Each ml of the solution contains: 50 mg of minoxidil.
Minoxidil 5% w/v cutaneous solution belongs to the group of medicinal products called other dermatological products.
Excipients/Inactive Ingredients: Ethanol, Propylene Glycol and purified water.
Minoxidil 5% w/v cutaneous solution is indicated in the treatment of androgenetic alopecia of moderate intensity.
Only for cutaneous use.
The recommended daily dose is 1 ml every 12 hours (each ml corresponding to 10 pumps) applied on the scalp, starting from the center of the area to be treated.
The recommended daily dose must be respected despite the extension of the area of alopecia. The maximum recommended daily dose is 2 ml (2 ml corresponding to 20 pumps).
If the patient has the impression that the effect of Minoxidil 5% w/v cutaneous solution is too strong or too weak, talk to the doctor or pharmacist.
If the patient forgets to use Minoxidil 5% w/v cutaneous solution: During the initial treatment period: Apply the missed dose as soon as possible and then continue treatment according to the application schedule recommended by the doctor. Do not use a double dose to make up for missed doses.
During the maintenance period: Apply the following dose according to schedule and continue treatment normally.
Effects when treatment with Minoxidil 5%w/v cutaneous solution is interrupted: If treatment is interrupted alter 3-4 months subjects can return to initial levels of alopecia.
If the described symptoms occur, consult the doctor.
If the patient uses more Minoxidil 5%w/v cutaneous solution than he/she should, contact the doctor or pharmacist immediately.
Accidental or voluntary overdose in topical application of Minoxidil 5%w/v cutaneous solution will produce an increase in the intensity of adverse dermatological reactions, especially itching (burning), dryness, irritation and eczema.
The signs and symptoms following accidental or voluntary oral ingestion of Minoxidil 5%w/v cutaneous solution are, amongst others, hypotension (lowering of blood pressure), tachycardia, oedema and congestive heart failure.
If the patient has any of these symptoms, he/she should immediately contact the doctor.
Do not use Minoxidil 5% w/v cutaneous solution: If the patient is allergic to minoxidil or to any of the others ingredients of this medicine.
If the patient has any problem or lesion on the scalp since a larger amount of the product can be absorbed; check to make sure there are no such problems before applying the product.
If the patient has a history of or suffer from any blood vessel or heart disease; since it should be recommended that the doctor check the blood pressure and heartbeat.
If the patient is a woman, she should be especially careful to wash the hands after using the product since if the product comes into contact with other parts of the body, there is a risk of hair growth in those areas.
If it comes in contact with the eyes, the patient must wash them with abundant water.
If the patient notices any other effect on the health or skin, stop treatment and consult the doctor.
Before beginning treatment with Minoxidil 5%w/v cutaneous solution, the doctor should conduct a complete check-up of the health.
Consult the doctor if any of the previous mentioned events has occurred to the patient at any time.
Use in subjects over 65 years of age and in children: The use of Minoxidil 5%w/v cutaneous solution is not recommended in the elderly or children as no studies have been carried out with those age groups.
Driving and using machines: There is no clinical data available regarding the possible effects of Minoxidil 5%w/v cutaneous solution on driving vehicles or using machines so any activities which require special concentration should be avoided until tolerance to the product has been ascertained.
Important information about some of the ingredients of Minoxidil 5%w/v cutaneous solution: Due to the presence of propylene glycol, Minoxidil 5%w/v cutaneous solution may cause irritation to the skin.
Ask the doctor or pharmacist for advice before taking any medicine.
Treatment with Minoxidil 5%w/v cutaneous solution is not recommended during pregnancy or breastfeeding.
Like all medicine, Minoxidil 5%w/v cutaneous solution can cause side effects.
The most frequently notified adverse reactions are itching (burning), dermatitis (reddening), dryness, irritation, eczema, and hypertrichosis (growth of hair on skin) which are generally of light-moderate intensity and disappear upon suspending treatment.
Nervous system disorders: Uncommon (≥1/1,000, <1/100): headache, paresthesia (feeling of numbness in arms and legs).
Eye disorders: Very rare (<1/10,000): alteration of sight and irritation.
Heart disorders: Uncommon (≥1/1,000, <1/100): tachycardia, palpitations, hypotension (lowering of blood pressure).
Skin and subcutaneous disorders: Common (≥1/100, <1/10): itching (burning), local irritation, contact dermatitis (reddening), dryness, and desquamation (flaking).
Uncommon (≥1/1,000, <1/100): erythematic rash (generalised reddening), eczema, alopecia, hypertrichosis (growth of hair and skin).
Rare (≥1/10,000, <1/1,000): pustular rash (generalised pustules) and acne.
If the patient notices these or any other side effects not listed, please tell the doctor or pharmacist.
Please tell the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without prescription since it could be necessary to interrupt the treatment of modify the dosage of some of them.
The combined administration of Minoxidil 5%w/v cutaneous solution with peripheral vasodilators and medications for the treatment of the blood pressure can produce a sudden fall in blood pressure. Also, it shouldn't be applied at the same time as other such topical products as corticoids, retinoids or occlusive ointments as they can increase its absorption.
How to use Minoxidil 5%w/v cutaneous solution: Follow these directions for use unless the doctor has advised others.
The doctor will establish the correct dosage and length of treatment for Minoxidil 5%w/v cutaneous solution. Do not interrupt treatment since data indicate that if treatment is interrupted after 3-4 months subjects can return to initial levels of alopecia.
Apply the solution on completely dry scalp, starting from the center of the area to be treated. Do not apply to other areas of the body.
As with other pharmaceutical products, response to treatment can vary from one subject to another and thus 4 months of treatment may be necessary before beginning to show hair growth.
Hands must be washed with abundant water after using Minoxidil 5%w/v cutaneous solution to avoid hair growth in unwanted areas.
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Please assemble the spray bottle according to the following steps: 1. Remove the spray pump parts (nozzle and pump) from the plastic bag.
2. Assemble the spray pump by pushing the bottom of the nozzle towards the top of the pump.
3. Remove the cap of Minoxidil 5% bottle by rotating it in anticlockwise direction. Then place the spray pump on the bottle neck and rotate the pump in clockwise direction to seal the bottle neck.
4. After the assembling of spray bottle, gently press the spray pump for 5 times to activate it before use.
D11AX01 - minoxidil ; Belongs to the class of other dermatologicals.
Cutaneous soln (bottle w/ dosage pump) 50 mg/mL (colourless to slightly coloured yellow-brown solution with alcohol odor) x 60 mL.