Loxon Max

Leaflet attached to the packaging: patient information

LOXON Max

Minoxidil
50 mg/ml, liquid for the skin

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 the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Loxon Max and what is it used for

Loxon Max is a liquid for application to the scalp, containing the active substance minoxidil. Minoxidil stimulates hair growth in androgenetic alopecia in women and men. Hair loss cessation was observed in the second month of use, and hair growth usually begins after two months of treatment with Loxon Max. The maximum effect is achieved after about 12 months of systematic use.
Indications:
Loxon Max is used to treat androgenetic alopecia (hair loss) in women and men aged 18-65.
Before starting treatment with Loxon Max, the patient should discuss it with their doctor or pharmacist and check, according to the diagram below, whether their hair loss symptoms correspond to androgenetic alopecia:

In cases where there is no family history of androgenetic alopecia or it is not possible to determine, the patient should consult a doctor before using the medicine.

2. Important information before using Loxon Max

When not to use Loxon Max

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has hypertension,
• in cases of sudden or unexplained hair loss. Additionally, Loxon Max should not be used if hair loss is associated with severe diseases, such as thyroid dysfunction, systemic lupus, hair loss from a certain skin area due to inflammation of the scalp or other diseases,
• if the patient has a shaved or diseased scalp (e.g. psoriasis, inflammation, redness, irritation, or pain),
• if the patient is using occlusive dressings or applying other medicines topically.

Warnings and precautions

Before starting treatment with Loxon Max, the patient should discuss it with their doctor or pharmacist.
Loxon Max should not be applied to other areas of the skin than the balding areas on the scalp.
In case of accidental contamination of other skin areas with the medicine, unwanted hair growth may occur in these areas, so after applying the medicine to the scalp, the hands should be washed thoroughly.
Loxon Max is for external use only.
Loxon Max should only be applied to healthy, intact scalp skin.
Patients with known cardiovascular diseases or heart rhythm disorders should consult their doctor before starting treatment with Loxon Max.
In some patients, minoxidil has caused changes in hair color and/or texture.
Using a larger or more frequent dose of Loxon Max than recommended will not accelerate treatment.
Inhaling the vapors and mist of the solution should be avoided. Do not swallow.
At the beginning of treatment (usually within 2-6 weeks of starting it), increased hair loss may occur. If increased hair loss persists for more than 2 weeks, the use of Loxon Max should be stopped and a doctor consulted.
The use of Loxon Max should be stopped and a doctor consulted if the patient experiences hypotension or chest pain, rapid heart rate, fainting or dizziness, sudden weight gain, swelling of the hands or feet, or persistent redness or irritation of the scalp.
There have been cases of excessive hair growth on the body of infants following contact with the skin of caregivers using minoxidil topically.
Hair growth returned to normal within a few months when the infant was no longer exposed to minoxidil.
Children should be kept away from areas of the body where minoxidil has been applied topically.
If excessive hair growth on the body of a child is observed during the use of minoxidil-containing products, a doctor should be consulted.

Children and adolescents (under 18 years) and the elderly

Loxon Max should not be used in children and adolescents under 18 years and in people over 65 years.
The medicine should be kept out of the reach of children, as accidental ingestion may cause serious heart-related side effects.

Loxon Max and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to use.
Loxon Max should not be used at the same time as other medicines applied topically to the scalp.
Substances such as corticosteroids, tretinoin, ditranol, and petroleum jelly may alter the protective properties of the stratum corneum, leading to increased absorption of the medicine into the bloodstream and its systemic effects.

Pregnancy and breastfeeding

Loxon Max should not be used during pregnancy and breastfeeding.

Driving and using machines

It is not expected that Loxon Max will affect the ability to drive or use machines.

Loxon Max contains ethanol 96%

This medicine contains 500 mg of alcohol (ethanol) in 1 ml of liquid, which is one dose (average volume of 10 sprays).
One spray of 0.1 ml of liquid contains 50 mg of ethanol.
The medicine contains alcohol, which may irritate the mucous membranes and eyes; in case of eye contact, they should be rinsed thoroughly with water.
The medicine may cause burning of damaged skin.
The medicine is flammable. It should not be used near an open flame, lit cigarette, or electrical appliances, such as a hair dryer.

