Finasteride 5 mg film-coated tablets

(Finasteride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Finasteride contains the active substance finasteride which belongs to the group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.

Finasteride is used in the treatment and control of benign (non-cancerous) enlargement of the prostate (benign prostatic hyperplasia BPH). It reduces the risk of you developing a sudden inability to pass urine (acute urinary retention) and the need for surgery.

Do not take Finasteride if you:

• are allergic to finasteride or any of the other ingredients (listed in section 6)
• are a woman (see also under ‘Pregnancy, breast-feeding and fertility’)
• are a child

Warnings and precautions

• reduced liver function
• difficulty emptying your bladder completely or greatly reduced urine flow (exclude other urinary obstruction first)
• any changes in breast tissue (lumps, pain, enlargement, nipple discharge)—report these promptly

If your sexual partner is or may be pregnant, avoid exposing her to your semen which could contain a tiny amount of the drug.

Mood alterations and depression

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported. If you experience these, contact your doctor as soon as possible.

Other medicines and Finasteride

Finasteride does not usually interfere with other medicines. Tell your doctor or pharmacist if you are taking any other medicines.

Finasteride with food and drink

Finasteride can be taken with or without food.

Pregnancy, breast-feeding and fertility

• Finasteride is only intended for men.
• Women who are or may be pregnant should not handle broken or crushed tablets—absorption may cause fetal genital malformation.

Driving and using machines

No evidence suggests Finasteride affects driving or machine use.

Finasteride contains lactose

If you have an intolerance to some sugars, contact your doctor before taking this medicine.

Finasteride contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet (essentially ‘sodium-free’).

The recommended dose is one tablet daily (5 mg finasteride). Swallow the film-coated tablet whole; do not break or crush. It may be taken with or without food.

If you take more Finasteride than you should

Contact a doctor, hospital casualty department or poison centre immediately.

If you forget to take Finasteride

Do not take a double dose. Take the next dose when it is due.

If you stop taking Finasteride

Although improvement may be noticed shortly, treatment should continue for at least 6 months. Do not alter or stop without medical advice.

Stop using and contact your doctor immediately if you experience any of the following (angioedema):

• Swelling of face, tongue or throat; difficulty swallowing; hives; breathing difficulties

Common (may affect up to 1 in 10 people):

• Decreased ejaculate volume
• Impotence
• Reduced sex drive

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

• Rash
• Ejaculation problems that may continue after stopping
• Breast swelling or tenderness

Not known (frequency cannot be estimated):

• Itching, hives
• Palpitations
• Increased liver enzymes
• Testicular pain
• Male infertility or poor semen quality
• Depression, anxiety

Combination therapy with doxazosin

When used with doxazosin, higher incidence of asthenia (16.8%), postural hypotension (17.8%), dizziness (23.2%) and ejaculation disorders (14.1%) versus placebo.

Reporting of side effects

Talk to your doctor or pharmacist about any side effects. You can also report them via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

• Keep out of sight and reach of children.
• No special storage conditions required.
• Do not use after the expiry date on the label (last day of that month).
• Do not dispose via wastewater or household waste; ask your pharmacist.

What Finasteride contains

• Active substance: finasteride 5 mg per film-coated tablet.
• Other ingredients:
  • Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, sodium starch glycolate, docusate sodium, magnesium stearate.
  • Film coating: hypromellose (E 464), titanium dioxide (E 171), indigo carmine aluminium lake (E 132), talc, iron oxide yellow (E 172).

What Finasteride looks like and pack sizes

Blue, round, film-coated tablets debossed ‘H’ and ‘37’. Available in blister packs of 15, 28, 30, 50, 90, 98 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom

Manufacturer:

Pharmadox Healthcare Ltd, Kordin Industrial Park, Paola PLA 3000, Malta

or

Amarox Limited, Congress House, 14 Lyon Road, Harrow, Middlesex HA1 2EN, United Kingdom

Authorisations in the EEA

• Germany: Finasterid Amarox 5 mg Filmtabletten
• Denmark: Finasterid Amarox 5 mg Filmovertrukne tabletter
• France: Finasteride Amarox 5 mg comprimé pelliculé
• Spain: Finasterida Tarbis 5 mg comprimidos recubiertos con película EFG
• Italy: Finasterida Amarox
• Netherlands: Finasteride Amarox 5 mg filmomhulde tabletten
• Portugal: Finasterida Amarox
• Sweden: Finasteride Amarox 5 mg Filmdragerad tablett
• United Kingdom: Finasteride 5 mg film-coated tablets

This leaflet was last revised in 09/2021.