REGAXIDIL 20 mg/ml CUTANEOUS SOLUTION

Introduction

Leaflet: Information for the User

Regaxidil 20 mg/ml Cutaneous Solution

minoxidil

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 30 days.

Contents of the Leaflet

1. What is Regaxidil 20 mg/ml and what is it used for
2. What you need to know before starting to use Regaxidil 20 mg/ml
3. How to use Regaxidil 20 mg/ml
4. Possible side effects
5. Storage of Regaxidil 20 mg/ml
6. Package contents and additional information

1. What is Regaxidil 20 mg/ml and what is it used for

Regaxidil is a solution for use on the scalp skin that stimulates hair growth in individuals with androgenetic alopecia (the most common type of baldness) when applied topically.

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

2. What you need to know before starting to use Regaxidil 20 mg/ml

Do not use Regaxidil 20 mg/ml

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Regaxidil 20 mg/ml.

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

• if you have any skin problems or wounds on the scalp, as more product may be absorbed, so you should ensure that these do not exist before application.
• if you have a history of or currently suffer from any vascular (circulatory) or heart disease, as it is recommended that your doctor monitor your blood pressure and heart rate.
• if you notice any other effect on your general condition or skin, interrupt treatment and consult your doctor or pharmacist.
• 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.
• if this medication comes into contact with your eyes or mucous membranes, you should rinse them with plenty of water. Consult an ophthalmologist if necessary.
• this medication may cause a sudden drop in blood pressure in patients treated with peripheral vasodilators (medications for the treatment of cerebrovascular disorders) and medications for the treatment of blood pressure.
• the treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA). It will be necessary to use specific protection on the treated area.
• due to its ethanol (alcohol) content, this medication may cause skin irritation and dryness.

You should consult your doctor or pharmacist if your condition 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 medications and Regaxidil 20 mg/ml

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

The concomitant administration of Regaxidil 20 mg/ml with peripheral vasodilators (medications for the treatment of cerebrovascular disorders) and medications 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 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 medication.

Treatment with Regaxidil 20 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 medication may affect driving or using machinery; however, avoid performing these tasks until you verify how you tolerate the medication.

Regaxidil 20 mg/ml contains propylene glycol (E-1520) and ethanol at 96%

This medication contains 104 mg of propylene glycol per milliliter.

Propylene glycol may cause skin irritation.

This medication contains 564 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 contact with the skin of caregivers who used topical minoxidil. Hair growth returned to normal within months after 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 you are using topical minoxidil products.

3. How to use Regaxidil 20 mg/ml

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Your doctor will determine the appropriate dose and duration of treatment with Regaxidil 20 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 before 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 area. 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 20 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 medications, the degree of response to treatment depends on each patient; therefore, a treatment period of 4 months may be necessary before hair growth begins.

For cutaneous 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 more Regaxidil 20 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 application of 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 (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 medication and the amount ingested.

If you forget to use Regaxidil 20 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 20 mg/ml

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

If you experience any symptoms, consult your doctor.

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

4. Possible side effects

Like all medications, this medication may cause side effects, although not all people experience 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):

• Local skin irritation (scaling and redness)
• Contact dermatitis
• Dry skin
• Edema (excessive fluid accumulation)
• Burning sensation and itching on the skin
• Hypertrichosis (hair growth on the skin)

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

• Allergic reactions
• Eczema (inflammatory skin condition)
• Headache and paresthesia (numbness sensation in arms or legs)
• Dizziness, weakness, malaise
• Neuritis (nerve inflammation) and altered taste
• Eye irritation, vision changes
• Otitis (ear inflammation) (particularly external otitis)

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

• Changes in blood pressure and heart rate
• Alopecia, uneven hair
• Chest pain

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: http://www.aemps.gob.es/

5. Storage of Regaxidil 20 mg/ml

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Regaxidil 20 mg/ml

The active ingredient is minoxidil. Each milliliter (ml) of solution contains 20 mg of minoxidil. One ml is equivalent to 10 sprays.

The other components (excipients) are: ethanol at 96%, propylene glycol, 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), 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 medication is available on the Spanish Medicines and Health Products Agency (AEMPS) website: http://www.aemps.gob.es/