Package leaflet: Information for the patient

DX2LEK, 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 additional information, consult your pharmacist.
If you experience any adverse reactions, including any 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 no improvement is observed after 60 days of treatment.

Table of contents

What DX2LEK is and what it is used for
Important information before using DX2LEK
How to use DX2LEK
Possible side effects
How to store DX2LEK
Contents of the package and other information

1. What DX2LEK is and what it is used for

DX2LEK is a topical solution applied to the scalp skin. DX2LEK contains the active substance minoxidil, which stimulates hair growth in male-pattern baldness. A reduction in excessive hair loss is typically observed after approximately 8 weeks of treatment, while the first signs of regrowth in the form of fine vellus hairs appear after 4 to 5 months of treatment.
Indications
DX2LEK is indicated for the treatment of male-pattern hair loss (alopecia androgenetica) in men and women aged 18 to 65 years.
DX2LEK is most effective in younger individuals during the early stages of hair loss. Better treatment outcomes are generally achieved in the vertex (crown) area compared to the fronto-temporal regions.
Discontinuation of treatment leads to reversal of the therapeutic effect within several months.
If no improvement is observed 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 DX2LEK

When not to use DX2LEK

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 lesions in seborrheic dermatitis, psoriasis, infections of the hairy scalp, or scalp skin with signs of disrupted epidermal continuity;
if the patient suffers from 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 using other topical medicines on the hairy scalp.

Warnings and precautions
Before starting to use DX2LEK, consult a doctor or pharmacist.
DX2LEK is intended for topical application to the scalp only.
DX2LEK may be used only on healthy scalp skin. Do not apply it to other parts of the body.
The medicine penetrates through the skin into the bloodstream in very small amounts; however, there is a risk that a larger dose may enter the body (e.g. when 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 swelling or swelling of the ankles and wrists, palpitations or accelerated heart rate, rapid weight gain, weakness, dizziness or fainting, visual disturbances, chest, shoulder or arm pain, persistent redness—discontinue use of the medicine and contact a doctor immediately.
Patients with cardiovascular diseases or cardiac arrhythmia should consult a doctor before using DX2LEK.
Some individuals may experience increased hair loss 2 to 6 weeks after starting treatment. If increased hair loss persists for more than 2 weeks, the patient should discontinue treatment and consult a doctor.
If scalp skin becomes injured or develops severe erythema due to excessive sun exposure during treatment, discontinue use of the medicine until the scalp skin has healed.
Accidental ingestion of the medicine may cause serious adverse cardiovascular effects. Therefore, keep the medicine out of reach of children.
In case of 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 application sites of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returned to normal within several months once the infant was no longer exposed to minoxidil. Care should be taken to prevent children from coming into contact with body areas where minoxidil has been applied.
If excessive hair growth on a child's body is observed during topical treatment with minoxidil-containing medicines, consult a doctor.

Children, adolescents, and elderly individuals
Do not use DX2LEK in children and adolescents (under 18 years of age) or in elderly individuals (over 65 years of age).

DX2LEK and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Interactions between DX2LEK and other medicines are not known.
Do not use DX2LEK simultaneously with other topical medicines applied to the scalp, such as corticosteroids, retinoids, dithranol, or vaseline, as they may increase the penetration of minoxidil into the bloodstream and thereby increase the risk of adverse effects.
When using antihypertensive medicines (e.g. guanethidine), consult a doctor before using DX2LEK due to the potential risk of excessive reduction in blood pressure.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use DX2LEK during pregnancy and breastfeeding.

Driving and operating machinery
DX2LEK has no effect on the ability to drive or operate machinery and does not impair psycho-physical performance.

DX2LEK 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 burning 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 DX2LEK

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 topical application on the scalp.
Unless otherwise advised by your doctor, the usual way of using this medicine is 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. The medicine should be applied dropwise using the pump (1 mL of solution is obtained after pressing the pump button five times).
Hands should be thoroughly washed 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 hair or scalp within 4 hours after applying the medicine.
Treatment should be discontinued 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 more than the recommended dose of DX2LEK
Overdosing with topical DX2LEK is not expected to have harmful health effects, as there are no known cases of minoxidil overdose when used topically.
However, increased absorption of the medicine and possible occurrence of adverse effects cannot be ruled out if the medicine is used in a manner not consistent with recommendations, e.g. using higher doses than recommended, 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 DX2LEK
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.
Adverse reactions occur approximately five times more frequently in women than in men.
You should immediately inform your doctor or go to the nearest hospital if you experience:

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

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

headache;
excessive hair growth outside the application site (site of administration);
itching at the application site, including with rash, itching in other parts of the body, eye itching.

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

decreased blood pressure;
shortness of breath;
temporary hair loss;
changes in hair color and texture;
irritation at the site of administration;
skin peeling;
rash;
acne-like rash;
skin inflammation;
dry skin, including at the application site;
peripheral edema;
redness 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, you should inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring of 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 the medicine DX2LEK

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep in the closed container, 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. This will help protect the environment.

6. Contents of the pack and other information

What DX2LEK contains

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

What DX2LEK looks like and contents of the pack
DX2LEK is a clear, colourless or slightly yellow liquid.
Pack
A white high-density polyethylene (HDPE) bottle closed with a cap made of polypropylene (PP) 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