Exemestane 25 mg. 30 tablets

WHAT Exemestane Actavis IS AND WHAT IT IS USED FOR?
Exemestane Actavis belongs to a group of medicines known as aromatase inhibitors. These drugs may affect the action of a substance called aromatase, necessary for the formation of female sex hormones - estrogens, particularly in postmenopausal women. The reduction in the levels of estrogens in the body is a way to treat hormone-dependent breast cancer.
Exemestane Actavis is used to treat hormone-dependent early breast cancer in postmenopausal women conducted after 2-3 years of treatment with tamoksifep.
Exemestane Actavis is also used to treat hormone-dependent advanced breast cancer in postmenopausal women when another hormone treatment did not lead to sufficient results.
2. BEFORE YOU TAKE Exemestane Actavis
Do not take Exemestane Actavis
• if you are or were allergic (hypersensitive) to exemestane (the active ingredient in Exemestane Actavis) or to any of the excipients of Exemestane Actavis. See section 6 ("What Exemestane Actavis") for a complete list of other ingredients.
• If you are not yet in "menopause", ie you still have a monthly cycle.
• if you are pregnant or could be pregnant, or are breast-feeding.
Take special care with Exemestane Actavis
Before treatment with Exemestane Actavis, your doctor may want to take blood samples to make sure that you have reached menopause.
Before taking Exemestane Actavis, tell your doctor if you have liver or kidney problems.
Tell your doctor if you have suffered or are suffering from a condition that affects the strength of your bones. Your doctor may want to measure your bone density before you start taking and while taking Exemestane Actavis. This is because the drugs of this class reduces the levels of female hormones and this may lead to loss of bone mineral content, which can reduce its strength.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Exemestane Actavis should not be given together with hormone replacement therapy (HRT).
The following drugs should be used with caution during treatment with Exemestane Actavis. Tell your doctor if you are taking medicines such as rifampicin (antibiotic), carbamazepine or phenytoin (used to treat epilepsy), the medicinal plant St. John's wort (Hypericum perforatum) or products containing it.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
Do not take Exemestane Actavis if you are pregnant or breast-feeding. Tell your doctor if you are pregnant or think you are pregnant. Discuss contraception with your doctor if there is any possibility to become pregnant.
Driving and using machines
If you experience drowsiness, dizziness, or weakness while taking Exemestane Actavis, you should not drive or operate machinery.
3. HOW TO TAKE Exemestane Actavis?
Adults and elderly
Actavis exemestane tablets should be taken orally after eating approximately the same time each day. Your doctor will tell you how and how long to take Exemestane Actavis. The recommended dose is one 25 mg tablet daily. Do not stop taking your tablets, even if you feel well, indirectly if your doctor tells you to.
If you need to go into hospital while taking Exemestane Actavis, tell the medical staff that conduct such treatment.
children
Exemestane Actavis is not suitable for use in children.
If you take more than the amount of Exemestane Actavis
If you have swallowed more tablets, contact your doctor or go to the emergency department of the nearest hospital. Show them the pack of Exemestane Actavis tablets.
If you forget to take Exemestane Actavis
Do not take a double dose to make up for a forgotten tablet. .
If you forget to take your tablet, take it as soon as you sit. If it is almost time for next dose, take it at the usual time.
If you have further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Exemestane Actavis can cause side effects, although not everybody gets them. Overall, Actavis Exemestane is well tolerated and the following side effects seen in patients treated with Exemestane Actavis are generally mild to moderate. Most side effects associated with estrogen deficiency (eg. Hot flushes).
Very common side effects (affecting more than 1 in 10 patients):
- Sleep disorders Headache Hot flashes
- Vomiting
- Excessive sweating
- Pain in muscles and joints (including osteoarthritis, back pain, arthritis and joint stiffness) - Tiredness
Common side effects (affects 1 to 10 users in 100):
- Loss of appetite
- Depression
- Dizziness, carpal tunnel syndrome (a combination of tingling, numbness and pain affecting the entire hand except the little finger)
- Pain in the stomach, vomiting, constipation, indigestion, diarrhea
- Skin rash, hair loss
- Thinning of the bones, which can reduce their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases
- Pain, swelling of hands and feet
Uncommon side effects (affects 1 to 10 users in 1000):
- Drowsiness
- Muscle weakness;
May develop inflammation of the liver (hepatitis). Symptoms include feeling generally unwell, nausea, jaundice (yellowing of the skin and eyes), itching, right hand abdominal pain and loss of appetite. Contact your doctor immediately !, if you think you have any of these symptoms.
If you have a blood test can be observed changes in hepatic function. Changes in the number of certain blood cells (lymphocytes) and platelets circulating in the blood may occur especially in patients with pre-existing lymphopenia (low blood lymphocytes).
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist as soon as possible.
5. HOW TO STORE Exemestane Actavis?
Keep out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use Exemestane Actavis after the expiry date stated on the carton and blister after EXP :. 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 medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Exemestane Actavis?
• The active substance is exemestane. Each tablet contains 25 mg of exemestane. '
• The other ingredients are: Core: Compulsory povidone, corn starch (bleached), starch, pregelatinized (in part), sodium starch glycolate type A, microcrystalline cellulose type 101, talc, colloidal anhydrous silica, magnesium stearate, polysorbate 80; film coating: polyvinyl alcohol Partial hydrolyzed, talc, macrogol 3350 and titanium dioxide (E 171) i
Exemestane Actavis looks like and contents of the pack?
Exemestane Actavis 25 mg film-coated tablet is white, round, biconvex, uniform appearance and smooth edges.
Pack sizes:
Blisters: 10, 30, 40, 60, 90 and 100 film-coated tablets
Not all pack sizes may be marketed.