Propecia

• For the treatment of male pattern hair loss
• For men with mild to moderate hair loss
• Not suitable for women
• Take tablet with or without food

Propecia contains a medicine called finasteride. Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia).

Male pattern hair loss is thought to be caused by a combination of genetic factors and a particular hormone, DHT (dihydrotestosterone). DHT causes a decrease in the growth phase and thinning of the hair.

Propecia lowers the levels of DHT in the scalp by inhibiting the action of an enzyme (5-alpha reductase type 2) that is responsible for converting testosterone into DHT.

Men with mild to moderate, but not complete hair loss, can benefit from using Propecia. Propecia slowed down the process of hair loss in the majority of men who had been treated with Propecia for five years. Hair growth improved in at least 50% of these men.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

• The recommended dose is one 1 mg-tablet finasteride each day.

The tablet can be taken with or without food. Do not exceed the recommended dose. Propecia will not work faster or better if you take it more than once a day.

Your doctor can help determine if Propecia is right for you. It is important to keep taking Propecia for as long as your doctor tells you. In order for Propecia to be effective long term, you need to keep taking it.

Alcohol/driving

Propecia is not likely to affect you being able to drive, use tools or machines.

If you use more Propecia than you should/stop using Propecia

If you take too many tablets by mistake, contact your doctor immediately.

If you miss a dose of Propecia, then skip the missed dose and continue with your regular dosing schedule. Never take a double dose to make up for the forgotten one.

Talk to your doctor before you stop taking this medicine. It may take three to six months for the full effect to develop. It is important to keep taking Propecia for as long as your doctor tells you. If you stop taking Propecia, you are likely to lose the hair you have gained within 9 to 12 months.

Propecia is not suitable for everyone. Do not take this medicine if:

• You are allergic to the active substance finasteride or any other ingredient in this medicine (see section ‘What Propecia contains’).
• You are a woman or a child (because this medicine is for men). Propecia should only be used by adult men. It has been shown in clinical trials that Propecia does not work in women with hair loss.

When should Propecia be used with caution?

Inform your doctor of any health issues or allergies. A doctor will know if Propecia is suitable for you.

Pregnancy and breastfeeding

Propecia is for the treatment of early-stage male pattern hair loss in men only. Propecia should not be taken by women. Do not touch crushed or broken Propecia tablets if you are a woman who is pregnant or planning to become pregnant. The active ingredient in Propecia (finasteride) is absorbed through the skin.

Finasteride in pregnant women may affect the normal development of a male baby’s genital organs. If a woman who is pregnant comes into contact with crushed or broken Propecia tablets, speak to a doctor. Whole tablets are coated to stop contact with the medicine during normal use.

Other medicines and Propecia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines alongside Propecia. This includes medicines that do not require a prescription. Propecia does not usually affect other medicines.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are temporary with continued treatment, or disappeared when treatment is stopped. The side effects of Propecia include:

Common (may affect up to 1 in 100 people):

• Decreased sexual drive (libido).
• Erection problems.
• Problems with ejaculation, for example a decrease in the amount of semen released during sex.
• Depressed mood.

Other reported side effects (frequency unknown):

• Allergic reactions such as skin rash, itching, hives, and swelling of the face and lips.
• Breast swelling or tenderness.
• Pain in the testicles.
• Palpitations (rapid heartbeat).
• Persistent difficulty having an erection after discontinuation of treatment.
• 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 effects of finasteride on fertility in men have not been conducted.
• Elevated liver enzymes.

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.

If the side effects are severe or if you get any side effects that are not listed in the package leaflet, talk to your doctor or pharmacist. It's particularly important that you see a doctor without delay if you experience severe side effects such as an allergic reaction. Symptoms of an allergic reaction include swelling of your lips, face, tongue and throat, difficulty swallowing, lumps under your skin (hives) and breathing difficulties.

The active substance in this medicine is finasteride. Each tablet contains 1 mg finasteride.

The other ingredients are:

Tablet core: lactose monohydrate 110.4 mg, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycolate, docusate sodium, magnesium stearate.

Coating: talc, hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), yellow and red iron oxide (E172).

The manufacturer of Propecia is:

Merck Sharp & Dohme

Quimica de Puerto Rico, Ltd
Road #2, kilometer 60.3
Sabana Hoyos
Arecibo, PR 00688
Puerto Rico

Read the package leaflet before use.