Leaflet: information for the user

Dinaxil 50mg/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 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 your doctor if you get worse or do not improve after 30 days.

1. What is Dinaxil and what it is used for

2. What you need to know before starting to use Dinaxil

3. How to use Dinaxil

4. Possible side effects

5. Storage of Dinaxil

6. Contents of the pack and additional information

Dinaxil is a solution for topical use on the scalp 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.

Do not use Dinaxil

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

Warnings and precautions

Before starting treatment with Dinaxil, your doctor will need to perform a complete clinical review. Consult your doctor or pharmacist before starting to use 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 its application. if you have a history or are currently suffering from any vascular disease (circulation) 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 state or skin, interrupt treatment and consult with your doctor or pharmacist.
• if you are a woman, you must take special care 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 wash 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 medications.
• 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 (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.

cases of excessive hair growth on the body have been reported in infants after contact with the skin in areas where minoxidil was applied to patients (caregivers) who used topical minoxidil. The hair growth normalized within months when the infants stopped being exposed to minoxidil. You should take precautions 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.

Children and adolescents

use of this medicine is not recommended as no studies have been conducted in this population (see section 3).

Use ofDinaxil with other medicines

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

the concomitant administration of Dinaxilwith peripheral vasodilators (medicines for the treatment of cerebrovascular disorders) and blood pressure medications 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, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

treatment with Dinaxilis not recommended if you are pregnant or breastfeeding

Driving and operating machinery

there is no evidence to suggest that treatment with this medicine can affect your ability to drive vehicles or use machines, however, be sure not to perform these tasks until you check how you tolerate the medicine.

Dinaxil contains propylene glycol

this medicine may cause skin irritation because it contains propylene glycol.

Follow these instructions unless your doctor has given you different instructions.

Your doctor will determine the appropriate dose and duration of treatment with Dinaxil.

Do not stop treatment as there is data indicating that if you stop treatment for 3-4 months, you may return to your initial state of alopecia before starting treatment.

For topical use only. Do not ingest.

Usage instructions:

• Wash your hands before application.
• The hair and scalp must be completely dry when applying the product.
• Apply 1 ml of solution corresponding to 10 sprays from 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 it to other areas of the body as there is a risk of hair growth in other areas of the body.
• After using Dinaxil, it is recommended to wash your hands with plenty of water to avoid 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 4-month pre-treatment before hair growth begins.

Dosage

The recommended daily dose is 1 ml of solution every 12 hours. Each ml corresponds to 10 sprays from the dosing pump.

The maximum recommended daily dose is 2 ml (20 sprays).

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

If you estimate that the action of Dinaxil is too strong or too weak, inform your doctor or pharmacist.

Use in patients over 65 years old

This product should not be used in patients over 65 years old, as the safety and efficacy of Dinaxil have not been established in this population.

Use in children and adolescents

This medication should not be used in patients under 18 years old, as the safety and efficacy of Dinaxil have not been established in this population.

If you use more Dinaxil than you should

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

Accidental or intentional overdose of topical minoxidil 50 mg/ml will produce an increase in the intensity of dermatological adverse effects, especially pruritus, dryness, skin irritation, and eczema.

The signs and symptoms after accidental or intentional ingestion of minoxidil 50 mg/ml may include, among others, hypotension, tachycardia, edema, and congestive 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.

Information for healthcare professionals:The treatment of the condition developed requires the use of diuretics for edema, beta-blockers or other inhibitors of the sympathetic nervous system for tachycardia, and sodium chloride in isotonic solution intravenously for hypotension. Sympathomimetics, such as adrenaline and noradrenaline, should be avoided due to cardiac overstimulation.

If you forgot to use Dinaxil

-In the initial treatment period:

Apply the missed dose as soon as possible and then follow the schedule recommended by your doctor. Do not use a double dose to compensate for the missed doses.

-In the maintenance period:

Apply the next dose as usual and continue your treatment.

If you interrupt treatment with Dinaxil

Stopping 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.

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 severe allergic reaction (frequency unknown, cannot be estimated from available data).

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

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)

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

- Headache and paresthesia (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 experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:https://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 Dinaxil after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dinaxil

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: 96% ethanol, propylene glycol, and purified water.

Appearance of the product and contents of the packaging:

Dinaxil is a topical solution. The solution is transparent with an alcohol odor. It is available in formats of 60 ml and 120 ml (2 bottles of 60 ml) provided with a bag containing a dosing pump, and in formats of 180 ml (3 bottles of 60 ml) and 240 ml (4 bottles of 60 ml) provided with two bags containing a dosing pump each.

Holder of the marketing authorizationand responsible for manufacturing:

Laboratorios Serra Pamies, S.A.

Carretera de Castellvell, 24

43206 Reus (Tarragona)

Date of the last review of this leaflet:

January 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/