Patient Information Leaflet

Read this leaflet carefully before you start using this medicine.

• Keep this leaflet as you may need to refer to it
• If you have further questions, ask your prescriber, doctor or pharmacist.
• This medicine has been prescribed for Do not pass it on to anyone else. It may harm them, even if their symptoms are the same as yours.
• In the unlikely event of any serious side effects, or if you notice any side effects not listed in this leaflet, please tell your prescriber, doctor or pharmacist.

In this leaflet you will learn:

1. What is topical Minoxidil and Finasteride and what is it used for?
2. What you need to know before using topical Minoxidil and Finasteride.
3. How to apply topical Minoxidil and Finasteride.
4. Possible side effects.
5. How to store topical Minoxidil and Finasteride.
6. Contents and other information.

1. WHAT IS TOPICAL MINOXIDIL AND FINASTERIDE AND WHAT IS IT USED FOR?

This topical medication combines two clinically proven hair loss treatments, compounded with synergistic active ingredients to treat common hereditary hair loss in those born male, aged 18 years and over, and those born female, once post-menopausal, by slowing down further hair thinning, maintaining hair density, and promoting hair regrowth.
Hereditary hair loss is recognised by various symptoms, including:

• Pattern hair loss (see diagrams)
• Hair loss and hair thinning starts gradually and progresses
• Family history of hair loss
• No other symptoms are present with your hair loss

Minoxidil works as a vasodilator, dilating blood capillaries at the site of application which creates an ideal growth environment for existing hair follicles. Whilst the method of action is still not entirely understood, Minoxidil is thought to induce an early anagen (growth) phase of the hair growth cycle and can keep follicles in the anagen phase for longer when topically applied to the scalp.

Topical Finasteride works by inhibiting the production of type 2 5α-reductase, an enzyme that converts the body’s testosterone into dihydrotestosterone - more commonly known as DHT. DHT is the primary hormone known to cause hereditary hair loss. As topical Finasteride is applied directly to the scalp it has a localised effect, meaning it gets to work directly on the area it is applied to.

Topical Minoxidil and Finasteride works best in those experiencing hereditary hair loss. Those who are younger, have been losing hair for a short period of time, or have a small area of hair loss, are likely to experience the best results. You are unlikely to benefit from topical Minoxidil and Finasteride if you have been losing your hair for many years or have a large area of hair loss.

Density+ Minoxidil 5% & Finasteride 0.1% Scalp Drops contain several other active ingredients which work synergistically to treat common hereditary hair loss:

• Melatonin: Melatonin hormone receptors are located within the hair follicle and are known to modulate hair growth. Research has shown that topical application of Melatonin may help to extend the anagen phase of the hair growth cycle. Research has also shown that Melatonin may help to positively impact hair loss by reducing oxidative stress, further protecting hair follicles.
• Zinc: Has been shown to have anti-androgen properties. Topical application may help to block DHT modulization by inhibiting the enzyme 5α-reductase to help prevent further hair loss. Zinc is also a known anti-inflammatory and helps to calm, soothe, and heal the skin, as well as improve skin barrier function.
• Caffeine: Helps to improve skin barrier function, support follicular penetration, has anti-inflammatory properties, and may help to promote hair growth through stimulation of the hair follicle.
  
  

2. WHAT YOU NEED TO KNOW BEFORE USING TOPICAL MINOXIDIL AND FINASTERIDE

This medication is unlicensed and is made and dispensed under pharmacist supervision. This treatment has been prescribed to meet your needs. As this medication has been made for you, it is an “unlicensed medication”. Prescribers may recommend an unlicensed medication if they think it will treat your condition effectively. Your prescriber will balance any risks of this medication against the benefits you may experience. If you are concerned about taking this medication, talk to your prescriber, doctor, or
pharmacist.

Do not use this medicine:

• If this medication was not prescribed for you
• If you were born male and are under the age of 18 years
• If you were born female, are of child bearing age and have not yet gone through the menopause
• If you have ever had a reaction to Minoxidil, Finasteride, or any of the other ingredients listed in section 6
• If you are already taking Finasteride, Dutasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia (BPH) or any other condition
• If you have hair loss caused by drug treatment
• If you have total hair loss or complete loss of all body hair
• If the cause of your hair loss is unknown or it is sudden and unexpected
• If you have uncontrolled blood pressure
• If you have any condition that affects your scalp, including sunburn and psoriasis
• If you have a shaved scalp
• If you are using creams, ointment or lotions used to treat scalp conditions e.g.
  - Dithranol – used to treat psoriasis
  - Tretinoin – used to treat acne or other skin disorders
  - Corticosteroids
  - Guanethidine
  - Petrolatum – a common ingredient in hair wax or gel

Speak to your prescriber, doctor or pharmacist before using this medication if:

• You need to have a blood test called a prostate–specific antigen (PSA) test. Finasteride may alter the result of the test.
• You are taking medicines for high blood pressure that dilate (widen) the blood vessels, such as hydralazine. There is a potential risk that Minoxidil will increase their effect.
• You suffer from a heart disease, including abnormal heart rhythms or rates, angina or chest pains, and/or circulation disorders.
• You are unsure whether your scalp is normal and healthy.
  
