Xatane 25 Mg Film-Coated Tablets
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Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
In this leaflet:
1. What Xatane is and what it is used for
2. Before you take Xatane
3. How to take Xatane
4. Possible side effects
5. How to store Xatane
6. Further information
If you take more Xatane than you should
If too many tablets are taken by accident, contact your doctor at once or go straight to the nearest hospital casualty department. Show them the pack of Xatane tablets.
If you forget to take Xatane
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 remember. If it is nearly time for the next dose, take it at the usual time.
If you stop taking Xatane
Do not stop treatment without consulting your doctor. If you stop the treatment your symptoms might reappear.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
1. What Xatane is and what it is used for
Your medicine is called Xatane. Xatane belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make the female sex hormones, oestrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer.
Xatane is used to treat hormone dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.
Xatane is also used to treat hormone dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough.
Do not take Xatane
• if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Xatane) or any of the other ingredients of Xatane. See section 6 (“What Xatane contains”) for full list of
other ingredients.
• if you have not already been through ‘the menopause', i.e. you are still having your monthly period.
• if you are pregnant, likely to be pregnant or breastfeeding.
Take special care with Xatane
• Before treatment with Xatane, your doctor may want to take blood samples to make sure you have reached the menopause.
• Before taking Xatane, tell your doctor if you have problems with your liver or kidneys.
• Tell your doctor if you have a history or are suffering from any condition which affects the strength of your bones. Your doctor may want to measure your bone density before and during the treatment of Xatane. This is because drugs of this class lower the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their 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.
Xatane should not be given at the same time as hormone replacement therapy (HRT).
The following medicines should be used cautiously when taking Xatane. Let your doctor know if you are taking medicines such as:
• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• herbal remedy St Johns Wort (Hypericum perforatum), or preparations containing it.
Pregnancy and breast-feeding
Do not take Xatane if you are pregnant or breastfeeding.
If you are pregnant or think you might be, tell your doctor.
Discuss contraception with your doctor if there is any possibility that you may become pregnant.
Driving and using machines
If you feel drowsy, dizzy or weak whilst taking Xatane, you should not attempt to drive or operate machinery.
3. How to take Xatane Adults and the elderly
Xatane tablets should be taken by mouth after a meal at approximately the same time each day. Your doctor will tell you how to take Xatane and for how long. The recommended dose is one 25 mg tablet daily.
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
If you need to go to the hospital whilst taking Xatane, let the medical staff know what medication you are taking.
Children and adolescents below 18 years
Xatane is not suitable for use in children and adolescents below 18 years.
Like all medicines, Xatane can cause side effects, although not everybody gets them. In general, Xatane is well tolerated and the following side effects observed in patients treated with Xatane are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes).
Very common side effects, (affecting more than 1 person in 10):
• Difficulty sleeping
• Headache
• Hot flushes
• Feeling sick
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)
• Tiredness
Common side effects, (affecting between 1 to 10 people in 100):
• Loss of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a combination of pins and needles, numbness and pain affecting all of the hand except the little finger)
• Stomach ache, vomiting (being sick), constipation, indigestion, diarrhoea
• Skin rash, hair loss
• Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases
• Pain, swollen hands and feet
Uncommon side effects, (affecting between 1 to 10 people in 1000):
• Drowsiness
• Muscle weakness
Inflammation of the liver (hepatitis) may occur. Symptoms include feeling generally unwell, nausea, jaundice (yellowing of the skin and eyes), itching, right sided abdominal pain and loss of appetite. Contact your doctor promptly if you think you have any of these symptoms.
If you have any blood tests done, it may be noticed that there are changes in your liver function. Changes in the amount of certain blood cells (lymphocytes) and platelets circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).
If any side effects get serious or if you notice any side effect not listed on this leaflet, please tell your doctor or your pharmacist as soon as possible.
Keep out of the reach and sight of children.
• This medicinal product does not require any special storage conditions.
• Do not use Xatane after expiry date which is stated on the outer carton and the blister after EXP.
The expiry date refers to the last day of the month.
• Xatane 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.
What Xatane contains:
The active ingredient is Exemestane. Each film-coated tablet contains 25 mg of Exemestane.
The other ingredients are:
Tablet Core: Silica, colloidal anhydrous, Crospovidone, Hypromellose 5cP, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Polysorbate 80 and Sodium Starch Glycolate (Type A).
Film-coating: Hypromellose 5cP, Macrogol, Talc and Titanium Dioxide (E171).
What Xatane looks like and contents of the pack
Xatane 25 mg Film-coated Tablets are white, round biconvex film-coated tablets
Xatane 25 mg Film-coated Tablets are available in blister packs of 14, 15, 20, 30, 60, 90, 100 and 120.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is Chanelle Medical, Loughrea, Co Galway, Ireland.
The manufacturer is Remedica Ltd, Limassol Industrial Estate, Limassol Cyprus, EU.
The distributor is Chanelle Medical, U.K. Ltd.
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