Lacovin 50 mg/ml cutaneous solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lacovin 50 mg/ml cutaneous solution
minoxidil
Read 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 or pharmacist.
- 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, talk to your doctor or pharmacist, even if they are side 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
- What Lacovin is and what it is used for
- What you need to know before using Lacovin
- How to use Lacovin
- Possible side effects
- How to store Lacovin
Contents of the pack and other information
1. What Lacovin is and what it is used for
Lacovin is a solution for topical use on 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 Lacovin
Do not use Lacovin:
- if you are allergic to minoxidil or to any of the other components of this medicine (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 the scalp, as more of the product may be absorbed; therefore, ensure these are not present before applying the medicine.
- 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 or 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 should be cautious when using this medicine. If used, you must take special care to wash your hands thoroughly after applying the medicine to the scalp, as contact with other parts of the body may lead to unwanted hair growth elsewhere on your body.
- this medicine must not come into contact with the eyes; if contact occurs, rinse thoroughly with plenty of water.
- if you notice any other effects on your general condition or on your 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 areas where minoxidil had been applied by patients (caregivers) using topical minoxidil. Hair growth normalized within a few months once the 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 your use of topical minoxidil products.
Children and adolescents
The use of Lacovin is not recommended in children and adolescents, as studies have not been conducted in these populations.
Before starting treatment with Lacovin, your doctor should perform a complete clinical evaluation.
Other medicines and Lacovin
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Concomitant use of Lacovin with peripheral vasodilators (medicines used to treat cerebrovascular disorders) and medicines for blood pressure may cause a sudden drop in blood pressure. Additionally, Lacovin 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 Lacovin is not recommended if you are pregnant or breastfeeding.
Driving and using machines
It is unlikely to have any effect.
Lacovin contains propylene glycol (E-1520) and ethanol
This medicine contains 500 mg of propylene glycol in each millilitre.
Propylene glycol may cause skin irritation.
Do not use on open wounds or large areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
This medicine contains 300 mg of alcohol (ethanol 96%) in each millilitre, equivalent to 30% by weight.
It may cause a burning sensation on damaged skin.
In newborns (premature 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 cases 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 Lacovin
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 2 ml per day (1 ml every 12 hours).
- Wash your hands before application.
- Hair and scalp must be completely dry when applying the product.
- Apply 1 ml of solution using the provided syringe, twice daily, in the morning and at night.
- Spread the solution over the affected area with the fingertips, starting from the center. Do not apply to other parts of the body.
- Do not use a hair dryer to speed up drying of the product.
- The daily dose must not exceed 2 ml, regardless of the size of the bald area being treated.
- Wash your hands thoroughly after application to avoid unwanted hair growth in other body areas.
As with other medicines, the response to treatment varies from patient to patient; therefore, it may take up to 4 months before hair growth begins.
The recommended daily dose must 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 Lacovin. Do not stop treatment prematurely, as there is evidence that discontinuing treatment for 3–4 months may result in a return to the initial state of alopecia present before starting treatment.
Use in elderly patients over 65 years
Use of Lacovin is not recommended in patients over 65 years of age, as studies have not been conducted in this population.
If you use more Lacovin than you should
If you have used more Lacovin 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, particularly 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 (increased heart rate), edema (swelling, excessive fluid accumulation), and congestive heart failure.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Lacovin
Do not use a double dose to make up for a missed dose.
- During the initial treatment period:
Apply the missed dose as soon as possible, then continue with your prescribed dosing schedule. 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 Lacovin
Interrupting treatment for 3–4 months may cause you to revert to the initial state of alopecia present before starting treatment.
If you experience any of the symptoms described, 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 experiences them.
Contact a doctor immediately if you notice any of the following symptoms – you may require urgent medical treatment.
- Swelling of the face, lips or throat which 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), 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 sensation in arms or legs)
- Rash (generalized redness)
- Eczema (inflammatory skin condition)
- Hypertrichosis (excessive hair growth on the skin)
- Pruritus (itching)
- Local skin irritation
- Skin dryness
- Cutaneous exfoliation (skin peeling)
- Temporary hair loss
- Changes in hair texture
- Changes in hair colour
Rare (may affect up to 1 in 1,000 people):
- Headache
- Tachycardia (rapid heartbeat)
- 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):
- Dyspnoea (difficulty breathing)
- Depression
- Peripheral oedema
- Musculoskeletal pain
Reporting of adverse effects
If you experience any type of 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 Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lacovin
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, following EXP. The expiry date refers to the last day of the month indicated.
The solution may develop a slightly yellowish coloration. This color change does not affect its effectiveness.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lacovin 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 (E1520), disodium edetate, purified water.
Appearance of the product and contents of the pack
The solution is clear, colourless or slightly yellowish.
Lacovin 50 mg/ml cutaneous solution: Packs 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 pack sizes may be commercially available.
Marketing Authorization Holder
Laboratorios Galderma, S.A.
Serrano Galvache, 56
28033 Madrid
Telephone: 902 02 7595
Manufacturer
Laboratorio Reig Jofré, S.A.
Gran Capitán, 10
08970 - Sant Joan Despí - Barcelona
Date of the most recent revision of this leaflet: September 2024.
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es