This document refers to the following topical preparations:
Minoxidil 5% PGF – once a day application
Minoxidil 5% PGF – twice a day application
Minoxidil 5%, Finasteride 0.1% – twice a day application
Minoxidil 5%, Tretinoin 0.01% – once a day application
Minoxidil 5%, Tretinoin 0.01%, Finasteride 0.1% – once a day application
Finasteride 0.2% – once a day application
This document contains important information about using your hair treatment. Before you start your treatment, please read all of the following information.
In this Patient Information Leaflet, you’ll find:
General treatment information
Information on your active and inactive ingredients
Indications
Contraindications
Warnings and precautions
Directions and how to use
Side-effects and how to report unwanted side-effects
Storage and disposal
1. General information
Your topical treatment will contain either 30ml or 60ml and has been made by Unit 5, Oakwood Business Park, Standard Road, London, NW10 6EX, United Kingdom. This treatment has been prescribed for you, and only you. Please don’t share this treatment with anyone else, as it may cause harm.
2. Information on your active and inactive ingredients
Your medication will contain either a single active ingredient or a combination of the active ingredients listed below. Please refer to the label on your treatment bottle (or in your email) to determine which of these active ingredients are in your treatment.
Active ingredients
Minoxidil 5%
Minoxidil helps to stimulate hair growth and reverse shrinkage of hair follicles which is the cause of hair thinning and loss. It does this by increasing the blood flow to the hair follicle due to its vasodilation properties (a medicine that opens/dilates blood vessels). This then enables hairs to grow for longer, and new hair starts to grow more quickly.
Finasteride (0.1% to 0.2%)
Finasteride is a 5-alpha-reductase inhibitor and blocks the conversion of testosterone to dihydrotestosterone (DHT), the androgen (sex hormone) responsible for male pattern hair loss (androgenetic alopecia) in genetically predisposed men. Blocking DHT around the hair follicle prevents it from shrinking and helps the hair to regrow.
Tretinoin 0.01%
Tretinoin can help support hair growth by enhancing the effects of topical treatments such as Minoxidil. It works by improving the absorption of these medicines into the scalp and stimulating the activity of hair follicles. Tretinoin promotes cell turnover in the scalp, helping dormant or miniaturised follicles become more active. This can lead to stronger, thicker hair and may speed up the growth of new hairs.
Inactive ingredients
Aqua, Lactic Acid, Polysorbate 20, Olivamidopropyl Betaine, Phenoxyethanol, Parfum, Rosmarinus Officinalis Leaf Oil, Lavandula Dentata Water, BHT, Juniperus Communis Fruit Oil, Juniperus Virginiana Oil, Amyris Balsamifera Bark Oil, Propanediol, Lavandula Angustifolia Oil, Melaleuca Alternifolia Leaf Oil, Eucalyptus Globulus Leaf Oil, Sodium Thiosulfate, Sodium Hydroxide.
All Finasteride formulations contain Diethylene Glycol Monoethyl Ether, PEG-40 Hydrogenated Castor Oil, Oleic Acid.
All Tretinoin formulations contain Butylated Hydroxytoluene (BHT), PEG-40 Hydrogenated Castor Oil, Oleic Acid.
3. Indications
Your treatment will have been prescribed to you for the treatment of one of the following reasons:
Androgenetic alopecia in women and those assigned female at birth (female pattern hair loss)
Androgenetic alopecia in men and those assigned male at birth (male pattern hair loss)
Generalised hair thinning
4. Contraindications
Do not use your treatment if you are allergic to any of the ingredients in your formulation (see section 2 for full details of all ingredients), or if you have inflamed, infected, irritated or painful scalp skin.
Minoxidil
Topical Minoxidil should not be applied if you have an inflammatory skin condition on your scalp (e.g. psoriasis, eczema) or if you have sunburn affecting your scalp skin.
Women and those assigned female at birth should not use this product if pregnant, breastfeeding or trying to conceive.
Finasteride
Drops/spray containing finasteride should not be applied if you have an inflammatory skin condition on your scalp (e.g. psoriasis, eczema) or if you have sunburn affecting the skin on your scalp.
Drops/spray containing finasteride should not be used if you are female or were assigned female at birth, and are trying to conceive, pregnant or breastfeeding.
