Tamoxifen Sandoz 10 mg x 100 compr. movie.

Read this leaflet carefully and entirely before you start using this medicine.

Keep this leaflet. It may be necessary to read it.

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

This medicine has been prescribed for you. You don’t have to give it to other people. Can do them harm, even if they have the same symptoms with yours.

If any of the adverse reactions becomes serious or if you notice any adverse reaction in this leaflet, please tell your doctor or pharmacist.

In this leaflet you can find:

Preparations with the active substance tamoximed is safe and available at the sports pharmacy

1. What is Tamoxifen Sandoz and what is used
2. Before using Tamoxifen Sandoz
3. How to use Tamoxifen Sandoz
4. Possible side effects
5. How to keep Tamoxifen Sandoz
6. Additional Information

1. What is Tamoxifen Sandoz and what is used

Tamoxifen Sandoz is a medicine for the treatment of breast cancer (breast carcinoma). Tamoxifen Sandoz is used for:

• Adjuvant treatment of the mammary gland tumors (breast carcinoma);
• Treatment of metastases of mammary gland tumors (breast carcinoma).

2. Before using Tamoxifen Sandoz

Do not use Tamoxifen Sandoz

• if you are allergic (hypersensitive) at Tamoxifen or any of the other components of Tamoxifen Sandoz;
• if you are pregnant;
• if you are under treatment with anastrozole;
• If you or someone in your family had or has a disease that can increase the risk of blood clots forming.

Take special care when using Tamoxifen Sandoz

• If you have a significant small number of blood platelets, white blood cells or increased blood calcium. As a result of these circumstances you must be carefully followed;
• If the values ​​of certain blood fats (triglycerides) are considerably increased during treatment with Tamoxifen Sandoz. A disorder of lipid metabolism (hypertriglyceridemia) may be present
• If you present bleeding after menopause or irregular bleeding before menopause. The gynecologist should immediately determine the causes of these bleeding. You should discuss with your doctor the need for a gynecological examination to determine the endometrial changes;
• If your visual acuity changes during treatment with Tamoxifen Sandoz. In this case you must be examined ophthalmologically immediately, because some changes determined in the early stages occur after discontinuation of Tamoxifen Sandoz treatment.

In general you must perform an ophthalmological examination before starting treatment with Tamoxifen Sandoz.

During treatment with Tamoxifen Sandoz you should periodically monitor the number of blood cells, blood calcium and liver function. It is necessary to monitor serum triglycerides.

Menstruation is suppressed in some women in premenopausal period treated with Tamoxifen. There is evidence for the frequent appearance of blood clots (thromboembolic events, including deep venous thrombosis and pulmonary embolism) during treatment with tamoxifen Sandoz.

The concomitant use with the following drugs should be avoided because a decrease in the effect of tamoxifen cannot be excluded: paroxetine, fluoxetine (eg antidepressants), bupropion (antidepressant drug or used as aid to stop smoking), quinidine (used in the treatment of irregular beats of heart) and fifale/dinner (for the treatment of parathyroid gland).

Effects in the case of abuse

Tamoxifen Sandoz can cause false positive results in anti -doping tests. Improper use of Tamoxifen Sandoz drug can affect your health.

Use of other drugs

Please tell your doctor or pharmacist if you have recently taken any other medicines, including those issued without a prescription.

In particular, you should inform your doctor if you take:

• paroxetine, fluoxetine (ie antidepressant drugs)
• bupropiona (antidepressant medicine or used as help stop smoking)
• quinidine (eg used in the treatment of irregular heartbeat)
• Cinaccăt (for the treatment of parathyroid gland diseases)

The effect of the following active substances or preparation groups can be influenced during concomitant treatment with Tamoxifen Sandoz.

• oral anticoagulants (medicines that prevent blood clots from forming) – in the case of their association it is necessary for your doctor to monitor you carefully;
• cytostatic drugs – due to the increased risk of thrombosis;
• Anastrozol, used in breast neoplasm;
• Rifampicin (a drug for the treatment of tuberculosis) – because it causes the decreased plasma concentrations of Tamoxifen Sandoz.

Hormonal preparations, especially those containing estrogen (eg contraceptive pill).

It is possible to reduce the effect. These preparations should not be taken during treatment with Tamoxifen Sandoz.

Concomitant administration of tamoxifen and aminoglutetimide can cause reduction of the concentration of tamoxifen and thus reduce the effect of tamoxifen.

Fertility, pregnancy and breastfeeding

Ask your doctor or pharmacist for recommendations before taking any medicine.

There is not enough experience on the use of tamoxifen during pregnancy. Therefore you should not use Tamoxifen Sandoz during pregnancy. The possibility of the existence of a pregnancy must be excluded before the initiation of treatment. Women at fertile age should use a non -hormonal method of contraception during and up to 2 months after the end of treatment (not the pill, but the ring, condoms) (see also. Use of other medicines).

In high doses, Tamoxifen completely inhibits milk production in humans. This does not start again at the end of treatment. In addition, it is not known if the active substances in Tamoxifen Sandoz are excreted in breast milk. Therefore you should not use Tamoxifen Sandoz during breastfeeding. If the treatment is required, you must stop breastfeeding.

Driving vehicles and using machinery

There is no effects on the ability to drive vehicles or use machines.

You need to keep in mind that Tamoxifen can affect your vision and determine drowsiness while driving vehicles or using machines.

Important information on some components of Tamoxifen Sandoz

This medicine contains lactose. If your doctor warned you that you have intolerant to some carbohydrate categories, please ask it before taking Tamoxifen Sandoz.

3. How to use Tamoxifen Sandoz

Always use Tamoxifen Sandoz exactly as your doctor told you. You need to talk to your doctor or pharmacist if you are not sure.

Adult and elderly patients

The recommended daily dose is 2 Tamoxifen Sandoz tablets.

For oral administration.

Take Tamoxifen Sandoz tablets without chewing them, with enough liquid (eg a glass of water) during a meal.

You have to take Tamoxifen Sandoz usually for a long time. The attending physician decides the duration of treatment. In the treatment of supporting the early breast carcinoma, a duration of treatment of at least 5 years is recommended.

It is not recommended to administer tamoxifen in children and adolescents, due to the insufficient data on safety and efficacy in this age group.

Please ask your doctor or pharmacist if you have the impression that the Tamoxifen Sandoz effect is too strong or too weak.

If you use more than you need from Tamoxifen Sandoz

Please ask your doctor. It can decide all the necessary measures according to the severity of overdose.

If you forget to use Tamoxifen Sandoz

Do not take a double dose to compensate for forgotten dose.

If you stop using Tamoxifen Sandoz

Do not interrupt treatment if your doctor has not recommended this. The success of the treatment can be affected.

If you have any additional questions about this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamoxifen Sandoz can cause side effects, although not all people.

Very frequently – affecting more than 1 patient in 10

Frequently – affecting less than 1 in 10 patients

Less frequent – affecting less than 1 in 100 patients

Rare – affecting less than 1 in 1000 patients

Very rare – affecting less than 1 in 10,000 patients with unknown frequency that cannot be estimated from available data

Possible side effects

• buffets;
• vaginal drain;
• Irregularities of menstruation until complete suppression before menopause.

• transient anemia;
• drowsiness, headache;
• Disorders of vision only partial starting from the opacification of the crystalline and changes of the cornea and retina (retinopathy). The long use of tamoxifen can lead to the opacification of the lens;
• nausea;
• Passing rash on the skin (very rare with round, prominent red spots that can occur in the mucous membranes and high fever as well as severe disorders of the general condition or vesicles partially filled with blood);
• hair loss;
• accumulation of fluid in tissues, growth of certain blood fats (serum triglycerides);
• disorders of infusion in the brain vessels, muscle cramps, blood clots formation in veins (thromboembolism), deep venous thrombosis and pulmonary embolism, especially during concomitant chemotherapy;
• At the beginning of the treatment bone pain and pain in the affected tissue;
• Itching sensation in the genital area, vaginal bleeding, growth of benign uterus tumors (myoma), increased endometrial polyps as well.

• reduction in the number of certain blood cells (neutropenia);
• reduction of the number of white blood cells (leukopenia);
• transient reduction of blood platelets (thrombocytopenia) most with values ​​of 80000-90000/µl, most often lower
• vomiting
• hypersensitivity reactions including tissue swelling (angioneurotic edema)
• Increased blood calcium in patients with bone metastases, especially at the beginning of treatment
• stroke
• modification of liver enzyme values;
• Malignant tumors of the endometrium (endometrial carcinoma). The frequency of the appearance of endometrial tumors produced by Tamoxifen Sandoz increases by 2-4%

• injury or inflammation of the optical nerve. In a small number of cases, blindness may occur;
• Fat deposition in the liver, bile flow disorders, liver inflammation (hepatitis), jaundice;
• ovarian cysts, uterine malignant tumors (uterine sarcoma).

• severe changes in the hemoleucogram (neutropenia, pancitopenia);
• pneumonia (interstitial pneumonia);
• increase of certain blood fats (hypertriglyceridemia), partially accompanied by the inflammation of the pancreas (pancreatitis).

With unknown frequency

• Reduce the number of white blood cells with severe impairment of liver cells;
• depressive state

If any of the adverse reactions becomes serious or if you notice any adverse reaction in this leaflet, please tell your doctor or pharmacist.

5. How to keep Tamoxifen Sandoz

Keep out of the reach and sight of children.

Do not use Tamoxifen Sandoz after the expiry date which is stated on the box, after Exp. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medications should not be thrown on the way of household water or household waste. Ask the pharmacist how to eliminate drugs that are no longer needed. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION

What does Tamoxifen Sandoz contains

Active substance is tamoxifen citrate. One film -coated tablet contains Tamoxifen 10 mg in the form of Tamoxifen citrate 15.2 mg.

The other components are: core: lactose monohydrate, sodium starch (type A), Polivone K 25, microcrystalline cellulose, magnesium stearate. Movie: Opadry White*). *) Opadry White composition: lactose, titanium dioxide (E 171), hydroxypropylmethylcellulose, macrogol 4000

What does Tamoxifen Sandoo look like and the contents of the packaging

Tamoxifen Sandoz tablets are round, biconvex, white.

Box with 2 PVC-PVDC/Al blisters of 10 film-coated tablets.

Box with 10 PVC-PVD/Al blisters of 10 film-coated tablets

The owner of the market for the market and the manufacturer

Hi Pharma Gmbh,

Otto-Von-Guericke Allee, 39179, Barleben, Germany

The marketing authorization holder

Industriesser 25, D-83607 Holzkirchen, Germany

This prospect has been approved in November 2011.

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