Consumer medicine information

What is REGAINE®?

REGAINE® is a foam that is to be used only on your scalp. It contains the active ingredient minoxidil in a foam base of alcohol, water, glycerol, cetyl alcohol, citric acid, lactic acid, stearyl alcohol, polysorbate 60, butyl hydroxytoluene and propellant.

What REGAINE® is used for & how it works

REGAINE® is used as a long-term treatment for common baldness. REGAINE® is not a cure for baldness, but in some men it can improve hair regrowth. However, exactly how REGAINE® works is not known.

How effective is REGAINE® in regrowing hair?

It is important for you to understand that REGAINE® does not work well in all people, and how well it works depends on a number of things. Your pharmacist or doctor can best decide whether you are likely to respond to treatment with REGAINE®. You should discuss what results you might expect from treatment with REGAINE® with your pharmacist or doctor.

If you respond to treatment with REGAINE®, your initial regrowth may at first be soft, downy hair ("vellus"), and may hardly be visible. After further treatment it is likely that your hair regrowth will change and become the same colour and thickness as the rest of your hair.

Patients using REGAINE® have reported that the loss of hair is slowed during treatment.

Treatment with REGAINE® is a long-term therapy for hair regrowth. If you respond to treatment, you will need to continue to use REGAINE® in order to keep the new hair and also to stop additional hair loss. If you stop using REGAINE® you will probably lose the hair that has already grown back. This hair loss will occur about three to four months after stopping treatment. The balding process will also start again.

Do not use REGAINE® if:

• You do not have a family history of hair loss.
• Your hair loss is patchy, and/or sudden or unexplained.
• Your scalp is red, inflamed, irritated, infected or painful.
• You have had an allergic reaction to REGAINE® or any of its ingredients.
• You use other medicines on the scalp.
• You are under 18 or over 65 years of age.
• The expiry date (EXP) printed on the pack has passed.
• You are a woman who is pregnant, intending to become pregnant or breast-feeding.

What should I tell my pharmacist or doctor before using REGAINE®?

Tell your pharmacist or doctor about medical problems you have now or have had in the past. In particular, tell your pharmacist or doctor if:

• you are taking any other medicines, including medicines you have bought without a prescription from a pharmacy or a supermarket
• you have any heart problems such as heart failure or disorders of heart rhythm
• you have blood pressure problems
• you have any skin diseases
• You have had a stroke

Some medicines may affect the way others work. Your pharmacist or doctor will be able to tell you what to do when using REGAINE® with other medicines.

Can REGAINE® be used by children or people over 65 years of age?

As there is no experience with the use of REGAINE® in children or people over 65 years of age, it should not be used by them.

Can I use REGAINE® while I am taking other medicines?

Theoretically, some people taking certain drugs to treat high blood pressure could experience a fall in blood pressure on standing. If you have any concerns please speak to your pharmacist or doctor.

Tell your pharmacist or doctor if you are using any other medicines to treat skin conditions of the scalp, as other topically applied skin treatments may affect the way that REGAINE® works.

Your treatment with REGAINE® may not be as effective, if you take diethylcarbamazine or paracetamol regularly.

While you are using REGAINE®

• An increase in hair shedding may occur within the first 2-6 weeks of treatment. This increase in hair loss is expected and temporary. However, if it continues, see your pharmacist or doctor.
• If you are going to have any laboratory tests (e.g. blood or urine), tell your doctor that you are using REGAINE®. It is also important to tell your doctor that you are using REGAINE® if your doctor is going to prescribe for you another type of medicine to take at the same time as using REGAINE®.
• Dizziness or decrease in blood pressure may occur. If affected, do not drive or operate machinery.
• If after 6 months of using REGAINE® no hair growth is seen, you should talk to your pharmacist or doctor about stopping the treatment as any gain from continued treatment is likely to be small.
• Do not change your dose of REGAINE® or stop using REGAINE® without first asking your pharmacist or doctor for advice.
• Do not use REGAINE® more than two times a day, and do not use more foam than your pharmacist or doctor tells you to.
• REGAINE® is for external use only. Never take REGAINE® orally to help hair growth. This could lead to serious side effects.
• Do not apply REGAINE® to any area of the body other than the scalp.
• It is not necessary to shampoo before applying REGAINE®, however if you do wash your hair wait until your hair is absolutely dry before using REGAINE® as it must be applied to a dry scalp. A hair dryer may be used to dry your hair after you have washed it, but do not use it to dry the REGAINE® foam after applying it. As REGAINE® needs to be in contact with your scalp for at least four hours at a time, do not wash or wet your scalp for at least four hours after use.
• Avoid contact with the eyes and irritated skin. If there is accidental contact of REGAINE® to your eyes, mouth, nose, ears, or broken or irritated skin, bathe the area with large amounts of cool tap water.
• Use of REGAINE® in conjunction with other products should be discussed with your pharmacist or doctor.

Common questions about using REGAINE®

• Hair sprays and other common hair products can be used while using REGAINE®, however REGAINE® should be applied to the clean, dry scalp before the other products are used.
• Your hair can continue to be dyed or permed. However, tell your hairdresser/barber that you are using REGAINE®. It may be best to stop using REGAINE® for 24 hours before having your hair dyed or permed to avoid the possibility of any chemical interactions.
• If you need to apply a sunscreen to the scalp, it should be applied four hours after the application of REGAINE® to ensure that the sunscreen does not interfere with the effectiveness of REGAINE®. If it is not possible, the sunscreen should be applied no sooner than two hours after application. For your second daily application, the sunscreen should be shampooed off the scalp. If your scalp gets sunburnt do not apply REGAINE® until the burn has healed. A hat may be worn as an alternative to using a sunscreen. Make sure you wait at least one hour after using REGAINE® before wearing your hat.
• You can use REGAINE® after swimming as long as your scalp is dry.

How and when to use REGAINE®

• REGAINE® must only be applied when the hair and scalp are completely dry.
• REGAINE® must only be applied to a healthy and intact scalp.
• You should continue to use REGAINE® as directed by your pharmacist or doctor. Once REGAINE® is stopped, the appearance of your hair will return to how it was before you started to use REGAINE® .

Directions For Use:

Before application, rinse your hands with cold water and dry thoroughly. For best results, apply MEN’S REGAINE® EXTRA STRENGTH FOAM sparingly, twice a day to the hair loss area, preferably in the morning and at night. Massage the foam lightly into your scalp. Wash your hands thoroughly afterwards. Up to half a capful of foam should be used. Men with a small area of hair loss may need to use less.

Using more than the recommended amount will not improve results. Each can should last approximately one month if used as directed. Never take REGAINE® by mouth or apply it to other parts of the body.

It has been shown that twice daily use of REGAINE® may be required for at least four months before you will see the evidence of cosmetically acceptable hair growth. Response to treatment with REGAINE® may vary widely, and some patients may see faster results than others.

How to open and apply:

1. Within the hair thinning area, part the hair into one or more rows to maximise scalp exposure.
2. Open the container by matching the arrow on the can ring with the line on the cap. Pull off cap.
3. The foam may begin to melt on contact with your warm skin. If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam.
4. Hold the can straight upside down and press the nozzle to dispense the topical foam product into the palm of your hand. The total amount of foam should not exceed half a capful.
5. Using your fingers, spread the foam over the hair loss area and gently massage into the scalp and then wash your hands well.
6. After each use, close the container by snapping the cap back onto the can, to make the cap child resistant.

What if I forget to use REGAINE®?

If you forget to use REGAINE® once or twice, just start your twice daily application again and return to your usual schedule.

Do not apply more than half a capful of REGAINE® and do not use more than twice daily to make up for the dose you missed.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using REGAINE®.

If you get any side effects that worry you, talk to your pharmacist or doctor as soon as you can. You may be advised to stop using REGAINE®.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you have.

It is important to remember that this list does not include every unwanted effect that has been reported with REGAINE®. This list includes the unwanted effects that are the most serious or the most common:

Tell your pharmacist or doctor if you notice any of the following and they worry you:

• allergic-type reactions
• itching and other skin irritations of the treated area of the scalp
• eczema
• redness of the scalp where REGAINE® is being applied
• dry skin/scalp flaking
• REGAINE® contains alcohol which could cause burning or irritation to the eyes, mouth, nose and ears, or sensitive skin areas
• excessive or unwanted hair grown on other parts of the body. Unwanted hair growth may be caused by the transfer of REGAINE® to areas other than the scalp, or by the absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of REGAINE®
• increased hair loss

These are the more common side effects of REGAINE®. For the most part these have been mild.

Some patients have experienced changes in hair colour and/or texture while using REGAINE®.

Stop use and tell your pharmacist or doctor as soon as possible if you notice any of the following:

• rapid heart rate or change in heart rate
• decrease in blood pressure or blood pressure changes
• unexplained rapid weight gain
• swelling or puffiness of hands, face, ankles, or stomach
• dizziness, light-headedness, or fainting
• problems with vision
• shortness of breath
• headaches
• persistent redness or irritation of the scalp

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following occur stop using REGAINE® and tell your doctor immediately or go to casualty at your nearest hospital:

• pain in the chest, arm or shoulder
• signs of severe indigestion.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

What to do if REGAINE® is accidentally swallowed

Accidental ingestion may cause serious side effects. If REGAINE® is accidentally swallowed contact your nearest hospital or Poisons Information Centre (telephone number AUS: 13 11 26, NZ: 0800 764 766) immediately. Some of the symptoms which you may experience are fast heart rate, low blood pressure (light-headedness or fainting), swelling or puffiness of the body.

How to store REGAINE®

• Keep REGAINE® in a cool place where the temperature stays below 25°C.
• REGAINE® is very flammable, and must be kept away from heat, sparks and naked flames. Never use REGAINE® while you are smoking.
• Do not leave REGAINE® in the car, or in the sun on hot days. Too much heat can destroy the product.
• Keep REGAINE® in a place where children cannot reach it, such as in a medicine cupboard.
• The expiry date is printed on the can. Do not use REGAINE® after this date has passed.
• Return any unused foam to your pharmacist.

Description

MEN’S REGAINE® EXTRA STRENGTH FOAM is available as:

• Foam containing minoxidil 5% w/w. The Identification Number for MEN’S REGAINE® EXTRA STRENGTH FOAM is AUST R 277919.

Where should I go for further information?

This is not all the information that is available on REGAINE®. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Who supplies your medicine

REGAINE® is supplied by:

Johnson & Johnson Pacific
AUSTRALIA ● NEW ZEALAND
45 Jones Street, Ultimo NSW 2007, AUSTRALIA and Auckland, NEW ZEALAND

® Registered Trademark

Approved: 12 September 2008

Published by MIMS January 2019

1 Name of Medicine

Minoxidil.

2 Qualitative and Quantitative Composition

Men's Regaine Extra Strength, Men's Regaine Extra Strength Foam, Women's Regaine.

Active ingredient.

Excipients with known effect.

Women's Regaine Regular Strength.

Active ingredient.

Excipients with known effect.

3 Pharmaceutical Form

Men's Regaine Extra Strength, Women's Regaine Regular Strength.

Men's Regaine Extra Strength Foam, Women's Regaine.

4 Clinical Particulars

4.1 Therapeutic Indications

Regaine Topical Application, Extra Strength Topical Application and Extra Strength Foam are indicated for the treatment of androgenetic alopecia (common baldness) in healthy adult males and females.