Loxon Max contains propylene glycol

The medicine contains 300 mg of propylene glycol in each ml of liquid.
Propylene glycol may cause skin irritation.

3. How to use Loxon Max

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The medicine should be applied twice a day.
1 ml of liquid (average volume of 10 sprays) should be applied to the scalp in the balding areas, morning and evening.
The volume of one spray is 0.1 ml.
The dose should not exceed 2 ml in 24 hours (on average, 2 x 10 sprays per day).
The medicine is for topical use only.
Loxon Max should be used according to the instructions, only on the scalp.
Before applying Loxon Max, the hair and scalp should be completely dry.
1 ml of liquid should be spread in the balding areas and massaged into the skin (most often the top of the head and the frontal area).

Note: after applying the medicine to the scalp, the hands should be washed thoroughly.
It may be necessary to use the medicine twice a day for four months or longer.
Hair growth usually begins after 2 months of treatment with Loxon Max.
If hair growth occurs after 2 months, it is necessary to continue using Loxon Max twice a day to maintain its effect.
Sometimes, after stopping minoxidil treatment, a cessation of hair growth and a return to the previous appearance within 3 to 4 months after stopping treatment have been observed.
Treatment should be stopped if no improvement occurs after 1 year of use.
Instructions for using the bottle with a dispenser
Before use, turn the applicator to the side and then press the dispenser to apply the medicine to the scalp (balding areas).

WARNING - PROTECT EYES, NOSE, AND MOUTH.

Using a larger dose of Loxon Max than recommended

There is no evidence that topically applied minoxidil is absorbed in quantities sufficient to cause systemic effects. When used as instructed, overdose is practically impossible.
Accidental ingestion of the medicine may cause symptoms of systemic minoxidil effects (2 ml of Loxon Max liquid contains 100 mg of minoxidil, which is the maximum recommended dose of minoxidil used to treat hypertension in adults). The most common symptoms include: tachycardia, fainting, dizziness, sudden weight gain due to fluid retention.
If similar symptoms are observed, the patient should immediately contact their doctor.

Children and adolescents (under 18 years) and the elderly

Loxon Max should not be used in children and adolescents under 18 years and in people over 65 years.

Missing a dose of Loxon Max

If a dose is missed, the medicine should be applied to the skin as soon as possible, unless it is close to the time of the next application.
A double dose should not be used to make up for a missed dose of Loxon Max.
If there are any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Loxon Max can cause side effects, although not everybody gets them.
The patient should immediately contact their doctor if they experience any of the following symptoms, as urgent medical attention may be necessary:

• Swelling of the face, lips, or throat, which makes swallowing or breathing difficult. These may be symptoms of a severe allergic reaction (frequency not known, cannot be estimated from the available data).

Common(in 1 to 10 out of 100 patients): may include headache, chest pain, itching, local redness, excessive hair growth, rash, skin inflammation, swelling.
Rare(in 1 to 10 out of 10,000 patients): may include hypotension, dryness and/or flaking of the scalp, and transient hair loss.
Frequency not known(cannot be estimated from the available data): allergic reactions, including angioedema (severe allergic reaction - swelling may involve the face, limbs, mouth, throat, and cause breathing difficulties).

Reporting side effects

If the patient experiences any side effects, including any possible side effects 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 Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Loxon Max

The medicine should be kept out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date (EXP) is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the pack and other information

What Loxon Max contains

The active substance of Loxon Max is minoxidil.
1 ml of liquid for the skin contains 50 mg of minoxidil.
Excipients: propylene glycol, ethanol 96%, purified water, citric acid.

What Loxon Max looks like and contents of the pack

Loxon Max is a liquid for the skin.
Packaging:60 ml of liquid for the skin 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)] with a dispenser [high-density polyethylene (HDPE), polypropylene (PP)], or with a pump [low-density polyethylene (LDPE), polypropylene (PP)] with a dispenser [polypropylene (PP)], placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
+48 (22) 852 55 51
Manufacturer:
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
To obtain more detailed information about the medicine, the patient should contact:
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
+48 (22) 852 55 51
Date of leaflet approval:October 2024