5 mg film-coated tablet
1. What Finasteride Sandoz is and what it is used for
Finasteride Sandoz is used by men to treat and control:
- Benign prostate enlargement, which is a benign enlargement of the prostate.
Finasteride Sandoz belongs to a group of medicines called 5-alpha-reductase inhibitors. They work by reducing the size of the prostate gland, improving urine flow and other symptoms of prostate enlargement. Finasteride Sandoz reduces the risk of sudden urination and the need for surgery.
Finasteride contained in Finasteride Sandoz 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.
2. What you need to know before you use Finasteride Sandoz
Do not use Finasteride Sandoz
if you are
- allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
- children or adolescents under 18 years of age.
In connection with the treatment of an enlarged prostate, it is recommended to talk to a urologist.
Warnings and cautions
Talk to your doctor before using Finasteride Sandoz.
Tell your doctor if any of the following apply to you:
- difficulty emptying the bladder or have greatly reduced urine flow your doctor will examine you before starting treatment with Finasteride Sandoz to rule out the risk of other urinary tract obstructions.
- if you need to take a ‘PSA’ test, a protein produced in the prostate gland
Tell your doctor or nurse that you are taking Finasteride Sandoz as this may alter your test results.
- if you have impaired liver function.
Women who are or may become pregnant must not come into contact with Finasteride Sandoz (for example, through semen or divided or crushed tablets, see section “Pregnancy and breast-feeding”).
Mood swings and depression
Mood swings such as depression, and, less commonly, suicidal ideation have been reported with the use of Finasteride Sandoz. If you experience any of these symptoms, contact your doctor as soon as possible for further medical advice.
Other medicines and Finasteride Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is not known that Finasteride Sandoz could affect or be affected by other medicines.
Pregnancy and breastfeeding
Finasteride Sandoz must not be used by women.
- If your sexual partner is or may become pregnant: Semen can contain extremely small amounts of Finasteride Sandoz. Therefore, you must ensure that your semen cannot come into contact with your partner, for example by using a condom.
- Women who are pregnant or who may be pregnant should not touch broken or crushed film-coated Finasteride Sandoz tablets. If Finasteride Sandoz enters the body of a pregnant woman, a baby fetus can be born with malformed genitals. Therefore, the tablets are film-coated to prevent contact with Finasteride Sandoz.
Driving and using machines
Finasteride Sandoz is unlikely to affect your ability to drive, use tools, or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Sandoz 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 film-coated tablet, ie essentially ‘sodium-free’.
3. How to use Finasteride Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
1 tablet (5 mg) once daily.
How Finasteride Sandoz is taken
The tablet should be swallowed whole with a glass of water. It can be taken with or without food but always at the same time.
Length of treatment
This is determined by your doctor.
Although there is often an improvement after a short time, it is necessary to continue treatment for at least 6 months.
If you take more Finasteride Sandoz 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 Sandoz
Do not take a double dose to compensate for a missed dose. Only take the next dose when it’s time.
If you stop taking Finasteride Sandoz
Do not change or end the treatment without the doctor’s permission as this can seriously injure you and reduce the effect of the treatment.
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 most common side effects are the inability to get an erection and decreased sex drive. These side effects occur early in treatment and disappear in most patients during continued treatment.
You should tell your doctor immediately if you experience changes in your breast tissue, e.g. lumps, pain, or discharge from the nipples, as such changes can be a sign of a serious illness such as breast cancer.
If you get an allergic reaction, stop taking the medicine and contact a doctor immediately. Signs of an allergic reaction may include:
- skin rash, itching, lumps under the skin ( hives )
- swelling of the lips, tongue, throat, and face, difficulty swallowing, difficulty breathing ( angioedema ). These side effects have been reported (occurring in an unknown number of users).
Side effects can occur to the following extent:
Common (may affect up to 1 in 10 people):
- inability to get an erection
- decreased sexual desire
- reduced amount of semen during ejaculation.
Uncommon (may affect up to 1 in 100 people):
- sore breasts or breast augmentation
- problems with sexual ejaculation
Very rare (may affect up to 1 in 10,000 people):
- fluid secretion from the breasts
- thoracic nodules which may need to be removed by surgery in individual patients.
Has been reported (occurs in an unknown number of users): palpitations
- increased liver enzymes
- testicular pain
- inability to get an erection that remains after treatment has ended
- a decreased sex drive that persists when treatment is completed
- male infertility and/or poor sperm quality. Normalization or improvement in sperm quality has been reported after completion of treatment.
5. How to store Finasteride Sandoz
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton and carton after EXP. or EXP.
The expiration date is the last day of the specified month.
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
- The active substance is finasteride. Each film-coated tablet contains 5 mg finasteride.
- The other ingredients are docusate sodium, hypromellose, indigo carmine (E132), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone K30, propylene glycol, sodium starch glycolate (type A), talc, titanium dioxide (E171).
What the medicine looks like and the contents of the pack
The film-coated tablets are round, blue, biconvex, and smooth on both sides.
The film-coated tablets are packaged in PVC / Alu pressure packs and inserted in cardboard.
10, 15, 30, 50, 60, 100, and 120 film-coated tablets in standard pressure packs
14, 28, and 56 film-coated tablets in a weekly pressure pack
50 film-coated tablets (50 x 1) in single-dose pressure packs
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark.