Exemestane 25mg Coated Tablets
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EXEMESTANE
25 mg coated tablets
(Exemestane)
Read all of this leaflet carefully before you start using this medicine. Even if you have already used Exemestane 25mg coated tablets or a similar medicine before, we advise you to read this text carefully. The information may have been changed.
- 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 effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Exemestane 25mg coated tablets is and what it is used for
2. Before you take Exemestane 25mg coated tablets
3. How to take Exemestane 25mg coated tablets
4. Possible side effects
5. How to store Exemestane 25mg coated tablets
6. Further information
1. WHAT EXEMESTANE 25MG COATED TABLETS IS AND WHAT IT IS USED FOR
Your medicine is called Exemestane 25mg coated tablets. Exemestane 25mg coated tablets belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make oestrogens (the female sex hormones), especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer.
Exemestane 25mg coated tablets is used to treat hormone-dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with a medicine called tamoxifen.
Exemestane 25mg coated tablets is also used to treat hormone-dependent advanced breast cancer in postmenopausal women when a different hormonal medicine has not worked well enough.
2. BEFORE YOU TAKE EXEMESTANE 25MG COATED TABLETS Do not take Exemestane 25mg coated tablets
• if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestane 25mg coated tablets) or any of the other ingredients of Exemestane 25mg coated tablets. See section 6 ('What Exemestane 25mg coated tablets 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 become pregnant or are breastfeeding.
Take special care with Exemestane 25mg coated tablets
• Before treatment with Exemestane 25mg coated tablets, your doctor may want to take blood samples to make sure you have reached the menopause.
• Before taking Exemestane 25mg coated tablets, 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 treatment with this medicine. This is because Exemestane 25mg coated tablets lowers the levels of female hormones which can result in a lowering of your bone mineral content and may weaken them.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Exemestane 25mg coated tablets at the same time as hormone replacement therapy (HRT).
The following medicines should be used cautiously when taking Exemestane 25mg coated tablets. Tell your doctor if you are taking medicines such as:
• rifampicin (an antibiotic).
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy).
• the herbal remedy St. Johns Wort (Hypericum perforatum), or preparations containing St. JohnsWort. Pregnancy and breast-feeding
Do not take Exemestane 25mg coated tablets and tell your doctor if you are pregnant, likely to become pregnant or are breastfeeding.
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 Exemestane 25mg coated tablets, you should not attempt to drive or operate machinery.
Important information about some of the ingredients of Exemestane 25mg coated tablets
• If you have previously been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. Exemestane 25mg coated tablets contain sucrose (a type of sugar), which may cause a problem in a small number of patients with hereditary intolerance to some sugars (glucose-galactose malabsorption, fructose intolerance or sucrose-isomaltase insufficiency).
• Exemestane 25mg coated tablets contains a small amount of methyl-parahydroxybenzoate, which may cause allergic reactions (possibly delayed); if this should happen please contact your doctor.
3. HOW TO TAKE EXEMESTANE 25MG COATED TABLETS Adults and the elderly
Exemestane 25mg coated tablets should be swallowed after a meal at approximately the same time each day. Your doctor will tell you how to take Exemestane 25mg coated tablets 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 Exemestane 25mg coated tablets, let the medical staff know that you are taking this medicine.
Children and adolescents
Exemestane 25mg coated tablets is not suitable for use in children and adolescents.
If you take more Exemestane 25mg coated tablets than you should
Contact your doctor immediately or go straight to the nearest hospital casualty department. Show them the pack of Exemestane 25mg coated tablets.
If you forget to take Exemestane 25mg coated tablets
Take it as soon as you remember. If it is nearly time for the next dose, take it at the usual time.
Do not take a double dose to make up for a forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Exemestane 25mg coated tablets can cause side effects, although not everybody gets them. In general, Exemestane 25mg coated tablets is well tolerated and the following side effects observed in patients treated with Exemestane 25mg coated tablets are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes).
Tell your doctor immediately if you get any of the following symptoms as they may be signs of hepatitis (inflammation of the liver): generally feeling unwell, feeling sick, jaundice (yellowing of the skin and eyes), itching, right sided abdominal pain and loss of appetite.
The following side effects may also occur:
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
FRONT SIDE
|
P286 | |
|
P445 | |
|
1 The proof colour could be different by 1 V true Pantone® reference 1 | |
This Artwork is Property of
PH&T
FILM TAMPERING UNLEAVED
Product Code:
00194PH
Draft N°:
02
Execution Date: Film
17-04-2013 Quality
Control
Product
PR-EXEMESTANE 25MG
Country:
Die Cut
Date
g/mq
Draft N°
Execution Date
01
17-04-2013
Date
Signature
At/WEif??-
02
03
04
05
17-04-2013
XX-XX-XXXX
XX-XX-XXXX
XX-XX-XXXX
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.
5. HOW TO STORE EXEMESTANE 25MG COATED TABLETS
• This medicine does not require any special storage conditions.
• As with all medicines, keep them in safe place out of the reach and sight of children.
• Do not use Exemestane 25mg coated tablets 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.
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 25mg coated tablets contains
• The active substance is exemestane. Each coated tablet contains 25 mg exemestane.
• The tablet core contains: colloidal hydrated silica, hypromellose, magnesium stearate, mannitol, sodium starch glycolate, polysorbate, croscarmellose sodium.
• The tablet coat contains: hypromellose, polyvinyl alcohol, simeticone, macrogol, sucrose, magnesium carbonate, titanium oxide (E171), methyl parahydroxybenzoate (E218), talc, carnauba wax.
What Exemestane 25mg coated tablets looks like and contents of the pack
Exemestane 25mg coated tablets is a round, biconvex, off-white, coated tablet.
Exemestane 25mg coated tablets is available in blister packs of 30 and 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
PHT S.p.A.
via Marostica 1, 20146 Milan (Italy) tel: +39 02 4385041 fax: +39 02 48195301 e-mail: phtmilan@tin.it
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno 48 - Quinto De' Stampi - 20089 Rozzano, MI (Italy).
Tel: +39 02 82271.1 Fax: +39 02 82271580 e-mail: info@doppel.it
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands - Exemestaan PH&T 25mg coated tablets
Germany - Exemestane PH&T
United Kingdom - Exemestane 25mg coated tablets
Italy - Mestane
Greece - Exemestane PH&T
Spain - Exemestano PH&T
This leaflet was last approved in September 2012
00194PH
PHT
BACK SIDE
|
P286 | |
|
P445 | |
|
1 The proof colour could be different by 1 V true Pantone® reference 1 | |
This Artwork is Property of
PH&T
FILM TAMPERING UNLEAVED
Product Code:
00194PH
Draft N°:
02
Execution Date: Film
17-04-2013 Quality
Control
Product
PR-EXEMESTANE 25MG
Country:
Die Cut
Date
g/mq
Draft N°
Execution Date
01
17-04-2013
Date
Signature
02
03
04
05
17-04-2013
XX-XX-XXXX
XX-XX-XXXX
XX-XX-XXXX
- 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 effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Exemestane 25mg coated tablets is and what it is used for
2. Before you take Exemestane 25mg coated tablets
3. How to take Exemestane 25mg coated tablets
4. Possible side effects
5. How to store Exemestane 25mg coated tablets
6. Further information
Your medicine is called Exemestane 25mg coated tablets. Exemestane 25mg coated tablets belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make oestrogens (the female sex hormones), especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer.
Exemestane 25mg coated tablets is used to treat hormone-dependent early breast cancer in postmenopausal women after they have completed 2-3 years of treatment with a medicine called tamoxifen.
Exemestane 25mg coated tablets is also used to treat hormone-dependent advanced breast cancer in postmenopausal women when a different hormonal medicine has not worked well enough.
Do not take Exemestane 25mg coated tablets
• if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestane 25mg coated tablets) or any of the other ingredients of Exemestane 25mg coated tablets. See section 6 ('What Exemestane 25mg coated tablets 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 become pregnant or are breastfeeding.
Take special care with Exemestane 25mg coated tablets
• Before treatment with Exemestane 25mg coated tablets, your doctor may want to take blood samples to make sure you have reached the menopause.
• Before taking Exemestane 25mg coated tablets, 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 treatment with this medicine. This is because Exemestane 25mg coated tablets lowers the levels of female hormones which can result in a lowering of your bone mineral content and may weaken them.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Exemestane 25mg coated tablets at the same time as hormone replacement therapy (HRT).
The following medicines should be used cautiously when taking Exemestane 25mg coated tablets. Tell your doctor if you are taking medicines such as:
• rifampicin (an antibiotic).
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy).
• the herbal remedy St. Johns Wort (Hypericum perforatum), or preparations containing St. JohnsWort. Pregnancy and breast-feeding
Do not take Exemestane 25mg coated tablets and tell your doctor if you are pregnant, likely to become pregnant or are breastfeeding.
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 Exemestane 25mg coated tablets, you should not attempt to drive or operate machinery.
• If you have previously been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. Exemestane 25mg coated tablets contain sucrose (a type of sugar), which may cause a problem in a small number of patients with hereditary intolerance to some sugars (glucose-galactose malabsorption, fructose intolerance or sucrose-isomaltase insufficiency).
• Exemestane 25mg coated tablets contains a small amount of methyl-parahydroxybenzoate, which may cause allergic reactions (possibly delayed); if this should happen please contact your doctor.
Adults and the elderly
Exemestane 25mg coated tablets should be swallowed after a meal at approximately the same time each day. Your doctor will tell you how to take Exemestane 25mg coated tablets 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 Exemestane 25mg coated tablets, let the medical staff know that you are taking this medicine.
Children and adolescents
Exemestane 25mg coated tablets is not suitable for use in children and adolescents.
If you take more Exemestane 25mg coated tablets than you should
Contact your doctor immediately or go straight to the nearest hospital casualty department. Show them the pack of Exemestane 25mg coated tablets.
If you forget to take Exemestane 25mg coated tablets
Take it as soon as you remember. If it is nearly time for the next dose, take it at the usual time.
Do not take a double dose to make up for a forgotten tablet.
Like all medicines, Exemestane 25mg coated tablets can cause side effects, although not everybody gets them. In general, Exemestane 25mg coated tablets is well tolerated and the following side effects observed in patients treated with Exemestane 25mg coated tablets are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hot flushes).
Tell your doctor immediately if you get any of the following symptoms as they may be signs of hepatitis (inflammation of the liver): generally feeling unwell, feeling sick, jaundice (yellowing of the skin and eyes), itching, right sided abdominal pain and loss of appetite.
The following side effects may also occur:
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
FRONT SIDE
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This Artwork is Property of PH&T FILM TAMPERING UNLEAVED |
Product: PR-EXEMESTANE 25MG |
Country: NL | |||||
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Measurement: 135 x 480 mm |
Font Size/Leading 8 / 9 |
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00194PH | |||||||
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Execution Date: |
Film ^t^^H Quality Control^BBBBBBI |
Signature |
MME■•igs.-. |
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1 The proof colour could be different by V true Pantone® reference |
17-04-2013 |
05 |
XX-XX-XXXX J | ||||
25 mg coated tablets
(Exemestane)
Read all of this leaflet carefully before you start using this medicine. Even If you have already used Exemestane 25mg coated tablets or a similar medicine before, we advise you to read this text carefully. The information may have been changed.
1. WHAT EXEMESTANE 25MG COATED TABLETS IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE EXEMESTANE 25MG COATED TABLETS
Taking other medicines
Important information about some of the ingredients of Exemestane 25mg coated tablets
3. HOW TO TAKE EXEMESTANE 25MG COATED TABLETS
4. POSSIBLE SIDE EFFECTS
FRONT SIDE
|
r P286 |
This Artwork is Property of PH&T FILM TAMPERING UNLEAVED |
Product: PR-EXEMESTANE 25MG |
Country: NL | ||||
|
Die Cut |
Measurement: 135 x 480 mm |
Font Size/Leading 8 / 9 |
Bar-Code: | ||||
|
Product Code: |
Materials: |
g/mq |
Tickness: |
Draft N° |
Execution Date | ||
|
00194PH | |||||||
|
01 |
17-04-2013 | ||||||
|
Draft N : |
PO Number: |
Date: |
Artworks Status: X/X |
02 |
17-04-2013 | ||
|
02 | |||||||
|
03 |
XX-XX-XXXX | ||||||
|
Execution Date: |
Film ^t^^H Quality Control^BBBBBBI |
Signature |
MMf |
04 |
XX-XX-XXXX | ||
|
1 The proof colour could be different by V true Pantone® reference |
17-04-2013 |
05 |
XX-XX-XXXX J | ||||
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.
• This medicine does not require any special storage conditions.
• As with all medicines, keep them in safe place out of the reach and sight of children.
• Do not use Exemestane 25mg coated tablets 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.
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.
• The active substance is exemestane. Each coated tablet contains 25 mg exemestane.
• The tablet core contains: colloidal hydrated silica, hypromellose, magnesium stearate, mannitol, sodium starch glycolate, polysorbate, croscarmellose sodium.
• The tablet coat contains: hypromellose, polyvinyl alcohol, simeticone, macrogol, sucrose, magnesium carbonate, titanium oxide (E171), methyl parahydroxybenzoate (E218), talc, carnauba wax.
What Exemestane 25mg coated tablets looks like and contents of the pack
Exemestane 25mg coated tablets is a round, biconvex, off-white, coated tablet.
Exemestane 25mg coated tablets is available in blister packs of 30 and 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
PHT S.p.A.
via Marostica 1, 20146 Milan (Italy) tel: +39 02 4385041 fax: +39 02 48195301 e-mail: phtmilan@tin.it
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno 48 - Quinto De' Stampi - 20089 Rozzano, MI (Italy).
Tel: +39 02 82271.1 Fax: +39 02 82271580 e-mail: info@doppel.it
This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands - Exemestaan PH&T 25mg coated tablets
Germany - Exemestane PH&T
United Kingdom - Exemestane 25mg coated tablets
Italy - Mestane
Greece - Exemestane PH&T
Spain - Exemestano PH&T
This leaflet was last approved in September 2012
00194PH
BACK SIDE
|
This Artwork is Property of PH&T FILM TAMPERING UNLEAVED |
Product: PR-EXEMESTANE 25MG |
Country: NL | |||||
|
Die Cut |
Measurement: 135 x 480 mm |
Font Size/Leading 8 / 9 |
Bar-Code: | ||||
|
P445 | |||||||
|
Product Code: |
Materials: |
g/mq |
Tickness: |
Draft N° |
Execution Date | ||
|
00194PH | |||||||
|
01 |
17-04-2013 | ||||||
|
Draft N : |
PO Number: |
Date: |
Artworks Status: X/X |
02 |
17-04-2013 | ||
|
02 | |||||||
|
03 |
XX-XX-XXXX | ||||||
|
Execution Date: |
Film ^t^^H Quality Control^BBBBBBI |
Signature |
MME■•igs.-. |
04 |
XX-XX-XXXX | ||
|
1 The proof colour could be different by V true Pantone® reference |
17-04-2013 |
05 |
XX-XX-XXXX J | ||||
5. HOW TO STORE EXEMESTANE 25MG COATED TABLETS
6. FURTHER INFORMATION
What Exemestane 25mg coated tablets contains
PHT
BACK SIDE
|
r P286 |
This Artwork is Property of PH&T FILM TAMPERING UNLEAVED |
Product: PR-EXEMESTANE 25MG |
Country: NL | ||||
|
Die Cut |
Measurement: 135 x 480 mm |
Font Size/Leading 8 / 9 |
Bar-Code: | ||||
|
Product Code: |
Materials: |
g/mq |
Tickness: |
Draft N° |
Execution Date | ||
|
00194PH | |||||||
|
01 |
17-04-2013 | ||||||
|
Draft N : |
PO Number: |
Date: |
Artworks Status: X/X |
02 |
17-04-2013 | ||
|
02 | |||||||
|
03 |
XX-XX-XXXX | ||||||
|
Execution Date: |
Film ^t^^H Quality Control^BBBBBBI |
Signature |
MMf |
04 |
XX-XX-XXXX | ||
|
1 The proof colour could be different by V true Pantone® reference |
17-04-2013 |
05 |
XX-XX-XXXX J | ||||