump Containing 100 ml of the Solution, with an Applicator, in a Cardboard Box.

Marketing Authorization 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
Date of Last Update of the Leaflet:October 2024