Piloxidil

Package Leaflet: Information for the Patient

Piloxidil,20 mg/mL, liquid for skin use
Minoxidil

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• Contact a doctor:
• if the patient feels worse,
• or if increased hair loss persists for more than 2 weeks,
• or if there is no improvement after 60 days of using the medicine.

Table of Contents of the Leaflet

• 1. What is Piloxidil and what is it used for
• 2. Important information before using Piloxidil
• 3. How to use Piloxidil
• 4. Possible side effects
• 5. How to store Piloxidil
• 6. Contents of the pack and other information

1. What is Piloxidil and what is it used for

Piloxidil is a liquid for topical use on the scalp. Piloxidil contains the active substance minoxidil, which stimulates hair growth in androgenetic alopecia. A decrease in excessive hair loss is observed after about 8 weeks of using the medicine, while the first regrowth in the form of thin vellus hair occurs after 4 to 5 months of treatment.

Indications

Piloxidil is indicated for the treatment of androgenetic alopecia (alopecia androgenetica) in women aged 18 to 65 years.
Piloxidil is most effective in younger people in the early stages of the hair loss process. Better treatment results are achieved in the vertex area of the scalp than in the frontal-temporal area.
Stopping treatment causes the therapeutic effect to reverse within a few months.
If there is no improvement after 60 days or if increased hair loss persists for more than 2 weeks, or if the patient feels worse, they should consult a doctor.

2. Important information before using Piloxidil

When not to use Piloxidil

• if the patient is hypersensitive to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• during pregnancy and breastfeeding;
• if the patient has scalp diseases, such as severe changes in seborrheic dermatitis, psoriasis, infections of the hairy scalp, scalp with signs of skin continuity disruption;
• if the patient has hypertension (treated and untreated);
• if the patient has sunburned scalp;
• if the patient has freshly shaved scalp;
• under occlusive dressing;
• if the patient is using other medicines topically on the hairy scalp at the same time.

Warnings and precautions

Before starting to use Piloxidil, the patient should discuss it with their doctor or pharmacist.
Piloxidil is intended for topical use on the scalp only.
Piloxidil can only be used on healthy scalp skin. It should not be used on other parts of the body.
The medicine penetrates the skin into the blood in very small amounts, nevertheless, there is a risk of penetration of a larger dose of the medicine into the body (e.g., in the case of using the medicine on damaged skin or improper use) and potential occurrence of systemic side effects.
In case of occurrence and persistence of any of the following symptoms, such as hypotension, facial or ankle edema, palpitations or accelerated heart rate, rapid weight gain, weakness and dizziness or fainting, vision disturbances, chest pain, shoulder or arm pain, persistent redness, the patient should stop using the medicine and contact their doctor.
Patients with cardiovascular diseases or cardiac arrhythmia should consult their doctor before using Piloxidil.
Some people may experience increased hair loss after 2 to 6 weeks of starting treatment. If increased hair loss persists for more than 2 weeks, the patient should stop the treatment and consult their doctor.
If the skin is injured or severe redness occurs after excessive sun exposure during treatment, the patient should stop using the medicine until the scalp heals.
Accidental ingestion of the medicine may cause severe side effects from the cardiovascular system. Therefore, the medicine should be kept out of the reach of children.
In case of contact of the medicine with damaged skin, eyes, or mucous membranes, these areas should be thoroughly rinsed with water.
Some people may experience changes in hair color and/or texture during treatment.
There have been cases of excessive hair growth on the body of infants as a result of contact with areas of application of minoxidil in patients (caregivers) using minoxidil topically.
Hair growth returned to normal within a few months when the infant was no longer exposed to minoxidil. Care should be taken to avoid contact between children and areas of the body where minoxidil has been applied topically. If excessive hair growth on the body of a child is observed during the use of topical minoxidil, the patient should consult their doctor.

Children and adolescents as well as the elderly

The medicine should not be used in children and adolescents (under 18 years of age) and in the elderly (over 65 years of age).

Piloxidil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.
Interactions between Piloxidil and other medicines are not known.
Piloxidil should not be used at the same time as other medicines used topically on the scalp, such as corticosteroids, retinoids, ditranol, or petroleum jelly, as they may increase the penetration of minoxidil through the skin into the blood and enhance the risk of side effects.
During the use of medicines that lower blood pressure (e.g., guanethidine), the patient should consult their doctor before using Piloxidil, due to the potential risk of excessive blood pressure reduction.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Piloxidil should not be used during pregnancy and breastfeeding.

