Dx2lek

Leaflet attached to the packaging: patient information

DX2LEK, 20 mg/mL, liquid for the skin

Minoxidil

Read the 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 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 DX2LEK and what is it used for
• 2. Important information before using DX2LEK
• 3. How to use DX2LEK
• 4. Possible side effects
• 5. How to store DX2LEK
• 6. Package contents and other information

1. What is DX2LEK and what is it used for

DX2LEK is a liquid for topical application to the scalp. DX2LEK contains the active substance minoxidil, which stimulates hair growth in male pattern baldness. Stopping excessive hair loss is observed after about 8 weeks of using the medicine, and the first regrowth of hair in the form of thin vellus hair occurs after 4 to 5 months of treatment.

Indications

DX2LEK is indicated for the treatment of male pattern baldness (androgenetic alopecia) in men and women aged 18 to 65 years.
DX2LEK is most effective in younger people in the early stages of the balding process. Better treatment results are achieved on the top of the head than on the frontal-temporal area.
Stopping treatment causes the therapeutic effect to reverse within a few months.
If after 60 days there is no improvement or increased hair loss persists for more than 2 weeks, or the patient feels worse, they should consult a 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 diseases, such as severe 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 a 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 DX2LEK, the patient should discuss it with their doctor or pharmacist.
DX2LEK is intended for topical use on the scalp only.
DX2LEK 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 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 DX2LEK.
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 in 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 is observed in a child during topical use of minoxidil, the patient should consult their doctor.

Children and adolescents and the elderly

Do not use the medicine in children and adolescents (under 18 years of age) and in the elderly (over 65 years of age).

DX2LEK and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Interactions between DX2LEK and other medicines are not known.
Do not use DX2LEK at the same time as other medicines applied topically to the scalp, such as corticosteroids, retinoids, ditranol, or petroleum jelly, as they may increase the penetration of minoxidil into the blood and enhance the risk of side effects.
During treatment with blood pressure-lowering medicines (e.g., guanethidine), the patient should consult their doctor before using DX2LEK, 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.
Do not use DX2LEK during pregnancy and breastfeeding.

Driving and using machines

DX2LEK does not affect the ability to drive and use machines or impair psychophysical performance.

DX2LEK 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. Do not use the medicine near an open flame, lit cigarette, or certain devices (e.g., hair dryers).
Avoid inhaling the vapors of the sprayed medicine.

3. How to use DX2LEK

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the scalp.
Unless the doctor has prescribed 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 skin 2 times a day, approximately every 12 hours, to the areas of hair loss and gently massaged with fingertips. Do not rub or dry these areas. The medicine should be applied drop by drop using the pump (1 mL of liquid is obtained after pressing the pump button 5 times).
Wash hands thoroughly after using the medicine.
Do not use more than 2 mL of the medicine per day. Do not use the medicine on other parts of the body.

Do not wash hair and scalp before 4 hours after using the medicine.

Stop treatment after 1 year if there are no visible results of treatment.
Do not increase the dose or frequency of using the medicine.
In case of clogging of the dosing tube 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 higher dose of DX2LEK than recommended

Overdosing on DX2LEK should not have negative effects on health, as there are no known cases of minoxidil overdose when used topically.
However, it cannot be ruled out that increased absorption of the medicine and potential occurrence of side effects may occur as a result of using the medicine contrary to the recommendations, e.g., using higher 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, and resulting dizziness and fainting, edema mainly of the face, hands, and feet, acute gastrointestinal disorders, blurred vision, chest pain.

Missing a dose of DX2LEK

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

4. Possible side effects

Like all medicines, DX2LEK can cause side effects, although not everybody gets them.
Side effects occur about 5 times more often in women than in men.

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• facial, lip, or throat edema that 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 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 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 with 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 Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store DX2LEK

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C.
Store in a 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What DX2LEK contains

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

What DX2LEK looks like and what the packaging contains

The medicine is a clear, colorless or slightly yellow liquid.
Packaging
A white HDPE bottle with a PP cap and a seal or a dosing pump [LDPE, HDPE, PP, POM, LDPE/PIB, LDPE/PP, stainless steel], placed in a cardboard box. The bottle contains 60 mL of liquid for the skin.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: +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

Date of last revision of the leaflet: