Hair + Me Patient Information Leaflet – Oral Treatments

This documents refers to the following oral preparations:

Minoxidil 0.5mg capsules
Minoxidil 1.25mg capsules
Finasteride 1mg, Minoxidil 2.5mg capsules
Dutasteride 0.5mg, Minoxidil 1.25mg capsules

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 side effects
Directions and how to use
Side effects and how to report unwanted side-effects
Storage

General information

Your capsules have been made by Unit 5 Oakwood Business Park, Park Royal, London, United Kingdom, NW10 6EX. These capsules have been prescribed for you, and only you. Please don’t share this treatment with anyone else, as it may cause harm.

Information on your active and inactive ingredients

Active ingredients

Minoxidil (0.5mg, 1.25mg, 2.5mg)

Minoxidil is a treatment used for hair loss that works by improving blood flow to hair follicles. By doing so, it helps hair follicles stay active longer, allowing them to produce thicker hair strands and potentially regrow hair in areas where it has started to thin or recede.

Finasteride

Finasteride is used to treat hair loss in men with male pattern baldness. It works by blocking the conversion of testosterone into dihydrotestosterone (DHT), a hormone that can shrink hair follicles on the scalp. By reducing DHT levels, finasteride helps to increase hair growth on the scalp and prevent further hair loss. Men with mild to moderate, but not complete hair loss, can benefit from using finasteride.

Dutasteride

Dutasteride is used to treat hair loss in men with male pattern baldness. It works by blocking the conversion of testosterone into dihydrotestosterone (DHT), a hormone that can shrink hair follicles on the scalp. By reducing DHT levels (more comprehensively than finasteride), dutasteride helps to prevent further hair loss and promote hair regrowth.

Inactive ingredients

Microcrystalline cellulose, hydroxypropyl methylcellulose capsule shell.

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)

Androgenetic alopecia, often called male (or female) pattern baldness, is a common type of hair loss that occurs due to a combination of genetic and hormonal factors. In men, it typically causes hair thinning and receding at the temples and crown of the head, eventually leading to baldness.

Generalised hair thinning

Contraindications

Do not use your treatment if you are allergic to any of the ingredients in this product (see section 2 for full details of all ingredients).

Minoxidil

Minoxidil acts as a systemic vasodilator (i.e. it dilates blood vessels) which can lead to an increase in heart rate (tachycardia) that may put strain on the heart (myocardial ischaemia). Accordingly, minoxidil should be avoided in patients who have angina or who have had a recent heart attack (myocardial infarction).

Minoxidil can also promote substantial fluid retention (by modulating kidney haemodynamics – how blood flows) thus should be avoided in patients with heart failure or those at high risk of it and those with a history of significant heart disease. Minoxidil should also not be used in people with pulmonary hypertension with mitral stenosis, as well as people with severe liver disease (hepatic impairment).

Minoxidil is contra-indicated in people with a pheochromocytoma (a tumour in the adrenal gland) because it may stimulate secretion of catecholamines from the tumour through its antihypertensive action.

Finasteride and Dutasteride

Finasteride and Dutasteride should not be taken by women, children or adolescents.

Finasteride and Dutasteride should not be taken by men who are taking ‘Proscar’ (finasteride 5mg) or any other 5α -reductase inhibitor for benign prostatic hyperplasia or any other condition.

Dutasteride should not be used if you have been diagnosed with liver disease.

Do not touch crushed or broken capsules of finasteride or dutasteride if you are a woman who is pregnant or planning to become pregnant.

If you develop an allergic reaction to your treatment then you must stop taking 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.

Warnings and side effects

Minoxidil

Do not take Minoxidil if you:

Are over the age of 65
Have been diagnosed with phaeochromocytoma
Have a history of heart disease (i.e. myocardial infarction, heart failure or uncontrolled hypertension)
Are trying to conceive, pregnant or breastfeeding

Salt and water retention – Minoxidil can cause retention of salt and water leading to physical signs such as oedema (build-up of fluid in the body) which is common (seen in between one in 10 and one in 100 users). It can also lead to clinical deterioration of some patients with heart failure, so we recommend avoiding it if you are already prone to this. This product should be used with particular attention to maintenance of salt and water balance in patients with renal (kidney) impairment, but who are not on dialysis.

Myocardial infarction – Patients who have had myocardial infarction (heart attack) should only use minoxidil after a stable post-infarction state has been established.

Tachycardia – Because minoxidil is a vasodilator (a medicine that opens/dilates blood vessels), reflex tachycardia may occur very commonly (seen one in 10 users) and possibly angina pectoris (chest pain or discomfort due to coronary heart disease) may occur in patients at risk.

