Leaflet: information for the user

Regaxidil 20 mg/ml topical solution

minoxidil

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any 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 it worsens or does not improve after 30 days.

1. What isRegaxidil 20 mg/mland what it is used for

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

3. How to useRegaxidil 20 mg/ml

4. Possible side effects

5. Storage ofRegaxidil 20 mg/ml

6. Contents of the pack and additional information

Regaxidil is a solution for useon the scalp skinthat 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.

Do not use Regaxidil 20 mg/ml

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

Warnings and precautions

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

A complete clinical review by your doctor will be necessary before starting treatment with this medicine.

• if you have any skin problems or wounds on the scalp, as it may absorb more of the product, so make sure these do not exist before application.
• if you have a history or are currently suffering from any vascular or heart disease, as it would be recommended that your doctor monitor your blood pressure and heart rate.
• if you notice any other effects on your general state or skin, interrupt treatment and consult your doctor or pharmacist.
• if you are a woman, you must 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 medicine comes into contact with your eyes or mucous membranes, you should rinse them 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 for the treatment of cerebrovascular disorders) and blood pressure medicines.
• the treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA). You will need to use a specific protection on the treated area.
• due to its ethanol content, this medicine may cause skin irritation and dryness.

You should consult your doctor or pharmacist if you worsen or improve after 30 days.

Children and adolescents

This product should not be used in patients under 18 years old, as no studies have been conducted on them.

Other medicines and Regaxidil 20 mg/ml

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

The concomitant administration of Regaxidil 20 mg/ml with peripheral vasodilators (medicines for the treatment of cerebrovascular disorders) and blood pressure medicines may cause a sudden drop in blood pressure.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The treatment with Regaxidil 20 mg/ml is not recommended if you are pregnant or breastfeeding.

Driving and operating machinery

There is no evidence to suggest that treatment with this medicine may affect driving vehicles or operating machinery, but be careful not to do these tasks until you check how you tolerate the medicine.

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

This medicine contains 104 mg of propylene glycol in each ml.

Propylene glycol may cause skin irritation.

This medicine contains 564 mg of alcohol (ethanol) in each ml.

It may cause a burning sensation on damaged skin.

There have been reported cases of excessive hair growth in infants after contact with the skin areas where minoxidil was applied on patients (caregivers) who used topical minoxidil. Excessive hair growth normalized within months when infants stopped being exposed to minoxidil. Be cautious to ensure that children do not come into contact with 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 in which you use topical products with minoxidil.

Follow exactly the medication administration instructions contained in this leaflet or those 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 beforehand, as there is data that if you discontinue treatment for 3-4 months, you may return to your initial state of alopecia 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, with the help of the syringe or 10 sprays if using the dosing pump.
• Extend the amount of solution with your finger tip over the area to be treated, starting from the center of the same. Do not apply it 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 abundant water to avoid hair growth in undesired areas, especially if you are a woman.

Like other medications, the degree of response to treatment depends on each patient, so it may be necessary to have a previous treatment of 4 months before hair growth begins.

For topical use only. DO NOT INGEST.

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

The maximum recommended daily dose is 2 ml.

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

Use in women

If you are a woman, you must 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 old

This product is not recommended for patients over 65 years old, 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 produce an increase in the intensity of dermatological adverse effects, especially itching, dryness, skin irritation, and eczema (acute or chronic inflammatory skin disease).

The signs and symptoms after accidental or intentional ingestion of minoxidil may be, among others, hypotension (low blood pressure), tachycardia (rapid heart rate), edema (swelling, excessive accumulation of fluid), 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Regaxidil 20 mg/ml

Do not use a double dose to compensate for the missed doses.

• In the initial treatment period: Apply the missed 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

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

If symptoms appear, consult your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Seek immediate medical attention 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 unknown, cannot be estimated from available data).

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

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

• Local skin irritation (peeling and redness)
• Contact dermatitis
• Skin dryness
• Edema (excessive fluid accumulation)
• Burning and stinging sensation on the skin
• Hirsutism (excessive hair growth on the skin)

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

• Allergic reactions
• Eczema (inflammatory skin condition)
• Headache and paresthesias (numbness in arms or legs)
• Dizziness, weakness, and discomfort
• Neuritis (nerve inflammation) and altered taste
• Irritation of the eyes, altered vision
• Otitis (ear inflammation) (particularly external otitis)

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

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 content of the packaging

Regaxidil is a topical solution. The solution is transparent, colorless, or slightly yellowish with an alcohol odor.

It is presented in multi-dose containers of 60 ml, 120 ml (2 containers of 60 ml), and 240 ml (4 containers of 60 ml) provided with a dosing pump and syringe.

Holder of the marketing authorization and responsible for manufacturing

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Last review date of this leaflet:October 2024

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