If born male and planning to conceive a child, you should stop using your topical treatment containing finasteride for 12 weeks before actively trying to conceive. Treatment containing finasteride should not be applied if your partner is pregnant or breastfeeding.
If your partner is currently pregnant or breastfeeding and you would like to use a treatment containing finasteride, you must use barrier protection during sexual intercourse, as finasteride may be excreted via semen.
Drops/spray containing finasteride should not be applied if you have a personal history of prostate disease, testicular cancer or a personal or family history of male breast cancer.
Do not use your Hair + Me treatment if you are already taking finasteride, dutasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia (BPH) or any other condition.
Tretinoin
Drops containing Tretinoin should not be applied if you have an inflammatory skin condition on your scalp (e.g. psoriasis, eczema) or if you have sunburn affecting the skin on your scalp.
Women and those assigned female at birth should not use this product if pregnant, breastfeeding or trying to conceive. Tretinoin may cause harm to an unborn baby if taken while pregnant. Do not use if you are pregnant. Use effective contraception during treatment and for one month after stopping. If you become pregnant or plan to conceive, stop treatment and contact your doctor.
5. Warnings and precautions
General
If you develop an allergic reaction to your treatment then you must stop applying it. For your reference, signs of an allergic reaction may include: rash, hives, itching, shortness of breath, wheezing, cough, swelling of the face, lips, tongue or throat. If in doubt, do not hesitate to ask your doctor or pharmacist for advice and call 999 in a medical emergency.
Your treatment is for external use only. Do not apply to areas of the body other than the scalp.
Using more than the recommended dose or more often will not improve results.
If you get your treatment on your hands, please wash your hands thoroughly after applying your treatment.
If you intend to dye or bleach your hair, stop your treatment 48 hours before, wash your hair to ensure all the treatment has been washed out before dying/bleaching the hair. You can resume treatment 24 hours after, or after any irritation has settled.
Finasteride
If your treatment contains finasteride and you notice any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge, please stop using your treatment and get in touch.
Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with oral finasteride (1mg tablet). The risk of these are significantly reduced when using a topical (drops/spray) formulation, however, if these occur please stop using your treatment and get in touch via hello@hairandme.com and speak to your GP.
Minoxidil
Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.
Some people may experience changes in hair colour and/or texture.
If you experience light-headedness, dizziness, chest pain, rapid heart beat, faintness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp or other unexpected new symptoms occur please stop using your treatment and get in touch with us, and please contact your GP.
You may experience increased hair shedding when starting treatment. This is most likely due to minoxidil’s action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks.
Accidental ingestion may cause serious cardiac adverse events. Therefore this product must be kept out of the reach of children.
DRIVING AND USING MACHINERY – Topical Minoxidil may cause dizziness or low blood pressure. If you experience these side effects, do not drive or operate machinery.
Tretinoin
Do not use this treatment if your scalp is sunburnt.
You may find that your scalp becomes more sensitive to sunlight and burns more easily whilst using tretinoin. If your scalp is exposed, use appropriate sun protection (SPF 30 or higher with UVA and UVB protection) or wear protective clothing such as a hat. Avoid sunbeds, tanning lamps and prolonged exposure to strong sunlight.
Avoid using exfoliating scalp products, harsh shampoos, products with a strong drying effect, alcohol-based products or heavily fragranced hair products, as these may increase irritation. Avoid waxing treated areas of the scalp whilst using this treatment.
Tretinoin may cause scalp irritation, redness, dryness or flaking, particularly when you first start treatment. If irritation becomes severe or persistent, reduce frequency of application and seek medical advice.
WARNING: TRETINOIN MAY CAUSE HARM TO AN UNBORN BABY IF USED WHILE PREGNANT. IF YOU ARE PREGNANT, BECOME PREGNANT OR ARE PLANNING A PREGNANCY WHILST USING THIS MEDICATION OR WITHIN ONE MONTH AFTER STOPPING TREATMENT, PLEASE CONTACT YOUR DOCTOR. PLEASE ENSURE ADEQUATE CONTRACEPTION IS TAKEN WHILST USING THIS MEDICATION AND STOP ONE MONTH BEFORE TRYING TO CONCEIVE.
