5 mg film-coated tablets 
finasteride

1. What Finasteride Aurobindo is and what it is used for

Finasteride Aurobindo belongs to a group of medicines called 5-alpha-reductase inhibitors. They work by reducing the size of the prostate gland in men.

Finasteride Aurobindo is used for the treatment and control of benign prostate enlargement ( benign prostatic hyperplasia – BPH ). The drug causes regeneration of the enlarged prostate, improves urine flow and the symptoms caused by BPH, and reduces the risk of acute urinary retention (inability to urinate) and the need for surgery.

Finasteride contained in Finasteride Aurobindo may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Finasteride Aurobindo

Do not use Finasteride Aurobindo

  • if you are allergic to finasteride or
  • if you are a woman (because this medicine is for men).
  • if you are a child

Warnings and cautions

Talk to your doctor or pharmacist before using Finasteride Aurobindo

  • if you have difficulty emptying your bladder and/or have a sharp decrease in urine flow. If this is the case, you should be closely monitored for narrowing of the urinary tract.
  • if you are going to do a PSA test (test to detect prostate cancer). Tell your doctor that you are taking finasteride.
  • If your sexual partner is or is likely to become pregnant, you should avoid exposing her to your semen as it may contain extremely small amounts of the drug that may affect the development of the baby’s genitals.

Talk to your doctor if any of the above apply to you now or have applied to you in the past.

Mood swings and depression

Mood swings such as depression, and, less commonly, suicidal ideation have been reported with the use of Finasteride Aurobindo. 

If you experience any of these symptoms, consult a doctor as soon as possible 

for further medical advice.

Other medicines and Finasteride Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Finasteride Aurobindo does not normally affect other medicines.

Finasteride Aurobindo with food, drink, and alcohol

Finasteride Aurobindo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Finasteride Aurobindo should not be taken by women.

Women who are pregnant or likely to become pregnant should not touch broken or crushed Finasteride Aurobindo tablets. If finasteride is absorbed through the skin or ingested through the mouth of a woman who is pregnant with a fetus, the baby may be born with malformed genitals. The tablets are film-coated, which prevents contact with finasteride provided that the tablets are not broken or crushed.

When a patient’s sexual partner is or may become pregnant, the patient should either avoid exposing his partner to semen (eg by using a condom) or discontinue finasteride treatment.

Driving and using machines

As far as is known, Finasteride Aurobindo does not affect the ability to drive or use machines.

Finasteride Aurobindo contains excipients

Finasteride  Aurobindo contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Finasteride Aurobindo contains sodium

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

3. How to use Finasteride Aurobindo

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults:

The recommended dose is one Finasteride Aurobindo 5 mg tablet daily (equivalent to 5 mg finasteride).

The film-coated tablets can be taken either on an empty stomach or with a meal. The film-coated tablet should be swallowed whole and must not be split or crushed. 

Although early improvement is seen, treatment for at least six months may be necessary to evaluate whether the treatment has given the desired result.  

Your doctor will tell you how long you should continue to take Finasteride Aurobindo 5 mg. Do not stop treatment prematurely as symptoms may return.

Patients with hepatic impairment

There is no experience from the use of Finasteride Aurobindo 5 mg in patients with hepatic impairment (see also “Take special care with Finasteride Aurobindo 5 mg”).

Patients with renal impairment

Dose adjustment is not necessary (see “Adults”). The use of Finasteride Aurobindo 5 mg in patients undergoing hemodialysis has not been studied to date. 

Elderly patients

Dose adjustment is not necessary (see “Adults”).

Talk to your doctor or pharmacist if you think Finasteride Aurobindo 5 mg has too strong or too weak an effect.

If you use more Finasteride Aurobindo then you should  

If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine contact a doctor, hospital, or the Poison Information Center for risk assessment and advice

If you forget to use Finasteride Aurobindo

If you forget to take a Finasteride Aurobindo 5 mg tablet, you can take it as soon as you remember, unless it is time for your next dose . In this case, you should take the next dose as usual according to your doctor’s prescription .

