ESCEPRAN 25 mg. 30 tablets

What is Escepran and what it is used
Escepran belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed for the production of female hormones, estrogen, especially in postmenopausal women. Reduction of estrogen levels in the body is a method of treating a hormone-dependent breast cancer.
Escepran is used to treat hormone-dependent breast cancer at an early stage in postmenopausal women, once they have completed 2-3 years of therapy with the drug tamoxifen.
Escepran is used to treat hormone-dependent breast cancer in an advanced stage in postmenopausal women when treatment with various hormonal drugs has not worked well enough.

2. What you need to know before you start taking Escepran
Do not take Escepran:
if you are or have previously been allergic to exemestane or any of the other ingredients of this medicine (listed in section 6);
if you have not gone through "menopause", ie you still have a monthly cycle;
if you are pregnant, may be pregnant or breast-feeding.
Warnings and Precautions
Talk to your doctor before taking Escepran.
Escepran contains a banned substance, which may give a positive result in tests for doping control;
Prior to treatment with Escepran, your doctor may want to take blood samples to make sure that you have reached menopause;
Before you take Escepran, tell your doctor if you have problems with your liver or kidneys;
Tell your doctor if you have a history or are suffering from a disease that affects bone strength. Your doctor may want to measure your bone density before and during treatment with Escepran. This is because the drugs of this class lower levels of female hormones and this may lead to loss of bone mineral content, which can reduce their strength;
Before starting treatment, your doctor may consider it necessary to assess your levels of vitamin E. Women with vitamin D deficiency should receive supplements with vitamin D.
Other medicines and Escepran
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Escepran should not be administered concurrently with hormone replacement therapy (HRT).

Tell your doctor if you are taking any of the following medications:
rifampicin (antibiotic);
drugs used for the treatment of epilepsy (phenytoin and carbamazepine);
herbal medicine, used as anti-depressants ((St. John's wort), (Hypericum perforatum)).
Escepran food, beverages and alcohol
Escepran should be taken after a meal at approximately the same time each day.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, you should consult with your doctor or pharmacist before you start taking this medicine.
Do not take exemestane, if you are pregnant or breast-feeding. If you are pregnant or think you may be pregnant, contact your doctor.
Discuss methods of contraception with your doctor if there is any possibility to be able to become pregnant.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
If you experience drowsiness, dizziness, or weakness while taking exemestane should not attempt to drive or operate

3. How to take Escepran
Escepran should be taken after a meal at approximately the same time each day.
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 25 mg tablet daily.
If you have to go into hospital while taking exemestane tablets, tell the medical staff what you have taken.

Use in children
Escepran is not suitable for use in children.

If you take more dose Escepran
If you accidentally take too many tablets, contact your doctor immediately or go to the emergency department of the nearest hospital. Show them the pack Escepran.

If you forget to take Escepran
Do not take a double dose to make up for a forgotten tablet. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, take it at the usual time.

If you stop taking Escepran
Do not stop taking your tablets even if you feel better, unless your doctor has told you that.

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Escepran well tolerated and the following side effects seen in patients treated with Escepran are mostly mild to moderate in nature. Most of the side effects associated with estrogen deficiency (such as "hot flashes").
The following adverse reactions have been reported by people taking exemestane tablets.

Very common side effects (may affect more than 1 in 10 people):
difficulty sleeping;
headache;
hot flashes;
nausea;
increased sweating;
muscle and joint pain (including osteoarthritis, back pain, arthritis and stiffness);
tiredness.
Common side effects (may affect up to 1 in 10 people):
loss of appetite;
depression;
dizziness, carpal tunnel syndrome (a combination of tingling, numbness and pain affecting the whole arm from the wrist down except the little finger);
stomach pain, vomiting, constipation, indigestion, diarrhea;
skin rash, hair loss, hives, itching;
thinning of the bones, which may decrease their strength (osteoporosis), leading to bone fracture (fracture or crack) in certain cases;
pain, swelling of hands and feet.
Uncommon side effects (may affect up to 1 in 100 people):
drowsiness;
muscle weakness;
appearance of purulent skin lesions;
hypersensitivity;
elevated liver enzymes;
increased bilirubin, problems with the drainage of bile (cholestasis) and hepatitis;
elevated enzyme levels (levels of alkaline phosphatase);
reduced number of blood cells (leukopenia).
Rare (may affect up to 1 in 1000 people):
reduced number of blood cells (thrombocytopenia).
Not known (frequency can not be estimated from the available data):
reduced number of blood cells (lymphocytes).
Symptoms of hepatitis include a general feeling of weakness, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right area of the abdomen and loss of appetite.
If you think that there are some of the above symptoms, immediately contact your doctor.
If your blood tests, you may notice that there are changes in liver function. May occur changes in the number of certain blood cells (lymphocytes) and platelets circulating in your blood, especially in patients with pre-existing lymphopenia (reduced lymphocytes in the blood).

Adverse event reporting
If you get any side effects, tell your doctor or pharmacist.
This includes any possible effects not listed in this leaflet. You can also report side effects directly through:
Drug Agency
str. "Damyan Gruev" № 8
1303 Sofia
website: www.bda.bg
As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.

5. How to store Escepran
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP / EXP". The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Escepran
The active substance is exemestane. Each tablet contains 25 g of exemestane (exemestane).

Other ingredients are:
Core: Mannitol, microcrystalline cellulose, crospovidone, sodium starch glycolate (type A), hypromellose E5, polysorbate 80, silica colloidal anhydrous, magnesium stearate.
Coating: Hypromellose 6cP (E464), titanium dioxide (E171), macrogol 400.