Minoxidil Viñas 50 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Minoxidil Viñas 50 mg/ml cutaneous solution

Minoxidil

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 months.

Contents of the leaflet

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

1. What Minoxidil Viñas is and what it is used for

This medicine is indicated for the treatment of moderate hair loss known as androgenetic alopecia (excessive hair loss).

This medicine contains minoxidil. Minoxidil is a solution for topical use on the scalp skin that stimulates hair growth in men with androgenetic alopecia.

You should consult a doctor if your condition worsens or does not improve after 3 months of treatment.

2. What you need to know before using Minoxidil Viñas

Do not use Minoxidil Viñas

• If you are allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6).
• If you have damaged skin on the scalp.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Minoxidil Viñas.

• If you have any skin condition or injury on the scalp, as more of the product may be absorbed; therefore, you must ensure such conditions are not present before applying the medicine.
• If you have a history of, or currently suffer from, any blood vessel or heart disease, as it would be advisable for your doctor to monitor your blood pressure and heart rate.
• If you are a woman, the risk of hypertrichosis (excessive hair growth in other areas) is higher than in men. Therefore, you must be cautious when using this medicine. If used, you should take special care to wash your hands thoroughly after applying the medicine to the scalp, since contact with other parts of the body may lead to hair growth in other body areas.
• If this medicine comes into contact with your eyes, rinse them immediately with plenty of water.
• If you notice any other effects on your general condition or on your skin, stop treatment and consult your doctor.
• Treated areas must not be exposed to sunlight (even on cloudy days) or to ultraviolet (UVA) lamps. Adequate protection must be used on the treated area.
• Cases of excessive body hair growth in infants have been reported after skin contact with application sites of minoxidil in patients (caregivers) using topical minoxidil. Hair growth normalized within months once infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with areas of the body where topical minoxidil has been applied.
• Consult your doctor if you notice excessive body hair growth in your child during the time you are using topical minoxidil products.

Use in children and elderly people

The use of Minoxidil Viñas is not recommended in children or elderly individuals, as studies have not been conducted in these populations.

Use of Minoxidil Viñas with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Concomitant use of Minoxidil Viñas with peripheral vasodilators or medications for blood pressure may cause a sudden drop in blood pressure. Additionally, it should not be applied simultaneously with other topical products such as corticosteroids, retinoids, or occlusive ointments, as these may increase its absorption.

Use of Minoxidil Viñas with food and drinks

Not applicable.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

There are no data on the effects of Minoxidil Viñas on the ability to drive or operate machinery. Therefore, avoid performing tasks requiring special attention until you know how you tolerate the medicine.

Minoxidil Viñas contains propylene glycol

This medicine contains 520 mg of propylene glycol per dose unit, equivalent to 520 mg/ml.

Propylene glycol may cause skin irritation.

3. How to use Minoxidil Viñas

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 1 ml (6 sprays) applied twice daily to the scalp area to be treated.

The daily dose should not exceed 2 ml (12 sprays), regardless of the extent of the area to be treated.

Frequency of application

One 1 ml application in the morning and one 1 ml application in the evening.

Do not increase the dose or frequency of application.

In all cases, strictly adhere to the recommended dose.

Duration of treatment

Results are not immediate: stopping hair loss or the new growth of hair will not occur until some time after starting treatment. A treatment period of 2 months, with two applications daily, may be required before hair growth stimulation becomes noticeable. The time interval and degree of response may vary from patient to patient.

Consult your doctor if you believe you need to use Minoxidil Viñas 50 mg/ml cutaneous solution for longer than 3 months.

If treatment is discontinued, a return to the initial condition is likely within the following 3 to 4 months, according to some observations.

Route of administration

For cutaneous use. For external use only.

Wash your hands thoroughly before and after applying the solution.

If you are a woman, take special care to wash your hands after applying the medication to the scalp, as contact with other parts of the body may result in unwanted hair growth in other body areas.

Hair and scalp must be completely dry when applying the product. Spread the amount of solution with your fingertips over the area to be treated, starting from the center. Do not apply the product to other areas of the body.

Method of application

Apply the solution to a completely dry scalp, starting from the center of the area to be treated. Do not apply it to other areas of the body.

The method of application will vary depending on the area to be treated and the applicator system used.

Treatment of large scalp areas: use the pump spray and dosing applicator.

1. Remove the outer transparent cap.

• Remove and discard the inner plug.

• Insert the spray nozzle into the bottle and screw it on tightly. Remove the small transparent cap.

• Direct the spray nozzle outlet toward the center of the area to be treated. Press once and spread the solution over the entire area with your fingertips. Perform 5 additional presses (total of 6), repeating the same procedure each time. After 6 presses, a dose of 1 ml will have been applied.

After using the bottle, replace the outer transparent cap.

Treatment of small areas or under the hair: use the applicator with cannula and nozzle.

1. Remove the outer transparent cap.
2. Remove and discard the inner plug.
3. Insert the spray nozzle into the bottle and screw it on tightly. Remove the small transparent cap.
4. Pull upwards to remove the spray head.
5. Insert the cannula nozzle into the headless end of the spray nozzle and press firmly.
6. Direct the cannula toward the center of the area to be treated or under the hair, press once, and spread the solution with your fingertips. Perform 5 additional presses (total of 6), repeating the same procedure each time. After 6 presses, a dose of 1 ml will have been applied.

Rinse the applicator with warm water after each use. Avoid inhaling the product during application.

Use in children

Minoxidil Viñas is not recommended for use in children.

If you use more Minoxidil Viñas than you should:

If you have used more minoxidil than you should, consult your doctor or pharmacist immediately.

Accidental or intentional overdose following topical application of minoxidil may increase the intensity of dermatological adverse effects, especially pruritus (itching), dryness, skin irritation, and eczema.

Signs and symptoms following accidental or intentional ingestion of minoxidil may include, among others, hypotension (low blood pressure), tachycardia, edema, and congestive heart failure.

If you experience any of these symptoms, consult your doctor immediately. Bring this leaflet with you. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to use Minoxidil Viñas

• During the initial treatment period:

Apply the missed dose as soon as possible, then continue with the schedule recommended by your doctor. Do not use a double dose to make up for missed doses.

• During the maintenance period:

Apply the next dose as usual and continue your treatment.

If you stop using Minoxidil Viñas

Stopping treatment for 3–4 months may cause you to return to the initial state of alopecia present before treatment began.

If any of the symptoms described occur, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact a doctor immediately if you notice any of the following symptoms. You may require urgent medical treatment.

• Swelling of the face, lips, or throat that may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from available data).

Frequent: may affect up to 1 in 10 people:

Pruritus (itching), local skin irritation, contact dermatitis (redness), and dryness and exfoliation of the skin (skin peeling).

Uncommon: may affect up to 1 in 100 people:

Headache and paresthesia (numbness sensation in arms or legs). Tachycardia, palpitations, and hypotension (low blood pressure). Erythematous rash (generalized redness), eczema, alopecia, and hypertrichosis (excessive hair growth on the skin).

Rare: may affect up to 1 in 1,000 people:

Pustular rash (generalized pustules) and acne.

Very rare: may affect up to 1 in 10,000 people:

Visual disturbance and eye irritation.

In all these cases, you must stop treatment and inform your doctor promptly.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Minoxidil Viñas

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle and the carton following EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any changes in the appearance of the solution.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Minoxidil Viñas:

The active substance is minoxidil. Each ml of solution contains 50 mg of minoxidil.

The other components (excipients) are: propylene glycol, 96% ethanol, and purified water.

Appearance of the product and contents of the container:

Minoxidil Viñas is a solution for topical use. The solution is clear, colourless or very slightly yellowish. It is available in pack sizes of 60 ml of solution, 0.120 ml (2 bottles of 60 ml), 180 ml (3 bottles of 60 ml), and 240 ml (2 bottles of 120 ml), each equipped with a spray pump dispenser and a dosing button with a nozzle.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Torrente Vidalet, 29

08012 Barcelona

Spain

Laboratorios Viñas, S.A.

Polígono Industrial Can Rosés, Avenida Can Rosés, s/n,

08191 Rubí

Spain

This leaflet was approved in July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/