REGAXIDIL 50 mg/ml CUTANEOUS SOLUTION

2. What you need to know before starting to use Regaxidil 50 mg/ml

Do not useRegaxidil50 mg/ml

if you are allergic to minoxidil or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Regaxidil 50 mg/ml.

Before starting treatment with this medicine, your doctor will need to perform a complete clinical review.

• this medicine may cause a sudden drop in blood pressure in patients treated with peripheral vasodilators (medicines for the treatment of cerebrovascular disorders) and medicines for the treatment of blood pressure.
• the treated areas should not be exposed to the sun (even on cloudy days) or to ultraviolet lamps (UVA). It will be necessary to use specific protection on the treated area.
• due to its ethanol (alcohol) content, this medicine may cause skin irritation and dryness.

You should consult your doctor or pharmacist if it worsens or improves after 30 days.

Children and adolescents

This product should not be used in patients under 18 years of age, as no studies have been conducted in this population.

Other medicines andRegaxidil50 mg/ml

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

The concomitant administration of Regaxidil 50 mg/ml with peripheral vasodilators (medicines for the treatment of cerebrovascular disorders) and medicines for the treatment of blood pressure may cause a sudden drop in blood pressure.

Similarly, it should not be applied at the same time as other topical products such as corticosteroids, retinoids, or occlusive pomades, as they may increase its absorption.

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 medicine.

Treatment with Regaxidil 50 mg/ml is not recommended if you are pregnant or breastfeeding.

Driving and using machines

There are no data to suggest that treatment with this medicine may affect driving or using machines, however, avoid performing these tasks until you verify how you tolerate the medicine.

Regaxidil50 mg/ml contains ethanol at 96%

This medicine contains 455.5 mg of alcohol (ethanol) per milliliter.

It may cause a burning sensation on damaged skin.

There have been reports of excessive body hair growth in infants after skin contact with the application areas of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returned to normal within months when the infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with the 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 when using topical minoxidil products.

3. How to use Regaxidil 50 mg/ml

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Your doctor will determine the appropriate dose and duration of treatment with Regaxidil 50 mg/ml. Do not discontinue treatment before, as there are data indicating that if you discontinue treatment for 3-4 months, you may return to the initial state of alopecia you had before starting treatment.

• Wash your hands before application.
• The hair and scalp must be completely dry when applying the product.
• Apply 1 ml of solution, using the syringe or 10 sprays if using the dosing pump.
• Spread the amount of solution with your fingertips over the area to be treated, starting from the center of the same. Do not apply to other areas of the body, as there is a risk of hair growth in other areas of the body.
• After using Regaxidil 50 mg/ml, it is recommended to wash your hands with plenty of water to avoid hair growth in unwanted areas, especially if you are a woman.

As with other medicines, the degree of response to treatment depends on each patient, so it may be necessary to have a 4-month treatment before hair growth begins.

For topical use only. DO NOT INGEST.

The recommended daily dose is 1 ml of solution every 12 hours (dosage with the syringe or 10 sprays if using the dosing pump).

The maximum recommended daily dose is 2 ml.

The recommended daily dose should be respected regardless of the extent of alopecia.

Use in women

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

Use in patients over 65 years of age

This product is not recommended for patients over 65 years of age, as no studies have been conducted in this population.

If you use moreRegaxidil50 mg/ml than you should

If you have used more Regaxidil than you should, consult your doctor or pharmacist immediately.

Accidental or intentional overdose after applying minoxidil will cause an increase in the intensity of adverse effects of a dermatological nature, especially itching, dryness, skin irritation, and eczema (inflammatory skin condition).

The signs and symptoms after accidental or intentional ingestion of minoxidil may include, among others, hypotension (low blood pressure), tachycardia (rapid heart rate), edema (swelling, excessive fluid accumulation), and congestive heart failure (heart failure).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Regaxidil 50 mg/ml

Do not use a double dose to make up for forgotten doses.

• In the initial treatment period: Apply the forgotten dose as soon as possible and then follow the schedule recommended by your doctor.
• In the maintenance period: Apply the next dose as usual and continue your treatment.

If you interrupt treatment with Regaxidil 50 mg/ml

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

If you experience any symptoms, consult your doctor.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Immediately contact a doctor if you notice any of the following symptoms - you may need 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).

The most frequently reported side effects are pruritus (itching), dermatitis (redness), dryness, skin irritation, eczema (inflammatory skin condition), and hypertrichosis (hair growth on the skin), usually of mild to moderate intensity and reversible upon discontinuation of treatment.

Frequent(may affect up to 1 in 10 people):

• Pruritus (itching)
• Local skin irritation
• Contact dermatitis (redness)
• Dry skin
• Cutaneous exfoliation (skin peeling).

Uncommon(may affect up to 1 in 100 people):

• Headache and paresthesia (numbness sensation in arms or legs)
• Tachycardia (rapid heart rate)
• Palpitations and hypotension (low blood pressure)
• Erythematous rash (generalized redness)
• Eczema (inflammatory skin condition)
• Alopecia
• Hypertrichosis (hair growth on the skin).

Rare(may affect up to 1 in 1,000 people):

• Pustular rash (generalized pustules)
• Acne.

Very rare(may affect up to 1 in 10,000 people):

• Visual disturbance.
• Eye irritation.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Regaxidil 50 mg/ml

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Regaxidil 50 mg/ml

The active ingredient is minoxidil. Each milliliter (ml) of solution contains 50 mg of minoxidil. One ml is equivalent to 10 sprays.

The other components (excipients) are: Ethanol at 96%; glycerol; methoxyethylene polymer with 2-butenedioic acid, monobutyl ester; and purified water.

Appearance of the product and package contents

Regaxidil is a cutaneous solution. The solution is transparent, colorless, or slightly yellowish with an alcoholic odor.

It is available in multidose containers of 60 ml, 120 ml (2 bottles of 60 ml), 180 ml (3 bottles of 60 ml), and 240 ml (4 bottles of 60 ml) with a dosing pump and syringe.

Marketing authorization holder and manufacturer

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Date of the last revision of this leaflet:October 2024

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