Regaine for Men Extra Strength safety information

Regaine for Men Extra Strength (minoxidil 5%) scalp solution is a cutaneous solution to be applied to the scalp. For external use only.

What Regaine for Men Extra Strength is used for

Regaine for Men Extra Strength is used to treat common hereditary hair loss in men aged 18-65 years. It is thought that it works by aiding the blood flow to the cells in your scalp which grow hair. The exact process by which this occurs is not known.

What Regaine for Men Extra Strength contains

Regaine for Men Extra Strength medicine contains minoxidil 50 mg/ml. It also contains ethanol (alcohol), propylene glycol and water. Each bottle contains 50 ml of solution — sufficient for 1 month of treatment. 3 different applicators (the pump spray, extended spray-tip, and rub-on applicators) are in the pack. The best applicator for you is outlined later in the “how to apply Regaine for Men Extra Strength” section of this page.

How to tell if Regaine for Men Extra Strength is suitable for you

Hereditary hair loss is recognisable because:

• You have a distinct hair loss pattern (see diagrams)
• It starts gradually and progresses
• You have a family history of hair loss
• No other symptoms are present with your hair loss

Regaine for Men Extra Strength works best in men with hair loss or thinning at the top of the scalp.

Those who are younger, those who have been losing hair for a short period of time or those who have a small area of baldness are likely to respond best to Regaine for Men Extra Strength.

N.B. You are unlikely to benefit from Regaine for Men Extra Strength if you have been bald for many years or have a large area of hair loss.

When Regaine for Men Extra Strength should not be used

Regaine for Men Extra Strength should not be used:

• If you suffer from a problem with blood pressure
• If you have any condition that affects your scalp including sunburn and psoriasis or if you use other creams, ointments, lotions etc. used to treat scalp conditions e.g. dithranol, tretinoin, corticosteroids (steroids) and petrolatum products (soft paraffin) or have any kind of dressing or bandage on your scalp
• For sudden, unexpected hair loss which may be linked to thyroid or other medical problems
• Total baldness or complete loss of all body hair
• Hair loss caused by drug treatment
• If you have a shaved head
• If you are allergic to minoxidil, ethanol or propylene glycol
• If you are under 18 or over 65 years
• If you are a woman

If you are still uncertain as to why you are losing your hair, please see your doctor.

N.B. If you suffer from heart disease (including abnormal heart rhythms or rates, angina or chest pains) and/or circulation disorders you should seek the advice of your doctor before using Regaine for Men Extra Strength.

There is a potential risk that minoxidil, the active ingredient in Regaine for Men Extra Strength, may interact with certain blood pressure medicines called “vasodilators”, and alter their effect. You should consult your doctor or pharmacist if you are taking such medication.

If too much minoxidil passes through the skin into the bloodstream it can cause side effects such as rapid heartbeat, faintness or dizziness, or swollen hands or feet. When Regaine for Men Extra Strength is used as recommended it is extremely unlikely that any of these side effects will occur. There is however a chance that the drug could get absorbed into the bloodstream if the medicine is over-used, or if a user is unusually sensitive to minoxidil, or if it is used when there is a scalp condition (such as psoriasis) present. For this reason, it is very important that you use Regaine for Men Extra Strength as recommended and follow the advice on this page.

Using Regaine for Men Extra Strength

What results can be expected?

Regaine for Men Extra Strength will not work for everyone and it is not possible to predict how you will respond. Hair growth is a slow process hence Regaine for Men Extra Strength takes a few months to work.

In clinical trials, 3 out of 5 men reported hair re-growth after 48 weeks of continual use of Regaine for Men Extra Strength. Hair re-growth should become noticeable after 2 months. Hair growth will be soft and downy at the start but should eventually become the same as normal hair. There may be a temporary increase in hair loss initially after 2-6 weeks of use. This is likely to be a result of the hair re-growth cycle and should subside within a couple of weeks. If shedding persists for longer than 2 weeks you should stop using Regaine for Men Extra Strength and consult your doctor.

If there is no hair re-growth after 12 months it is very unlikely that you will respond and you should stop using Regaine for Men Extra Strength. You should consult your doctor or pharmacist if you are concerned at any time during treatment.

N.B. You should continue to use Regaine for Men Extra Strength every day if hair regrowth occurs, to maintain re-growth. If you stop using Regaine for Men Extra Strength, re-grown hair may disappear within 3-4 months.

How to apply Regaine for Men Extra Strength

Precautions

The solution is flammable. Do not use while smoking, or near any naked flame or strong heat source. Avoid exposure of the container and contents to naked flames during use, storage and disposal.

Regaine for Men Extra Strength must only be used on the scalp. Before using check the scalp is normal and healthy. Do not use Regaine for Men Extra Strength on other parts of the body. If accidentally applied to any other part of the body, rinse thoroughly with water.

Avoid contact with the eyes, broken skin and sensitive areas. If accidentally applied to these parts wash with lots of water.

Your hair and scalp should be thoroughly dry before using Regaine for Men Extra Strength.

Dosage

Apply a 1ml dose to the affected area/s of the scalp twice daily (with a 12-hour interval in between) using the appropriate applicator. Each applicator is designed to accurately release a 1ml dose when used as described on pages 6, 7 and 8. Do not use more than 2ml Regaine for Men Extra Strength daily. Exceeding the recommended dose will not re-grow your hair any more quickly and you may risk side effects.

Regaine for Men Extra Strength should be massaged lightly into the scalp after application.

Always wash your hands thoroughly after applying Regaine for Men Extra Strength and rinse other areas that have come into contact with Regaine for Men Extra Strength.

Which applicator should you use?

The method of application depends on the degree of baldness / thinning and the type of applicator used (see diagrams).

Pump spray applicator

1. This applicator works best for applying Regaine for Men Extra Strength to large areas of the scalp.
2. Remove large outer cap; remove smaller inner cap and discard it.
3. Insert the spray applicator into the bottle and screw on firmly.
4. After aiming the pump toward the centre of the bald area of the scalp, press the pump once and spread Regaine for Men Extra Strength with fingertips to cover all of the bald area. Repeat a further 5 times, to apply a dose of 1ml of solution. Avoid breathing spray mist. Place outer cap on bottle when not in use.

Extended spray-tip applicator

1. This applicator works best for applying Regaine for Men Extra Strength to small areas of the scalp, or under hair.
2. The pump spray applicator must be on the bottle to use the extended tip applicator. Follow steps 2 and 3 as for the pump spray applicator above.
3. Remove small spray head from top of pump spray applicator; fit the extended spray applicator onto the spray shaft and push down firmly. Remove the small cap on the end of the extended tip.
4. After aiming the applicator toward the centre of the bald area of the scalp, press the pump once and spread Regaine for Men Extra Strength with fingertips to cover all of the bald area. Repeat a further 5 times to apply a dose of 1 ml solution. Avoid breathing spray mist. Replace the small cap on end of extended tip when not in use.

Rub-on applicator

1. This applicator works best for applying Regaine for Men Extra Strength to small areas of the scalp.
2. Remove large outer cap; remove small inner cap and discard it.
3. Insert the rub-on applicator into the bottle and screw on firmly.
4. Holding the bottle upright, squeeze the bottle to fill the upper chamber to the black line. The chamber contains one full dose (1ml of solution).
5. Holding the bottle upside down, rub the applicator on the bald scalp area until the chamber is completely empty. Place large outer cap on bottle when not in use.

Side effects of Regaine for Men Extra Strength

Stop using Regaine for Men Extra Strength if you get any of the following:

• Blood pressure changes
• Rapid heartbeat
• New or worsening pain in the chest
• Dizziness, light-headedness, or fainting
• Unexplained rapid weight gain of more than 2 kg or 5 pounds
• Swelling or puffiness of the hands or feet
• Persistent redness or irritation of the scalp

You may find that Regaine for Men Extra Strength irritates your skin (e.g. local redness, itching, dryness, scalp flaking). This might be due to the presence of propylene glycol in the product. Although this might only be a temporary effect, stop using the product if it persists.

Stop using Regaine for Men Extra Strength if you notice changes in hair colour and/or texture.

Regaine for Men Extra Strength contains ethanol (alcohol) which will cause burning and irritation if you get it in the eye. If you get Regaine for Men Extra Strength in your eye, mouth or on a cut or damaged skin, wash the area well with lots of cool tap water.

Unwanted non-scalp hair has occasionally been reported. Always wash your hands thoroughly after application and if accidentally applied to parts of the body other than the scalp, rinse thoroughly with water.

If anyone, including a child, swallows any Regaine for Men Extra Strength, take them to a hospital immediately (with the Regaine for Men Extra Strength bottle if possible, as the doctor may like to have some idea of how much they have swallowed).

If you experience any other side effects not mentioned already, you should consult your doctor.

How to store Regaine for Men Extra Strength

Check the expiry date that is printed on the package. If it is out of date, or becomes out of date during use, tell your pharmacist.

There is enough Regaine for Men Extra Strength in each bottle for 1 month of treatment. Keep the bottle in a safe place, below 25°C (normal room temperature).

Keep out of the reach and sight of children. When empty, dispose of the bottle safely. To dispose of a partially used bottle, empty the contents as much as you can into a sink, and wash away with running water. Never try to burn a Regaine for Men Extra Strength bottle.