Loxon max

Patient Information Leaflet

LOXON Max
Minoxidil
50 mg/ml, solution for topical use
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or if you feel worse, you should contact your doctor.

Table of contents

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

Loxon Max is a topical solution applied to the scalp and contains the active substance minoxidil. Minoxidil stimulates hair growth in androgenetic alopecia in both men and women. A reduction in hair loss is typically observed within the second month of treatment, while hair regrowth usually begins after two months of treatment with Loxon Max. Maximum effect is achieved after approximately 12 months of consistent use.

Indications:
Loxon Max is indicated for the treatment of androgenetic alopecia (hair loss) in men and women aged 18–65 years.

Before starting treatment with Loxon Max, the patient should consult with a doctor or pharmacist and check, according to the diagrams below, whether their hair loss symptoms correspond to androgenetic alopecia:

If there is no family history of androgenetic alopecia or if such history cannot be determined, medical advice should be sought before using this medicine.

2. Important information before using Loxon Max

When not to use Loxon Max

• 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 high blood pressure,
• in cases of sudden or unexplained hair loss. Additionally, Loxon Max should not be used if hair loss is associated with serious diseases such as thyroid dysfunction, systemic lupus erythematosus, hair loss from a specific area of the scalp due to inflammatory skin 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 is using occlusive dressings (sealed) or applying other topical medicines.

Warnings and precautions
Before starting treatment with Loxon Max, discuss it with your doctor or pharmacist.
Do not apply Loxon Max to any areas of the skin other than balding areas on the scalp.
If the medicine accidentally comes into contact with other areas of the skin, unwanted hair growth may occur in those areas; therefore, hands should be thoroughly washed after applying the medicine to the scalp.
Loxon Max is for external use only.
Loxon Max should be applied only to intact, healthy scalp skin.
Patients diagnosed with cardiovascular diseases or heart rhythm disorders should consult a doctor before starting treatment with Loxon Max.
In some patients, minoxidil use has led to changes in hair color and/or texture.
Using a higher dose or applying the medicine more frequently than recommended will not speed up treatment.
Avoid inhaling vapors or spray mist. Do not swallow.
At the beginning of treatment (usually within 2–6 weeks after starting), increased hair loss may occur. If increased hair loss persists for longer than 2 weeks, discontinue use of Loxon Max and consult a doctor.
Discontinue use of Loxon Max and contact a doctor if experiencing low blood pressure, chest pain, rapid heartbeat, fainting or dizziness, sudden weight gain, swelling of hands or feet, or persistent redness or irritation of the scalp.
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 use of topical products containing minoxidil, consult a doctor.

Children and adolescents (under 18 years of age) and elderly individuals
Loxon Max should not be used in children and adolescents under 18 years of age or in individuals over 65 years of age.
The medicine should be stored out of children’s reach, as accidental ingestion may cause serious cardiovascular adverse effects.

Loxon Max and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Loxon Max should not be used simultaneously with other medicines applied topically to the scalp.
Substances such as corticosteroids, tretinoin, dithranol, and vaseline may alter the protective properties of the stratum corneum, potentially increasing systemic absorption of the medicine and leading to systemic effects.

Pregnancy and breastfeeding
Loxon Max should not be used during pregnancy or breastfeeding.

Driving and operating machinery
Loxon Max is not expected to affect the ability to drive or operate machinery.

Loxon Max contains 96% ethanol
This medicine contains 500 mg of alcohol (ethanol) per 1 ml of solution, which corresponds to one dose (average volume of 10 sprays).
One spray, delivering 0.1 ml of solution, contains 50 mg of ethanol.
The 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 stinging on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or electrical devices such as hair dryers.

Loxon Max contains propylene glycol
The medicine contains 300 mg of propylene glycol in each ml of solution.
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 directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The medicine should be used twice daily.
Apply 1 ml of the solution (equivalent to an average of 10 sprays) to the scalp skin in areas of hair loss, in the morning and evening.
The volume of one spray is 0.1 ml.
Do not exceed a dose of 2 ml per day (typically 2 x 10 sprays per day).
This medicine is for topical use only.
Loxon Max should be used according to the instructions, and applied exclusively to the scalp skin.
Before applying Loxon Max, hair and scalp should be completely dry.
Apply 1 ml of the solution to the areas of hair loss and gently massage into the skin (usually the crown and frontal hairline).

Note: After applying the medicine to the scalp, hands should be thoroughly washed.
It may be necessary to use the medicine twice daily for four months or longer.
Hair regrowth usually begins after 2 months of treatment with Loxon Max.
If hair regrowth occurs after 2 months, continued use of Loxon Max twice daily is necessary to maintain its effect. Sometimes, after discontinuation of topical minoxidil treatment, cessation of hair growth and return to the previous appearance have been observed within 3 to 4 months of stopping treatment.
Treatment should be discontinued if no improvement is seen after 1 year of use.

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

WARNING – PROTECT EYES, NOSE, AND MOUTH.
Use of a higher than recommended dose of Loxon Max
There is no evidence that topically applied minoxidil is absorbed in amounts sufficient to cause systemic effects. When used according to instructions, overdose is practically impossible.
Accidental ingestion of the medicine may cause symptoms of systemic minoxidil effects (2 ml of Loxon Max solution contains 100 mg minoxidil, which corresponds to the maximum recommended dose of minoxidil used in the treatment of hypertension in adults). The most commonly observed symptoms include: tachycardia, fainting, dizziness, and sudden weight gain due to fluid retention.
If such symptoms occur, the patient should contact a doctor immediately.

Children and adolescents (under 18 years of age) and elderly individuals
Loxon Max should not be used in children and adolescents under 18 years of age or in individuals over 65 years of age.

Missed application of Loxon 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 Loxon Max.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 not known, cannot be estimated from available data).

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

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Loxon Max

Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date (EXP) 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 you no longer use.
This will help protect the environment.

6. Contents of the package and other information

What Loxon Max contains
The active substance is minoxidil.
1 ml of topical solution contains 50 mg of minoxidil.
Excipients: propylene glycol, 96% ethanol, purified water, citric acid.

What Loxon Max looks like and contents of the pack
Loxon Max is a topical solution.
Pack: 60 ml of topical solution in a high-density polyethylene (HDPE) bottle with a pump [polyethylene (LDPE, HDPE), polypropylene (PP), stainless steel, ethylene vinyl acetate (EVA), polyoxymethylene (POM)] and dispenser [polyethylene (HDPE), polypropylene (PP)] or with a pump [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 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

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