Do not take a double dose to make up for a forgotten dose . 

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects have been reported with this medicine:

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

  • You may not be able to get an erection ( impotence )
  • You may experience less sex drive
  • You may have problems with ejaculation, e.g. reduced amount of semen during ejaculation The reduction in the amount of semen does not seem to affect normal sexual function.The above mentioned side effects are usually transient if you continue to take Finasteride Aurobindo. If not, they usually disappear when you stop taking Finasteride Aurobindo.

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

  • Swollen breasts or chest tightness
  • Rash
  • Difficulty ejaculating

Has been reported (occurs in an unknown number of users):

  • Palpitation er (irregular or severe heartbeat)
  • Changes in how well your liver works, this is demonstrated using blood tests.
  • Pain in your testicles
  • Anxiety
  • Allergic reactionsIf you get an allergic reaction , stop taking Finasteride and see a doctor immediately. Symptoms may include:
    • Skin rash, itching , or small blisters under the skin ( hives )
    • Swelling of the lips, tongue, throat and face.
  • Depression, decreased sexual drive that may persist after completion of treatment
  • Erection problems that may persist after the end of treatment
  • Male infertility and / or poor sperm quality. Infertility has been reported in men who took finasteride for a long time and had other risk factors that may affect fertility . After completion of finasteride treatment, it has been seen that sperm quality has improved or returned to normal.

Contact your doctor as soon as possible if you notice changes in the breasts such as lumps, pain, enlarged breasts or a change in the nipple, as this may be a sign of a serious condition such as breast cancer.

For more information about this tumor classification system or study, talk to your doctor.

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. It is helpful if you make a note of what happened, when it started and how long it lasted. You can also report side effectsdirectly to

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

By reporting side effects , you can help increase drug safety information.

5. How to store Finasteride Aurobindo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment 

6. Contents of the packaging and other information

Content declaration

  • The active substance is finasteride. Each film-coated tablet contains 5 mg finasteride.
  • The other ingredients are: lactose monohydrate , microcrystalline cellulose, sodium starch glycolate (type A), pregelatinized starch (maize), docusate sodium, magnesium stearate, hydroxypropylcellulose, hypromellose, titanium dioxide, talc, indigo carmine aluminum lacquer (E132), yellow

What the medicine looks like and contents of the pack

Film-coated tablet.

Blue, round, biconvex, facade, film-coated tablet debossed with “E” on one side and “61” on the other side.

Finasteride Aurobindo 5 mg tablets are available in PVC / PE / PVdC aluminum foil blisters and white opaque HDPE jars closed with polypropylene lids.

Blister pack: 10, 14, 15, 20, 28, 30, 45, 50, 60, 90, 98, 100 and 120 film-coated tablets.

HDPE can: 30, 50, 60, 90, 98, 100 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aurbindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913

Malta

Manufacturer

Milpharm Limited

Ares, Odyssey Business Park

West End Road, South Ruislip HA4 6QD

UK

tel: ++ 44 20 8845 8811

fax: ++ 44 20 8845 8795

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

or

Adamed Sp. z oo

Pienk6w 149

05-152 Czosn6w

Poland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

This medicinal product is authorized under the European Economic Area under the names:

Cyprus Finasterid Aurobindo 5 mg Reciprocating Disease With Disease

Germany Finasteride Aurobindo 5 Mg Film Tablet

Denmark Finasteride Aurobindo 5 mg film-coated tablets

Spanien FINASTERIDA AUROBINDO 5 mg compressed with EFG film

France FINASTERIDE ARROW LAB 5 mg, compressed pelleted

Ireland Fintrid 5 mg film-coated tablets

Netherlands Finasteride Aurobindo 5 mg, film-coated tablet

Poland ADASTER

Portugal Finasterida Aurobindo

UK Finasteride 5 mg film-coated tablets

Muhammad Nadeem

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