Package leaflet: Information for the patient

Piloxidil, 20 mg/mL, topical solution
Minoxidilum
Please read the entire 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 patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contact your doctor:
if you feel worse,
or if increased hair loss persists for more than 2 weeks,
or if there is no improvement after 60 days of treatment.

Table of contents

What Piloxidil is and what it is used for
Important information before using Piloxidil
How to use Piloxidil
Possible side effects
How to store Piloxidil
Contents of the package and other information

1. What Piloxidil is and what it is used for

Piloxidil is a topical solution applied to the scalp skin. Piloxidil contains the active substance minoxidil, which stimulates hair growth in androgenetic alopecia. A reduction in excessive hair loss is observed after approximately 8 weeks of treatment, while the first regrowth in the form of fine vellus hairs appears 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 individuals during the early stages of hair loss. Better treatment outcomes are achieved in the vertex area of the scalp than in the frontal-temporal regions.
Discontinuation of treatment leads to reversal of the therapeutic effect within several months.
If there is no improvement after 60 days, or if increased hair loss persists for more than 2 weeks, or if you feel worse, consult your doctor.

2. Important information before using Piloxidil

When not to use Piloxidil

if the patient is allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
during pregnancy and breastfeeding;
if the patient has scalp skin disorders, e.g. severe seborrheic dermatitis, psoriasis, infections of the scalp, or scalp skin with signs of disrupted epidermal continuity;
if the patient has arterial hypertension (treated or untreated);
if the patient has sunburned scalp skin;
if the patient has recently shaved scalp skin;
under occlusive dressings;
if the patient is simultaneously applying other topical medicines to the hairy scalp.

Warnings and precautions
Before starting to use Piloxidil, discuss this with your doctor or pharmacist.
Piloxidil is intended for topical use on the scalp only.
Piloxidil should only be used on healthy scalp skin. Do not apply it to other parts of the body.
The medicine passes through the skin into the bloodstream in very small amounts; however, there is a risk that a larger amount of the medicine may be absorbed (e.g. if applied to damaged skin or due to improper use), potentially causing systemic adverse effects.
If any of the following symptoms occur and persist: hypotension, facial or hand and ankle swelling, palpitations or accelerated heart rate, rapid weight gain, weakness, dizziness or fainting, blurred vision, chest, shoulder or arm pain, or persistent redness, discontinue use of the medicine and contact your doctor.
Patients with cardiovascular diseases or cardiac arrhythmia should consult their doctor before using Piloxidil.
Some individuals may notice increased hair loss 2 to 6 weeks after starting treatment. If increased hair loss persists for more than 2 weeks, the patient should stop treatment and consult a doctor.
If during treatment the scalp skin becomes injured or develops severe redness due to excessive sun exposure, discontinue use of the medicine until the scalp skin has healed.
Accidental ingestion of the medicine may cause serious adverse effects on the cardiovascular system. Therefore, keep the medicine out of reach of children.
If the medicine comes into contact with damaged skin, eyes, or mucous membranes, rinse the affected areas thoroughly with water.
Some individuals may experience changes in hair color and/or hair structure during treatment.
Cases of excessive body hair growth in infants have occurred following skin contact with areas where minoxidil was applied by patients (caregivers) using topical minoxidil. Hair growth returned to normal within several months after the infant was no longer exposed to minoxidil. Care should be taken to prevent children from coming into contact with areas of the body where minoxidil has been applied topically. If excessive hair growth is observed on a child during topical use of minoxidil-containing medicines, consult a doctor.

Children, adolescents, and elderly patients
Do not use this medicine in children and adolescents (under 18 years of age) or in elderly patients (over 65 years of age).

Piloxidil and other medicines
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
Interactions between Piloxidil and other medicines are not known.
Do not use Piloxidil simultaneously with other topical medicines applied to the scalp, such as corticosteroids, retinoids, dithranol, or petroleum jelly, as they may increase the penetration of minoxidil into the bloodstream and thereby increase the risk of adverse effects.
Before using Piloxidil, consult your doctor if you are taking medicines that lower blood pressure (e.g. guanethidine), due to the potential risk of excessive reduction in blood pressure.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not use Piloxidil during pregnancy and breastfeeding.

Driving and operating machinery
Piloxidil does not affect the ability to drive or operate machinery, nor does it impair psycho-physical performance.

Piloxidil contains propylene glycol and ethanol

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

Ethanol
This medicine contains 541.12 mg of alcohol (ethanol) in each 1 mL of solution.
The medicine may cause a stinging sensation on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
Avoid inhaling the spray mist.

3. How to use Piloxidil

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
This medicine is intended for application to the scalp.
Unless otherwise advised by your doctor, the medicine is usually used as described below.
Adults (aged 18 to 65 years)
Apply 1 mL of the medicine as drops onto dry scalp twice daily, approximately every 12 hours, to areas of hair loss and gently massage in with fingertips. Do not rub or dry these areas.
Apply the medicine as drops using the pump (1 mL of liquid is obtained after pressing the pump button five times).
Wash hands thoroughly after applying the medicine.
Do not use more than 2 mL of the medicine per day. Do not apply the medicine to other parts of the body.
Do not wash the hair or scalp within 4 hours after applying the medicine.
Discontinue treatment after one year if no visible results are observed.
Do not increase the dose or frequency of application.
If the dispenser tube becomes blocked due to crystallized medicine, it may be rinsed with warm, boiled water.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Piloxidil
Overdosing on Piloxidil should not have negative health effects, as there are no known cases of overdose with topical minoxidil.
However, increased absorption of the medicine and possible occurrence of adverse effects cannot be ruled out when the medicine is used contrary to recommendations, e.g. using higher than recommended doses, too frequent application, application to other parts of the body or large body surface areas, or application to damaged skin.
In case of accidental ingestion, contact a doctor immediately, as serious adverse symptoms may occur, such as rapid heartbeat and palpitations, decreased blood pressure and resulting dizziness and fainting, swelling mainly of the face, hands and feet, acute gastrointestinal disturbances, blurred vision, chest pain.

Missed dose of Piloxidil
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop using the medicine immediately and contact your doctor if any of the following symptoms occur,
as urgent medical attention may be required:

swelling of the face, lips or throat, causing difficulty in swallowing or breathing. These may be symptoms of a severe allergic reaction (frequency unknown, cannot be estimated from available data);
chest pain, rapid heartbeat, fainting, dizziness, sudden weight loss, swelling of hands or feet, decreased blood pressure.

You should stop using the medicine and contact your doctor if persistent
redness and skin irritation occur.
Other adverse reactions listed below may also occur.
Common (may occur in fewer than 1 in 10 people):

headache;
excessive hair growth in areas other than the application site;
itching at the application site, including with rash, itching in other parts of the body, itching of the eyes.

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

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

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

palpitations;
increased heart rate;
chest pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel. + 48 22 49 21 301,
Fax + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Piloxidil medicine
Keep the medicine out of sight and reach of children.
Store below 25°C.
Store in closed packaging, away from sources of fire. 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Piloxidil contains

The active substance in Piloxidil is minoxidil at a concentration of 2%. 1 mL of the topical solution contains 20 mg of minoxidil.
Other ingredients: ethanol, propylene glycol, purified water.

What Piloxidil looks like and contents of the pack
Piloxidil is a clear, colourless or slightly yellow liquid.
Packaging
White high-density polyethylene (HDPE) bottle closed with a polypropylene (PP) cap with 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 topical solution.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Profarm Pharmaceutical and Cosmetic Production Company Sp. z o.o.
ul. Słupska 18
84-300 Lębork