Product Information for the User

Lacovin 50 mg/ml Topical Solution

minoxidil

Read this entire product information carefully before starting to use this medication,because it contains important information for you.

Follow exactly the administration instructions for the medication contained in this product information or those indicated by your doctor or pharmacist.

• Keep this product information, 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 product information. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 30 days.

Contents of the package and additional information

Lacovin is a solution for topical use on the scalp 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.

No use Lacovin:

• 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 Lacovin.

• if you have any skin problems or wounds on your scalp, as it may absorb more of the product, so make sure these do not exist before application.
• if your scalp is red, inflamed, infected, irritated, or painful, or if you are using other medications for your 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 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 palpitations, dizziness, or dizziness, 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 it comes into contact with other parts of your body, there is a risk of hair growth in other areas of your body.
• this medication should not come into contact with your 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 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 in 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. You should 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

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

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

Other medications and Lacovin

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

The concurrent administration of Lacovin with peripheral vasodilators (medications for the treatment of cerebrovascular disorders) and medications for the treatment of high blood pressure may cause a sudden drop in your blood pressure. Additionally, do not apply it at the same time as other topical products such as tretinoin, anthralin, or dipropionate of betamethasone, as they may modify the amount of minoxidil that reaches the blood.

Pregnancy, lactation, 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 Lacovin is not recommended if you are pregnant or breastfeeding.

Driving and operating machinery

It is unlikely to cause any effect.

Lacovin 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 300 mg of alcohol (ethanol 96%) in each milliliter, which is equivalent to 30% by weight.

It may cause a burning sensation on damaged skin.

In newborns (preterm babies and full-term babies), high concentrations of ethanol may 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. If in doubt, ask your doctor or pharmacist.

The recommended dose is 2 ml per day (1 ml every 12 hours).

- 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 syringe, 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 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 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.

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

Your doctor or pharmacist will indicate the duration of your treatment with Lacovin. Do not discontinue treatment prematurely, as there are data indicating that if you discontinue treatment for 3-4 months, you may return to your initial state of alopecia before starting treatment.

Use in patients over 65 years old

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

If you use more Lacovin than you should

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

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

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 forgot to use Lacovin

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

- In 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.

- In the maintenance period:

Apply the next dose as usual and continue your treatment.

If you interrupt treatment with Lacovin

Discontinuing treatment for 3-4 months may cause you to return to your 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 – 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

- Dryness of the skin

- Skin exfoliation (peeling of the skin)

- Temporary hair loss

- Changes in hair texture

- Changes in hair color

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

- Headache.

- Tachycardia (rapid heartbeat)

- Palpitations (low blood pressure)

- Chest pain

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

• Visual disturbances.
• Irritation of the eyes
• 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 that appears on the label of the container, after CAD. 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at 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 Lacovin 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 (E1520), disodium edetate, purified water.

Appearance of the product and contents of the packaging

The solution is transparent, colorless or slightly yellowish.

Lacovin 50 mg/ml topical solution:Packages containing 60 ml, 120 ml (2 bottles of 60 ml), 180 ml (3 bottles of 60 ml) and 240 ml (4 bottles of 60 ml) of solution with dosing syringe.

Only some package sizes may be marketed.

Marketing authorization holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Telephone 902 02 7595

Responsible for manufacturing

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 - Sant Joan Despí - Barcelona

Last review date of this prospectus:September 2024.

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