Language selection

Government of Canada

Search

Details for: HAIR REGROWTH FORMULA

Company: VITA HEALTH PRODUCTS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02356597HAIR REGROWTH FORMULAMINOXIDIL20 MG / MLSOLUTIONTOPICAL
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

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

HAIR REGROWTH FORMULA 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 FORMULA 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 FORMULA 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

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 FORMULA 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 FORMULA. 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 FORMULA;
  • 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 (eg. 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 non-medicinal ingredients are

Alcohol, Purified Water and Propylene Glycol.

What dosage form it comes in

HAIR REGROWTH FORMULA is available as a 60 mL solution in a bottle with one or more of the following metered disposable applicators: Pump Spray, Extended Spray Tip and a Rub-On-Applicator

Warnings and precautions
  • Apply HAIR REGROWTH FORMULA only on the scalp.
  • Inhalation of spray mist should be avoided.
  • Avoid contact with eyes as HAIR REGROWTH FORMULA 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 FORMULA 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 FORMULA 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 FORMULA and consult their doctor.

HAIR REGROWTH FORMULA should not be used in males under 18 or over 65 years of age.

BEFORE using HAIR REGROWTH FORMULA, 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 FORMULA 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 FORMULA (Minoxidil) also may increase the effect of hydralazine (drug to treat high blood pressure).

Proper use of this medication

Application

  • HAIR REGROWTH FORMULA 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 FORMULA. However, if you wash your scalp before applying HAIR REGROWTH FORMULA, 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 FORMULA to a sunburned or irritated, broken or shaved scalp.
  • For HAIR REGROWTH FORMULA to work best, you should allow HAIR REGROWTH FORMULA 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 3 different applicators. Each applicator contains one dose of medicine.
  • If you are planning to be in the sun after applying HAIR REGROWTH FORMULA, 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 FORMULA. You may use hair sprays, mousses, conditioners, gels, etc. However, you should apply HAIR REGROWTH FORMULA 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 FORMULA. However, to avoid possible scalp irritation, you should make sure all of the HAIR REGROWTH FORMULA 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 center 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 FORMULA and seek the advice of your physician.
  • One bottle of HAIR REGROWTH FORMULA 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

In case of drug overdose or accidental ingestion, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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. Rub-On Applicator
C. Extended Spray-Tip Applicator

USING THE APPLICATORS

A. Pump-Spray Applicator

Works best for applying HAIR REGROWTH FORMULA to large areas of the scalp.

  1. Remove Child-Resistant cap by pushing down while turning the cap anti-clockwise. Retain Child-Resistant cap.
  2. Insert the pump-spray applicator into the bottle and screw on tightly.
  3. After aiming the pump at the centre of the thinning or bald area of the scalp, press the pump once and spread HAIR REGROWTH FORMULA with fingertips to cover all the thinning or bald area. Repeat for a total of 4 times to apply a total dose of 1 mL. Avoid breathing spray mist.
  4. To retain Child-Resistant feature, remove Pump-Spray applicator and retain for next application. Replace ChildResistant cap by tightly screwing on in a clockwise direction.
B. Rub-On Applicator

Works best for applying HAIR REGROWTH FORMULA to small areas of the scalp.

  1. Remove Child-Resistant cap by pushing down while turning the cap anti-clockwise. Retain Child-Resistant cap.
  2. Insert the rub-on applicator into the bottle and screw on tightly. Remove outer cap and keep it.
  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. Hold the bottle upside down then rub applicator on your scalp to apply HAIR REGROWTH FORMULA over the whole thinning or bald area until the chamber is completely empty. Replace outer cap over the rub-on applicator when not in use.
  5. To retain Child-Resistant feature, remove Rub-On applicator and retain for next application. Replace ChildResistant cap by tightly screwing on in a clockwise direction.
C. Extended Spray-Tip Applicator

Works best for applying HAIR REGROWTH FORMULA to small areas of the scalp or under hair.

  1. Remove Child-Resistant cap by pushing down while turning the cap anti-clockwise. Retain Child-Resistant cap.
  2. Insert the pump-spray applicator into the bottle and screw on tightly.
  3. Remove small spray head from top of pump-spray applicator.
  4. Fit the extended spray-tip applicator onto the spray shaft and push down firmly.
  5. Remove the small cap on the end of the extended tip and keep it.
  6. After aiming the applicator at the centre of the thinning or bald area of the scalp, press the pump once and spread HAIR REGROWTH FORMULA with fingertips to cover all the thinning or bald area. Repeat for a total of 4 times to apply a total dose of 1 mL. Avoid breathing spray mist.
  7. To retain Child-Resistant feature, remove Extended Spray-Tip applicator and retain for next application. Replace Child-Resistant cap by tightly screwing on in a clockwise direction.
Side effects and what to do about them

HAIR REGROWTH FORMULA 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 FORMULA 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 FORMULA.
  • HAIR REGROWTH FORMULA 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 taking HAIR REGROWTH FORMULA, contact your doctor or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Very Rare
Swollen face, lips, mouth, tongue, and throat     ✔
Skin redness, rash, severe irritation, throat tightness     ✔
Chest pain     ✔
Rapid or irregular heartbeat     ✔
High or low blood pressure     ✔
Shortness of breath or difficulty breathing     ✔
How to store

HOW TO STORE IT

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

REPORTING SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Vita Health Products Inc., at: 1-800-665-8820.

This leaflet was prepared by:

Vita Health Products Inc.
150 Beghin Avenue
Winnipeg, MB Canada
R2J 3W2


Last revised: October 6, 2020

Date modified: