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NETAMISE 25 MG FILM-COATED TABLETS

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P18/0696/01

PACKAGE LEAFLET: INFORMATION FOR THE USER

Netamise 25 mg Film-coated Tablets
(Exemestane)
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 Netamise is and what it is used for
2. Before you take Netamise
3. How to take Netamise
4. Possible side effects
5. How to store Netamise
6. Further information
1. What Netamise is and what it is used for
Your medicine is called Netamise. Netamise 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.
Netamise 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.
Netamise is also used to treat hormone dependent advanced breast cancer in postmenopausal women when a
different hormonal drug treatment has not worked well enough.
2.

Before you take Netamise

Do not take Netamise
• if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Netamise)
or any of the other ingredients of Netamise. See section 6 (“What Netamise 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 Netamise
• Before treatment with Netamise, your doctor may want to take blood samples to make sure you have
reached the menopause.
• Before taking Netamise, 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 Netamise. 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.

If you take more Netamise 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 Netamise tablets.
If you forget to take Netamise
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 Netamise
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.
4.

Possible side effects

Like all medicines, Netamise can cause side effects, although not everybody gets them. In general, Netamise is well
tolerated and the following side effects observed in patients treated with Netamise 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.
5.

How to store Netamise

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
Netamise should not be given at the same time as hormone replacement therapy (HRT).
The following medicines should be used cautiously when taking Netamise. 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.

Keep out of the reach and sight of children.

Pregnancy and breast-feeding
Do not take Netamise 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.

What Netamise contains:
The active ingredient is Exemestane. Each film-coated tablet contains 25 mg of Exemestane.

3.

How to take Netamise

Adults and the elderly
Netamise tablets should be taken by mouth after a meal at approximately the same time each day. Your doctor will
tell you how to take Netamise 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 Netamise, let the medical staff know what medication you are taking.


6.

This medicinal product does not require any special storage conditions.
Do not use Netamise 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.
Netamise 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.
Further information

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 Netamise looks like and contents of the pack
Netamise 25 mg Film-coated Tablets are white, round biconvex film-coated tablets
Netamise 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.

Children and adolescents below 18 years
Netamise is not suitable for use in children and adolescents below 18 years.
This leaflet was prepared in: January 2011

P18/0696/01

Driving and using machines
If you feel drowsy, dizzy or weak whilst taking Netamise, you should not attempt to drive or operate machinery.




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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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