5 mg film-coated tablets 
finasteride

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

Finasteride Actavis contains the active substance finasteride, which belongs to a group of medicines called “5-alpha-reductase inhibitors”. They work by reducing the size of the prostate ( bladder neck gland ) in men.

Finasteride Actavis is used to treat and control benign prostatic hyperplasia (which does not involve cancer).

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

What you need to know before you take Finasteride Actavis

Do not take Finasteride Actavis

  • if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
  • if you are a woman or a child (see also “Pregnancy and breast-feeding” in this section).

Warnings and cautions

Talk to your doctor or pharmacist before taking Finasterid Actavis.

  • if you have impaired liver function.
  • If you have difficulty emptying your bladder or have a sharp decrease in urine flow, your doctor should carefully examine you before you start taking Finasteride Actavis to rule out other urinary tract obstructions.
  • If you notice any changes in your breast tissue such as lumps, pain, enlargement of breast tissue, or secretion of fluid from the nipple, then this may be a sign of a serious illness, such as breast cancer. You should report this to your doctor immediately if you notice any of these changes.

If your sexual partner is or is likely to become pregnant, you should avoid exposing her to your semen, which may contain a very small amount of the medicine (see also “Pregnancy and breast-feeding” in this section).

If you need to perform a blood test called “PSA”, be sure to tell your doctor or nurse that you are using finasteride beforehand, as finasteride may affect the results of the test.

Mood swings and depression

Mood swings such as depression, depression, and, less commonly, suicidal ideation have been reported with the use of Finasteride Actavis. If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.

Other medicines and Finasteride Actavis

Finasteride Actavis tablets can normally be taken with other medicines. However, consult your doctor before taking other medicines at the same time.

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

Finasteride Actavis with food and drink

Finasteride Actavis can be taken with or without food.

Pregnancy and breastfeeding

Finasteride Actavis is for men only. If your sexual partner is or is likely to become pregnant, you should avoid exposing her to your semen, which may contain a very small amount of the medicine.

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

Driving and using machines

There is no evidence that Finasterid Actavis affects the ability to drive or use machines.

Finasteride Actavis 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.

How to take Finasteride Actavis

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

The recommended dose is 1 tablet daily.

The tablet should be swallowed whole and should not be split or crushed. It can be taken with or without food.

If you take more Finasterid Actavis then you should

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

If you forget to take Finasteride Actavis

Do not take a double dose to make up for a forgotten tablet. Just take the next dose you should.

If you stop taking Finasteride Actavis

Although an improvement is often noticed after a short time, it may be necessary to continue treatment for at least 6 months. Do not change the dosage or stop the treatment without asking your doctor.

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.

Stop using Finasteride Actavis and contact your doctor immediately if you experience any of the following symptoms ( angioedema ): swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing. These symptoms may be signs of an allergic reaction that has been reported (occurs in an unknown number of users).

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

Inability to get an erection, decreased sex drive, decreased amount of semen during ejaculation.

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

Breast tenderness, rash, breast enlargement, difficulty ejaculating.

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

Depression, testicular pain, inability to maintain an erection even after treatment with Finasteride Actavis, persistent decreased desire to have sex after treatment, male infertility and/or poor sperm quality, itching, urticaria ( hives ), irregular, hard or fast heartbeat, altered liver values.

You should contact your doctor immediately if you notice changes in your breast tissue such as lumps, pain, enlargement of the breast tissue, or secretion of fluid from the nipple, as this may be a sign of a serious illness, such as breast cancer.

5. How to store Finasteride Actavis

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 label 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 (the ingredient that makes the medicine work) is finasteride. One film-coated tablet contains 5 mg finasteride.
  • The other ingredients in the tablet core are lactose monohydrate microcrystalline cellulose, pregelatinized starch (corn), lauroyl macrogol glycerides, sodium starch glycolate, magnesium stearate. The tablet coating contains hypromellose, macrogol, titanium dioxide (E171), and indigo carmine (E132).

What the medicine looks like and the contents of the pack

Finasteride Actavis is a blue, round, biconvex tablet marked “F5”. The diameter is 7 mm. Blister packs containing 7, 10, 14, 15, 20, 28, 30, 49, 50, 60, 98, 100 or 300 tablets.

Plastic jars containing 10, 30, 50, 100 or 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Muhammad Nadeem

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