Patient leaflet - Minoxidil 5% cutaneous solution
1. What Minoxidil 5% solution is and what it is used for
Minoxidil 5% solution is a medicine used to treat common female pattern hair loss in women aged 18 – 65 years, by preventing further hair loss and helping hair re-growth.
It contains the active substance minoxidil which is thought to work by aiding the blood flow to the hair follicles on your scalp.
- This medicine is for use in women aged between 18 and 65 years.
- This medicine works best in women who have general hair thinning of the scalp.
- Those who are younger or have been losing hair for a short period of time are likely to experience the best results.
- You are unlikely to benefit from Minoxidil 5% solution if you have been balding/thinning for many years or have a large area of hair loss.
Hereditary hair loss is recognisable because:
- Of the pattern of hair loss (see diagrams).
- It starts gradually and progresses.
- You have a family history of hair loss.
- No other symptoms are present with your hair loss.
2. What you need to know before you use Minoxidil 5% solution
Do not use Minoxidil 5% solution if:
- you have ever had a bad reaction to minoxidil, ethanol, or propylene glycol.
- you are male.
- you have high blood pressure (even if it is being treated).
- you have inflamed, infected, irritated or painful scalp skin.
- you have any condition that affects your scalp, including sunburn and psoriasis.
- you have a shaved scalp.
- you have any kind of dressing or bandage on your scalp.
- you have hair loss caused by drug treatment.
- you have total baldness or complete loss of all body hair.
- the cause of your hair loss is unknown, is due to childbirth, or it is sudden and unexpected.
you are using creams, ointments or lotions used to treat scalp conditions, e.g.
- Dithranol - used to treat psoriasis.
- Tretinoin - used to treat acne or other skin disorders.
- Corticosteroids - a type of anti-inflammatory.
- Petrolatum - a common ingredient in hair wax or gel.
- you are under the age of 18 or over the age of 65.
- you are pregnant or breast-feeding.
If any of these apply to you now or in the past, get advice from a doctor or pharmacist before using Minoxidil 5% solution.
Warnings and precautions
Talk to your doctor or pharmacist before using Minoxidil 5% solution:
- If you are at all unsure whether your scalp is normal and healthy.
- If you suffer from heart disease, including abnormal heart rhythms or rates, angina or chest pains and/or circulation disorders.
If you are taking or using any other medicines including:
- Certain blood pressure medicines called 'vasodilators' e.g. hydrazaline. There is a potential risk that minoxidil, the active ingredient in Minoxidil 5% solution may interact with these medicines and increase their effect.
If any of these apply to you now or in the past, talk to a doctor or pharmacist before using Minoxidil 5% solution.
Talk to your doctor or pharmacist if while using Minoxidil 5% solution you experience low blood pressure, chest pain, rapid heartbeat, faintness or dizziness, sudden weight gain, swollen hands or feet or persistent redness or irritation of the scalp.
Cases of excessive hair growth on the body of infants have been reported following skin contact with minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returned to normal within months when infants were no longer exposed to minoxidil. Care should be taken to ensure that children do not come into contact with areas of your body where you have applied minoxidil topically. Consult a doctor if you notice excessive hair growth on the body of your child during the period you are using topical minoxidil products.
Avoid contact with the eyes, mouth, broken skin and sensitive areas. If the solution is accidentally applied to areas of the body other than the scalp, rinse thoroughly with plenty of water.
Warning Flammable Liquid and Vapour. Keep away from heat/sparks/open flames/ hot surfaces- No smoking. Avoid exposure of the container and contents to naked flames during use, storage and disposal. Keep container tightly closed. Store in a well-ventilated place.
Other medicines and Minoxidil 5% solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Particularly those prescribed by a doctor, including:
- Betamethasone dipropionate (a corticosteroid used to treat skin disorders).
- Tretinoin (used to treat acne)
- Anthralin (used to treat psoriasis)
- Guanethidine (used to treat high blood pressure).
Minoxidil 5% s solution should not be used with any other medicines that are applied to the scalp.
Pregnancy and breast-feeding
Minoxidil 5% solution should not be used if you are pregnant or breast-feeding.
Driving and used machines
Minoxidil 5% solution may cause dizziness or low blood pressure. If you experience these side effects do not drive or operate machinery.
Minoxidil 5% solution contains propylene glycol
This medicine contains 520mg propylene glycol in each 1ml of cutaneous solution. This may cause skin irritation.
Minoxidil 5% solution contains ethanol
This medicine contains 243mg alcohol (ethanol) in each ml of cutaneous solution. It may cause a burning sensation on damaged skin.
3. How to use Minoxidil 5% solution
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the suitable dose and length of treatment with Minoxidil 5% solution.
Minoxidil 5% solution is for topical and external use only. Do not ingest. It should only be applied directly to the scalp area.
Do not apply to areas of the body other than the normal healthy scalp. It should not be used on inflamed, infected, irritated or painful scalp skin.
Daily dose for women aged 18-65 years
The recommended daily dose is 1ml of solution once a day (10 sprays from the dosage pump is equivalent to 1ml of solution).
Minoxidil 5% solution should only be used once a day. Do not apply more than 1ml of solution per day.
- Wash hands thoroughly with water before application.
- The hair and scalp must be completely dry when applying the solution.
