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1. What Minoxidil Viñas is and what it is used for
This medicine is indicated for the treatment of moderate hair loss called androgenic alopecia (excessive hair loss) in men.
This medicine contains minoxidil. Minoxidil is a solution for use on the skin of the scalp to stimulate hair growth in men with adrogenic alopecia.
It is not recommended in women because of the high frequency of hypertrichosis (abnormal hair growth).
A doctor should be consulted if it worsens or does not improve after 3 months of treatment.
2. What you need to know before using Minoxidil Viñas
Do not use Minoxidil Vinas
If you are allergic to minoxidil or 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 you start using Minoxidil Vinas.
If you have any problem or any wound on the skin of the scalp as more product may be absorbed, so you should make sure that these do not exist before application.
If you have a history of or are currently suffering from any disease of the blood vessels or heart, as it would be advisable for your doctor to check your blood pressure and heart rate.
It should not be used in women because of the possibility of hypertrichosis (abnormal hair 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 skin, stop treatment and consult your doctor.
The treated areas should not be exposed to the sun (even if it is cloudy) or to ultraviolet (UVA) lamps. Specific protection should be used on the treated area.
Use on children and the elderly
The use of Minoxidil Viñas is not recommended for children or elderly people as no studies have been carried out on them.
Use of Minoxidil Viñas and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including medicines obtained without a prescription.
Taking Minoxidil Viñas together with peripheral vasodilators and medicines for the treatment of blood pressure may cause a sudden drop in your blood pressure. It should not be used at the same time as other topical products such as corticosteroids, retinoids or occlusive ointments as they may increase their absorption.
Use of Minoxidil Viñas with food and drink
Not applicable.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and machine use
There are no data on how Minoxidil Viñas affects driving or using machinery, so try not to perform tasks that may require special attention until you have checked how well you tolerate the medicine.
Minoxidil Viñas contains propylene glycol
This medicine contains 520 mg of propylene glycol in each dosage unit equivalent to 520 mg/ml.
Propylene glycol may cause skin irritation.
3. How to use Minoxidil Vinas
Follow exactly the instructions for use given in this leaflet or as directed by your doctor or pharmacist. If in 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.
Frequency of application
One application of 1 ml in the morning and 1 ml in the evening.
Do not increase doses or frequency of application.
In all cases, strictly adhere to the dosage.
Duration of treatment
The result is not immediate: the cessation of hair loss or the resumption of hair growth will not occur until some time after the start of treatment. A treatment of 2 months, with a frequency of two applications per day, may be required before stimulation of hair growth is noticed. The time interval and degree of response may vary from patient to patient.
Consult your doctor if you think you need to use Minoxidil Viñas 50 mg/ml skin solution for more than 3 months.
If treatment is stopped, a return to baseline is likely to occur within 3-4 months, according to some observations.
Route of administration
Cutaneous use. For external use.
Wash hands thoroughly before and after application of the solution.
The hair and scalp should be completely dry when applying the product. Spread the amount of solution with the fingertips over the area to be treated, starting from the centre of the area. Do not apply to other areas of the body.
How to apply
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 method of application will vary according to the area to be treated and the applicator system.
Treatment of large areas of the scalp: use the applicator with spray pump and dosage pump.
Remove the outermost transparent cap.
b) Remove and discard the inner cap.
c) Place the sprayer inside 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 (total 6), repeating the same operation each time. After the 6 pulses, the dose of 1 ml will have been applied.
After use, replace the cap with the outer transparent cap.
Treatment of small surfaces or under the hair: use the applicator with cannula and nozzle.
Remove the outermost transparent cap.
Remove and discard the inner cap.
Place the sprayer inside the bottle and screw it on tightly. Remove the small transparent cap.
Pull upwards to remove the spray head.
Insert the nozzle of the cannula into the headless end of the sprayer and press firmly.
Point 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 (total 6), repeating the same operation each time. After the 6 strokes, the 1 ml dose will have been applied.
instructions 2
instructions 3
Rinse the applicator with warm water after each use. Avoid inhalation of the product during application.
Use in children
The use of Minoxidil Viñas in children is not recommended.
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 following topical application of minoxidil will result in 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 hypotension (low blood pressure), tachycardia, oedema and congestive heart failure.
If you experience any of these symptoms, you should consult your doctor immediately. Take this leaflet with you. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poisons Information Service, telephone 91 562 04 20.
If you forget to use Minoxidil Viñas
- In the initial period of treatment:
Apply the forgotten dose as soon as possible and then continue with the regimen 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 stop treatment with Minoxidil Viñas
Discontinuation of treatment for 3-4 months may cause you to return to the initial state of alopecia prior to treatment.
If the symptoms described above appear, consult your doctor.
If you have any other questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
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 that may cause difficulty in 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), skin dryness and peeling (flaking of the skin).
Rare: up to 1 in 100 people may be affected:
Headache and paraesthesias (numbness in arms or legs). Tachycardia, palpitations and hypotension (low blood pressure). Erythematous rash (generalised redness), eczema, alopecia and hypertrichosis (hair growth on the skin).
Rare: may affect up to 1 in 1000 people:
Pustular rash (generalised pustules) and acne.
Very rare: may affect up to 1 in 10,000 people:
Visual impairment and eye irritation.
In all these cases, you should stop treatment and tell your doctor quickly.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects you can help to provide more information on the safety of this medicine.
5. Storage of Minoxidil Viñas
Do not store at temperatures above 30ºC.
Keep 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 is the last day of the month shown.
Do not use this medicine if you notice any change in the appearance of the solution.
Medicines should not be flushed down the drain or thrown away. Dispose of unneeded medicines and containers at the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine containers and medicines. In this way, you will help to protect the environment.
6. Package contents and additional information
Composition of Minoxidil Viñas:
The active substance is minoxidil. Each ml of solution contains 50 mg of minoxidil.
The other ingredients (excipients) are: propylene glycol, ethanol 96% and purified water.
