Leaflet: information for the user

Regaxidil 50 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 isRegaxidil50 mg/ml and what it is used for

2. What you need to know before starting to useRegaxidil50 mg/ml

3. How to useRegaxidil50 mg/ml

4. Possible side effects

5. Storage ofRegaxidil50 mg/ml

6. Contents of the pack and additional information

Regaxidil is a solution for useon the scalpthat 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.

No useRegaxidil50 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 50 mg/ml.

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

• If you have any skin problems or wounds on your scalp, as it may absorb more of the product, so make sure they do not exist before application.
• If you have a history or are currently suffering from any vascular or heart disease, 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 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 your 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 wash 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 high blood pressure.
• Treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA). You will need to use specific protection on the treated area.
• Due to its ethanol content, this medication 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 medications andRegaxidil50 mg/ml

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

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

Similarly, 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 medication.

The treatment with Regaxidil 50 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 medication may affect driving vehicles or operating machinery, but be careful not to perform these tasks until you check how you tolerate the medication.

Regaxidil50 mg/ml contains ethanol at 96%

This medication contains 455.5 mg of alcohol (ethanol) in each ml.

It may cause a burning sensation on damaged skin.

Cases of excessive hair growth in infants have been reported after contact with the skin in areas where minoxidil was applied to patients (caregivers) using topical minoxidil. 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. 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 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 the tip of your fingers 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 50 mg/ml, it is recommended to wash your hands with abundant water to prevent hair growth in unwanted 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 50 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 condition).

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 50 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 50 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 questions 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):

- Pruritus (itching)

- Local skin irritation

- Contact dermatitis (redness)

- Dry skin

- Skin exfoliation (peeling of the skin).

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

- Headache and paresthesias (numbness in arms or legs)

- Tachycardia (rapid heartbeat)

- Palpitations and hypotension (low blood pressure)

- Erythematous rash (generalized redness)

- Eczema (inflammatory skin condition)

- Alopecia

- Hirsutism (excessive hair growth on the skin).

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

- Generalized pustular rash

- Acne.

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

- Visual disturbances.

- Eye irritation.

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 Medicinal Products 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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; methoxyethoxy polymer with 2-butendioic acid, monobutyl ester, and purified water.

Appearance of the product and contents 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), 180 ml (3 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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/