- Apply a 1ml dose of solution (10 sprays from the dosage pump) to the total affected area of the scalp. Avoid breathing in the spray mist.
- Remember the solution needs to be applied to your scalp, NOT your hair.
- Within your hair thinning areas, make a centre parting to help maximise scalp exposure. Part your hair at least 2 more times on each side of the centre parting.
- The solution should be gently spread over the scalp using your fingertips.
- After using Minoxidil 5% solution, wash hands thoroughly with plenty of water.
- If the solution accidentally comes into contact with your forehead, face or other areas of the body, rinse thoroughly with plenty of water to avoid any unwanted hair growth.
- Allow the solution to dry completely, especially if applied before going to bed.
Continued use of Minoxidil 5% solution
You may need to use this medicine once a day for at least 4 months before you see new hair growth, this is because hair growth is a slow process.
Hair growth may be soft and downy at the start but should eventually become the same as normal hair.
Once the hair has begun to re-grow, you need to continue using this medicine once a day for the growth to continue.
If you have no improvement in your hair growth after one year of use, you should discontinue treatment.
If at any time during your treatment you are concerned you should talk to your doctor or pharmacist.
Use in children and adolescents
Minoxidil 5% solution should not be used in patients aged less than 18 years.
If you use more Minoxidil 5% solution than you should
If you have used more Minoxidil 5% solution than you should, tell your doctor or pharmacist immediately.
Using more Minoxidil 5% solution than you should, can cause an increase in the intensity of side effects affecting the skin, especially itching (pruritus), dryness, skin irritation and eczema (acute or chronic inflammatory skin disorder).
Accidental ingestion may cause serious cardiac events. The signs and symptoms following ingestion of minoxidil can include low blood pressure (hypotension), fast heartbeat (tachycardia), swelling/excessive fluid retention (oedema) and heart failure (congestive heart disease). If anyone, including a child, swallows any of the solution, take them to a hospital immediately with the medicine pack, if possible, as the doctor may like to have some idea of how much they have swallowed.
If you forget to use Minoxidil 5% solution
In the initial treatment period:
- Apply the forgotten dose as soon as possible and then follow the guideline recommended by your doctor. Do not use a double dose to make up for a forgotten dose. • In the maintenance period: Carry on as normal as if you had not missed the dose.
If you stop treatment with Minoxidil 5% solution
If you stop treatment you may return to the initial state of hair loss before starting treatment within 3-4 months.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop using the medicine and seek immediate medical help:
- Chest pain.
- Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction.
Contact a doctor right away if you notice any of the following symptoms- you may need urgent medical treatment.
- Low blood pressure.
- Fast or irregular heartbeat (palpitations)
- Faintness or dizziness, shortness of breath or difficulty breathing.
- Swollen hands or feet.
- Sudden unexplained weight gain.
- Persistent redness, rash or irritation of the scalp.
Other side effects which may occur:
Very common (may affect more than 1 in 10 people):
- Headache.
Common (may affect up to 1 in 10 people):
- Itching of the skin or rash.
- Unwanted non-scalp hair has been reported (including facial hair growth in women). Always wash your hands thoroughly after application and if you accidentally apply the solution to parts of your body other than the scalp, rinse thoroughly with plenty of water. Allow sufficient drying time before going to bed.
Uncommon (may affect up to 1 in 100 people):
- Feeling sick (nausea).
Rare (may affect up to 1 in 1,000 people):
- Change in hair texture may occur. If this happens, you should stop using Minoxidil 5% solution.
Not known (frequency cannot be estimated from the available data):
- Depressed mood.
- Eye irritation (including itchy eyes).
- Being sick (vomiting).
- Temporary hair loss may occur during the first 2-6 weeks of use. This is likely to be as a result of a change within the growth cycle, and it should stop within a couple of weeks. If this hair loss continues for longer than two weeks, stop using the product and talk to your doctor. - Change in hair colour may occur. If this happens, you should stop using Minoxidil 5% solution.
- Application site reactions which may include itching, irritation, pain, rash, swelling, dry skin and redness on the scalp, ears or face, but can sometimes be more severe and include flaking, dermatitis, blistering, bleeding and ulceration. This may be due to the ingredient, propylene glycol.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Minoxidil 5% solution
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
Warning Flammable Liquid and Vapour. Keep away from heat/ sparks/ open flames/ hot surfaces- No smoking. Avoid exposure of the container and contents to naked flames during use, storage and disposal. Keep container tightly closed. Store in a well-ventilated place.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Minoxidil 5% solution contains
- The active substance is minoxidil. Each millilitre (ml) of solution contains 50mg of minoxidil. 1 ml is equivalent to 10 sprays.
- The other ingredients are alcohol (ethanol 96%), propylene glycol and purified water.
What Minoxidil 5% solution looks like and content of the pack
Minoxidil 5% solution is transparent, colourless to slightly yellowish, with an alcohol aroma. Minoxidil 5% solution is supplied in 60ml and 120ml (2 bottles of 60ml) fitted with a spray dosage pump.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Careforsons Limited
4-5 Gough Square
London
EC4A 3DE
United Kingdom
Manufacturer
Industrial Farmaceutica Cantabria, S.A.
Barrio Solia no 30, La Concha,
Villaescusa 39690 Santander, Spain