Label: information for the user

MINOXIDIL CINFA 50 mg/ml topical solution

Read this label carefully before starting to use this medicine, as it contains important information for you

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist

• Keep this label, 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 not listed in this label. See section 4.
• You should consult a doctor if it worsens or does not improve after 30 days.

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 topically.

This medication is indicated for the treatment of moderate hair loss of androgenetic origin in adults.

Do not use MINOXIDIL CINFA

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 MINOXIDIL CINFA.

• If you have any skin problems or wounds on your scalp, as it may absorb more of the product, so you should make sure these do not exist before its application.
• If your scalp is red, inflamed, infected, irritated, or painful, or if you are using other medications for the scalp.
• If you have no family history of hair loss, the hair loss is sudden and/or irregular, the hair loss is after childbirth, or the reason for hair loss is unknown.
• If you have a history or are currently suffering from any vascular or heart disease, as it would be recommended that your doctor monitor your blood pressure and heart rate.
• If you experience a decrease in blood pressure, chest pain, increased heart rate, palpitations, dizziness, or fainting, sudden unexplained weight gain, swelling of hands or feet, persistent redness or irritation of the scalp, you should interrupt treatment and contact your doctor.
• 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.
• This medication should not come into contact with the eyes, if it comes into contact with your eyes, you should rinse them with plenty of water.
• If you notice any other effects on your general state or skin, interrupt treatment and consult your doctor or pharmacist.
• Do not expose treated areas to the sun (even on cloudy days) or ultraviolet lamps (UVA).
• Accidental ingestion may cause severe cardiac side effects. Therefore, this product should be kept out of the reach of children.

Cases of excessive hair growth in infants have been reported after skin contact with areas of minoxidil application in patients (caregivers) using topical minoxidil. Excessive 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.

Children and adolescents

This medication is not recommended for use in children or adolescents as no studies have been conducted in them.

Before starting treatment with MINOXIDIL CINFA, a complete clinical review will be necessary.

Other medications and MINOXIDIL CINFA

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

The concurrent administration of MINOXIDIL CINFA with peripheral vasodilators (medications for the treatment of cerebrovascular disorders) and medications for the treatment of hypertension may cause a sudden drop in your blood pressure.

Also, do not apply at the same time with other topical products such as tretinoin, anthralin, or dipropionate of betamethasone, as they may modify the amount of minoxidil that reaches the blood.

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 medication.

Treatment with MINOXIDIL CINFA is not recommended if you are pregnant or breastfeeding.

Driving and operating machinery

It is unlikely to cause any effect.

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

This medication contains 520 mg of propylene glycol (E-1520) in each ml.

Propylene glycol may cause skin irritation.

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

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

Products containing ethanol, which is a flammable substance, should not be used near an open flame, lit cigarette, or some devices (such as hair dryers).

Follow exactly the administration instructions of the medication contained in this leaflet or indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

• 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 dosing pump (each ml corresponds to 10 sprays) twice a day, in the morning and at night.
• Extend the amount of solution with the fingertips over the area to be treated, starting from the center of the same. Do not apply it to other areas of the body.
• Do not use a hand dryer to speed up the drying of the product.
• The daily dose will not exceed 2 ml, regardless of the extent of the bald area to be treated.
• Wash your hands carefully after application to avoid hair growth in other unwanted areas of the body.

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

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

Your doctor or pharmacist will indicate the duration of your treatment with MINOXIDIL CINFA. Do not discontinue treatment prematurely, as there are data that if you discontinue treatment for 3-4 months, you may return 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 plug that closes it. Adapt by screwing the dosing pump to the bottle.

To apply: direct the pump towards the center of the area to be treated. Press and extend the product with the fingertips to cover the entire area to be treated.

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

Dosage

Only for topical use.

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 should 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 estimate that the action of MINOXIDIL CINFA is too strong or weak, inform your doctor or pharmacist.

Use in children and adolescents

This product should 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 people over 65 years old

MINOXIDIL CINFA is not recommended for use in people over 65 years old, as no studies have 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 of MINOXIDIL CINFA after topical application will produce an increase in the intensity of dermatological side effects, especially pruritus (itching), dryness, skin irritation, and eczema (acute or chronic inflammatory skin disease).

The signs and symptoms after accidental or intentional ingestion of MINOXIDIL CINFA may include, 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 call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use MINOXIDIL CINFA

-In the initial period of treatment:

Apply the missed dose as soon as possible and then follow the schedule recommended by your doctor or pharmacist. 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 MINOXIDIL CINFA

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

If symptoms appear, consult your doctor or pharmacist.

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, as you may require urgent medical treatment:

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.

Rare(may affect up to 1 in 100 people)

- Paresthesias (numbness in arms or legs)

- Rash (generalized redness)

- Eczema (inflammatory skin condition)

- Hirsutism (excessive hair growth on the skin)

- Pruritus (itching)

- Local skin irritation

- Dry skin

-Exfoliation (skin peeling)

- Temporary hair loss

- Changes in hair texture

- Changes in hair color

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

- Visual disturbances.

- Eye irritation

- Hypotension (low blood pressure)

- Pustular rash (generalized pustules)

- Acne

- Contact dermatitis (redness)

- Erythema at the application site

Frequency unknown(cannot be estimated from available data)

- Dyspnea (difficulty breathing)

- Depression

- Peripheral edema

- Musculoskeletal pain

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 the Pharmacovigilance of Medicinal Products for Human Use: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.

This medication does not require special conservation conditions.

The solution must be used at most within 2 months after the first opening of the 60 ml container and at most within 4 months for the 120 ml container.

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of MINOXIDIL CINFA

- The active ingredient is minoxidil. Each 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

MINOXIDIL CINFA is a transparent, colorless, and alcohol-smelling solution for cutaneous use, presented in formats of 60 ml, 120 ml (1 bottle of 120 ml), 180 ml (3 bottles of 60 ml), and 240 ml (2 bottles of 120 ml) of solution provided with a dosing pump.

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Laboratorios Serra Pamies, S.A.

Carretera de Castellvell, 24

43206 Reus (Tarragona) – Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Revision date of this leaflet:October 2024

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/