Minoxidil Cinfa 50 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MINOXIDIL CINFA 50 mg/ml cutaneous solution

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

Follow exactly the instructions for use provided 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 30 days.

Contents of the leaflet

1. What MINOXIDIL CINFA is and what it is used for
2. What you need to know before using MINOXIDIL CINFA
3. How to use MINOXIDIL CINFA
4. Possible adverse effects
5. How to store MINOXIDIL CINFA
6. Contents of the pack and other information

1. What MINOXIDIL CINFA is and what it is used for

MINOXIDIL CINFA 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 medicinal product is indicated for the treatment of moderate hair loss of androgenic origin in adults.

2. What you need to know before using MINOXIDIL CINFA

Do not use MINOXIDIL CINFA

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use MINOXIDIL CINFA.

• If you have any skin problems or wounds on the scalp, as this may increase absorption of the product; ensure such conditions are not present before applying the product.
• If your scalp is red, swollen, infected, irritated, or painful, or if you are using other scalp medications.
• If you do not have a family history of hair loss, if hair loss is sudden and/or irregular, if hair loss occurred after childbirth, or if the cause of hair loss is unknown.
• If you have a history of, or currently suffer from, any blood vessel or heart disease, as your doctor should monitor your blood pressure and heart rate.
• If you experience low blood pressure, chest pain, increased heart rate, palpitations, fainting or dizziness, unexplained sudden weight gain, swelling of hands or feet, persistent redness or irritation of the scalp, you should stop treatment and contact your doctor.
• If you are a woman, you must be especially careful 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.
• This medicine must not come into contact with the eyes. If contact occurs, rinse thoroughly with plenty of water.
• If you notice any other effects on your general condition or on your skin, stop treatment and consult your doctor or pharmacist.
• Do not expose treated areas to sunlight (even on cloudy days) or to ultraviolet (UVA) lamps.
• Accidental ingestion may cause serious cardiac adverse effects. Therefore, this product must be kept out of the reach of children.

Cases of excessive body hair growth in infants have been reported following skin contact with areas where minoxidil was applied on patients (caregivers) using topical minoxidil. Excessive hair growth resolved within months once 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 observe 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 in children or adolescents, as studies have not been conducted in these populations.

Before starting treatment with MINOXIDIL CINFA, your doctor should perform a complete clinical evaluation.

Other medicines and MINOXIDIL CINFA

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

Concomitant use of MINOXIDIL CINFA with peripheral vasodilators (medicines used to treat cerebrovascular disorders) and medicines for treating blood pressure may cause a sudden drop in blood pressure.

Also, do not apply at the same time as other topical products such as tretinoin, anthralin, or betamethasone dipropionate, as they may alter the amount of minoxidil absorbed into the bloodstream.

Pregnancy, breastfeeding 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 MINOXIDIL CINFA is not recommended if you are pregnant or breastfeeding.

Driving and use of machines

It is unlikely to have any effect.

MINOXIDIL CINFA contains propylene glycol (E-1520) and ethanol (96%)

This medicine contains 520 mg of propylene glycol (E-1520) per ml.

Propylene glycol may cause skin irritation.

Do not use on open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.

This medicine contains 243 mg of alcohol (ethanol) per ml. It may cause a burning sensation on damaged skin.

Products containing ethanol, which is a flammable substance, must not be used near open flames, lit cigarettes, or certain devices (e.g., hair dryers).

3. How to use MINOXIDIL CINFA

Follow exactly the administration instructions contained in this leaflet or indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

• Wash your hands before application.
• Hair and scalp must be completely dry when applying the product.
• Apply 1 ml of solution using the dosing pump (each ml corresponds to 10 sprays) twice daily, in the morning and at night.
• Spread the amount of solution with your fingertips over the area to be treated, starting from the center. Do not apply to other areas of the body.
• Do not use a hair dryer to accelerate drying of the product.
• The daily dose must not exceed 2 ml, regardless of the extent of the bald area to be treated.
• Wash your hands thoroughly after application to avoid unwanted hair growth in other body areas.

As with other medicines, the degree of response to treatment depends on each individual patient; therefore, it may be necessary to undergo 4 months of treatment before hair starts to grow.

The recommended daily dose must be respected regardless of the extent of alopecia. Do not increase the dose or frequency of application.

Your doctor or pharmacist will advise you on the duration of your treatment with MINOXIDIL CINFA. Do not stop treatment prematurely, as there is evidence that if treatment is discontinued for 3–4 months, you may revert to the initial state of alopecia you had before starting treatment.

Use of the dosing pump

Remove the cap from the bottle and unscrew the closure plug. Attach the dosing pump by screwing it onto the bottle.

For application: direct the pump toward the center of the area to be treated. Press and spread the product with your fingertips to cover the entire area to be treated.

As with other medicines, the degree of response to treatment depends on each individual patient; therefore, it may be necessary to undergo 4 months of prior treatment before hair starts to grow.

Dosage

For topical use only.

The recommended daily dose is 1 ml of solution every 12 hours (each ml corresponds to 10 sprays), starting from the center of the area to be treated.

The recommended daily dose must be respected regardless of the extent of alopecia. Do not increase the dose or frequency of application.

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

If you feel that the effect of MINOXIDIL CINFA is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This product must not be used in patients under 18 years of age, as the safety and efficacy of MINOXIDIL CINFA have not been established in this population.

Use in patients over 65 years of age

The use of MINOXIDIL CINFA is not recommended in patients over 65 years of age, as studies have not been conducted in this population.

If you use more MINOXIDIL CINFA than you should

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

Accidental or intentional overdose following topical application of MINOXIDIL CINFA may increase the intensity 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 CINFA 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use MINOXIDIL CINFA

• During the initial treatment period:

Apply the missed dose as soon as possible, then continue with the schedule recommended by your doctor or pharmacist. Do not use a double dose to make up for missed doses.

• During the maintenance period:

Apply the next dose as usual and continue your treatment.

If you stop using MINOXIDIL CINFA

Stopping treatment for 3–4 months may cause you to revert to the initial state of alopecia present before starting treatment.

If any of the described symptoms occur, consult your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Contact a doctor immediately if you notice any of the following symptoms, as 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).

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

Uncommon (may affect up to 1 in 100 people)

• Paresthesia (numbness or tingling sensations in arms or legs)
• Rash (generalized redness)
• Eczema (inflammatory skin condition)
• Hypertrichosis (excessive hair growth on the skin)
• Pruritus (itching)
• Local skin irritation
• Skin dryness
• Skin exfoliation (peeling of the skin)
• Temporary hair loss
• Changes in hair texture
• Changes in hair color

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

• Headache
• Tachycardia (increased heart rate)
• Palpitations (drop in blood pressure)
• Chest pain

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

• Vision disturbance
• Eye irritation
• Hypotension (low blood pressure)
• Pustular rash (generalized pustules)
• Acne
• Contact dermatitis (redness)
• Erythema at the application site

Frequency not known (cannot be estimated from available data)

• Dyspnea (difficulty breathing)
• Depression
• Peripheral edema
• Musculoskeletal pain

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MINOXIDIL CINFA

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

This medicine does not require any special storage conditions.

The solution should be used within a maximum of 2 months after first opening the 60 ml container and within a maximum of 4 months for the 120 ml container.

Do not use this medicine after the expiry date stated on the packaging after 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and additional information

Composition of MINOXIDIL CINFA

• The active substance is minoxidil. Each ml of solution contains 50 mg of minoxidil. One ml corresponds to 10 sprays.
• The other components (excipients) are: ethanol 96%, propylene glycol and purified water.

Appearance of the product and contents of the container

MINOXIDIL CINFA is a transparent, colorless solution for topical use with an alcoholic odor, available in 60 ml, 120 ml (1 bottle of 120 ml), 180 ml (3 bottles of 60 ml), and 240 ml (2 bottles of 120 ml) containers equipped with a dosing pump.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Serra Pamies, S.A.

Carretera de Castellvell, 24

43206 Reus (Tarragona) – Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of latest review of this leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/