What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12063/0038.


Boots Hair Loss Treatment Regular Strength

Information for the user

Boots Hair Loss Treatment Regular Strength

(Minoxidil)

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1. What is this medicine and what is it used for?

This medicine contains:

  • minoxidil which acts on the scalp to help hair growth on the bald area.

This solution is used for the treatment of common hereditary baldness (a condition called alopecia androgenetica).

2. Is this medicine suitable for you?

Do not take this medicine if you:

  • are allergic to minoxidil or any of the other ingredients
  • suffer from high blood pressure, whether treated or not
  • have scalp conditions, including psoriasis (an itchy inflammatory skin condition) or sunburn
  • have a shaved scalp
  • are using other medicines or occlusive dressings, such as plasters or air tight dressings, on your scalp
  • are pregnant or breast feeding
  • are younger than 18 years or older than 65 years.

If you are using other medicines that are applied to the scalp which contain any of the following ingredients, please see your doctor or pharmacist before taking this medicine:

  • corticosteroids
  • tretinoin
  • dithranol
  • petrolatum
  • guanethidine.

These medicines may cause minoxidil to be absorbed quickly and increase the risk of side effects.

If you are taking any of the following medicines please see your doctor:

  • medicines for high blood pressure that dilate (widen) the blood vessels, such as hydralazine.

Information about some of the ingredients in this medicine:

  • Contains propylene glycol.
    May cause skin irritation.
  • Contains ethanol (alcohol).
    Can cause burning and irritation to the eyes. If the product comes into contact with the eyes, broken skin or lining of the mouth, throat or nose, bathe the area with large amounts of cool tap water.

3. How to use this medicine

Before you start to use this medicine, check with your doctor that your scalp is normal and healthy. This medicine is for use on the scalp only. Do not apply it to other areas of the body. Make sure that the scalp is clean and dry before applying.

Men and women aged 18 to 65 years:

Apply 1 ml of the solution to the bald area twice daily, using the applicators provided (below).

Do not use more than 2 ml of the solution in 24 hours.

Pump spray applicator

This is useful for large areas of baldness.

  • spray several times away from your head and body prior to first application to remove any airlocks
  • aim the pump at the centre of the bald area
  • press once and spread the solution with your fingertips over the whole area
  • repeat for a total of 6 sprays to apply the 1 ml dose
  • the spray has a deliverable volume of a mean dose of 1.0ml ± 1.0ml
  • avoid breathing the spray mist.

Extended spray tip applicator

This is useful for small areas, or under the hair.

  • the pump spray applicator must be in place to use this applicator
  • attach the extended applicator to the spray applicator
  • use in the same way as the pump spray applicator.

Dropper

This is useful for small areas.

  • fill the dropper to the 1 ml mark
  • apply the solution to the bald area until the dropper is empty.
  • the dropper has a deliverable volume of a mean dose of 1.0ml ± 0.1ml.

Do not exceed the stated dose.

If you use too much of the solution by mistake, or if it is accidentally swallowed:

Contact your doctor or pharmacist straight away.

If you use your fingertips to rub the solution into your scalp, make sure that you wash your hands afterwards.

If the product comes into contact with the eyes, broken skin or lining of the mouth, throat or nose:

Bathe the area with large amounts of cool tap water.

If no re-growth occurs after 12 months use, stop using this medicine.

The hair may take up to 4 months to re-grow, and in some people may not grow at all. The new hair may be fine hair, similar to baby hair. This medicine is a treatment and needs to be continued for hair growth to be maintained.

If you stop the treatment, the new hair will disappear after 3 to 4 months

4. Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop using the medicine immediately, and see your doctor or pharmacist.

If any of the below effects occur, seek medical advice immediately:

  • swelling of the face, lips, tongue and/or throat
  • throat tightness
  • palpitations and/or fast heart beat
  • breathing difficulty
  • changes such as skin rash and redness leading to itching, dry and flaking skin and/or swelling where the product is applied, or around the ears and face, blistering, bleeding and ulcers
  • chest pain
  • swelling in the feet and/or legs
  • sudden, unexplained weight gain
  • dizziness, feeling faint due to low blood pressure

If any of the below effects occur, discontinue use and seek advice from your pharmacist:

Very common (may affect more than 1 in 10 people):

  • headache.

Common (may affect up to 1 in 10 people):

  • unwanted hair growth on the face or body
  • itching
  • rash
  • dermatitis.

Uncommon side effects (may affect up to 1 in 100 people):

  • eye irritation
  • feeling sick and/or being sick
  • flaking skin, skin rash, dry skin or other skin problems such as dermatitis
  • acne (spots and oily skin)
  • changes in hair colour/texture of the newly grown hair
  • temporary hair loss.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store your medicine

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack.

Store upright, below 25°C and protect from light.

When the bottle is empty, the bottle and applicators must be disposed of safely.

6. What is in this medicine?

Each 1 ml dose of clear solution contains the active ingredient: minoxidil 20 mg

The other ingredients are: propylene glycol, ethanol, water.

This pack contains 60 ml of solution and 3 applicators.

7. Who makes this medicine?

The Marketing Authorisation holder and manufacturer is

Wrafton Laboratories Limited
Braunton
Devon
EX33 2DL
United Kingdom

Text Revised: April 2017

The enclosed applicators (which include a pump spray, extended spray tip and dropper applicator) are CE registered components (CE 0120) and are manufactured by

Wrafton Laboratories Limited
Braunton
Devon
EX33 2DL
UK

CE0120

If you would like any further information about this product, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Hairloss Treatment Regular Strength

Reference number: 12063/0038

This is a service provided by the Royal National Institute of Blind People