Full Prescribing Info
Each tablet contains 1 mg finasteride.
Excipients/Inactive Ingredients: The other ingredients are lactose monohydrate, pregelatinised starch, sodium laurilsulfate, sodium starch glycolate (type A), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, iron oxide red (E172) and iron oxide yellow (E172).
Male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). DHT contributes to shortening of the growth phase of the hair and to thinning of the hair.
In the scalp, finasteride specifically lowers the levels of DHT by blocking an enzyme (type 2 5-alpha reductase) that converts testosterone to DHT.
Finasteride-Teva is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). If after reading, the patient has any questions about male pattern hair loss, he should ask the doctor.
Only men with mild to moderate, but not complete hair loss can expect to benefit from the use of Finasteride. In most of the men treated with finasteride for 5 years, the progression of hair loss was slowed, and at least half of these men also had some kind of improved hair growth.
This product is not approved for the prevention of prostate cancer.
Dosage/Direction for Use
Always take Finasteride-Teva exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
Taking this medicine: The usual dose is one tablet each day.
The tablets can be taken with or without food.
Finasteride-Teva will not work faster or better if taken more than once a day.
The doctor will help to determine if Finasteride-Teva is working for the patient. It is important to take Finasteride-Teva for as long as the doctor prescribes it. Finasteride-Teva can only work over the long term if the patient continues taking it.
If the patient forgets to take Finasteride-Teva: If the patient forgets to take a tablet, skip the missed dose. Take the next one as usual. Do not take a double dose to make up for the forgotten dose.
If the patient stops taking Finasteride-Teva: It may take 3 to 6 months for the full effect to develop. It is important to keep taking Finasteride-Teva as long as advised by the doctor. If the patient stops taking Finasteride-Teva, he is likely to lose the hair he has gained within 9 to 12 months.
Reproductive system: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain.
If the patient has any further questions on the use of this product, he should ask the doctor or pharmacist.
If the patient takes too many tablets by mistake, he should talk to the doctor promptly.
Do not take Finasteride-Teva if: The patient is a woman (because this medicine is for men, see Use in Pregnancy & Lactation). It has been shown in clinical trials that finasteride does not work in women with hair loss.
The patient is allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in Description). If the patient is not sure, talk to the doctor or pharmacist.
Special Precautions
Take special care with Finasteride-Teva: Finasteride-Teva should not be taken by children and teenagers under the age of 18 years.
If the patient is to have a blood test called prostate-specific antigen (PSA) he should tell the doctor or pharmacist that he is taking Finasteride-Teva as it may affect the results.
The patient should tell the doctor or pharmacist about any medical problems he has or has had, and about any allergies.
Mood alterations and depression: Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 1mg. Patients should be monitored for psychiatric symptoms and if these occur, treatment with finasteride should be discontinued and the patient advised to seek medical advice.
Important information about some of the ingredients of Finasteride-Teva: Patients who are intolerant to lactose should note that Finasteride-Teva tablets contains lactose. If the patient has been told by the doctor that he has an intolerance to some sugars, the patient should contact the doctor before taking this medicinal product.
Driving and using machines: Finasteride-Teva is not expected to or known to affect the ability to drive or operate machinery.
Use In Pregnancy & Lactation
Finasteride-Teva is for the treatment of male pattern hair loss in men only.
Women must not use Finasteride-Teva due to the risk of pregnancy.
Crushed or broken tablets of Finasteride-Teva should not be touched by a woman who is pregnant or may potentially be pregnant.
If the active ingredient of Finasteride-Teva is absorbed after oral use or through the skin by a woman who is pregnant with a male baby, this may cause the male baby to be born with abnormalities of the sex organs.
If a woman who is pregnant comes into contact with the active ingredient of Finasteride-Teva, a doctor should be consulted.
Finasteride-Teva tablets are coated and will prevent contact with the active ingredient during normal use.
If the patient's sexual partner is or may be pregnant, he must avoid exposing her to his semen (e.g. by using a condom).
If the patient has questions, ask the doctor.
Side Effects
Like all medicines, Finasteride-Teva can cause side effects, although not everybody gets them.
The side effects have usually been temporary with continued treatment or disappeared when treatment is stopped.
Uncommon (affects 1 to 10 users in 1,000): Less desire to have sex.
Difficulty having an erection.
Problems with ejaculation such as a decrease in the amount of semen released.
Depressed mood.
Frequency not known: Allergic reactions such as rash, itching, lumps under the skin (hives) and swelling of the lips and face.
Breast swelling or tenderness.
Pain in the testicles.
Faster heartbeat.
Persistent difficulty having an erection after discontinuation of treatment.
Infertility has been reported in men who took finasteride for a long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effect of finasteride on fertility in men have not been conducted.
Elevated liver enzymes.
Post-marketing cases of male breast cancer have been reported with the use of finasteride.
Use of this product may increase the risk of high-grade prostate cancer.
The patient should promptly report to the doctor any changes in the breast tissue such as lumps, pain, enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.
Stop taking Finasteride-Teva and talk to the doctor immediately if the patient has any of the following symptoms: Swelling of the face, tongue or throat; Difficulty swallowing; Lumps under the skin (hives); Breathing difficulties.
If any of the side effects gets serious, or if the patient notices any side effects not listed, please tell the doctor or pharmacist.
Drug Interactions
Taking other medicines: Finasteride-Teva can usually be taken with other medicines.
Please tell the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Taking Finasteride-Teva with food and drink: Finasteride-Teva can be taken with or without food.
Store below 25°C.
This product does not require any special storage precautions.
Medicines should not be disposed of via waste water or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
ATC Classification
D11AX10 - finasteride ; Belongs to the class of other dermatologicals.
FC tab 1 mg (brown and round in shape, marked with "FNT1" on one side and plain on the other) x 30's.
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