Aloxidil 50 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aloxidil 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 use provided in this 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 more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not see improvement after 3 months.

Contents of the leaflet

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

1. What Aloxidil 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 topical solution for 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 Aloxidil

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

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

• If you have any skin problems or wounds on the scalp, as this may increase absorption of the product. Ensure such conditions are absent before applying the medication.
• If you have a history of, or currently suffer from, any blood vessel or heart disease, 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 of the body) is higher than in men. Therefore, you should be cautious when using this medicine. If used, special care should be taken to wash your hands thoroughly after applying the medication to the scalp, as contact with other body areas may lead to unwanted hair growth.
• If this medicine comes into contact with your eyes, rinse them thoroughly 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 of the treated area is necessary.
• Cases of excessive body hair growth in infants have been reported following skin contact with areas where minoxidil was applied on patients (caregivers) using topical minoxidil. Hair growth normalized within months once infants were no longer exposed to minoxidil. Precautions must be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.
• Consult your doctor if you notice excessive hair growth on your child’s body during your use of 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

Inform 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 antihypertensive medications may cause a sudden drop in blood pressure. Additionally, it should not be used 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 drink

Not applicable.

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 Aloxidil

Follow exactly the administration instructions contained in this leaflet or those given 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 affected area of the scalp.

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

Frequency of application

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

Do not increase the dose or frequency of application.

In all cases, strictly observe the recommended dose.

Duration of treatment

Results are not immediate: stopping hair loss or the onset of new hair growth will not occur until some time after starting treatment. A treatment period of 2 months, with two applications per day, may be needed 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 Aloxidil 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 areas.

Hair and scalp must be completely dry when applying the product. Spread the amount of solution with the 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 perfectly dry scalp, starting from the center of the area to be treated. Do not apply 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 areas of the scalp: 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 the fingertips. Repeat this process five more times (total of 6 sprays). After 6 sprays, 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 the fingertips. Repeat this process five more times (total of 6 sprays), repeating each time the same procedure. After 6 sprays, 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

Aloxidil is not recommended for use in children.

If you use more Aloxidil than you should:

If you have used more Aloxidil 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 Aloxidil

• During the initial treatment period:

Apply the missed dose as soon as possible, then continue with your prescribed dosing schedule. 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 Aloxidil

Discontinuing treatment for 3–4 months may result in a return to the initial state of alopecia prior to treatment.

If any of the described symptoms 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 swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from available data).

Common: may affect up to 1 in 10 people:

Pruritus (itching), local skin irritation, contact dermatitis (redness), skin dryness and exfoliation (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 should 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 via 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 Aloxidil

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 carton after 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 unused containers and medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 transparent, colourless or very slightly yellowish. It is available in pack sizes of 60 ml of solution, 120 ml (2 bottles of 60 ml), 180 ml (3 bottles of 60 ml), and 240 ml (2 bottles of 120 ml), supplied with a spray pump dispenser and dosing pump, and a nozzle with cannula.

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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/