MEN'S GLN-MINOXIDIL

1 Dosing Considerations • FOR EXTERNAL USE ONLY. Do not ingest. Use Men’s GLN-MINOXIDIL (5 % minoxidil topical foam) only as directed. Apply Men’s GLN-MINOXIDIL when the hair and scalp are thoroughly dry. The safety and efficacy of Men’s GLN-MINOXIDIL in users aged under 18 or in men over 65 years of age have not been established.

2 Recommended Dose and Dosage Adjustment Men’s GLN-MINOXIDIL A dose of half (½) capful (equal to 1 gram of foam or 50 mg minoxidil), Men’s GLN-MINOXIDIL should be applied to the total affected hair loss areas of the scalp (not on the hair) twice daily.

The total daily dosage should not exceed 2 grams of foam (100 mg minoxidil) in men. It may take twice-daily applications for 2 months or more before evidence of hair growth can be expected. If hair regrowth occurs, twice daily applications of Men’s GLN-MINOXIDIL are necessary for continued hair growth.

Regrown hair may disappear three to four months after stopping Men’s GLN- MINOXIDIL application and the balding process will continue. Treatment should be discontinued if there is no improvement after one year. Health Canada has not authorized an indication for pediatric use.

4 Administration Men’s GLN-MINOXIDIL 1) To open container: Match arrow on can ring with arrow on cap. Pull off cap. 2) Hold the can upside down and press nozzle to dispense the foam. The total amount of foam applied should not exceed half (½) capful (equivalent to one gram of foam) 3) The foam may begin to melt on contact with warm skin.

If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam. 4) The foam should be massaged lightly into the affected areas of the scalp. 5 Missed Dose Men’s GLN-MINOXIDIL If one or two applications are missed, the missed application(s) should be skipped, and treatment should be resumed with the next scheduled application/dose.

Do not use twice as much, or twice as often, the prescribed dose. Men’s GLN-MINOXIDIL Minoxidil Foam Page 6 of 37

7% for Placebo Foam group) were not considered drug related, and no serious event resulted in discontinuing study participation. 7% in the Minoxidil Foam 5% group, 7% in the Placebo Foam group) reflected mild to moderate pain or skin irritation.

2% in the Placebo Foam group) were headache, alopecia, and rash (one case each) in the Minoxidil Foam 5% group, and tachycardia, nausea, and hyperventilation (one case each) in the Placebo Foam group. 2% for Placebo Foam). 0% for Placebo Foam).

2% for Placebo Foam). 0% for Placebo Foam). 0% for Placebo Foam). For the long-term treatment with Men’s Minoxidil FOAM 5% BID (an open-label safety extension phase of Study 006), 114 subjects out of 143 subjects completed one year of treatment.

1% of the subjects reported adverse events. 3%). 0 %) but were not considered to be drug related. All other adverse events were considered mild or moderate in nature. 2% of the subjects reporting adverse events. 8% overall). In general, the overall post-marketing safety experience to date has been consistent with that Men’s GLN-MINOXIDIL Minoxidil Foam Page 10 of 37 observed in the clinical trial program.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Men’s MINOXIDIL FOAM 5% In a randomized, double-blind, placebo-controlled, multi-centre (involving 14 centers) trial (Study 006), the efficacy and safety of a topical 5% Minoxidil Foam formulation for the treatment of male androgenetic alopecia were evaluated.

General • Men’s GLN-MINOXIDIL is for external use only. Apply only to scalp. Do not ingest. • Before applying Men’s GLN-MINOXIDIL, the user should determine that the scalp is normal and healthy. • Hands should be washed thoroughly after use.

• Inhalation of the spray should be avoided. • Men’s GLN-MINOXIDIL contain ethanol (alcohol) which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), the area should be bathed with large amounts of cool tap water.

• Men’s GLN-MINOXIDIL also contain butylated hydroxytoluene, cetyl alcohol, and stearyl alcohol. , contact dermatitis), or irritation to the eyes or mucous membranes. , contact dermatitis). • Some patients have experienced changes in hair colour and/or texture with Men’s GLN- MINOXIDIL use.

• Shedding of hair may occur within two to six weeks after initiating therapy, likely due to minoxidil’s action on shifting hairs from the resting telogen phase to the growing anagen phase. If shedding persists for more than two weeks, users should stop applying Men’s GLN- MINOXIDIL and consult their doctor.

• Men’s GLN-MINOXIDIL should not be used when there is no family history of hair loss, hair loss is sudden and/or patchy, or the reason for hair loss is unknown. • Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application site of patients (caregivers) using topical minoxidil.

Hypertrichosis was reversible, within months, when infants were no longer exposed to minoxidil. Contact between children and minoxidil application sites should be avoided. Men’s GLN-MINOXIDIL Minoxidil Foam Page 8 of 37 Cardiovascular • Accidental ingestion may cause serious cardiac adverse events.

• Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Men’s GLN-MINOXIDIL. • Although the following systemic effects have not been associated with the topical use of Men’s GLN-MINOXIDIL, there is some absorption of minoxidil from the skin and the potential exists for systemic effects such as salt and water retention, hypertension, tachycardia, angina, and edema.

Men’s GLN-MINOXIDIL is contraindicated: • in Women • in individuals with a history of hypersensitivity to minoxidil or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

• in individuals with treated or untreated hypertension. • in individuals whose baldness is not due to hereditary factors. Men’s GLN-MINOXIDIL is only effective for the treatment of male vertex alopecia androgenetica. • in individuals with any scalp abnormality (including psoriasis and sunburn).

• in individuals with a shaved scalp or whose scalp’s skin is broken, inflamed, irritated, infected, or severely sunburned. • if occlusive dressings or other topical therapeutic medications for treating disorders of the skin of the scalp are being used.

, cornrowing, tight ponytails), may also cause temporary hair loss which should not be treated with Men’s GLN-MINOXIDIL.