Minoxidil 5% (liquid): full leaflet, how to apply, contraindications, side effects.

The information presented here is based on the original medicine leaflet, ensuring the accuracy and reliability of the data.

We recommend that you read it carefully. If you have any questions, consult your doctor or pharmacist for expert advice.

What is Minoxidil and what is it used for?

Minoxidil 5% is a hair solution indicated to treat androgenic alopecia, better known as hereditary baldness, in adult men. This condition is characterized by gradual hair loss, usually due to genetic factors.

It was originally developed as a treatment for high blood pressure, but researchers found that one of the side effects was hair growth. This led to the creation of products for topical use (applied to the skin) at a recommended concentration of 5%, to treat hair loss.

How does it work?

When applied directly to the scalp, Minoxidil 5% can help to stop the hair loss process and, in some cases, stimulate the growth of new hair.

Here's how it works:

1. Reactivates Dormant Hair Follicles: Sometimes, hair follicles that are dormant can be reactivated by minoxidil, causing them to start producing hair again.
2. Increases Blood Flow: When you apply minoxidil to your scalp, it increases blood flow to your hair follicles (the tiny “roots” where your hair grows). With more blood, your follicles receive more nutrients and oxygen, which can help stimulate hair growth.
3. Increases Hair Growth Phase: Hair goes through different growth phases. Minoxidil helps increase the phase in which hair is growing, rather than falling out. This can result in new hair strands and thicker hair.

To achieve the desired results, It is necessary to apply Minoxidil 5% twice daily for at least two months.

However, the time it takes to see results and the amount of hair that can grow back varies from person to person.

What should I know before using this medicine?

Scalp conditions

Do not use minoxidil 5% if your skin or scalp is inflamed, red, irritated, painful, or has conditions such as sunburn or dermatitis.

Hair loss when starting to use Minoxidil

When you first start using minoxidil, you may notice that your hair is falling out even more in the first few weeks. This is because minoxidil is working to remove the weak, thin hairs, making room for new, stronger, longer hairs to grow.

Here's what's going on:

1. Action: Minoxidil causes old, weaker hairs to fall out to make way for new hairs. This may give the impression that your hair is falling out even more and that minoxidil has made the situation worse, but this is wrong, as this process is necessary for new hairs to grow stronger.
2. Growing time: It will take a few weeks for new hairs to start appearing. Hair growth can take 2 to 3 months, so during this time, hair loss may seem more intense.
3. Don't Despair: This shedding phase is normal and is a sign that the treatment is working. The important thing is to continue using minoxidil as recommended so that new, stronger hair can grow.

In summary, Initial hair loss is a necessary part of the process for new hair to grow. Stay calm and continue the treatment – this is a good sign that the minoxidil is working.

Time to see results with Minoxidil

When you start using minoxidil to treat hair loss, it is important to know that the results are not immediate. Treatment requires patience and consistency. Here's what you can expect in terms of time to start seeing results:

1. First Weeks: In the first few weeks, you may notice some hair loss. This is normal and part of the process. Minoxidil is helping to remove old, weak hairs to make room for new hair.
2. First Months: After 2-4 months of regular use, you may start to see some signs of new hair growth. However, the new hair may still be thin and weak at first.
3. 6 to 12 Months: Around 6 months, many users begin to see more significant improvements. The new hairs tend to be thicker and stronger. Most people notice more visible results after 12 months of continuous use.

Hair growth is a slow process and everyone responds differently. Some people may see results more quickly, while others may need more time.

Minoxidil is a proven and effective treatment, but it takes time to show results. Continue regular use and be patient – progress may be gradual, but over time, you should see significant improvements in your hair growth and thickness.

Is the use continuous and lifelong?

Minoxidil is an effective treatment for genetic baldness, but it is important to understand that it is not a definitive cure for the hereditary condition, because It does not reverse the genetic cause of hair loss, but it helps to stimulate the growth of new hairs and strengthen existing ones.

Effect of Discontinued Use: If you stop using minoxidil, new hair growth may stop.

In a period of 3 to 4 months after stopping treatment, you may notice that the new hairs that grew with minoxidil start to fall out and the treated area may return to the state it was in before treatment began or even get worse.

Not recommended situations

Minoxidil 5% is not recommended in the following cases:

• Sudden or patchy hair loss.
• Complete baldness or total loss of body hair.
• Hair loss due to medications, dietary deficiencies, chemotherapy, disease or damage to the scalp.

Use in women

The concentration of 5% of minoxidil not recommended for women, as they are more susceptible to side effects due to hormonal sensitivity with the use of this higher concentration.

The concentration that is generally recommended and approved for use in women is 2%.

Changes noticed in hair

In some patients, There may be a change in hair color and/or texture after using topical Minoxidil.

History of illnesses

Tell your doctor if you have heart disease and should not be used if there is no family history of hair loss or if the cause of hair loss is unknown.

Eye contact, irritated skin and ingestion

Minoxidil 5% contains an alcohol base that may cause stinging, burning, and irritation of the eyes. Avoid contact with eyes and irritated skin.

In case of contact, wash the area with plenty of cold water. If irritation persists, consult a doctor.

This medicine is for external use only. If accidental ingestion occurs, seek medical attention immediately.

Risks of Minoxidil in contact with cats and pets

Minoxidil can be highly toxic to cats. If a cat ingests, “licks” or comes into contact with minoxidil, it can suffer serious adverse effects.

Although less sensitive than cats, the dogs may also have adverse reactions.

Symptoms of Poisoning: Ingestion or contact with minoxidil can cause symptoms of poisoning in cats, such as vomiting, diarrhea, excessive salivation, weakness, difficulty breathing, tremors and even seizures.

It is crucial to avoid getting the product on your pets. Wash your hands thoroughly after application and avoid using it in areas where your cat might lie down or touch.

Inhalation and flammability

Liquid minoxidil is a flammable product, because it contains alcohol in its formula, therefore, avoid apply it while smoking or near sources of intense heat.

Driving vehicles and operating machinery

There is no evidence that using minoxidil 5% affects your ability to drive or operate machinery.

Drug Interactions

Do not use minoxidil 5% together with other topical products, such as tretinoin and anthralin, as this may increase the absorption of minoxidil. Tell your doctor or dentist if you are taking other medications.

Warning

Do not use any medicine without your doctor's knowledge. It may be dangerous to your health. The effectiveness of this medicine depends on the patient's functional capacity.

Where and how should I store Minoxidil?

Where to Store: Store minoxidil 5% at room temperature, between 15 and 30°C. Keep the medicine out of the reach of children.

How to Store: Protect the product from light, heat and moisture. After use, close the bottle tightly.

Validity: Check the batch number, manufacturing date and expiration date on the packaging. Do not use the medicine after the expiration date.

Aspect: Minoxidil 5% is a clear to slightly yellowish hair solution. Before using, check the appearance of the product. If you notice any changes, even within the expiration date, consult a pharmacist.

Ingredients and formulation

Each (1) ml of hair solution contains:

When not to use

Minoxidil 5% should not be used:

• If you are allergic to any of the ingredients present in the formula;
• AND contraindicated for women, as they are more susceptible to side effects with the use of minoxidil 5%. The concentration that is generally recommended and approved for use in women is 2%.
• Do not use on babies and children;
• Discontinue use if your scalp is red, inflamed, infected, irritated or painful.

How to use minoxidil? (instruction)

1. Hair Preparation:

• It is not necessary to wash your hair before application.
• If you choose to wash, use a mild shampoo and avoid products with silicone.
• Make sure your hair and scalp are completely dry and healthy before applying minoxidil.

2. Product Application:

• Apply 1 ml of minoxidil 5% directly on the scalp, focusing on and around bald areas. (It is not necessary to apply to the hair strands)
• Use the following method to apply: Direct the spray or “dropper” toward the center of the bald area, press the valve once and spread the minoxidil with your fingertips until it covers the entire treated area. Repeat until you reach the total dose of 1 ml.
• After application, wash your hands thoroughly.
• The total daily dose should not exceed 2 ml (1 ml in the morning and 1 ml in the evening).

3. Care and Interactions:

• Wait at least four hours after application to wash your hair again.
• The use of blow dryers, gels, creams or sprays does not affect the effectiveness of minoxidil.
• Do not apply minoxidil on the same day you dye or perm your hair. Make sure your scalp is clean of minoxidil before applying chemicals.

4. Interruption of Treatment:

• If you stop using minoxidil, new hair growth will stop and may revert to its pre-treatment state within three to four months.

5. Additional Care:

After use, clean the outside of the applicator before storing the product to prevent clogging or valve malfunction due to crystallization.

What to do if I forget to use it?

If you forget to apply minoxidil at the scheduled time, apply it as soon as you remember. However, if it is close to the time of your next dose, skip the missed application and continue with the next dose as normal.

Do not double the dose to make up for the forgotten one.

Remember that missing a dose may affect the effectiveness of the treatment. For further questions, consult your pharmacist, doctor or dentist.

Side effects and adverse reactions of Minoxidil 5%

Potential Systemic Effects

Although minoxidil 5% does not usually cause systemic effects, its excessive use or an unusual individual sensitivity can lead to problems such as:

• Palpitations
• Chest pain (angina)
• Weakness or dizziness
• Unexplained weight gain
• Excessive sweating on hands and feet
• Swelling

If you experience these symptoms, stop taking the medication and contact your doctor immediately.

Common effects

Those affecting 1% to 10% users include:

• Unwanted hair growth outside the scalp (including the face, especially in women)
• Local allergic reactions
• Itch
• Dry or flaky scalp
• Temporary increase in hair loss

This increase in hair loss usually occurs between two and six weeks after starting treatment and tends to improve within a few weeks. If hair loss persists for more than two weeks, discontinue use and consult your physician.

Rare Effects

In rare cases (less than 0.01% of patients), the following may occur:

• Allergic skin inflammation
• Inflammation of hair follicles
• Increased secretion of sebaceous glands

If you notice any adverse reactions, inform your doctor, dentist or pharmacist. To report undesirable effects, contact the Consumer Service Center (CAC).

What to do if you use more than the recommended amount?

There are no records of overdose cases due to topical application of minoxidil 5%. However, it is essential to follow the recommended dosage to avoid problems.

If minoxidil 5% is accidentally ingested, systemic effects may occur due to its vasodilatory action. Possible symptoms include:

• Cardiovascular problems
• Fluid retention
• Drop in blood pressure
• Tachycardia (increased heart rate)

If these symptoms occur, seek medical attention immediately for appropriate treatment. If a significant amount of the medication is ingested, seek medical help immediately and, if possible, take the medication packaging or leaflet with you. For further guidance, call 0800 722 6001.

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Sources and bibliography:

This article was extracted from the original package insert from the manufacturer Aché (Pant), in August 2024, under technical supervision of the responsible pharmacist.

To check the leaflet of other brands, you can visit ANVISA electronic bulletin board and search for the manufacturer of your choice.

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