Dx2lek max

Package leaflet: Information for the patient

DX2LEK max, 50 mg/mL, cutaneous aerosol, 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
the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your doctor or 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 using the medicine.

Contents of the leaflet

1. What DX2LEK max is and what it is used for
2. Important information before using DX2LEK max
3. How to use DX2LEK max
4. Possible side effects
5. How to store DX2LEK max
6. Contents of the pack and other information

1. What DX2LEK max is and what it is used for

DX2LEK max is a topical solution for application to the scalp and contains the active substance
minoxidil. Minoxidil stimulates hair growth in androgenetic alopecia in both women and men.
Reduction in hair loss is observed within the second month of treatment. Hair regrowth usually
appears after two months of treatment with DX2LEK max. Maximum effect is achieved after
approximately 12 months of continuous use.
Indications
Treatment of androgenetic alopecia (hair loss) in men and women aged 18 to 65 years.
Contact your doctor:

• if there is no improvement after 60 days of treatment;
• if increased hair loss persists for more than 2 weeks;
• if you feel worse.

Before starting treatment with DX2LEK max, the patient should discuss this with a doctor or
pharmacist and verify, according to the diagram below, whether hair loss symptoms correspond
to androgenetic alopecia.
Androgenetic alopecia is characterized by gradual thinning of the hair. In men, it usually begins
with recession of the hairline at the forehead and formation of temples. In women, thinning
occurs mainly at the crown of the head.

In cases where there is no family history of androgenetic alopecia or it cannot be established,
consultation with a doctor is recommended before using the medicine.

2. Important information before using DX2LEK max

When not to use DX2LEK max

• 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 hypertension (treated or untreated);
• in cases of sudden or unexplained hair loss;
• if hair loss is associated with serious medical conditions such as thyroid disorders, systemic lupus erythematosus, hair loss due to inflammatory scalp conditions, or other diseases;
• if the patient has shaved or diseased scalp skin (e.g. psoriasis, inflammation, redness, irritation, or painful scalp);
• if the patient uses occlusive dressings or applies other topical medications (see section "DX2LEK max and other medicines");
• in children and adolescents under 18 years of age and in elderly patients.

Warnings and precautions
Before starting treatment with DX2LEK max, consult your doctor or pharmacist.
DX2LEK max is intended for topical use only on healthy scalp skin.

• Do not apply DX2LEK max to any other parts of the body except balding areas of the scalp.
• Accidental contact with other areas of the skin may lead to unwanted hair growth in those areas. Therefore, hands should be thoroughly washed after applying the medicine to the scalp.
• Patients diagnosed with cardiovascular diseases or heart rhythm disorders should consult a doctor before starting treatment with DX2LEK max.
• In some patients, changes in hair color and/or texture have occurred after using minoxidil.
• Applying a larger amount or more frequent doses of DX2LEK max than recommended will not speed up treatment.
• Avoid inhaling vapors or spray mist of the solution. Do not swallow.
• At the beginning of treatment (usually within 2 to 6 weeks after starting), increased hair loss may occur. If increased hair loss persists for longer than 2 weeks, discontinue use of DX2LEK max and consult a doctor.
• Discontinue use of DX2LEK max and contact your doctor if you experience hypotension, chest pain, rapid heartbeat, fainting or dizziness, sudden weight gain, swelling of hands or feet, or persistent redness or irritation of the scalp.
• In case of contact with eyes or mucous membranes, rinse thoroughly with water.

Children and adolescents (under 18 years of age) and elderly patients
DX2LEK max should not be used in children and adolescents (under 18 years of age) or in elderly patients (over 65 years of age).
Keep the medicine out of reach of children, as accidental ingestion may cause serious adverse effects on the heart.
Cases of excessive body hair growth in infants have been reported following skin contact with application sites of minoxidil in 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 in a child during topical use of minoxidil-containing products, consult a doctor.

DX2LEK max and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
DX2LEK max should not be used simultaneously with other topical medicines applied to the scalp, such as corticosteroids, tretinoin, dithranol, or petroleum jelly, as they may increase the penetration of minoxidil through the skin into the bloodstream and increase the risk of adverse effects.

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

Driving and operating machinery
DX2LEK max does not affect the ability to drive or operate machinery.

