NORMOPIL 50 mg/ml CUTANEOUS SOLUTION

2. What you need to know before starting to use Normopil

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 problem or wound on the scalp skin, 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 is 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, the risk of hypertrichosis (hair growth in other areas) is higher, so you should be cautious when using this medication, and if you use it, you should 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 the body, there is a risk of hair growth in other areas of your 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 effect on your general condition or skin, discontinue treatment and consult your doctor or pharmacist.
• do not expose the treated areas to the sun (even if cloudy) 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 normalized within months when 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 no studies have been conducted in this population.

Before starting treatment with Normopil, it will be necessary for your doctor to perform a complete clinical examination.

Other Medications and Normopil

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

The concomitant administration of Normopil 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 blood.

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 Normopil is not recommended if you are pregnant or breastfeeding.

Driving and Using Machines

It is unlikely to produce any effect.

Normopil contains propylene glycol (E 1520) and ethanol

This medication contains 500 mg of propylene glycol in each milliliter.

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 (96% ethanol) in each milliliter.

It may cause a burning sensation on damaged skin.

In newborns (premature and full-term babies), 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, a lit cigarette, or certain devices (e.g., hair dryers).

3. How to use Normopil

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

The recommended dose is 2 ml per day. It should be applied twice 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 largeareas 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 solution using the syringe (Figure 3).
4. Spread the amount of solution with your 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 1 Figure 2 Figure 3 Figure 4

1. Dosing pump (1 ml = 5 sprays)

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

1. Insert the cannula into the pump: hold the pump body firmly, supporting your fingers on the actuator (Figure 1).
2. Remove the cap from the bottle (Figure 2).
3. Insert the assembled dosing pump (Figure 3). Screw firmly (Figure 4).
4. For application: direct the sprayer towards the area to be treated (Figure 5). Press once and spread the product with your fingertips over the area to be treated, starting from the center of the same. Repeat the operation 5 times to apply 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 accelerate the drying of the product.

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

As with other medications, the degree of response to treatment depends on each patient, so 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 Normopil. Do not discontinue treatment prematurely, as there are data indicating that if you discontinue treatment for 3-4 months, you may return to the initial state of alopecia you had before starting treatment.

Use in People Over 65 Years

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

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 after topical application of minoxidil will produce an increase in the intensity of adverse effects of a dermatological nature, especially pruritus (itching), dermatitis (redness), 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 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 go to a medical center, or call the Toxicology 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 make up for forgotten doses.

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 interrupt treatment with Normopil

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

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

If you have any other doubts 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, 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), 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):

• Paresthesias (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 contribute to providing more information on the safety of this medication.

5. Storage of Normopil

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

The solution may take on a slightly yellowish color. The color change does not affect its effectiveness.

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

Medications should not be thrown away through wastewater or household waste. Deposit 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 the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Normopil 50 mg/ml Cutaneous 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 Package Contents

The solution is transparent, colorless, or slightly yellowish.

Package 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).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.

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

Date of the Last Revision of this Package Leaflet:September 2024

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