4.2 Dose and Method of Administration

For external use only.
Use Regaine Topical Application, Extra Strength Topical Application and Extra Strength Foam only as directed. Do not apply Regaine to any area of the body other than the scalp. Make sure the scalp and hair are thoroughly dry and that the skin is healthy and intact.
Do not use a hairdryer to speed the drying of Regaine, because blowing air on the scalp may decrease the effectiveness of Regaine. Regaine must remain in contact with the scalp for several hours (up to 4 hours).
At least four months of twice daily applications of Regaine (once a day application for Women's Regaine) are generally required before evidence of hair regrowth can be expected. Onset and degree may be variable among patients.

Note.

Dose: topical application (solution).

Directions for use of solution.

Dropper.

Dose: topical foam.

Men's Regaine Extra Strength Topical Foam.

Women's Regaine Topical Foam.

Directions for use of foam.

4.3 Contraindications

Regaine topical foam and topical solution are contraindicated in patients with a history of hypersensitivity to minoxidil, or ethanol.
Regaine topical solution is also contraindicated in patients with a history of hypersensitivity to propylene glycol.
Regaine is also contraindicated in pregnant or nursing women.

4.4 Special Warnings and Precautions for Use

Keep this and all medications out of the reach of children.
Accidental ingestion of Regaine could lead to serious adverse effects.
Before starting a patient on Regaine, the physician or pharmacist should ascertain that the patient has a healthy, normal scalp. It should not be applied to inflamed, infected, irritated or painful scalp skin.
Although extensive use of topical minoxidil has not revealed evidence that enough minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically to a systemic effect, and physicians and patients need to be aware of this.
Regaine is recommended for use only in healthy adults with normal cardiovascular status. The safety of Regaine is unknown in patients with cerebrovascular disease or cardiovascular disease (including ischaemic heart disease, cardiac arrhythmias or congestive heart failure). Patients with a history of underlying heart disease should be aware that adverse effects in them might be especially serious (also see Section 4.8 Adverse Effects (Undesirable Effects)).
The patient should stop using Regaine and see a physician if hypotension is detected or if experiencing chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp. If affected by dizziness or hypotension do not drive or operate machinery.
In the event of severe dermatological reactions patients should discontinue use of Regaine and contact their physician or pharmacist.
Regaine contains an alcohol base which will cause burning and irritation of the eye on contact. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), the area should be bathed with copious amounts of cool tap water.
The effects of Regaine in patients with concomitant skin diseases, or in those using topical corticosteroids or other dermatological preparations, are unknown. There is a possibility that an increase in bioavailability of topically administered minoxidil may occur in the presence of inflammatory conditions of the scalp and such situations are to be avoided. Topical minoxidil should not be used concurrently with any other medications on the scalp.
If a patient wishes to wear any form of protective headgear, they should be instructed to allow 1 hour to elapse after using Regaine before covering the head. Some patients have experienced changes in hair colour and/or texture with use of Regaine.
Topical minoxidil therapy should be stopped if hair regrowth is not evident after 6 months of treatment.
Topical minoxidil should not be used if hair loss is patchy and/or sudden or if the reason for the hair loss is unknown. Using more than the recommended dose or more often will not improve results. Continued use is necessary to increase and maintain hair re-growth, or hair loss will begin again. A temporary increase in hair shedding may occur within the first 2-6 weeks of treatment. Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.
Products labelled for women: topical minoxidil should not be used if hair loss is due to childbirth.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are currently no known drug interactions associated with the use of Regaine. Although it has not been clinically demonstrated, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic hypotension in patients currently taking peripheral vasodilators. In vitro studies have shown that paracetamol and diethylcarbamazine may inhibit the stimulation of hair growth by minoxidil.
The use of Regaine concurrently with cutaneously used drugs which alter the stratum corneum barrier, e.g. tretinoin and anthralin/dithranol is not recommended due to the possibility of increased absorption of cutaneously used minoxidil and consequently, increased potential for adverse drug reactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

May cause dizziness or hypotension (see Section 4.8 Adverse Effects (Undesirable Effects)). If affected do not drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

