Dinaxil 50 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dinaxil 50 mg/ml Topical Solution
Minoxidil
Read the entire package leaflet carefully before you start using this medicine, because it contains important additional information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
You should consult your doctor if your condition worsens or if there is no improvement after 30 days.
Contents of the package leaflet
- What Dinaxil is and what it is used for
- What you need to know before using Dinaxil
- How to use Dinaxil
- Possible adverse effects
- How to store Dinaxil
- Contents of the pack and other information
1. What Dinaxil is and what it is used for
Dinaxil is a solution for topical use on the scalp skin that stimulates hair growth in individuals with androgenetic alopecia (the most common type of baldness) when applied cutaneously.
This medicine is indicated for the treatment of moderate hair loss of androgenetic origin.
2. What you need to know before using Dinaxil
Do not use Dinaxil
- if you are allergic (hypersensitive) to minoxidil or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Dinaxil, your doctor should perform a complete clinical examination. Talk to your doctor or pharmacist before starting to use this medicine.
- if you have any skin problems or wounds on the scalp, as this may increase absorption of the product; therefore, ensure these are not present before application.
- if you have a history of, or currently suffer from, any blood vessel (circulatory) 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 condition or on your skin, stop treatment and consult 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, since if the product comes into contact with other parts of the body, there is a risk of unwanted hair growth in other areas.
- if this medicine comes into contact with your eyes or mucous membranes, rinse thoroughly 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 used to treat cerebrovascular disorders) and medicines for treating high blood pressure.
- treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet (UVA) lamps. It is necessary to use 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 your condition worsens or if there is no improvement after 30 days.
Cases of excessive body hair growth in infants have been reported following skin contact with areas where minoxidil had been applied on patients (caregivers) using topical minoxidil. The excessive hair growth resolved within a few months once the infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.
Consult your doctor if you notice excessive body hair growth in your child during your use of topical minoxidil products.
Children and adolescents
The use of this medicine is not recommended, as studies have not been conducted in this population (see section 3).
Use of Dinaxil with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Concomitant administration of Dinaxil with peripheral vasodilators (medicines used to treat cerebrovascular disorders) and medicines for treating high blood pressure may cause a sudden drop in blood pressure.
Also, it should not be applied simultaneously with other topical products such as corticosteroids, retinoids, or occlusive ointments, as these may increase its absorption.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Treatment with Dinaxil is not recommended if you are pregnant or breastfeeding.
Driving and using machines
There are no data suggesting that treatment with this medicine may affect the ability to drive or operate machinery. Nevertheless, avoid performing these activities until you know how you tolerate the medicine.
Dinaxil contains propylene glycol
This medicine may cause skin irritation because it contains propylene glycol.
3. How to use Dinaxil
Follow these instructions unless your doctor has given you different ones.
Your doctor will determine the appropriate dose and duration of treatment with Dinaxil.
Do not stop the treatment prematurely, as there is evidence that discontinuing treatment for 3–4 months may result in a return to the initial state of hair loss you had before starting treatment.
For topical use only. DO NOT ingest.
Instructions for use:
- Wash your hands before application.
- Hair and scalp must be completely dry when applying the product.
- Apply 1 ml of solution, corresponding to 10 actuations of the dosing pump.
- Spread the solution evenly over the affected area using the fingertips, starting from the center. Do not apply to other areas of the body, as there is a risk of unwanted hair growth in other areas.
- After using Dinaxil, wash your hands thoroughly with plenty of water to avoid unwanted hair growth, especially if you are a woman.
As with other medications, the degree of response to treatment depends on the individual patient. Therefore, it may take up to 4 months of treatment before hair growth begins.
Dosage
The recommended daily dose is 1 ml of solution every 12 hours. Each ml corresponds to 10 actuations of the dosing pump.
The maximum recommended daily dose is 2 ml (20 actuations).
The recommended daily dose should be followed regardless of the extent of hair loss.
If you feel that the effect of Dinaxil is too strong or too weak, inform 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 medicine 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 recommended, consult your doctor or pharmacist immediately.
Accidental or intentional overdose following topical application of minoxidil 50 mg/ml may increase the severity of dermatological adverse effects, especially pruritus (itching), dryness, skin irritation, and eczema (acute or chronic inflammatory skin condition).
Signs and symptoms following accidental or intentional ingestion of minoxidil 50 mg/ml may include, among others, hypotension (low blood pressure), tachycardia (increased 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, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
Information for healthcare professionals: Management of the resulting condition requires the use of diuretics for edema, beta-blockers or other sympathetic nervous system inhibitors for tachycardia, and intravenous isotonic sodium chloride solution for hypotension. Sympathomimetic agents such as adrenaline and noradrenaline should be avoided due to the risk of excessive cardiac stimulation.
If you forget to use Dinaxil
- During the initial treatment period:
Apply the missed dose as soon as possible, then continue with your prescribed schedule. Do not use a double dose to make up for a missed dose.
- During the maintenance period:
Apply the next dose as usual and continue your treatment.
If you stop treatment with Dinaxil
Discontinuing treatment for 3–4 months may cause you to revert to the initial state of hair loss that existed before treatment began.
If any of the described symptoms occur, consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Contact a doctor immediately if you experience 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 not known, cannot be estimated from available data).
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The most frequently reported adverse effects are pruritus (itching), dermatitis (redness), dryness, skin irritation, eczema (inflammatory skin condition), hypertrichosis (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 (skin peeling)
Uncommon (may affect up to 1 in 100 people):
- Headache and paresthesia (numbness or tingling sensation in arms or legs)
- Tachycardia (increased heart rate)
- Palpitations and hypotension (low blood pressure)
- Erythematous rash (generalized redness)
- Eczema (inflammatory skin condition)
- Alopecia
- Hypertrichosis (excessive 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):
- Vision disturbance
- Eye irritation
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dinaxil
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use Dinaxil after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dinaxil
The active substance is minoxidil. Each millilitre (ml) of solution contains 50 mg of minoxidil. One ml corresponds to 10 sprays.
The other components (excipients) are: 96% ethanol, propylene glycol and purified water.
Appearance of the product and contents of the container:
Dinaxil is a solution for cutaneous use. The solution is clear with an alcoholic odour. It is available in 60 ml and 120 ml (2 bottles of 60 ml) packs, supplied with one bag containing a metering pump, and in 180 ml (3 bottles of 60 ml) and 240 ml (4 bottles of 60 ml) packs, supplied with two bags each containing a metering pump.
Marketing Authorisation Holder and Manufacturer:
LABORATORIOS SERRA PAMIES, S.A.
Carretera de Castellvell, 24
43206 REUS (Tarragona)
Date of the most recent revision of this leaflet:
January 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/