Package Insert: Information for the User

Minoxidil Viñas 50 mg/ml Topical Solution

Minoxidil

Read this package insert carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 package insert. 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 when using this medication and, if you use it, you must take special care 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 effects on your general state or skin, interrupt 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 in areas where minoxidil was applied to 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 these groups.

Use of Minoxidil Viñas and other medications

Inform your doctor or pharmacist if you are using or have used recently or may need 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. Additionally, 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 beverages

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 operating machinery

There is no data on how Minoxidil Viñas affects driving vehicles or operating machinery, so be careful 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 dose unit 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.

Always strictly follow the dose 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 Minoxidil Viñas 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 your fingertips over the area to be treated, starting from the center of this area. 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 in firmly. Remove the small transparent cap.

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

Clear the applicator with hot water after each use.Prevent inhalation of the product during application.

Use in children

Do not recommend the use of Minoxidil Viñas 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 after topical application of 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 forget to use Minoxidil Viñas

-In the initial treatment period:

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

-In the maintenance period:

Apply the next dose as usual and continue your treatment.

If you interrupt the treatment with Minoxidil Viñas

The interruption of 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 produce adverse effects, although not all people 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 unknown, 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 1000 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.

No special storage conditions are required.

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 notice changes in the appearance of the solution.

Medicines should not be thrown down the drain or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

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, 96% ethanol 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 available in formats of 60 ml 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/