The most frequently encountered adverse effect in clinical trials with Regaine was mild dermatitis of the scalp. The dermatological events were of a similar type and severity in the 2% and 5% groups, but the incidence was greater in the 5% group.
Most frequently reported adverse reactions with 2% and 5% topical minoxidil in commercial marketing experience are dermatological reactions and include: local erythema, itching and dry skin/scalp flaking. Increased hair shedding can occur due to minoxidil's action of shifting hairs in the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks (first sign of action of minoxidil).
Other adverse reactions that have been reported very rarely (< 0.01%) include irritant dermatitis (redness/erythema, scaling/rash scaly and burning), non-specific allergic reactions, hives, hypersensitivity, allergic contact dermatitis, allergic rhinitis, facial swelling, folliculitis, alopecia, hypertrichosis, hair abnormalities, seborrhoea, shortness of breath, headache, neuritis, dizziness/lightheadedness, syncope, vertigo, oedema, chest pain, blood pressure changes (decreased and increased blood pressure, hypotension, hypertension), palpitations and pulse rate changes, rapid heart beat/tachycardia.
Rare cases of hypertrichosis (unwanted non-scalp hair including facial hair growth in women) have been reported.

Clinical trial data.

Post-marketing data.

Reporting suspected adverse events.

4.9 Overdose

Due to the high concentration of minoxidil in Regaine, accidental ingestion may produce systemic effects related to the vasodilatory action of minoxidil. Signs and symptoms of drug overdosage would most likely be cardiovascular effects associated with fluid retention, tachycardia or lowered blood pressure. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled by administration of a beta-adrenergic blocking agent. Symptomatic hypotension should be treated by intravenous administration of normal saline. Sympathomimetic drugs, such as noradrenaline and adrenaline, should be avoided because of their excessive cardiac stimulating activity.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Following topical application, minoxidil is poorly absorbed from normal intact skin. Of the total applied dose an average of 1.7% (range 0.3-4.5%) of the topical solution reaches the systemic circulation. The relative absorption of the topical foam is approximately 50% of a similar dose of topical solution. In contrast, minoxidil is almost completely absorbed from the gastrointestinal tract following oral administration of minoxidil tablets. Following cessation of topical dosing of Regaine, approximately 95% of systemically absorbed minoxidil is eliminated within 4 days. The effects of concomitant dermal diseases on absorption are unknown.
The metabolic biotransformation of minoxidil absorbed following topical application has not been fully determined. But the active form of the drug appears to be a sulfated metabolite, minoxidil sulfate. Orally administered minoxidil is metabolised predominantly by conjugation with glucuronic acid at the N-oxide position in the pyrimidine ring but also by conversion to more polar products. Minoxidil does not bind to plasma proteins and its renal clearance corresponds to the glomerular filtration rate. Minoxidil does not cross the blood-brain barrier. Minoxidil and its metabolites are haemodialysable and are excreted principally in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Men's Regaine Extra Strength, Women's Regaine Regular Strength.

Men's Regaine Extra Strength Foam, Women's Regaine.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Topical applications.

Foams.

6.5 Nature and Contents of Container

Men's Regaine Extra Strength topical solution is available in a 60 mL and 4 x 60 mL bottle (Aust R 79914).
Women's Regaine Regular Strength topical solution is available in a 60 mL and 3 x 60 mL bottle (Aust R 81852).
Men's Regaine Extra Strength topical foam is available in a 60 g and 2 x 60 g aerosol can (Aust R 277919).
Women's Regaine topical foam is available in a 60 g and 2 x 60 g aerosol can (Aust R 240952).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Minoxidil, a peripheral vasodilator, occurs as a white or off-white, odourless, crystalline solid which is readily soluble in propylene glycol or ethanol, soluble in water to the extent of 2 mg/mL and is almost insoluble in acetone, chloroform or ethyl acetate. The chemical name for minoxidil is 2, 4-diamino-6-piperidino-pyrimidine-3- oxide, (MW = 209.25).

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 2.

Summary Table of Changes