6. Directions and how to use
It is important to use your treatment regularly and as directed to ensure the best results.
Your treatment solution should be applied as follows:
Apply your treatment to dry/towel-dried hair and scalp. Part the hair to allow delivery onto the scalp zones most impacted with loss or thinning of hair. Remember, you are treating the scalp and not the hair.
Apply 1ml of the solution once OR twice daily (please refer to the directions in your shipping confirmation email/the blue box your treatment arrives in) by parting your hair and applying along your centre parting, temples and crown, evenly. You can do this at a time which best suits you.
Using more than the prescribed amount will not enhance results and will mean you will lose product unnecessarily.
If you get the medication on your hands, please wash them thoroughly after use.
7. Side-effects and how to report unwanted side-effects
Minoxidil
The most common (seen in between one in 10 and one in 100 users) side-effects when starting with minoxidil are local skin irritation such as itching (including eyes) and redness. These effects tend to settle with time. Another common side effect is hypertrichosis (unwanted non-scalp hair including facial hair growth in women).
Headaches have been very commonly reported (seen in one in 10 users), this is due to the increased blood flow to the area, again, this should settle as you adjust to use. More severe but less common side effects (seen in between one in 1,000 and one in a 100 users) such as dizziness, feeling faint due to low blood pressure, palpitations and/or fast heart beat, swelling in the hands, feet or legs, or shortness of breath and sudden, unexplained weight gain.
Finasteride
Side effects of finasteride are uncommon (seen between one in 1,000 and one in 100 users) but these may include local irritation, decrease in libido (sex drive), testicular pain, erectile dysfunction, poor semen quality, depression/low mood and palpitations.
Stop using the medicine and get in touch with use, your own doctor or a pharmacist if you experience any of the following; change in your mood, any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge, testicular pain or sexual side-effects.
Post-finasteride syndrome (PFS) is a term used to describe a range of symptoms reported by a small number of men who use finasteride orally. Most side effects are temporary and usually resolve with continued use or after stopping treatment. In rare cases, persistent symptoms have been reported, including sexual changes (decreased libido, erectile difficulties, or changes in ejaculation), mood changes (such as depression), and other physical effects. PFS is rare, mainly patient-reported, and not yet fully understood, with research ongoing to understand its causes and frequency.
Tretinoin
You may notice a brief sensation of warmth or stinging on the scalp immediately after applying this medication.
Local side effects such as dryness, redness, itching, irritation, mild flaking or peeling are common (affecting between 1 in 10 and 1 in 100 people). These effects are usually mild and tend to settle as your scalp adjusts to treatment.
Some people may notice a temporary increase in hair shedding when starting treatment. This can occur as older hairs shed to allow new hairs to grow and is usually short-term.
Less commonly (between 1 in 100 and 1 in 1,000 people), more significant irritation may occur, including swelling, blistering, burning sensation, crusting, skin discolouration or more pronounced peeling of the scalp.
Rarely (between 1 in 1,000 and 1 in 10,000 people), changes in skin pigmentation (darkening or lightening of the skin) or severe allergic reactions may occur.
There have been three case reports of topical tretinoin being associated with Idiopathic Intracranial Hypertension. There is no clear evidence that topical tretinoin causes this condition. However, if you have a history of Idiopathic Intracranial Hypertension, this treatment may not be suitable for you. If you develop symptoms such as persistent headache, visual disturbances, nausea or vomiting, stop treatment and seek medical advice promptly.
If you experience any unwanted side effects, you should contact us via the Dermatology Support Team (hello@hairandme.com) or talk to your GP or healthcare professional.
Also, you can help to make sure medicines remain as safe as possible for everyone by reporting any unwanted side effects at www.mhra.gov.uk/yellowcard. Alternatively, you can call Freephone 0808 100 3352 (available between 10am-2pm Monday to Friday) or fill in a paper form available from your local pharmacy.
8. Storage and disposal
KEEP THIS MEDICATION OUT OF SIGHT AND REACH OF CHILDREN
Do not flush unused medication or pour it down the sink, and do not place it in the general waste bin. Please ask your pharmacist what to do with unused medication. These measures are in place to help the environment.
Do not store above 25 degrees celsius. Do not use your medication after the expiry date which is shown on the bottle.