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Tamoxifen "Ebewe" 10 mg Tamoxifen "Ebewe" 20 mg tablets

tamoxifen citrate

Read this leaflet carefully before you start taking this medicine.

Keep this leaflet that you'll need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if the symptoms are the same as yours.

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.

In this leaflet:

First What is the medicine tamoxifen "Ebewe" and what it is used

Second What you should know before you start taking Tamoxifen "Ebewe" using

Third How to take Tamoxifen "Ebewe" is used

4th Possible side effects

5 How to Tamoxifen "Ebewe" store

6th For more information

First WHAT IS Tamoxifen "EBEWE" AND WHAT IT IS USED

This medicine is used to treat some types of breast cancer.

Second WHAT YOU SHOULD KNOW BEFORE YOU TAKE Tamoxifen "EBEWE" USE

Do not use Tamoxifen "Ebewe"

- If you are allergic / hypersensitive (/ s) to tamoxifen or any other ingredients of Tamoxifen "Ebewe".

- If you are pregnant

- If your doctor found a significant decrease in blood platelets (thrombocytopenia), or a significant reduction in the number of white blood cells (leukopenia)

- If your doctor found a significant increase in the amount of calcium in the blood (hypercalcemia)

Take special care with Tamoxifen "Ebewe" is needed

- If you have liver or kidney disease, diabetes

- If you have already occurred narrowing or blockage of blood vessels (thromboembolism)

- If you have poor vision

- Before starting treatment with tamoxifen, "Ebewe" must be made for patients, physical examination, especially for women, gynecological. Women should be monitored during treatment gynecologist.

Taking other medicines

Please tell your doctor about all medicines you are taking or have taken (and recently), including medicines that are available without a prescription.

Concomitant treatment with other medicines containing estrogen (a type of female sex hormones) may reduce the effect of both products (eg the effect of unreliable contraceptive "pill").

Concomitant use of tamoxifen and some drugs which lower blood clotting may cause a reduction in their effect. Your blood clotting is therefore frequently monitored during treatment.

In the event that you are being treated / and still other cytotoxic agents, may increase the incidence of certain adverse effects (such as clogging arteries).

Concomitant treatment with bromocriptine (medicine used to treat gynecological disorders, along with other drugs also to treat some forms of Parkinson's disease) increases the value of tamoxifen and its active metabolite in blood serum.

Taking Tamoxifen "Ebewe" with food and drink

Effect of food administration on the effect of tamoxifen has not been studied, but is unlikely to influence its effect.

Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine.

Tamoxifen should not be used during pregnancy. During the use of breast-feeding is not recommended because it is not known whether this medicine is excreted in breast milk. Before starting therapy should discontinue breast-feeding.

Driving and using machines

It is unlikely that treatment with tamoxifen adversely affect your ability to drive or ability to operate machinery.

Important information about some of the ingredients

This product contains lactose. If your doctor told you that you have intolerance to some sugars, talk to your doctor before taking this medicine.

Third HOW TO USE Tamoxifen "EBEWE" USED

Always take Tamoxifen "Ebewe" exactly as directed by your doctor. If you are not sure (s), check with your doctor or pharmacist. The usual dose is 20 mg / day. Doses of 30 or 40 mg used in patients (patients) with advanced disease.

In elderly patients or patients with renal or hepatic impairment dose adjustment is required.

For administration of Tamoxifen "Ebewe" in children has not provided any dosing schedule.

The maximum daily dose is 40 mg of Tamoxifen. Response to treatment is usually seen 4 to 10 weeks of treatment, but in patients with bone metastases may take up to several months.

The tablets should be swallowed with fluid.

If it is necessary to use more than one tablet daily of tamoxifen, it is possible to take tablets once or twice a day.

Duration of treatment depends on the degree of severity of the disease, commonly it is a long-term treatment, which is terminated only when there is a relapse (reappearance of the disease).

If you take (and) more of Tamoxifen "Ebewe" than you should (a)

If you take (and) more of Tamoxifen "Ebewe" than you should (a), or accidental ingestion of a child, as soon as possible consult with your doctor or pharmacist.

If you forget (and) take the medicine tamoxifen "Ebewe"

Double dose to make up (and) missed.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4th POSSIBLE SIDE EFFECTS

Like all medicines can cause product Tamoxifen "Ebewe" side effects, although not everybody gets them.

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.

There may be hot flushes, menstrual disorders, vaginal bleeding, vaginal itching, vaginal discharge. When taking Tamoxifen "Ebewe" may sometimes form uterine tumors (uterine enlargement works) that can cause discomfort in the pelvic or vaginal bleeding. It may affect cancer of the endometrium or uterus. There could be stomach problems (including nausea and vomiting), dizziness, headache, retention (retention) of fluid (commonly observed as a swelling of the ankles), thrombocytopenia (platelet deficiency), hypertriglyceridemia (increased fats in the blood), sometimes together with pancreatitis (inflammation of the pancreas), skin rash or itching, and peeling skin, hair loss, abnormal liver function, jaundice (yellow skin and mucous membranes caused by increased amount of bile pigment), visual disturbances, difficulty with the right vision, which are probably caused by the due to cataract (cataract), changes in the cornea or retina diseases. For premenopausálních women (the period prior to menopause) may occur and ovarian cysts can cause suppression of menstruation. Tamoxifen "Ebewe" may increase the risk of blood clots. There may be an inflammatory lung disease that can have the same symptoms as pneumonia - shortness of breath and cough. There may be fatigue. At the beginning of treatment may temporarily worsen symptoms of breast cancer (a type of breast cancer), such as increased pain and / or enlargement of the affected tissue. If you currently suffer from severe nausea, vomiting and thirst, consult with your doctor. These difficulties may be caused by changes in the concentration of calcium in the blood and will need to perform some blood tests. In men, impotence can occur rarely.

5th HOW TO STORE Tamoxifen "EBEWE" KEEP

Store at 25 ° C in the original package to protect from light.

Keep out of reach and sight of children.

The product Tamoxifen "Ebewe" Do not use after expiry date stated on the carton or vial label after EXP. The expiry date refers to the last day of that month.

Do not use Tamoxifen "Ebewe" if you notice any discoloration of tablets.

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 protect the environment.

6th FURTHER INFORMATION

What medicine Tamoxifen "Ebewe" contains

The active ingredient is tamoxifen citrate

- The other ingredients are: Lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica

How does Tamoxifen "Ebewe" looks like and contents of the pack

Description of the product:

Tamoxifen "Ebewe" 10 mg off-white, round, flat tablets with čtvrtícím cross on one side

Tamoxifen "Ebewe" 20 mg off-white, round, flat tablet, scored on one side

Packaging: White PP container hinged white PE cap, box

Pack size: Tamoxifen "Ebewe" 10 mg (20 mg) in 1 box 30, 40 and 100 tablets

The market, not all pack sizes.

Marketing Authorisation Holder and Manufacturer

EBEWE Pharma Ges.m.b.H. Nfg. KG, A-4866 Unterach, Austria

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