Hair Regrowth Treatment: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Hair Regrowth Treatment is used for the treatment of male pattern baldness (androgenetic alopecia) on the top of the scalp (vertex) in men aged 18-65 years. It prevents further hair loss and helps hair re-growth.

Hair Regrowth Treatment has no effect on receding hairlines. It does not permanently reverse male pattern baldness; most new hair is lost within three to four months after stopping the medication.

What it does:

Hair Regrowth Treatment contains minoxidil, which is thought to work by aiding the blood flow to hair follicles on your scalp and thereby helping hair re-growth. Initial hair re-growth may look soft, downy (“vellus”) hair and may be barely visible. After further treatment, hair re-growth may change and become the same colour and thickness as the rest of the hair.

Hair Regrowth Treatment is more effective if you are experiencing gradually thinning hair or gradual hair loss on the top of the head (as shown in the image).

Gradual hair loss on the top of the scalp

Male Pattern Baldness or Hereditary Hair Loss is recognizable because:

• Of the pattern of hair loss (see diagrams above).
• Hair loss starts gradually and progresses.
• You have a family history of hair loss.
• No other symptoms are present with your hair loss.

You must use Hair Regrowth Treatment for at least 4 months, and possibly for up to 1 year, before you see any effect.

The amount of hair regrowth is different for each person. Not everyone will respond to Hair Regrowth Treatment. The response to this medicine cannot be predicted. No one will be able to grow back all of their hair.

You may respond better if you have been losing your hair for a shorter period of time (less than 10 years) or have little initial hair loss (less than a diameter of 10 cm).

When it should not be used:

Do not use this medicine if you:

• are female
• have an allergic reaction (hypersensitivity) to minoxidil or any of the other ingredients in Hair Regrowth Treatment
• have treated or untreated high blood pressure
• have baldness not due to male pattern baldness
• have any condition that affects your scalp such as redness, inflammation, irritation, pain on touching, sunburn, or psoriasis
• have a shaved scalp or broken skin on the scalp
• are treated with any kind of dressing or bandage (occlusive dressing) or other topical medication (e.g. anthralin, tretinoin or corticosteroids) on your scalp for any skin scalp problems
• have temporary hair loss as a result of taking certain medications (cancer chemotherapy) or having certain disease state or nutritional problems, as well as poor grooming habits.
• have secondary syphilis

What the medicinal ingredient is: minoxidil

What the important non-medicinal ingredients are: alcohol, propylene glycol and water.

What dosage forms it comes in:

Hair Regrowth Treatment with pump-spray, extended spray-tip and rub-on applicators.

WARNINGS AND PRECAUTIONS

• Apply Hair Regrowth Treatment only on the scalp.
• Inhalation of spray mist should be avoided.
• Avoid contact with eyes as Hair Regrowth Treatment contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If contact occurs, rinse thoroughly with large amounts of cool tap water. Stop use and speak to your doctor if irritation persists.
• Hair Regrowth Treatment may rarely cause low blood pressure, salt and water retention that lead to chest pain (angina), rapid heartbeat (tachycardia), swollen hands and feet
• May change colour/texture of hair
• Hair Regrowth Treatment 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
• Shedding of hair may occur within two to six weeks after using the product. If shedding persists for more than two weeks, users should stop applying Hair Regrowth Treatment and consult their doctor.

Hair Regrowth Treatment should not be used in males under 18 or over 65 years of age.

Before using Hair Regrowth Treatment, talk to your doctor or pharmacist if any of the following conditions applies to you:

• High or low blood pressure or heart disease or irregular heartbeat (arrhythmia).
• Under other treatment for any scalp conditions.

INTERACTIONS WITH THIS MEDICATION

Before using Hair Regrowth Treatment talk to your pharmacist or doctor if you are taking or have recently taken prescription drugs, non-prescription drugs or natural health product

The following medications may increase the absorption of minoxidil:

• Anthralin – used to treat psoriasis

• Tretinoin – used to treat acne or other skin conditions

  Hair Regrowth Treatment (Minoxidil) also may increase the effect of hydralazine (drug to treat high blood pressure).

PROPER USE OF THIS MEDICATION

Application:

• Hair Regrowth Treatment is for topical and external use only. It should only be applied directly to the scalp area. Make sure your hair and scalp are completely dry before applying the solution.
• Shampooing is not required before applying Hair Regrowth Treatment. However, if you wash your scalp before applying Hair Regrowth Treatment, use a mild shampoo. Dry hair and scalp before application.
• Do not apply to areas of the body other than the scalp.
• Do not apply Hair Regrowth Treatment, to a sunburned or irritated, broken or shaved scalp.
• For Hair Regrowth Treatment to work best, you should allow Hair Regrowth Treatment to remain on the scalp for at least 4 hours.
• Wash your hands thoroughly before and after applying the solution and rinse other areas that have come into contact with the solution.
• Please see special instructions below for 2 different applicators. Each applicator contains one dose of medicine.
• If you are planning to be in the sun after applying Hair Regrowth Treatment, use headwear. Do not use sunscreens or sun-blocking agents.
• Avoid swimming, showering or physical activity involving excessive sweating or wetting in rain for at least 4 hours after application.
• To minimize breakage of existing hair, the scalp should be massaged gently. Comb hair with a widely spaced, round tooth comb to avoid excessive pulling.
• There is no need to change your usual hair care routine when using Hair Regrowth Treatment. You may use hair sprays, mousses, conditioners, gels, etc. However, you should apply Hair Regrowth Treatment first and wait for it to dry before applying your styling aids.

