1. WHAT IS TAMOXIFEN SOPHARMA AND WHAT IT IS USED
Tamoxifen is a non-steroidal anti-estrogenic anti-tumor product. It is used to treat breast carcinoma.
2. BEFORE YOU TAKE TAMOXIFEN SOPHARMA
Do not take Tamoxifen Sopharma
if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of tamoxifen.
if you are pregnant or breast-feeding.
Take special care with Tamoxifen Sopharma
before starting tamoxifen treatment, a pregnancy exclusion specialist is required.
if you take contraception, you should know that the action of some contraceptives is affected by tamoxifen.
if you have unusual vaginal bleeding, menstrual disorders, a feeling of vaginal weights, tension or pelvic pain while using tamoxifen or, for some time, contact your doctor for further investigation because of the possibility of changes in the uterine lining that can be very serious.
if you have or have previously had thromboembolic events (forming blood clots in the vessels, sometimes leading to blockage).
when taking tamoxifen, blood counts (especially platelet and leucocyte counts), calcium content in the blood, periodic monitoring of liver function tests and vision are required.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take tamoxifen with the following medicines:
allopurinol (a medicine to treat gout);
rifampicin (a medicine used to treat tuberculosis).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Tamoxifen is not used during pregnancy and lactation. May cause defects in the development of the fetus.
Patients should not become pregnant while taking tamoxifen.
Driving and using machines
There is no evidence of Tamoxifen Sopharma's influence on the ability to concentrate attention and motor activity.
Important information about some of the ingredients of Tamoxifen Sopharma The
medicinal product contains the excipient lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ingredients of the medicinal product are wheat starch. It does not pose a risk to people with celiac disease. Patients with wheat allergy (other than celiac disease) should not take this medicine.
3. HOW TO TAKE TAMOXIFEN SOPHARMA
Always take Tamoxifen Sopharma exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual daily dose is 2 tablets, divided into 2 intakes. The dosage for long-term treatment is 2 tablets per day.
If you take more Tamoxifen Sopharma than
you should If you have taken more than the necessary dose, contact your doctor or your nearest hospital physician immediately.
If you forget to take Tamoxifen Sopharma
If you miss a dose, take it as soon as possible. If it's almost time for the next dose, take it as usual. Do not take a double dose to make up for forgotten, as this may increase the chance of side effects. Continue to take the medicine as prescribed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tamoxifen Sopharma can cause side effects, although not everybody gets them.
Compared to other hormonal products (estrogenic, androgenic), tamoxifen exhibits less undesirable effects.
More often, you can see: dizziness, headache, nausea, vomiting, hot flushes, fluid retention, bone and tumor pain, hair loss, corneal changes, retina, cataracts, vaginal bleeding, vaginal discharge, pruritus, menstrual disorders, hypertriglyceridemia (increased blood fats) in some cases with pancreatitis, blood clotting (an increased risk of these incidents exists when tamoxifen is used in combination with cytostatics), changes in liver enzymes and fatal degeneration, impaired bile flow (cholestasis), hepatitis. Skin rashes, light sensitivity, changes in blood count (decreased platelet count, white blood cells, anemia), hypercalcaemia (increased blood calcium),menopause ), growth of the lining of the uterus, polyps and uterine tumors. Although it is rare to see urticaria (hives); severe allergic reactions that cause swelling of the face or throat; severe skin lesions, Stevens-Johnson syndrome, which result in blistering of the skin, mouth, eyes and genitals, inflammation of the lungs, which causes breathlessness, coughing, and temperature rise.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Tamoxifen SOPHARMA
In the original package to protect from moisture and light.
Store below 25 ° C.
Keep out of the reach and sight of children.
Do not use Tamoxifen Sopharma after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the eye Clean the bottom environment.
6. ADDITIONAL INFORMATION
What Tamoxifen Sopharma contains
The active substance is: tamoxifen citrate, eq. of 10 mg tamoxifen.
The other ingredients are: lactose monohydrate, wheat starch, microcrystalline cellulose, myo-inositol, hypromellose, magnesium stearate; colloidal anhydrous silica.
What Tamoxifen Sopharma looks like and contents of the pack
Round, biconvex, 8 mm diameter, white to off-white, odorless tablets. 10 tablets in a blister of PVC / aluminum foil. Three blisters in a cardboard box together with a leaflet.
Marketing Authorization Holder and Manufacturer
16, Iliensko shose Str., 1220 Sofia, Bulgaria