DINAXIL 50 mg/ml CUTANEOUS SOLUTION

1. What is Dinaxil and what is it used for

Dinaxil 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 Dinaxil

Do not use Dinaxil

• if you are allergic (hypersensitive) to minoxidil or any of the other components of this medication (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 medication.

• 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 are currently suffering 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 to ultraviolet (UVA) lamps. 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.

There have been reports of excessive body hair growth in infants after skin contact with the application areas of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returned to normal within a few months when 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 using topical minoxidil products.

Children and Adolescents

The use of this medication is not recommended, as studies have not been conducted in this population (see section 3).

Using Dinaxil with other medications

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

The concomitant administration of Dinaxil 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 its 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 Dinaxil 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 your ability to drive vehicles or operate machinery; however, do not perform these tasks until you have verified how you tolerate the medication.

Dinaxil contains propylene glycol

This medication may cause skin irritation because it contains propylene glycol.

3. How to use Dinaxil

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 prematurely, as there are data indicating that if you stop treatment for 3-4 months, you may return to your initial state of alopecia before starting treatment.

For cutaneous use only. DO NOT INGEST.

Instructions for use:

• Wash your hands before application.
• The hair and scalp must be completely dry before applying the product.
• Apply 1 ml of solution, which corresponds 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.

As with other medications, the degree of response to treatment depends on each patient; therefore, it may be necessary to have a 4-month treatment period before hair growth begins.

Dosage

The recommended daily dose is 1 ml of the 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 recommended daily dose should be respected, regardless of the extent of alopecia.

If you think the effect of Dinaxil is too strong or too weak, tell your doctor or pharmacist.

Use in patients over 65 years of age

This product should not be used in patients over 65 years of age, 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 of age, 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 after topical application of minoxidil 50 mg/ml will cause an increase in the intensity of adverse effects of a dermatological nature, especially pruritus (itching), dryness, skin irritation, and eczema (inflammatory skin condition).

The signs and symptoms after accidental or intentional ingestion of minoxidil 50 mg/ml may include, among others, hypotension (low blood pressure), tachycardia (rapid heart rate), edema (swelling, 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.

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

If you forget 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 make up for missed doses.

• In the maintenance period:

Apply the next dose as usual and continue your treatment.

If you interrupt treatment with Dinaxil

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

If you experience the described 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

Contact a doctor immediately 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).

Like all medications, this medication can cause side effects, although not everyone experiences them.

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):

• Pruritus (itching)
• Local skin irritation
• Contact dermatitis (redness)
• Dry skin
• Cutaneous exfoliation (skin peeling)

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

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

• Visual disturbances
• Eye irritation

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 package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dinaxil

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 stated on the packaging after the abbreviation 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 SIGRE collection point in your pharmacy. 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. Contents of the packaging and additional information

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

Appearance of the product and packaging contents:

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

Marketing authorization holder and manufacturer:

LABORATORIOS SERRA PAMIES, S.A.

Carretera de Castellvell, 24

43206 REUS (Tarragona)

Date of the last revision of this package leaflet:

January 2025

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