ALOXIDIL 50 mg/ml CUTANEOUS SOLUTION

2. What you need to know before starting to use Aloxidil

Do not use Minoxidil Viñas

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

Warnings and precautions

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

• If you have any problem or wound on the scalp skin, as more product may be absorbed, so you should ensure that these do not exist before application.
• If you have a history of or currently suffer from any vascular or heart disease, as it is recommended that your doctor monitor your blood pressure and heart rate.
• If you are a woman, the risk of hypertrichosis (hair growth in other areas) is higher than in men, so you should be cautious when using this medication and, if you use it, you should be especially careful to wash your hands after applying the medication to the scalp, as if it comes into contact with other parts of the body, there is a risk of growth in other body areas.
• If this medication comes into contact with your eyes, you should rinse them with plenty of water.
• If you notice any other effect on your general condition or skin, interrupt treatment and consult your doctor.
• The treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet lamps (UVA). It will be necessary to use specific protection on the treated area.
• Cases of excessive body hair growth have been reported in infants after skin contact with the application areas of minoxidil in patients (caregivers) using topical minoxidil. Hair growth normalized within months when infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with the body areas where minoxidil has been applied topically.
• Consult your doctor if you observe excessive hair growth on your child's body during the period when using topical minoxidil products.

Use in children and the elderly

The use of Minoxidil Viñas is not recommended in children or the elderly, as no studies have been conducted in these populations.

Use of Minoxidil Viñas and other medications

Inform your doctor or pharmacist if you are using or have recently used or may need to use other medications, including those purchased without a prescription.

The concomitant administration of Minoxidil Viñas with peripheral vasodilators and medications for the treatment of blood pressure may produce a sudden drop in blood pressure. Similarly, it should not be applied at the same time as other topical products such as corticosteroids, retinoids, or occlusive pomades, as they may increase absorption.

Use of Minoxidil Viñas with food and beverages

This is not applicable.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

There is no data on how Minoxidil Viñas affects driving or using machinery, so try not to perform tasks that require special attention until you verify how you tolerate the medication.

Minoxidil Viñas contains propylene glycol

This medication contains 520 mg of propylene glycol in each dose unit, equivalent to 520 mg/ml.

Propylene glycol may cause skin irritation.

3. How to use Aloxidil

Follow the administration instructions contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is 1 ml (6 sprays) applied twice a day 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.

Application frequency

One application of 1 ml in the morning and 1 ml at night.

Do not increase the doses or application frequency.

In all cases, strictly respect the dose.

Treatment duration

The result is not immediate: the cessation of hair loss or the new onset of hair growth will not occur until some time after the start of treatment. A 2-month treatment, with a frequency of two applications per day, may be required before hair growth stimulation is noted. The time interval and degree of response may vary from patient to patient.

Consult your doctor if you think you need to use Aloxidil 50 mg/ml cutaneous solution for more than 3 months.

If treatment is suspended, it is likely that the initial state of alopecia prior to treatment will return within 3-4 months, according to some observations.

Route of administration

Topical use. For external use only.

Wash your hands well before and after applying the solution.

If you are a woman, you should be especially careful to wash your hands after applying the medication to the scalp, as if it comes into contact with other parts of the body, there is a risk of growth in other body areas.

The 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.

Application method

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

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

Treatment of large scalp areas: the applicator with spray pump and doser will be used.

1. Remove the outer transparent cap.

• Remove and discard the inner plug.

• Place the spray pump inside the bottle and screw it firmly. Remove the small transparent cap.

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

After using the bottle, replace the outer transparent cap.

Treatment of small areas or under the hair: the applicator with cannula and nozzle will be used.

1. Remove the outer transparent cap.
2. Remove and discard the inner plug.
3. Place the spray pump inside the bottle and screw it firmly. Remove the small transparent cap.
4. Pull up to remove the spray pump head.
5. Insert the cannula nozzle into the end of the spray pump without the head and press firmly.
6. Direct the cannula towards the center of the area to be treated or under the hair, press once, and spread the solution with your fingertips. Perform 5 more presses (total 6), repeating the same operation each time. After the 6 presses, the 1 ml dose will have been applied.

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

Use in children

The use of Aloxidil is not recommended 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 after topical application of minoxidil will produce an increase in the intensity of adverse effects of a dermatological nature, especially pruritus (itching), dryness, skin irritation, and eczema.

The signs and symptoms after 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, you should consult your doctor immediately. Bring this prospectus with you. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to use Aloxidil

• In the initial treatment period:

Apply the forgotten dose as soon as possible and then follow the schedule recommended by your doctor. Do not use a double dose to make up for forgotten doses.

• In the maintenance period:

Apply the next dose as usual and continue your treatment.

If you interrupt treatment with Aloxidil

Interrupting treatment for 3-4 months may cause you to return to the initial state of alopecia prior to treatment.

If you experience any of the described symptoms, consult your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Immediately contact a doctor 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), dryness, and skin 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 (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 disturbances and eye irritation.

In all these cases, you should stop treatment and notify your doctor quickly.

Adverse effect reporting

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 prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aloxidil

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Minoxidil Viñas:

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

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

Appearance of the product and package contents:

Minoxidil Viñasis a solution for topical use. The solution is transparent, colorless, or very slightly yellowish. It is available in 60 ml, 120 ml (2 bottles of 60 ml), 180 ml (3 bottles of 60 ml), and 240 ml (2 bottles of 120 ml) formats, provided with a spray pump and doser, and a pulsator 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 prospectus was approved in July 2025

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