DX2LEK max contains propylene glycol and ethanol

Propylene glycol
The medicine contains 139.53 mg of propylene glycol in each 1 mL of solution.

Ethanol
This medicine contains 533.0 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 of the medicine.

3. How to use DX2LEK max

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for topical use on the scalp only.
Unless otherwise advised by a doctor, the medicine is usually used as described below.
Adults (aged 18 to 65 years)
Apply 1 mL of the solution to the scalp in areas of hair loss and massage it into the skin (most commonly
the crown and frontal hairline), twice daily, in the morning and evening.
The volume of one spray (one press of the pump applicator) is 0.2 mL. 1 mL of solution is obtained
after five presses of the pump applicator.
Do not use more than 2 mL of solution per day.
Before application, hair and scalp should be completely dry.
Instructions for use
WARNING: PROTECT EYES, NOSE, AND MOUTH.
Before first use, prime the pump applicator. To do this, hold the container upright and press the
pump applicator four times.
The medicine requires attaching the dosing nozzle before first use.

• To apply the medicine to the scalp in areas of hair loss, rotate the applicator sideways before use, then press.

• Direct the applicator toward the affected skin area.

• Press the applicator five times to deliver a 1 mL dose.
• Spread the solution with fingertips, ensuring even distribution.

After applying the medicine to the scalp, wash hands thoroughly.
Duration of treatment
It may be necessary to use the medicine twice daily for 4 months or longer.
Hair regrowth usually begins after 2 months of treatment with DX2LEK max.
If hair regrowth occurs after 2 months, continued use of DX2LEK max twice daily is necessary
to maintain its effect.
After discontinuation of minoxidil topical aerosol or solution, cessation of hair growth and sometimes
reversion to the previous appearance may occur within 3 to 4 months.
Treatment should be discontinued if no improvement is observed after 12 months of use.
Use of more than the recommended dose of DX2LEK max
There is no evidence that topically applied minoxidil is absorbed in amounts sufficient to produce
systemic effects. When used as directed, overdose is practically impossible.
Accidental ingestion of the medicine may cause symptoms of systemic minoxidil effects.
The most commonly observed symptoms include: tachycardia (rapid heartbeat), fainting,
dizziness, and sudden weight gain due to fluid retention.
If such symptoms occur, the patient should contact a doctor immediately.
Missed dose of DX2LEK max
If a dose is missed, apply the medicine as soon as possible, unless it is almost time for the next dose.
Do not use a double dose to make up for a missed dose of DX2LEK max.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately 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).

Common (may affect up to 1 in 10 people):

• headache;
• chest pain;
• itching;
• local erythema;
• excessive hair growth;
• rash;
• dermatitis;
• swelling.

Rare (may affect up to 1 in 1,000 people):

• hypotension;
• dry skin;
• skin desquamation;
• transient hair loss.

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
Phone: +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 medicinal product DX2LEK max

Keep the medicinal product out of sight and reach of children.
Store below 25 °C. Keep in the original packaging to protect from light.
Do not store in the refrigerator or freeze.
Do not use this medicinal product after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Shelf-life after first use: 3 months.
Medicinal products should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicinal products no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What DX2LEK max contains

• The active substance is minoxidil. 1 mL of solution contains 50 mg of minoxidil.
• The other ingredients are: propylene glycol, 96% ethanol, monohydrate citric acid, purified water.

What DX2LEK max looks like and contents of the pack
DX2LEK max is a clear, colourless to yellow cutaneous aerosol solution.
The pack consists of a HDPE bottle with a spray pump made of
LDPE/HDPE/PP/POM/LDPE/PIB/LDPE/PP/stainless steel and an applicator made of PP/POM,
or a HDPE bottle with a spray pump made of LDPE/HDPE/PP/POM/LDPE/PIB/LDPE/PP/stainless
steel and an applicator made of LDPE/PP/LDPE/PP/stainless steel, containing 60 mL of solution
(minimum 240 doses), in a cardboard box.
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
Przedsiębiorstwo Produkcji Farmaceutyczno – Kosmetycznej „PROFARM” Sp. z o.o.
ul. Słupska 18
84-300 Lębork