  

OTHER MEDICATION AND TOPICAL MINOXIDIL AND FINASTERIDE

Speak to your prescriber, doctor or pharmacist if you are taking or using any other medicines including:

• Blood pressure medications – there is a potential risk that topical Minoxidil may interact with these medications and increase their effect.
• If you are unsure about the medication you are taking or using, ensure your prescriber knows about this so they can inform you.
  
  

WARNINGS AND PRECAUTIONS

• Topical Finasteride should not be used by those born female of child bearing age. This medication is only suitable for post- menopausal use.
• Those born female who are, or may potentially be pregnant should not come into contact with this medicine. If Finasteride is absorbed through the skin or taken by mouth by a pregnant person carrying a male foetus, the child may be born with malformed genital organs. When the patient’s sexual partner is, or may become pregnant, the patient should discontinue treatment with this medicine immediately.
• Topical Finasteride may affect male fertility. Patients who are planning to father a child should consider stopping treatment.
• Mood alterations such as depressed mood have been reported in patients treated with oral Finasteride tablets. If you experience any of these symptoms from using the topical treatment, stop using the treatment and contact your doctor for further medical advice.

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.

3. HOW TO APPLY TOPICAL MINOXIDIL AND FINASTERIDE

1. Apply at a regular time each day. Measure the correct dose of 2.5ml using the graduated pipette. The treatment is applied directly to the scalp in the thinning areas using the pipette applicator. Hold the dropper in contact with the scalp, tilt the head backwards slightly, and squeeze the solution slowly onto the scalp in small partings, systematically covering the thinning areas. Distribute the solution in circular motions using the tip of the pipette or your fingertips.
2. Take care to avoid contact with facial skin and eyes, and wash hands thoroughly after use. If the drops do come into contact with eyes or facial skin, rinse immediately with plenty of water. In the case of contact with eyes, consult your doctor.
3. For best results apply topical Minoxidil and Finasteride to a dry scalp. Wait a few minutes for the drops to be absorbed before going to bed. Hair and scalp should be shampooed the following morning or before the next application. Always apply topical Minoxidil and Finasteride to a clean scalp to ensure proper absorption of the actives.

4. POSSIBLE SIDE EFFECTS

Like all medicines, topical Minoxidil and Finasteride can cause side effects, although not everybody will be affected. The most common side effect is itching or irritation on the treated area of skin. If skin irritation continues, stop using the medicine and contact your prescriber or doctor.
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

If you experience any of the following, stop using the medicine and talk to your prescriber or doctor:

• Allergic reactions including swollen face, skin redness or itching, or throat tightness
• Low blood pressure
• Fast heartbeat or an increased awareness of the heartbeat (palpitations)
• Faintness or dizziness
• Swollen hands or feet
• Shortness of breath
• Sudden unexplained weight gain
• Persistent local redness or rash
  
  Common side effects (may affect up to 1 in 10 people) include:
• Headache
• Itching or dermatitis
• Unwanted non-scalp hair. Always wash your hands thoroughly after application and if you accidentally apply the treatment to parts of your body other than the scalp, rinse thoroughly with plenty of water.
  
  Uncommon side effects (may affect up to 1 in 100 people) include:
• Nausea

Other side effects which may occur, but it is not known how often:

• Temporary hair loss during the first 2-6 weeks of use. This is likely due to a change in the hair growth cycle and should stop within a few weeks
• Depressed mood
• Eye irritation
• Vomiting
• Scalp irritation such as local redness, dryness, or flaky skin
• Acne-like rash, itchy rash, blistering, bleeding or ulceration
• Change in hair colour

Although uncommon, in clinical trials 3.8% of patients receiving a treatment of oral Finasteride tablets noticed some sort of sexual side effects, compared to 2.1% of patients who were taking the placebo. These side effects included less desire to have sex, difficulties with erectile function and decreases in the volume of semen released during sex. The side effects are usually temporary and disappear when the treatment is stopped. It is important to note that these side effects were observed in trials of oral Finasteride (tablet form) and that there is no conclusive evidence that the same symptoms are likely to occur with the use of topical Finasteride.

5. HOW TO STORE TOPICAL MINOXIDIL AND FINASTERIDE

Topical Minoxidil and Finasteride must be stored at room temperature between 19-25°C in its original packaging. Keep away from heat, direct light and moisture.
Contains ethanol in solution which is extremely flammable. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources.

• Keep this medicine out of reach and sight of children.
• Do not use this medicine after its expiration date, which is printed on the dispensing label.
• Do not throw away any medicine via wastewater or household waste. For safe disposal, please take medications, including unopened packs, to your local pharmacy. This measure will help to protect the environment.
  
  

6. CONTENTS OF PACK AND OTHER INFORMATION

Density+ Minoxidil 5% & Finasteride 0.1% Scalp Drops contains: Minoxidil 5%, Finasteride 0.1%, Ethanol, Water, Propylene Glycol, Caffeine, Zinc, Melatonin and Hydrochloric Acid.
1 bottle contains 85ml (approximately 30 doses). Each dose is 2.5ml.

Other information: Maintaining good general health, adequate nutrition and a healthy scalp, all help to ensure that the hair remains in the growth phase for the maximum period of time.
Contact details: [email protected], 0207 237 7100.
Address: Philip Kingsley Products, 54 Green Street, London, W1K 6RU