LACOVIN 20 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Lacovin 20 mg/ml Cutaneous Solution

minoxidil

Read the entire package leaflet carefully before starting to use this medication,as it contains important informationfor you.

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

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 30 days.

Contents of the Package Leaflet

1. What is Lacovin and what is it used for
2. What you need to know before starting to use Lacovin
3. How to use Lacovin
4. Possible side effects
5. Storage of Lacovin
6. Package Contents and Additional Information

1. What is Lacovin and what is it used for

Lacovin is a solution for use on the scalp skin 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 androgenic origin in adults.

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

Do not 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 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, you should be especially 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 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 can 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 products containing minoxidil.

Children and Adolescents

The use of Lacovin is not recommended in children and adolescents, as no studies have been conducted in them.

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

Other Medications and Lacovin

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

The concomitant administration of Lacovin with peripheral vasodilators (medications for the treatment of cerebrovascular disorders) and medications for the treatment of blood pressure may produce 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 modify 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 Lacovin is not recommended if you are pregnant or breastfeeding.

Driving and Using Machines

It is unlikely to produce any effect.

Lacovin contains propylene glycol (E-1520) and ethanol

This medication contains 100 mg of propylene glycol per milliliter, which is equivalent to 100 mg/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 567 mg of alcohol (96% ethanol) per milliliter, which is equivalent to 50.5% by weight.

It may cause a burning sensation on damaged skin.

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

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

3. How to use Lacovin

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 (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.
• Spread the amount of solution with your 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 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 other unwanted areas of the body.

As with 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 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 Lacovin. 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 Lacovin is not recommended in people over 65 years, as no studies have been conducted in them.

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 after topical application of minoxidil will produce an increase in the intensity of adverse effects of a dermatological nature, especially pruritus (itching), dryness, skin irritation, and eczema (inflammatory condition of the skin).

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 Lacovin

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 stop treatment with Lacovin

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 symptoms described, 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 experiences 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 condition of the skin), and hypertrichosis (hair growth on the skin), usually of mild to moderate intensity and reversible upon discontinuation of treatment.

Common(may affect up to 1 in 10 people):

• Local skin irritation (scaling and redness)
• Contact dermatitis
• Dry skin
• Edema (excessive fluid accumulation)
• Burning sensation and itching on the skin
• Hypertrichosis (hair growth on the skin)

Uncommon(may affect up to 1 in 100 people):

• Allergic reactions
• Eczema (inflammatory condition of the skin)
• Headache and paresthesia (numbness in arms or legs)
• Dizziness, weakness, discomfort
• Neuritis (inflammation of a nerve) and altered taste
• Eye irritation, vision changes
• Otitis (ear inflammation) (particularly external otitis)

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

• Changes in blood pressure and heart rate
• Alopecia, uneven hair
• Chest pain

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 Lacovin

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 yellow color. The color change does not affect its effectiveness.

Medications should not be disposed of 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 packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacovin 20 mg/ml Cutaneous Solution

• The active ingredient is minoxidil. Each milliliter of solution contains 20 mg of minoxidil.
• The other components are: ethanol, propylene glycol (E1520), purified water.

Appearance of the Product and Package Contents

The solution is transparent, colorless, or slightly yellowish.

Lacovin 20 mg/ml Cutaneous Solution: Package 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 a dosing syringe.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Galderma, S.A.

Serrano Galvache, 56

28033 Madrid

Phone 902 02 7595

Manufacturer

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 - Sant Joan Despí – Barcelona

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