Driving and using machines

Piloxidil does not affect the ability to drive and use machines or impair psychophysical performance.

Piloxidil contains propylene glycol and ethanol

Propylene glycol

The medicine contains 156 mg of propylene glycol in each 1 mL of liquid.

Etanol

This medicine contains 541.12 mg of alcohol (ethanol) in each 1 mL of liquid.
The medicine may cause burning of damaged skin.
The medicine is flammable. It should not be used near an open flame, lit cigarette, or certain devices (e.g., hair dryers).
The patient should avoid inhaling the vapors of the sprayed medicine.

3. How to use Piloxidil

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the scalp.
Unless the doctor advises otherwise, the medicine is usually used as described below.
Adults (18 to 65 years of age)
1 mL of the medicine should be applied drop by drop to dry scalp 2 times a day, approximately every 12 hours, to the areas of hair loss and gently massaged with fingertips. The areas should not be rubbed or dried.
The medicine should be applied drop by drop using the pump (1 mL of liquid is obtained after pressing the pump button 5 times).
The patient should wash their hands thoroughly after using the medicine.
No more than 2 mL of the medicine should be used per day. The medicine should not be used on other parts of the body.

The patient should not wash their hair and scalp before 4 hours after using the medicine.

Treatment should be stopped after a year if there are no visible results of the treatment.
The patient should not increase the dose or frequency of using the medicine.
In case the dosing nozzle is clogged by crystallized medicine, it can be rinsed with warm, boiled water.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a larger dose of Piloxidil than recommended

Overdose of Piloxidil should not have negative effects on health, as there are no known cases of overdose of minoxidil used topically.
However, it cannot be ruled out that increased absorption of the medicine and potential occurrence of side effects may result from using the medicine not in accordance with the recommendations, e.g., using larger doses than recommended, using it too frequently, using it on other parts of the body, or using it on large areas of the body, or using it on damaged skin.
In case of accidental ingestion of the medicine, the patient should immediately consult their doctor, as severe side effects may occur, such as accelerated heart rate, decreased blood pressure, resulting dizziness and fainting, edema mainly of the face, hands, and feet, acute gastrointestinal disturbances, blurred vision, chest pain.

Missing a dose of Piloxidil

The patient should not use a double dose to make up for a missed dose.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Piloxidil can cause side effects, although not everybody gets them.

The patient should stop using the medicine and consult their doctor immediately if they experience any of the following symptoms, as they may require urgent medical attention:

• swelling of the face, lips, or throat, which makes swallowing or breathing difficult. These may be symptoms of a severe allergic reaction (frequency not known, cannot be estimated from the available data);
• chest pain, accelerated heart rate, fainting, dizziness, sudden weight loss, edema of the hands or feet, decreased blood pressure.

The patient should stop using the medicine and consult their doctor if they experience persistent redness and skin irritation.
The following side effects may also occur.
Common(may occur in less than 1 in 10 people):

• headache;
• excessive hair growth outside the application area;
• itching at the application site, including rash, itching in other parts of the body, eye itching.

Uncommon(may occur in less than 1 in 100 people):

• decreased blood pressure;
• shortness of breath;
• temporary hair loss;
• changes in hair color and texture;
• irritation at the application site;
• skin peeling;
• rash;
• acne-like rash;
• dermatitis;
• dry skin, including at the application site;
• peripheral edema;
• redness at the application site.

Rare(may occur in less than 1 in 1000 people):

• palpitations;
• accelerated heart rate;
• chest pain.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Piloxidil

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Store in the closed packaging, away from heat sources. Protect from light.
The medicine is flammable.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Piloxidil contains

• The active substance of the medicine is minoxidil at a concentration of 2%. 1 mL of liquid for skin use contains 20 mg of minoxidil.
• The other ingredients are ethanol, propylene glycol, purified water.

What Piloxidil looks like and contents of the pack

The medicine is a clear, colorless or slightly yellowish liquid.
Packaging
White polyethylene (HDPE) bottle with a polypropylene (PP) cap and a seal or a dosing pump [low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), polyoxymethylene (POM), low-density polyethylene/polyisobutylene (LDPE/PIB), low-density polyethylene/polypropylene (LDPE/PP), stainless steel], placed in a cardboard box. The bottle contains 60 mL of liquid for skin use.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Phone: +48 42 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
Pharmaceutical and Cosmetic Production Company "Profarm" Sp. z o.o.
Słupska 18
84-300 Lębork

Date of last revision of the leaflet: