Label: information for the user

Aloxidil 50 mg/ml topical solution

Minoxidil

Read this label carefully before starting to use this medicine, as it contains important information for you.

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

• Keep this label, 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 label. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 months.

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

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

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

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 problems or wounds on the scalp skin as it may absorb more of the product, so you should ensure that these do not exist before its application.
• If you have a history or are currently suffering from any vascular 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 hirsutism (hair growth in other areas) is higher than in men, so you must be cautious with the use of this medication and, if you use it, you must 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 hair growth in other body areas.
• If this medication comes into contact with your eyes, you should wash them with plenty of water.
• If you notice any other effect on your general state or skin, discontinue treatment and consult your doctor.
• The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA). You will need to use a specific protection on the treated area.
• Cases of excessive hair growth on the body have been reported in infants after contact with the skin on the application areas of minoxidil in patients (caregivers) who used topical minoxidil. Excessive hair growth normalized within months when infants stopped being exposed to minoxidil. You should be cautious to ensure that children do not come into contact with areas of the body where minoxidil has been applied topically.
• Consult your doctor if you observe excessive hair growth on your child's body during the period in which you use topical products with minoxidil.

Use in children and in elderly people

Minoxidil Viñas is not recommended for use in children or in elderly people as no studies have been conducted in them.

Use of Minoxidil Viñas and other medications

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

The concurrent administration of Minoxidil Viñas with peripheral vasodilators and blood pressure medications may cause a sudden drop in your blood pressure. In addition, do not apply it at the same time as other topical products such as corticosteroids, retinoids, or occlusive creams as they may increase its absorption.

Use of Minoxidil Viñas with food and drinks

Not applicable.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

There are no data on how Minoxidil Viñas affects driving vehicles or operating machinery, so try not to perform tasks that may require special attention until you check how you tolerate the medication.

Minoxidil Viñas contains propylene glycol

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

Propylene glycol may cause skin irritation.

Follow exactly the administration instructions contained in this prospectus or those 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 area of the scalp 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 dose or the frequency of application.

Respect the dose strictly in all cases.

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. It may take a treatment of 2 months, with a frequency of two applications per day, before noticing the stimulation of hair growth. The time interval and the degree of response may vary from one patient to another.

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

If treatment is suspended, it is likely that the initial state will return in 3 to 4 months, according to some observations.

Route of administration

Topical use. For external use.

Wash your hands well before and after applying the solution.

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

The hair and scalp must be completely dry when applying the product. Extend the amount of solution with the tip of your fingers over the area to be treated, starting from the center of this. Do not apply the product to other areas of the body.

Method of application

Apply the solution to the scalp perfectly dry, 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.

Treatment of large scalp surfaces: the applicator with a spray pump and dosifier will be used.

1. Remove the transparent outer cap.

b)Remove and discard the inner plug.

c)Place the sprayer inside the bottle and screw it firmly in place. Remove the small transparent cap.

d)Direct the outlet of the sprayer towards the center of the area to be treated. Press once and extend the solution over the entire area with the tip of your fingers. Repeat the same operation 5 more times (total 6). After 6 presses, a dose of 1 ml will have been applied.

After using the bottle, replace the transparent outer cap.

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

1. Remove the transparent outer cap.
2. Remove and discard the inner plug.
3. Place the sprayer inside the bottle and screw it firmly in place. Remove the small transparent cap.
4. Pull upwards to remove the head of the sprayer.
5. Insert the nozzle of the cannula into the headless end of the sprayer and press firmly.
6. Direct the cannula towards the center of the surface to be treated or under the hair, press once and extend the solution with the tip of your fingers. Repeat the same operation 5 more times (total 6). After 6 presses, a dose of 1 ml will have been applied.

Clean the applicator with hot water after each use.Prevent inhalation of 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 Aloxidilthan you should, consult your doctor or pharmacist immediately.

Accidental or intentional overdose of topical minoxidil will produce an increase in the intensity of dermatological side effects, especially 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, 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 Toxicological Information Service, phone 91 562 04 20.

If you forgot to use Aloxidil

-During the initial treatment period:

Apply the missed dose as soon as possible and then continue with the regimen recommended by your doctor. Do not use a double dose to compensate for the missed doses.

-During 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 your initial state of alopecia prior to treatment.

Consult your doctor if symptoms appear.

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

Like all medications, this medicationmay cause adverse effects, although not everyone will experience them.

Seek immediate medical attention 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).

Frequent: may affect up to 1 in 10 people:

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

Infrequent: may affect up to 1 in 100 people:

Headache and paresthesias (numbness in arms or legs). Tachycardia, palpitations, and hypotension (low blood pressure). Erythematous rash (generalized redness), eczema, alopecia, and hirsutism (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 disturbances and eye irritation.

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

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

This medication does not require special preservation conditions.

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

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

Do not use this medicationif you observe changes in the appearance of the solution.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you do not need. In this way, you will help protect the environment.

Composition of Minoxidil Viñas:

The active principle 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 contents of the packaging:

Minoxidil Viñasis a topical solution. The solution is transparent, colorless or very pale yellow. It is presented in formats 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), provided with a spray pump and dosifier, and a trigger with a cannula.

Holder of the authorization and responsible for the manufacturing

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

This leaflet has been approved in October 2024

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/