Hypertrichosis – Hypertrichosis (unwanted non-scalp hair including facial hair growth in women and those assigned female at birth) can occur very commonly (seen one in 10 users) if treated with oral minoxidil. Most patients will experience lengthening, thickening and enhanced pigmentation of fine body hair. Usually these signs will emerge three to six weeks after starting treatment. They initially emerge in the face, and they may slightly subside with continued treatment. Spontaneous reversal to the pre-treatment state can be expected one to six months after cessation of therapy.

ECG alterations – Soon after starting minoxidil therapy, approximately 60% of patients exhibit ECG (electrocardiogram – a test that records the electrical activity of your heart) alterations in the direction and magnitude of their T waves. Large changes may encroach on the ST segment, unaccompanied by evidence of ischaemia. These asymptomatic changes usually disappear with continuing minoxidil treatment. The ECG reverts to the pre-treatment state when minoxidil is discontinued.

Thrombocytopenia and leukopenia – Thrombocytopenia (low platelet count) and leukopenia (decrease in white blood cell count) have been rarely reported (seen in between one in 1000 and one in 10,000 users).

Pericarditis, Pericardial Effusion and Tamponade – Although there is no evidence of a causal relationship, there have been multiple reports of pericarditis (inflammation of the lining around your heart) occurring in association with minoxidil. Pericardial effusion and occasionally tamponade, has been observed in about 3-5% of treated patients not on dialysis (seen in between one in 10 and one in 100 users). While in many cases, the pericardial effusion is associated with other potential aetiologies, there have been cases in which these potential causes of effusion were not present. Patients should be observed closely for any suggestion of a pericardial effusion and pericardiocentesis, or surgery may be required. If the effusion persists, withdrawal of minoxidil should be considered in light of other means of controlling hypertension and the patient’s clinical status.

Fertility, pregnancy and lactation – Hair + Me oral minoxidil should not be used if trying to conceive, pregnant or breastfeeding.

DRIVING AND USING MACHINERY – Minoxidil may cause dizziness or low blood pressure. If you experience these side effects, do not drive or operate machinery.

Finasteride

Do not take finasteride if you:

Are under the age of 18
Have a personal of family history of breast cancer
Have been diagnosed with Benign Prostatic Hyperplasia (BPH)
Are undergoing Prostate-Specific Antigen (PSA) monitoring, have been diagnosed with prostate cancer or have a first-degree relative diagnosed with prostate or testicular cancer
Experience sexual dysfunction (e.g. erectile dysfunction)
Are actively trying to conceive, undergoing fertility treatment or have a known low sperm count
Are experiencing or have a history of depression, anxiety or mental health concerns

Infertility – Infertility has been reported in men who took finasteride for a long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effect of finasteride on fertility in men have not been conducted.

Mood alterations – Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with finasteride. If you experience any of these symptoms stop taking finasteride and contact your GP for further medical advice as soon as possible.

Breast cancer – Breast cancer has been reported in men taking finasteride. You should promptly report to your doctor any changes in the breast tissue such as lumps, pain, enlargement of the breast or nipple discharge as these may be signs of a serious condition, such as breast cancer.

Inform us of any medications you’re currently taking to ensure they do not interact with the treatment.

WARNING: WOMEN MUST NOT USE FINASTERIDE DUE TO THE RISK IN PREGNANCY. AVOID CONTACT WITH LEAKING CAPSULES OF FINASTERIDE IF YOU ARE A WOMAN WHO IS PREGNANT OR MAY POTENTIALLY BE PREGNANT.

Dutasteride

Do not take dutasteride if you:

Are under the age of 18
Have liver problems (e.g. cirrhosis, hepatitis, non-alcoholic fatty liver disease)
Have a personal of family history of breast cancer
Have been diagnosed with Benign Prostatic Hyperplasia (BPH)
Are undergoing Prostate-Specific Antigen (PSA) monitoring, have been diagnosed with prostate cancer or have a first-degree relative diagnosed with prostate or testicular cancer
Experience sexual dysfunction (e.g. erectile dysfunction)
Are actively trying to conceive, undergoing fertility treatment or have a known low sperm count
Are experiencing or have a history of depression, anxiety or mental health concerns

Prostate cancer – In a clinical study of men at increased risk of prostate cancer, men taking dutasteride had a serious form of prostate cancer more often than men who did not take dutasteride. The effect of dutasteride on this serious form of prostate cancer is not clear.

Semen quality – Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. The possibility of reduced male fertility cannot be excluded.

