5 mg film-coated tablets
finasteride
1. What Finasteride Teva is and what it is used for
The active substance in Finasteride Teva is finasteride, which belongs to a group of medicines called 5-alpha-reductase inhibitors. They work by reducing the size of the prostate gland in men.
Finasteride Teva is used to treat and control benign prostatic hyperplasia ( benign prostatic hyperplasia – BPH ). It promotes the regeneration of an enlarged prostate, improves urine flow, reduces the symptoms of BPH, reduces the risk of acute urinary retention (inability to urinate), and reduces the risk of needing surgery.
What you need to know before you take Finasteride Teva
Do not take Finasteride Teva
- if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or may become pregnant. Finasteride Teva should not be used by women. Special care is required for women taking Finasteride Teva when they are or may become pregnant (see section Pregnancy, breast-feeding, and fertility ).
Finasteride Teva should not be used by children.
ASK YOUR DOCTOR OR PHARMACIST IF YOU ARE UNSURE.
Warnings and cautions
Talk to your doctor or pharmacist before taking Finasteride Teva:
- if you have difficulty emptying your bladder and/or have a sharp decrease in urine flow. In this case, you should be carefully examined for narrowing of the urinary tract.
- if you have impaired liver function. The levels of finasteride in the blood may increase in these patients.
- if your sexual partner is or may become pregnant. You should avoid exposing her to your semen, as it may contain a small amount of the medicine.
Contact your doctor as soon as possible if you notice changes in your breasts such as lumps, pain, or discharge from the nipple, as this may be a sign of a serious condition such as breast cancer.
A clinical examination (including rectal examination) and a determination of prostate-specific antigen (PSA) in serum should be performed before and during treatment with finasteride.
Mood swings and depression
Mood swings such as depression, and, less commonly, suicidal ideation have been reported with the use of Finasteride Teva. If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.
Other medicines and Finasteride Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
There are no data to suggest that Finasteride Teva affects or is affected by concomitant treatment with other drugs.
Pregnancy, breastfeeding, and fertility
Finasteride Teva is for men only.
If you are or may become pregnant, you must not come into direct contact with split or crushed Finasteride Teva tablets. If finasteride is absorbed through the skin or ingested through the mouth of a woman who is pregnant with a baby fetus, the baby may be born with malformed genitals. The tablets are coated, which prevents contact with finasteride provided that the tablets are not split or crushed.
When the patient’s sexual partner is or may become pregnant, the patient should either avoid exposing their partner to semen (eg by using a condom) or end treatment with finasteride.
Driving and using machines
There are no data to suggest that Finasteride Teva affects the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Finasteride Teva contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Finasteride Teva
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 (equivalent to 5 mg finasteride).
The film-coated tablet can be taken with or without food. The film-coated tablet should be swallowed whole and must not be split or crushed.
Although rapid improvement often occurs, it may be necessary to continue treatment for at least six months to evaluate the outcome of treatment.
Your doctor will tell you how long to continue taking Finasteride Teva. Do not stop treatment prematurely, as the symptoms may return.
Hepatic impairment
There is no experience in patients receiving Finasteride Teva in patients with hepatic impairment (see also Warnings and precautions).
Renal impairment
No dose adjustment is necessary. The use of Finasteride Teva in patients treated with hemodialysis has not yet been studied.
Elderly
No dose adjustment is necessary.
If you have the impression that the effect of Finasteride Teva is too strong or weak, talk to your doctor or pharmacist.
If you take more Finasteride Teva then you should
If you have ingested too much medicine or if e.g. a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Finasteride Teva
If you forget to take a dose of Finasteride Teva, you can take it as soon as you remember, provided it is not soon for the next dose. In this case, continue with the treatment according to your usual dosing schedule. Do not take a double dose to make up for a forgotten tablet.
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.
Allergic reactions
If you get an allergic reaction, stop taking Finasteride Teva and contact your doctor immediately. Symptoms of this may include:
- skin rash, itching, swelling of the skin (hives).
Other side effects may include:
- inability to get an erection ( impotence )
- decreased sexual desire (decreased libido )
- reduced amount of semen during ejaculation. This reduction in the amount of semen does not appear to affect normal sexual function.
These side effects are common (may affect up to 1 in 10 people) and may go away after a while if you continue to take Finasteride Teva. If they do not, they usually disappear after finishing treatment with Finasteride Teva.
Other side effects that have been reported in some men are:
Uncommon (may affect up to 1 in 100 people):
- rash
- sore breasts or breast augmentation
- problems with sexual ejaculation that may persist after completion of treatment.
Has been reported (occurs in an unknown number of users):
- anxiety
- fast heartbeat (palpitations)
- changes in how your liver works, as evidenced by a blood test
- testicular pain
- male infertility and/or poor sperm quality. Improvement in sperm quality has been reported after completion of treatment.
- Depression
- decreased sexual desire that may continue after completion of treatment
- erection problems that may continue after treatment has ended.
Stop using Finasteride Teva and contact your doctor immediately if you experience any of the following symptoms ( angioedema ): swelling of the face, tongue, and throat; difficulty swallowing, hives, and difficulty breathing.
Contact your doctor as soon as possible if you notice changes in the breasts such as lumps, pain, enlarged breasts or secretions from the nipples, as this may be a sign of a serious condition such as breast cancer.
Finasteride may affect the results of PSA tests.
5. How to store Finasteride Teva
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 carton, blister, and can after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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. One film-coated tablet contains 5 mg finasteride.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), pregelatinized starch, povidone, magnesium stearate, sodium lauryl sulfate, hypromellose (E464), titanium dioxide (E171), macrogol 6000, macrogarmin 400, macrogarmin 400, macrogolmin 400.
What the medicine looks like and the contents of the pack
- Finasteride Teva is a blue capsule-shaped film-coated tablet with the inscription “FNT5” on one side.
- Finasteride Teva is available in blister packs of 14, 15, 20, 28, 30, 50, 50 x 1 (hospital packs), 56, 60, 84, 90, 98, 100, 105 or 120 tablets.
- Finasteride Teva is available in an HDPE tablet jar with a polypropylene screw cap with 100 tablets, in an outer carton.
Not all pack sizes may be marketed.