• It is not known if hair colouring, perming or relaxing agents change the effect of Hair Regrowth Treatment.

  However, to avoid possible scalp irritation, you should make sure all of the Hair Regrowth Treatment has been washed off the hair and scalp before using these products.

Usual dose:

• 1 ml applied twice daily to the scalp, beginning at the centre of the affected area; for example, once in the morning and once at night. Do not exceed 2 ml in a day. Exceeding the recommended dosage may cause increased side effects.
• If you do not see any results after 1 year, stop using Hair Regrowth Treatment and seek the advice of your physician.
• One bottle of Hair Regrowth Treatment should last for 25-30 days, if applied twice a day according to directions.

Missed dose:

• If a dose is missed, use as soon as remembered if it is within a few hours of the usual time applied. Do not apply if it is almost time for the next dose. If a dose is missed, the amount used in the next dose should not be doubled.

Overdose:

INSTRUCTIONS FOR USE OF APPLICATORS

APPLICATOR OPTIONS

Hair styles and degree of hair loss can be very different for each person. We have included three applicators that have been designed especially for men. You can choose whichever one works best for you.

A. Pump-Spray Applicator

B. Extended Spray-Tip Applicator

C. Rub-on Applicator

USING THE APPLICATORS

• A. Pump-Spray Applicator

  Works best for applying Hair Regrowth Treatment to large areas of the scalp.

  1. 1)

     Unscrew small cap and discard it.

     1. 2) Insert the pump spray applicator into bottle and screw on firmly. Remove outer cap and keep it.
     2. 3) After aiming the pump toward the centre of the bald area of the scalp, press the pump once and spread Hair Regrowth Treatment solution with fingertips to cover all the bald area. Repeat for a total of 6 times, to apply a dose of 1 mL. Avoid breathing spray mist.
     3. 4) Replace outer cap over the pump spray applicator when not in use.

     • B. Extended Spray-Tip Applicator

       Works best for applying Hair Regrowth Treatment to small areas of the scalp or under hair.

       1. 1) Unscrew small cap and discard it.
       2. 2) Insert the pump spray applicator into bottle and screw on firmly. Remove outer cap and discard it.
       3. 3) Remove small spray head from top of pump spray applicator.
       4. 4) Fit the extended spray-tip applicator onto the spray shaft and push down firmly.
       5. 5) Remove the small cap on the end of the extended tip and keep it.
       6. 6)

          After aiming the pump toward the centre of the bald area of the scalp, press the pump once and spread Hair Regrowth Treatment solution with fingertips to cover all the bald area. Repeat for a total of 6 times, to apply a dose of 1 mL.

          Avoid breathing spray mist.

       7. 7) Replace the small cap onto the end of the
     • extended tip when not in use.

• C. Rub-on Applicator

Works best for applying Hair Regrowth Treatment to small areas of the scalp.

1. 1) Unscrew small cap and discard it.
2. 2) Insert the rub-on applicator into bottle and screw on firmly. Remove outer cap and keep it.
3. 3) Hold the bottle upright and squeeze it once to half fill the upper chamber. The level of liquid in the chamber will automatically adjust to deliver one full dose (1 mL).
4. 4)

   Hold the bottle upside down then rub applicator on your scalp to apply Hair Regrowth Treatment over the entire bald area until the chamber is completely empty.

   1. 5) Replace outer cap over the rub-on applicator when not in use.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Hair Regrowth Treatment may cause side-effects.

If you experience any of the following, stop using the medicine and tell your doctor

• Faintness or dizziness - if affected do not drive or operate machinery

• Sudden unexplained weight gain
• Swollen hands or feet
• Headache
• Muscle pain
• Depressed mood

Other side effects include:

• Unwanted non-scalp hair. This may be due to the frequent applying of Hair Regrowth Treatment on areas of the skin other than the scalp.
• Scalp irritation such as local redness, itchiness, dryness, flaky skin have all been reported. This is usually only a temporary effect, but if it is persistent you should stop using this product.
• Temporary hair loss may occur during the first 2-6 weeks of use. If this hair loss continues for longer than 2 weeks, stop using the product and talk to your doctor.
• Change in hair colour and/or texture may occur. If this happens you should stop using Hair Regrowth Treatment.
• Hair Regrowth Treatment should be applied only to the scalp. The risk of side effects may be greater when it is applied to other parts of the body.

This is not a complete list of side effects. For any unexpected effects while using Hair Regrowth Treatment contact your doctor or pharmacist.

HOW TO STORE Hair Regrowth Treatment

• Keep out of the reach and sight of children.
• Store at a controlled temperature range of 15°C to 30°C, in an upright position.
• Do not use after the expiry date
• Ask your pharmacist how to dispose of medicines no longer required.

Reporting Side Effects

MORE INFORMATION

If you want more information about Hair Regrowth Treatment:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last revised: April 06, 2020