Heart failure – In two long-term studies, people taking both dutasteride and an alpha blocker (like tamsulosin) had a slightly higher chance of heart failure compared to those not using the combination. However, the overall risk was still lower than for those not taking either medication, and there’s not enough evidence to say that dutasteride alone increases the risk of heart failure.

Breast enlargement/tenderness – Dutasteride may cause breast enlargement and tenderness. If this becomes troublesome, or if you notice breast lumps or nipple discharge you should talk to your doctor about these changes as these may be signs of a serious condition, such as breast cancer.

Some medicines can react with dutasteride and may make it more likely that you’ll have side-effects. These medicines include:

Verapamil or diltiazem (for high blood pressure)
Ritonavir or indinavir (for HIV)
Itraconazole or ketoconazole (for fungal infections)
Nefazodone (an antidepressant)
Alpha-blockers (for enlarged prostate or high blood pressure)

WARNING: WOMEN MUST NOT USE DUTASTERIDE DUE TO THE RISK IN PREGNANCY. AVOID CONTACT WITH LEAKING CAPSULES OF FINASTERIDE IF YOU ARE A WOMAN WHO IS PREGNANT OR MAY POTENTIALLY BE PREGNANT.

Directions and how to use

It is important to take your Hair + Me oral minoxidil regularly and as directed to ensure the best results. One capsule should be taken once a day with a glass of water – swallow whole, do not chew or crush.

Side effects and how to report unwanted side-effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the treatment and seek immediate medical attention if you have any of the following symptoms: swelling of your lips, face, tongue and throat; difficulty swallowing; lumps under your skin (hives) and breathing difficulties as this may be indicative of an allergic reaction.

Minoxidil

Stop using the treatment and contact us via the Dermatology Support team or talk to your GP or healthcare professional if the following occur:

You feel faint or dizzy, especially when you stand up.
Your body could hold on to more water than normal: you may notice that your ankles get puffy, or your rings get tight, or you put on weight.
You find that you get more wheezy, breathless and tired, especially if you already have a weak heart.
You may notice angina (usually pains in your chest) for the first time, or if you have angina already it could get worse.

Other side effects include:

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

Increased heart rate, inflammation of the lining that surrounds the heart, abnormal electrocardiogram (ECG), hypertrichosis (increased hair growth on areas of the body), hair colour changes.

Common: may affect up to 1 in 10 people:

Accumulation of fluid around the heart, compression of the heart due to a buildup of fluid, fluid retention.

Rare: may affect up to 1 in 1,000 people:

Decrease in white blood cells, reduction in blood platelets, which increases risk of bleeding or bruising, serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome), inflammation and blistering of the skin, rash.

Not known: frequency cannot be estimated from the available data:

Accumulation of fluid between the layers of tissue that line the lungs and chest cavity (pleural effusion), chest pains (angina), gastrointestinal disorders, swelling of the ankles, feet or fingers associated with or independent of weight gain, breast tenderness, reduced kidney function resulting in increased creatinine and urea levels in your blood.

Finasteride

You should promptly report to your doctor any changes in the breast tissue such as lumps, pain, enlargement of the breast or nipple discharge as these may be signs of a serious condition, such as breast cancer.

Uncommon: may affect up to 1 in 100 people:

Erectile dysfunction, decreased libido, ejaculation disorder (including decreased volume of ejaculate), depression

Not known: frequency cannot be estimated from the available data:

Hypersensitivity reactions, such as rash, pruritus, urticaria and angioedema (including swelling of the lips, tongue, throat and face), breast tenderness and enlargement, testicular pain, blood in the sperm, male infertility and/or poor quality of semen (see section 5), fast heartbeat, elevated liver enzymes, anxiety, suicidal thoughts

Side effects have usually been temporary with continued treatment and disappeared when treatment is stopped but persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation problems) has been reported.

Dutasteride

Common: may affect up to 1 in 10 people:

Impotence, decreased libido, ejaculation disorder (including decreased volume of ejaculate), breast tenderness and enlargement

Uncommon: may affect up to 1 in 100 people:

Alopecia (primarily body hair loss), hypertrichosis

Not known: frequency cannot be estimated from the available data:

Depression, testicular pain and swelling, angioedema, hypersensitivity, localised oedema, skin reactions

If any of these side effects become severe, or if you observe any side effects not listed in this leaflet, please discontinue use and contact us for further advice, or consult your GP or healthcare provider.

Reporting of suspected adverse reactions

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), download the MHRA Yellow Card App in the Google Play or Apple App Store or fill in a paper form available from your local pharmacy.

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.

Storage

WARNING: KEEP THIS MEDICATION OUT OF SIGHT AND REACH OF CHILDREN

Do not flush unused medication 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.