MINOXIDIL CINFA 50 mg/ml CUTANEOUS SOLUTION

2. What you need to know before starting to use MINOXIDIL CINFA

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 the scalp, as more product may be absorbed, so you should ensure that these do not exist before application.
• If the scalp is red, inflamed, infected, irritated, or painful, or if you are using other medications for the scalp.
• If you do not have a family history of hair loss, hair loss is sudden and/or irregular, hair loss occurs after childbirth, or the reason for hair loss is unknown.
• If you have a history of or currently suffer from any vascular or heart disease, as it is 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, fainting, or dizziness, sudden unexplained weight gain, swelling of hands or feet, persistent redness or irritation of the scalp, you should discontinue treatment and contact your doctor.
• If you are a woman, you should be 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 does, you should rinse your eyes with plenty of water.
• If you notice any other effect on your general condition or skin, discontinue treatment and consult your doctor or pharmacist.
• You should not expose the treated areas to the sun (even on cloudy days) or to ultraviolet lamps (UVA).
• Accidental ingestion may cause serious cardiac side effects. Therefore, this product should be kept out of the reach of children.

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

This medication is not recommended for use in children or adolescents, as its safety and efficacy have not been established in this population.

Before starting treatment with MINOXIDIL CINFA, your doctor will need to perform a complete clinical examination.

Other Medications and MINOXIDIL CINFA

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

The concomitant administration of MINOXIDIL CINFA 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 tretinoin, anthralin, or betamethasone dipropionate, as they may alter the amount of minoxidil that reaches the bloodstream.

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

Driving and Using Machines

It is unlikely to produce any effect.

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

This medication 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 consulting your doctor or pharmacist first.

This medication 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, should not be used near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

3. How to use MINOXIDIL CINFA

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

• Wash your hands before application.
• The hair and scalp must be completely dry before 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.
• 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 the drying of the product.
• The daily dose will not exceed 2 ml, regardless of the extent of the hairless area to be treated.
• Wash your hands carefully after application to avoid hair growth in unwanted areas of the body.

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

The recommended daily dose should be respected, regardless of the extent of the 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 indicating that if treatment is discontinued for 3-4 months, you may return to the initial state of alopecia that existed before starting treatment.

Using the Dosing Pump

Remove the cap from the bottle and unscrew the cap that closes it. Attach the dosing pump to the bottle by screwing it on.

For application: direct the pump towards 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 medications, the degree of response to treatment depends on each patient; therefore, a prior treatment period of 4 months may be necessary before hair growth begins.

Dosage

For cutaneous use only.

The recommended daily dose is 1 ml of the 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 the alopecia. Do not increase the dose or frequency of application.

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

If you think the effect of MINOXIDIL CINFA is too strong or too 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 Adults over 65 Years

The use of MINOXIDIL CINFA is not recommended in adults over 65 years of age, 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 after topical application of MINOXIDIL CINFA will produce an increase in the intensity of dermatological side effects, especially pruritus (itching), dryness, skin irritation, and eczema (inflammatory skin condition), usually of mild to moderate intensity and reversible upon discontinuation of treatment.

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 fluid accumulation), and congestive heart failure (heart failure).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use MINOXIDIL CINFA

• In the initial treatment period:

Apply the forgotten dose as soon as possible and then follow the schedule recommended by your doctor or pharmacist. Do not use a double dose to make up for forgotten doses.

• In the maintenance period:

Apply the next dose as usual and continue your treatment.

If you stop using MINOXIDIL CINFA

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

If you experience the described symptoms, consult your doctor or pharmacist.

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

4. Possible Side Effects

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

Immediately contact a doctor 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).

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.

Uncommon(may affect up to 1 in 100 people)

• Paresthesia (numbness sensation in arms or legs)
• Rash (generalized redness)
• Eczema (inflammatory skin condition)
• Hypertrichosis (hair growth on the skin)
• Pruritus (itching)
• Local skin irritation
• Dryness of the skin
• Exfoliative dermatitis (skin peeling)
• Temporary hair loss
• Changes in hair texture
• Changes in hair color

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

• Headache
• Tachycardia (rapid heart rate)
• Palpitations (low blood pressure)
• Chest pain

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 Not Known(cannot be estimated from available data)

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

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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of MINOXIDIL CINFA

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date shown on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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

Appearance of the Product and Package Contents

MINOXIDIL CINFA is a clear, colorless, and alcohol-scented cutaneous solution and is 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) formats, provided 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 the Last Revision of this Package Leaflet:October 2024

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