Regaxidil 50 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Regaxidil 50 mg/ml topical solution

minoxidil

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 30 days.

Contents of the leaflet

1. What Regaxidil 50 mg/ml is and what it is used for
2. What you need to know before using Regaxidil 50 mg/ml
3. How to use Regaxidil 50 mg/ml
4. Possible adverse effects
5. How to store Regaxidil 50 mg/ml
6. Contents of the pack and other information

1. What Regaxidil 50 mg/ml is and what it is used for

Regaxidil is a solution for topical application to the scalp skin that stimulates hair growth in individuals with androgenetic alopecia (the most common type of baldness) when applied cutaneously.

This medicinal product is indicated for the treatment of moderate hair loss of androgenetic origin.

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

Do not use Regaxidil 50 mg/ml

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

Warnings and precautions

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

Before beginning treatment with this medicine, your doctor must perform a complete clinical examination.

• if you have any skin problems or wounds on the scalp, as this may increase absorption of the product; therefore, ensure these are not present before applying the medicine.
• if you have a history of, or currently suffer from, any blood vessel (circulatory) or heart disease, as it would be advisable for your doctor to monitor your blood pressure and heart rate.
• if you notice any other effects on your general condition or on your skin, stop treatment and consult your doctor or pharmacist.
• if you are a woman, take special care to wash your hands after applying the product to the scalp, since if the product comes into contact with other parts of the body, there is a risk of unwanted hair growth in other areas.
• if this medicine comes into contact with your eyes or mucous membranes, rinse thoroughly with plenty of water. Consult an ophthalmologist if necessary.
• this medicine may cause a sudden drop in blood pressure in patients treated with peripheral vasodilators (medicines used to treat cerebrovascular disorders) and medicines for the treatment of high blood pressure.
• treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet (UVA) lamps. Adequate protection of the treated area is required.
• due to its ethanol (alcohol) content, this medicine may cause skin irritation and dryness.

You should consult your doctor or pharmacist if your condition worsens or if there is no improvement after 30 days.

Children and adolescents

This product must not be used in patients under 18 years of age, as studies have not been conducted in this population.

Other medicines and Regaxidil 50 mg/ml

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use of Regaxidil 50 mg/ml with peripheral vasodilators (medicines used to treat cerebrovascular disorders) and medicines for the treatment of high blood pressure may cause a sudden drop in blood pressure.

Also, do not apply this medicine at the same time as other topical products such as corticosteroids, retinoids, or occlusive ointments, as they may increase its absorption.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 use of machines

There are no data suggesting that treatment with this medicine may impair your ability to drive or operate machinery. Nevertheless, avoid such activities until you know how you tolerate the medicine.

Regaxidil 50 mg/ml contains ethanol at 96%

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

It may cause a burning sensation on damaged skin.

Cases of excessive body hair growth in infants have been reported following skin contact with areas where minoxidil was applied on patients (caregivers) using topical minoxidil. Excessive hair growth resolved within months once infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.

Consult your doctor if you observe excessive body hair growth in your child during your use of topical minoxidil products.

3. How to use Regaxidil 50 mg/ml

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Your doctor will determine the appropriate dose and duration of treatment with Regaxidil 50 mg/ml. Do not stop treatment prematurely, as there is evidence that discontinuing treatment for 3–4 months may result in a return to the initial state of alopecia you had before starting treatment.

• Wash your hands before application.
• 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 solution evenly over the affected area using the fingertips, starting from the center. Do not apply to other areas of the body, as there is a risk of unwanted hair growth in other body areas.
• After using Regaxidil 50 mg/ml, wash your hands thoroughly with plenty of water to avoid unwanted hair growth, especially if you are a woman.

As with other medications, the response to treatment varies from patient to patient; therefore, it may take up to 4 months of initial treatment before hair growth begins.

For topical use only. DO NOT ingest.

The recommended daily dose is 1 ml of solution every 12 hours (administered 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 followed regardless of the extent of alopecia.

Use in women

If you are a woman, you must take special care to wash your hands after applying the product to the scalp, as contact of the product with other parts of the body may result in unwanted hair growth in other areas.

Use in patients over 65 years of age

This product is not recommended for patients over 65 years of age, as studies have not been conducted in this population.

If you use more Regaxidil 50 mg/ml than you should

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

Accidental or intentional overdose following minoxidil application may increase the severity of dermatological adverse effects, particularly itching, dryness, skin irritation, and eczema (acute or chronic inflammatory skin condition).

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 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 a missed dose.

• During the initial treatment period: Apply the missed dose as soon as possible, then continue with the dosing schedule prescribed by your doctor.
• During the maintenance period: Apply the next dose as usual and continue your treatment.

If you stop treatment with Regaxidil 50 mg/ml

Stopping treatment for 3–4 months may cause you to revert to the initial state of alopecia you had before treatment began.

If any of the described symptoms occur, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 swallowing or breathing. This could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from available data).

The most commonly reported adverse effects are pruritus (itching), dermatitis (redness), dryness, skin irritation, eczema (inflammatory skin condition), and hypertrichosis (excessive hair growth on the skin), generally mild to moderate in 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
• Skin exfoliation (skin peeling)

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

• Headache and paresthesia (numbness or tingling sensation in arms or legs)
• Tachycardia (increased heart rate)
• Palpitations and hypotension (low blood pressure)
• Erythematous rash (generalized redness)
• Eczema (inflammatory skin condition)
• Alopecia
• Hypertrichosis (excessive 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):

• Vision disturbance
• Eye irritation

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or in household waste. Unwanted medicines and their containers should be taken to a SIGRE collection point at a pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Regaxidil 50 mg/ml

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

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

Appearance of the product and contents of the pack

Regaxidil is a cutaneous solution. The solution is clear, 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), supplied 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 most recent review of this leaflet: October 2024

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