Leaflet: information for the user

Normopil 50 mg/ml topical solution

minoxidil

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 30 days.

1. What isNormopiland what it is used for

2. What you need to know before starting to useNormopil

3. How to useNormopil

4. Possible side effects

5. Storage ofNormopil

6. Contents of the pack and additional information

Normopil contains minoxidil as its active ingredient and is a solution for topical use on the scalp skin that stimulates hair growth in individuals with androgenetic alopecia (the most common type of hair loss) when applied topically.

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

Do not use Normopil

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 Normopil:

• If you have any skin problems or wounds on your scalp, as it may absorb more of the product, so make sure they 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, the risk of hirsutism (hair growth in other areas) is higher, so you must be careful when using this medication and if you use it, you must be especially careful to wash your hands after applying the medication to the scalp, as if the product comes into contact with other parts of your body, there is a risk of hair growth in other areas of your body.
• This medicationshould not come into contact with the eyes;if it comes into contact with your eyes, you should wash them with plenty of water.
• If you notice any other effects on your general state or skin,interrupt treatment and consult with 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 on the body have been reported in infants after contact with the skin on areas where minoxidil was applied to patients (caregivers) who used topical minoxidil. Excessive hair growth normalized within months when infants were no longer 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 adolescentssince no studies have been conducted in this population.

Before starting treatment with Normopil, a complete clinical examination will be necessary.

Other medications and Normopil

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

The concurrent administration of Normopil 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 it at the same time as other topical products such as tretinoin, anthralin, or betamethasone dipropionate, as they may modify the amount of minoxidil that reaches the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

It is unlikely to cause any effect.

Normopil contains propylene glycol(E 1520) and ethanol

This medication contains 500 mg of propylene glycol 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 255 mg of alcohol (ethanol 96%) in each milliliter.

It may cause a burning sensation on damaged skin.

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

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

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

The recommended dose is 2 ml per day. It must be appliedtwice a day,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. Dosing syringe.
2. Dosing pump

Wash your hands before application.

The hair and scalp must be completely dry when applying the product.

1. Dosing syringe (1 ml)

It is recommended to use it for large areas of the scalp.

1. Remove the cap from the bottle (Figure 1).
2. Insert the syringe into the bottle and withdraw 1 ml of the product (Figure 2).
3. Apply 1 ml of the solution with the help of the syringe (Figure 3).
4. Extend the amount of solution with the fingertips over the area to be treated, starting from the center of the same (Figure 4). Do not apply it to other areas of the body.
5. Replace the cap on the bottle after use.

Figure 1Figure 2Figure 3Figure 4

1. Dosing pump (1 ml = 5 sprays)

It is recommended to use this applicator for small areas of the scalp.

1. Insert the cannula into the pump: keep the pump body firmly in place by pressing the fingers on the trigger (Figure 1).
2. Loosen and remove the cap from the bottle (Figure 2).
3. Insert the dosing pump (Figure 3). Tighten firmly (Figure 4).
4. For application: direct the sprayer towards the area to be treated (Figure 5). Press once and extend the product with the fingertips over the area to be treated, starting from the center of the same. Repeat the operation5 timesin order to apply a dose of 1 ml.
5. Remove the dosing pump.
6. Replace the cap on the bottle after use.

Figure 1Figure 2Figure 3Figure 4Figure 5

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

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

Like other medications, the degree of response to treatment depends on each patient, so it may be necessary to treat for 4 months before hair growth begins.

You should respect the recommended daily dose 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 Normopil. Do not stop treatment prematurely, as there are data that if you stop treatment for 3-4 months you may return to the initial state of alopecia you had before starting treatment.

Use in patients over 65 years old

Normopil is not recommended for use in patients over 65 years old as there have been no studies in this age group.

If you use more Normopil than you should

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

Accidental or intentional overdose of topical minoxidil will cause an increase in the intensity of dermatological side effects, especially itching, dryness, skin irritation, and eczema (acute or chronic inflammatory skin disease).

The signs and symptoms after accidental or intentional ingestion of minoxidil 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 go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Normopil

Do not use a double dose to compensate for the missed doses.

During the initial treatment period:

• 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.

During the maintenance period:

• Apply the next dose as usual and continue treatment.

If you interrupt treatment with Normopil

Stopping 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 can 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:

• 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), hirsutism (excessive hair growth on the skin), generally of mild to moderate intensity and reversible upon discontinuation of treatment.

Uncommon(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
• Skin dryness
• 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 (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 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 Pharmacovigilance of Medicines 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.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging label, after CAD. The expiration date is the last day of the month indicated.

The solution may turn slightly yellow. The color change does not affect its effectiveness.

After the first opening of the bottle, the medication's validity period is 40 days.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Normopil 50 mg/ml topical solution

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

Appearance of the product and content of the packaging

The solution is transparent, colorless, or slightly yellowish.

Packaging 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 a dosing pump (one milliliter is equivalent to 5 sprays).

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON S.A.

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

Date of the last review of this leaflet:September 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es