LOXON 2%

Patient Information Leaflet

LOXON 2%
Minoxidilum
20 mg/ml, solution for topical use
{logo of the responsible entity}
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 the patient leaflet or as directed by
a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse, contact a doctor.

Table of Contents

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

1. What Loxon 2% is and what it is used for

Loxon 2% is a topical solution intended for application to the scalp and contains the active substance minoxidil. Minoxidil stimulates hair growth in androgenetic alopecia in both women and men. It reverses or inhibits miniaturization of hair follicles and exerts a strong stimulatory effect on cell proliferation within hair follicles during the growth phase. A reduction in hair loss is typically observed by the second month of treatment, while new hair growth generally begins after 4 months of treatment with Loxon 2%. Maximum effect is achieved after approximately 12 months of consistent use, and treatment outcomes largely depend on regular application of the product and individual patient characteristics.

2. Important information before using Loxon 2%

When not to use Loxon 2%

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has hypertension.
• if the patient is under 18 or over 65 years of age.

Warnings and precautions
Before starting treatment with Loxon 2%, discuss it with your doctor or pharmacist.
This medicine is intended for topical use on the scalp only; it should not be applied to damaged skin (inflammatory conditions, psoriasis) or shaved scalp.
Loxon 2% should not be used during treatment with other topical medicines. Topical agents such as corticosteroids, tretinoin, dithranol, and petrolatum may alter the protective properties of the stratum corneum, potentially leading to increased absorption of minoxidil into the bloodstream and systemic effects.
Treatment with Loxon 2% should be discontinued if hypotension, chest pain, increased heart rate, fainting, dizziness, or limb swelling occur.
If persistent redness of the scalp or irritation develops, discontinue use and contact your doctor.
Patients with cardiovascular diseases or cardiac rhythm disorders should consult a doctor before starting treatment.
At the beginning of treatment (usually within 2–6 weeks), increased hair loss may occur.
If excessive hair loss persists for more than 2 weeks, discontinue use of Loxon 2% and consult your doctor.
Avoid inhaling the medicine.
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 ensure that children do not come into contact with areas of the body where minoxidil has been applied.
If excessive hair growth is observed in a child during use of topical minoxidil products, consult your doctor.

Loxon 2% and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.

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 her doctor or pharmacist before using this medicine.

Pregnancy
This medicine should not be used during pregnancy.

Breastfeeding
This medicine should not be used during breastfeeding.

Driving and operating machinery
This medicine does not affect patients' psycho-physical performance.

Loxon 2% contains 96% ethanol
One spray containing 0.1 ml of solution contains 50 mg of ethanol.
This medicine contains alcohol, which may irritate mucous membranes and eyes; if the medicine gets into the eye, rinse thoroughly with water.
The medicine may cause a burning sensation on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or electrical devices such as hair dryers.

Loxon 2% contains propylene glycol
The medicine contains 300 mg of propylene glycol per ml of solution.
Propylene glycol may cause skin irritation.

3. How to use Loxon 2%

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Apply the medicine twice daily.
Dilute 1 ml of the solution over the balding area and massage into the scalp (usually the crown and frontal hairline).
The volume of one spray is 0.1 ml.
The average volume of 10 sprays is 1 ml.
Do not exceed a dose of 2 ml per day.
Note: After applying the solution to the scalp, wash hands thoroughly.
Treatment should be discontinued if no improvement is observed after 1 year of use.

Use in children and adolescents
Do not use in children under 18 years of age.
If you feel that the effect of Loxon 2% is too strong or too weak, consult your doctor.

Instructions for using the bottle with dispenser
Before use, turn the applicator to the side, then press the pump to apply the medicine to the scalp (balding areas).

WARNING – PROTECT EYES, NOSE AND MOUTH.

Use of a higher than recommended dose of Loxon 2%
There are no known cases of overdose with topical minoxidil.
However, due to the high concentration of minoxidil in Loxon 2%, accidental ingestion of the medicine may cause symptoms related to systemic effects of minoxidil. The most frequently observed symptoms include: tachycardia (rapid heartbeat), fainting, dizziness, and sudden weight gain.
If such symptoms occur, contact your doctor immediately.

Missed dose of Loxon 2%
If you miss one application, apply the medicine as soon as possible, unless it is almost time for the next dose.
Do not apply a double dose to make up for a missed dose of Loxon 2%.

4. Possible adverse reactions

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, which makes swallowing or breathing difficult. These may be symptoms of a severe allergic reaction (frequency unknown, cannot be estimated from available data).

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Rare (in 1 to 10 out of 10,000 patients): skin reactions such as: skin irritation and itching, excessive hair growth (including appearance of facial hair in women), local redness, dryness/flaking of the scalp skin, and increased hair loss.
Rare cases of hypotension.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Reactions of Medicinal Products, 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 Loxon 2%

Store the medicine at a temperature below 25 °C.
Keep the medicine in a place out of sight and reach of children.
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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Loxon 2% contains
The active substance is minoxidil.
1 ml of topical solution contains 20 mg of minoxidil.
The other ingredients are: propylene glycol, ethanol 96%, purified water, citric acid.

What Loxon 2% looks like and contents of the pack
Loxon 2% is a topical solution.
Packaging: 60 ml of topical solution in a high-density polyethylene (HDPE) bottle with a pump [low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), stainless steel, ethylene vinyl acetate (EVA), polyoxymethylene (POM)] and dispenser [high-density polyethylene (HDPE), polypropylene (PP)] or with a pump [low-density polyethylene (LDPE), polypropylene (PP), stainless steel] and dispenser [polypropylene (PP)], placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz