Package leaflet: Information for the patient

Symex, 25 mg, coated tablets
Exemestanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

What Symex is and what it is used for
Important information before taking Symex
How to take Symex
Possible side effects
How to store Symex
Contents of the pack and other information

1. What Symex is and what it is used for

Exemestane belongs to a group of medicines known as aromatase inhibitors. These medicines act on a substance called aromatase, which is essential for the production of female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a method of treating hormone-dependent breast cancer.
Exemestane is used:

for the treatment of early hormone-dependent breast cancer in postmenopausal women who have completed 2 to 3 years of tamoxifen therapy.
for the treatment of advanced hormone-dependent breast cancer in postmenopausal women in whom prior hormonal therapy has not been sufficiently effective.

2. Important information before using Symex

When not to use Symex

if the patient is allergic to exemestane or any of the other ingredients of this medicine (listed in section 6),
if the patient is not yet "postmenopausal", i.e. menstruation has not yet ceased,
if the patient is pregnant or may be pregnant,
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Symex, discuss this with your doctor or pharmacist.

Prior to administration of Symex, your doctor may perform blood tests to confirm that the patient is postmenopausal.
Before starting treatment, your doctor may recommend routine measurement of vitamin D levels, as these may be very low in the early stages of breast cancer. Women with vitamin D deficiency should receive supplementation to correct the deficiency.
Inform your doctor about any existing liver or kidney disorders before taking Symex.
Inform your doctor if you have had, in the past or currently, any condition affecting bone strength. Your doctor may recommend a bone density test before or during treatment with Symex. This is due to the effect of drugs in this class on reducing the activity of female sex hormones, which may lead to loss of minerals from bones and reduced bone strength.

Symex and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, plan to take, or those available without prescription.
Symex must not be used concomitantly with hormone replacement therapy (HRT).
The following medicines should be used with caution during treatment with Symex. The patient should inform the doctor if she is taking any of the following:

rifampicin (an antibiotic),
carbamazepine or phenytoin (antiepileptic medicines used to treat epilepsy),
herbal products containing St. John's wort (Hypericum perforatum) or preparations containing St. John's wort.

Symex and food
Symex should preferably be taken after a meal.
Pregnancy and breastfeeding
Do not take Symex if you are pregnant or breastfeeding.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a child, you should consult your doctor before using this medicine.
Discuss contraception with your doctor if there is any possibility of becoming pregnant.
Driving and operating machinery
If you experience drowsiness, dizziness or weakness while taking Symex, you should not attempt to drive or operate machinery.
Symex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to use Symex

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor.
Dosage
The recommended dose is one 25 mg tablet per day.
Method of administration
Symex should be taken orally, after food, approximately at the same time each day.
Your doctor will inform you how and for how long to take this medicine.
If hospitalization is required during treatment with exemestane, inform the medical staff at the
hospital about all medicines currently being taken.
Use in children
Symex is not indicated for use in children.
Taking more Symex than recommended
In case of taking more than the recommended dose, contact your doctor immediately or go to the
nearest hospital. Bring the Symex packaging with you.
Missed dose of Symex
Do not take a double dose to make up for a missed tablet.
Take the missed tablet as soon as possible. If it is almost time for the next dose, take the next
dose at the usual time.
Stopping treatment with Symex
Do not stop taking Symex even if you feel well, unless instructed by your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Symex is generally well tolerated, and the following adverse reactions observed in patients treated with Symex are mostly mild or moderate in intensity.
Most adverse reactions are related to oestrogen deficiency (e.g. hot flushes).
The following adverse reactions may occur:

Hypersensitivity, hepatitis and cholangitis, which causes yellowing of the skin (hepatitis with cholestasis). Symptoms include: general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, abdominal pain on the right side, and loss of appetite. If any of these symptoms occur, the patient should contact a doctor immediately to obtain medical assistance.

Very common adverse reactions (may affect more than 1 in 10 patients):

Depression
Insomnia
Headache
Hot flushes
Dizziness
Nausea
Increased sweating
Muscle and joint pain (including osteoarthritis, back pain, joint inflammation and stiffness)
Fatigue
Decreased white blood cell count
Abdominal pain
Increased liver enzyme activity
Increased concentration of haemoglobin breakdown products in blood
Increased blood enzyme activity due to liver damage
Pain

Common adverse reactions (may affect less than 1 in 10 patients):

Loss of appetite
Carpal tunnel syndrome (simultaneous tingling, numbness and pain in the entire hand except the little finger) or skin tingling/burning
Abdominal pain, vomiting, constipation, dyspepsia, diarrhoea
Hair loss
Rash, urticaria and itching
Bone thinning, which may reduce bone strength (osteopor游戏副本

5. How to store the medicine Symex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blisters after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What the medicine Symex contains

The active substance is exemestane. Each coated tablet contains 25 mg of exemestane.
The other components are: colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium carboxymethyl starch (type A), polyethylene glycol 400, titanium dioxide (E 171), talc, polyethylene glycol 6000.

What Symex looks like and contents of the pack
Symex is a white, round, biconvex coated tablet with a diameter of approximately 5.7 mm.
Symex is available in PVC/PVDC/Aluminium blister packs containing 10, 15, 20, 30, 90, 100, 105 and 120 coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]
Manufacturer
Remedica Ltd.
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus
This medicine is authorised for marketing in the European Economic Area countries under the following names:
Poland: Symex