Minoxidil Viñas 5% Cutaneous Sun 240 ml

This medicine is indicated for the treatment of moderate hair loss called androgenic alopecia (excessive hair loss).

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

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

Do not use Minoxidil Vineyards

• If you are allergic to minoxidil or any of the other ingredients of this medicine (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 skin of your scalp, as more of the product may be absorbed, you should make sure that these do not exist before applying it.
• If you have a history of or currently suffer from any disease of the blood vessels or heart, it would be advisable for your doctor to monitor your blood pressure and heart rate.
• If you are a woman, the risk of hypertrichosis (hair growth in other areas) is greater than in men, so you should be careful when using this medicine and, if you use it, you should take special care to wash your hands after applying the medicine to the scalp, since if it comes into contact with other parts of the body, there is a risk of growth in other areas of the body.
• If this medicine comes into contact with your eyes, you should wash them 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 should not be exposed to sunlight (even when cloudy) or ultraviolet (UVA) lamps. Specific protection must be used in the treated area.

Use in children and the elderly

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

Using Minoxidil Vines and other medications

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

The joint administration of Minoxidil Viñas with peripheral vasodilators and medications for the treatment of blood pressure can cause a sudden drop in your blood pressure. Likewise, it should not be applied at the same time with other topical products such as corticosteroids, retinoids or occlusive ointments since they can increase their absorption.

Using Minoxidil Vineyards with food and drink

Not applicable.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Minoxidil Viñas contains propylene glycol

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

Propylene glycol may cause skin irritation.

Always follow the instructions for administration exactly as given in this leaflet or as indicated by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

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

The daily dose should not exceed 2 ml (12 sprays), regardless of the size 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 frequency of application.

In all cases, strictly adhere to the dosage.

Duration of treatment

The result is not immediate: hair loss will not stop or hair growth will start again some time after the start of treatment. A treatment of 2 months, with a frequency of two applications per day, may be necessary before stimulation of hair growth is noticed. The time interval and 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 cutaneous solution for more than 3 months.

If treatment is discontinued, a return to baseline status is likely to occur within 3 to 4 months, according to some observations.

Route of administration

Cutaneous use. For external use.

Wash hands thoroughly before and after applying the solution.

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

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

Application mode

Apply the solution to a perfectly dry scalp, starting from the centre of the area to be treated. Do not apply 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 areas of the scalp: use the applicator with a spray pump and dispenser.

1. Remove the outermost transparent cap.

b) Remove and discard the inner plug.

c) Place the sprayer into the bottle and screw it on tightly. Remove the small transparent cap.

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

After use, replace the bottle with the outer transparent cap.

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

1. Remove the outermost transparent cap.
2. Remove and discard the inner plug.
3. Place the spray bottle into the bottle and screw it on tightly. Remove the small transparent cap.
4. Pull up to remove the spray head.
5. Insert the cannula nozzle into the headless end of the sprayer and press firmly.
6. Direct the cannula towards the centre of the surface to be treated or under the hair, press once and spread the solution with your fingertips. Press 5 more times (6 in total), repeating the same operation each time. After 6 presses, the 1 ml dose will have been applied.

Rinse the applicator with warm water after each use. Avoid inhalation of 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 after topical application of minoxidil will produce an increase in 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, but are not limited to, hypotension (low blood pressure), tachycardia, edema, and congestive heart failure.

If you experience any of these symptoms, you should consult a doctor immediately. Take this leaflet with you. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service on 91 562 04 20.

If you forget to use Minoxidil Viñas

- In the initial period of treatment :

Take the missed dose as soon as possible and then continue with the schedule recommended by your doctor. Do not take a double dose to make up for a forgotten dose.

- During the maintenance period :

Take the next dose as usual and continue your treatment.

If you stop treatment with Minoxidil Viñas

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

If the symptoms described appear, consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets 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 which may cause difficulty in swallowing or breathing. This may be a sign of a serious allergic reaction (frequency not known, cannot be estimated from the available data).

Common: may affect up to 1 in 10 people:

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

Uncommon: may affect up to 1 in 100 people:

Headache and paresthesia (numbness in the 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 disturbance and eye irritation.

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

Communication of adverse effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

Do not store above 30ºC.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of any packaging and any medicines you no longer need at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and any medicines you no longer need. 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 ingredients (excipients) are: propylene glycol, 96% ethanol and purified water.

Product appearance and package contents:

Minoxidil Viñas is a solution for cutaneous use. The solution is clear, colourless or very slightly yellowish. It is available in 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) formats, provided with a spray and dosing pump, and a push-button with a cannula.

Authorization holder and manufacturer responsible

Vineyard Laboratories, S.A.

Provence, 386

08025 Barcelona

This prospectus was approved in January 2020

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