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 oral Finasteride and what is it used for?
2. What you need to know before taking oral Finasteride.
3. How to take oral Finasteride.
4. Possible side effects.
5. How to store oral Finasteride.
6. Contents of pack and other information.

1. WHAT IS ORAL FINASTERIDE AND WHAT IS IT USED FOR?

This oral medication combines Finasteride, a clinically proven hair loss treatment, compounded with synergistic active ingredients to treat common hereditary hair loss in those born male, aged 18 years and over, by slowing down further hair thinning, maintaining hair density, and promoting hair regrowth. Finasteride belongs to a group of medicines called 5α-reductase inhibitors, which are used to prevent the progression of hereditary hair loss (also known as androgenic alopecia).

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

Oral 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. By lowering the levels of DHT, Finasteride may help to reverse and prevent any further hair loss.

Density+ Finasteride 1mg Complex contains several other active ingredients which work synergistically to treat common hereditary hair loss:

• Biotin 500ug: Increasing Biotin intake contributes to the maintenance of normal hair and skin, and helps to maintain the normal hair growth cycle. Biotin also contributes to normal energy-yielding metabolism, normal functioning of the nervous system, normal macronutrient metabolism, normal psychological function, and the maintenance of normal mucous membranes.

• Vitamin D 1000IU: Government guidelines advise that all UK adults should supplement with Vitamin D to prevent deficiencies over the winter months. Vitamin D is known to play a role in modulation of hair growth, important for the differentiation and proliferation of hair cells. It is also known to exert anti-inflammatory and immunoregulatory effects. Vitamin D receptors can be found in the hair follicle, and deficiency in vitamin D has been associated with hair loss.

2. WHAT YOU NEED TO KNOW BEFORE TAKING 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 female
• If you were born male and are under the age of 18 years
• If you are allergic to Finasteride or any of the other ingredients listed in section 6

WARNINGS AND PRECAUTIONS:

• If you are already taking Finasteride or any other 5α-reductase inhibitors for benign prostatic hyperplasia (BPH) or any other condition
• If you are already taking Propecia or Dutasteride, used for a prostate problem called benign prostatic hyperplasia (BPH)
  
  Speak to your prescriber, doctor, or pharmacist before taking Finasteride 1mg Complex if you are going to have a blood test for prostate cancer called a PSA (prostate-specific antigen) test. This is because Finasteride can affect the result of this test. Be aware that taking Finasteride can cause high testosterone results in blood tests. Make your doctor aware that you are taking Finasteride before having any kind of hormone blood test.

EFFECTS ON FERTILITY:

Finasteride may affect male fertility. Patients who are planning to father a child are advised to stop treatment immediately. For those that chose to continue treatment, condoms must be used whilst taking Finasteride to prevent harm to the baby. Normalisation or improvement of seminal quality has been reported after discontinuation of Finasteride. Long-term clinical studies about the effects of Finasteride on fertility in those born male, have not been conducted.

Do not touch Finasteride tablets if you were born female and are pregnant or planning to become pregnant. If taken during pregnancy, it can affect the normal development of male foetus’s sex organs. If a pregnant person comes into contact with Finasteride tablets, speak to a doctor immediately.

MOOD ALTERATIONS AND DEPRESSION:

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts, have been reported by patients taking Finasteride. If you experience any of these symptoms, stop taking this medication and contact your prescriber or doctor to seek advice immediately.

OTHER MEDICINES AND FINASTERIDE:

Tell your doctor or pharmacist if you are taking, have recently taken, or might have taken any other medicines. Finasteride does not usually affect other medicines.

3. HOW TO TAKE FINASTERIDE

• Always take this medicine exactly as your prescriber has directed. Check the dispensing label or ask your prescriber or pharmacist if you are not sure.
• The prescribed dose is one Finasteride 1mg capsule once daily. It can be taken on an empty stomach or with a meal. The capsules should be swallowed whole and should not be opened.
• If you take too many capsules by mistake, contact your doctor immediately. Finasteride will not work faster or better if you take more than one capsule per day.
  • If you forget to take Finasteride, DO NOT take a double dose to make up for a forgotten one.
• Hereditary hair loss is a condition that develops over a long period of time. In general, daily use for three to six months may be necessary before you notice any increase in hair density or reduction in hair loss.
• For some people, Finasteride may not work to regrow hair, and maintenance may be the best outcome. If you have been taking Finasteride for more than a year without improvement, please contact your prescriber to discuss further options.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Finasteride can cause side effects, although not everyone will experience them. Some of the side effects are temporary with continued treatment or disappear when treatment is stopped.

If you experience any side effects, speak to your prescriber, doctor or pharmacist immediately. This includes side effects not listed in this leaflet.

If you experience any of the following, stop taking Finasteride 1mg Complex and seek immediate medical assistance:

• Symptoms of an allergic reaction: swelling of your lips, face, tongue or throat; difficulty swallowing; lumps under your skin (hives) or breathing difficulties.
Stop taking Finasteride and talk to your doctor if you experience:
• Depression (feelings of severe sadness and unworthiness).
• You should promptly report to your doctor any changes in your breast tissue; such as lumps, pain, enlargement or nipple discharge, as these may be signs of a serious condition, such as breast cancer.

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

• You may be unable to have an erection (impotence)
• You may have less desire to have sex
• You may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function

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

• Breast swelling or tenderness
• Palpitations (feeling your heartbeat)
• Changes in the way your liver is working, which can be shown by a blood test
• Pain in the testicles
• Blood in semen
• Persistent difficulty having an erection after discontinuation of treatment
• Persistent decrease in sex drive after discontinuation of treatment
• Persistent problems with ejaculation after discontinuation of treatment
• Male infertility and/or poor quality of semen
• Anxiety

If you experience any listed side effect, or if you notice any that are not listed in this leaflet, please tell your doctor or pharmacist immediately.

5. HOW TO STORE CAPSULES

• 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.
• Do not store above 30°C. Keep them in the original packaging.
  
  
  

6. CONTENTS OF PACK AND OTHER INFORMATION

Density+ Finasteride 1mg Complex contains: Finasteride 1mg, Biotin 500ug, Vitamin D 1000IU. Excipients: Cellulose, Colour (Fast Green), Hydroxypropyl Methylcellulose (Capsule Shell).

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