Exemestane Teva
Italy
Table of Contents
Package leaflet: Information for the patient
Exemestane Teva 25 mg film-coated tablets
Exemestane
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Exemestane Teva is and what it is used for
- What you need to know before taking Exemestane Teva
- How to take Exemestane Teva
- Possible side effects
- How to store Exemestane Teva
- Contents of the pack and other information
1. What Exemestane Teva is and what it is used for
This medicine is called Exemestane Teva. Exemestane Teva belongs to a group of medicines called "aromatase inhibitors". These medicines interfere with a substance called aromatase, which is involved in producing the female sex hormone, oestrogen, particularly in postmenopausal women. Reducing the levels of oestrogen in the body is a way of treating hormone-dependent breast cancer.
Exemestane Teva is used to treat early-stage hormone-dependent breast cancer in postmenopausal women who have already completed a 2-3 year course of treatment with the medicine tamoxifen.
Exemestane Teva is also used to treat advanced-stage hormone-dependent breast cancer in postmenopausal women when treatment with another hormonal medicine has not been sufficiently effective.
2. What you need to know before taking Exemestane Teva
Do not take Exemestane Teva
if you are or have previously been allergic to exemestane (the active substance in Exemestane Teva)
or to any of the other ingredients of this medicine (listed in section 6);
if you have not yet reached menopause, i.e. if you still have menstrual periods;
if you are pregnant, trying to become pregnant, or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Exemestane Teva
Before starting treatment with Exemestane Teva, your doctor may ask you to have blood tests to confirm that you have already entered menopause.
Before starting treatment, routine checks of your vitamin D levels may be performed, as these levels may be very low in early breast cancer. If your levels are below normal, you will be given supplemental vitamin D therapy.
Before taking Exemestane Teva, inform your doctor if you have liver or kidney problems.
- Inform your doctor if you currently have or have previously had conditions that affect bone strength. Your doctor may wish to measure your bone density before and during treatment with Exemestane Teva. This is because medicines of this class reduce levels of female hormones, which may lead to loss of bone mineral content and result in weaker bones.
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
Exemestane Teva is not suitable for use in children and adolescents.
Other medicines and Exemestane Teva
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Exemestane Teva must not be administered together with hormone replacement therapy. The following medicines should be used with caution when taking Exemestane Teva. Inform your doctor if you are taking medicines such as:
rifampicin (an antibiotic);
carbamazepine or phenytoin (anticonvulsants used to treat epilepsy);
the herbal remedy St John’s wort (Hypericum perforatum), or preparations containing it.
Exemestane Teva and food
Exemestane Teva should be taken once daily, preferably after a meal.
Pregnancy and breastfeeding
Do not take Exemestane Teva if you are pregnant or breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Discuss with your doctor which contraceptive methods to use if there is any possibility that you could become pregnant.
Driving and using machines
If you experience drowsiness, dizziness, or weakness during treatment with Exemestane Teva, avoid driving or operating machinery.
3. How to take Exemestane Teva
Adults and elderly
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Exemestane Teva tablets should be taken orally once daily, preferably after a meal.
Your doctor will tell you how much Exemestane Teva to take and for how long.
The recommended dose is one 25 mg tablet daily.
If you need to go to hospital during treatment with Exemestane Teva, inform the medical staff about the medicines you are taking.
Use in children and adolescents
Exemestane Teva is not suitable for use in children and adolescents.
If you take more Exemestane Teva than you should
If you accidentally take too many tablets at one time, contact your doctor immediately or go to the nearest emergency room. Show the medical staff the Exemestane Teva tablet pack.
If you forget to take Exemestane Teva
Do not take a double dose to make up for the forgotten tablet.
If you forget to take a tablet, take it as soon as you remember. If it is almost time for your next dose, take the next tablet at the usual time.
If you stop taking Exemestane Teva
Do not stop taking the tablets even if you feel well, unless your doctor tells you to stop treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
In general, Exemestane Teva is well tolerated and the following side effects observed in patients treated with
Exemestane Teva are predominantly mild or moderate in nature. Most of the side effects are related to oestrogen deficiency (for example, hot flushes).
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver bile ducts which may cause yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. If you think you are experiencing any of these symptoms, contact your doctor immediately to receive urgent medical assistance.
Very common: may affect more than 1 in 10 people
Depression
Difficulty sleeping
Headache
Hot flushes
Dizziness
Nausea
Increased sweating
Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
Fatigue
Decreased white blood cell count
Abdominal pain
Elevated liver enzymes
Elevated levels of degraded haemoglobin in the blood
Elevated levels of an enzyme in the blood due to liver damage
Pain
Common: may affect up to 1 in 10 people
Loss of appetite
Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the whole hand except the little finger) or skin tingling
Stomach discomfort, vomiting (nausea), constipation, indigestion, diarrhoea
Hair loss
Skin rash, hives, and itching
Thinning of the bones which may reduce their strength (osteoporosis), possibly leading in some cases to bone fractures (breaks or cracks)
Pain, swelling in hands and feet
Decreased platelet count in the blood
Muscle weakness
Uncommon: may affect up to 1 in 100 people
Hypersensitivity
Rare: may affect up to 1 in 1,000 people
Rupture of small blisters in an area of skin affected by a skin rash
Somnolence
Liver inflammation
Inflammation of the liver bile ducts causing yellowing of the skin
Not known: frequency cannot be estimated from the available data
Low levels of a certain type of white blood cells in the blood
Additionally, changes in the levels of certain blood cells (lymphocytes) and platelets (the blood cells responsible for clotting) circulating in the blood may occur, especially in patients with pre-existing lymphopenia (reduced lymphocyte count in the blood).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Exemestane Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after Exp.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Exemestane Teva contains
The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
The other components are:
Tablet core:
mannitol, copovidone, crospovidone, silicified microcrystalline cellulose (containing microcrystalline cellulose and anhydrous colloidal silica), sodium carboxymethyl starch (type A), magnesium stearate
Film coating:
hypromellose, macrogol 400, titanium dioxide.
Description of the appearance of Exemestane Teva and package contents
Exemestane Teva is a white to off-white, round, film-coated tablet, 6 mm in diameter, imprinted with "25" on one side and smooth on the other.
Exemestane Teva is available in the following blister pack sizes:
10, 14, 20, 30, 50x1, 60, 90, 100 (blister packs of 10, 14 or 30) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturers
EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road, Waterford (Ireland)
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem (The Netherlands)
Teva Pharma B.V.
Computerweg 10, 3542DR Utrecht (The Netherlands)
Teva UK Limited
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)