Normopil 50 mg/ml cutaneous solution

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Normopil 50 mg/ml cutaneous solution

minoxidil

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 given by your doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if there is no improvement after 30 days.

Contents of the leaflet

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

1. What Normopil is and what it is used for

Normopil contains minoxidil as the active substance and is a solution for topical application to the scalp skin that stimulates hair growth in individuals with androgenetic alopecia (the most common type of baldness) when applied topically.

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

2. What you need to know before using Normopil

Do not use Normopil

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 Normopil:

• if you have any skin condition or wound on the scalp, as this may increase absorption of the product; ensure such conditions are not present before application.

• 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 occurs 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 it would be advisable for your doctor to monitor your blood pressure and heart rate.

• if you experience a drop in 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, the risk of hypertrichosis (excessive hair growth in other areas) is higher; therefore, you must be cautious when using this medicine. If used, special care should be taken to wash your hands thoroughly after applying the medicine to the scalp, since if the product comes into contact with other parts of the body, there is a risk of unwanted hair growth elsewhere on your body.

• this medicine must not come into contact with the eyes; if contact occurs, rinse the eyes thoroughly with plenty of water.

• if you notice any other effects on your general condition or 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 application sites of minoxidil in 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 notice excessive body hair growth in your child during the period you are using topical minoxidil products.

Children and adolescents

The use of this medicine is not recommended in children and adolescents, as studies have not been conducted in this population.

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

Other medicines and Normopil

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use of Normopil with peripheral vasodilators (medications used to treat cerebrovascular disorders) and antihypertensive medications may cause a sudden drop in blood pressure. Additionally, Normopil should not be applied simultaneously with 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 Normopil is not recommended if you are pregnant or breastfeeding.

Driving and use of machines

It is unlikely to have any effect.

Normopil contains propylene glycol (E 1520) and ethanol

This medicine contains 500 mg of propylene glycol 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 medicine contains 255 mg of alcohol (96% ethanol) per millilitre.

It may cause a burning sensation on damaged skin.

In newborns (preterm infants and full-term newborns), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in case of occlusion).

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 Normopil

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 2 ml per day. It should be applied twice daily, 1 ml in the morning and 1 ml at night.

Instructions for use:

The instructions for use depend on the type of applicator used.

1. Measuring syringe
2. Dosing pump

Wash your hands before application.

Hair and scalp must be completely dry when applying the product.

1. Measuring syringe (1 ml)

Its use is recommended for large areas of the scalp.

1. Remove the cap from the bottle (Figure 1).
2. Insert the syringe into the bottle and draw up 1 ml of the product (Figure 2).
3. Apply 1 ml of solution using the syringe (Figure 3).
4. Spread the solution evenly over the treatment area with the fingertips, starting from the center (Figure 4). Do not apply to other areas of the body.
5. Replace the cap on the bottle after use.

Figure 1 Figure 2 Figure 3 Figure 4

1. Dosing pump (1 ml = 5 sprays)

This applicator is recommended for small areas of the scalp.

1. Insert the cannula into the pump: hold the pump body firmly, placing your fingers on the button (Figure 1).
2. Unscrew and remove the cap from the bottle (Figure 2).
3. Insert the assembled dosing pump (Figure 3). Screw it on tightly (Figure 4).
4. For application: direct the spray nozzle toward the area to be treated (Figure 5). Press once and spread the product with the fingertips over the treatment area, starting from the center. Repeat this procedure five times to deliver a dose of 1 ml.
5. Remove the dosing pump.
6. Replace the cap on the bottle after use.

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5

• Do not use a hair dryer to speed up drying of the product.

• Wash your hands thoroughly after application to avoid unwanted hair growth in other body areas.

As with other medications, the degree of response to treatment varies from patient to patient; therefore, it may be necessary to undergo 4 months of treatment before hair growth begins.

The recommended daily dose should be observed 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 Normopil. Do not discontinue treatment prematurely, as there is evidence that stopping treatment for 3–4 months may result in a return to the initial state of alopecia present before starting treatment.

Use in patients over 65 years of age

The use of Normopil is not recommended in patients over 65 years of age, as no studies have been conducted in this population.

If you use more Normopil than you should

If you have used more Normopil than recommended, consult your doctor or pharmacist immediately.

Accidental or intentional overdose following topical application of minoxidil 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 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, 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.

If you forget to use Normopil

Do not use a double dose to make up for missed doses.

During the initial treatment period:

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

During the maintenance period:

• Apply the next dose as usual and continue your treatment.

If you interrupt treatment with Normopil

Interrupting treatment for 3–4 months may cause you to revert to the initial stage 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 can cause adverse effects, although not everyone will experience 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 frequently reported adverse effects are pruritus (itching), dermatitis (redness), dryness, skin irritation, eczema (inflammatory skin condition), and 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
• Dry skin
• Skin exfoliation (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 (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 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: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Normopil

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container label, after EXP. The expiry date refers to the last day of the month indicated.

The solution may develop a slightly yellowish color. This color change does not affect its effectiveness.

After first opening the bottle, the medicine remains valid for 40 days.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Normopil 50 mg/ml cutaneous solution

• The active substance is minoxidil. Each millilitre of solution contains 50 mg of minoxidil.
• The other components are: ethanol, propylene glycol (E 1520), disodium edetate, purified water.

Appearance of the medicinal product and contents of the pack

The solution is clear, colourless or slightly yellowish.

Pack containing 1 bottle of 90 ml, 2 bottles of 90 ml or 3 bottles of 90 ml of solution, and a plastic bag containing a dosing syringe and dosing pump (one millilitre corresponds to 5 sprays).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos- Madrid (SPAIN)

Date of the most recent revision of this leaflet: September 2024

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