Trazec
nateglinide
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 pharmacist.
What Trazec is and what it is used for
Before you take Trazec
How to take Trazec
Possible side effects
How to store Trazec
Further information
Medicinal product no longer authorised
Trazec is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics).
It is used by people with type 2 diabetes. (This kind of diabetes is also called non-insulin-dependent diabetes mellitus.)
Insulin is a substance produced by a body organ called the pancreas. It helps to decrease blood sugar levels, especially after meals. In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals. Trazec works by stimulating the pancreas to produce insulin more quickly. This helps to keep the blood sugar controlled after meals.
Your doctor will prescribe Trazec together with another oral anti-diabetic containing metformin. Trazec tablets start to act quickly after you take them and are eliminated from the body rapidly.
Follow all instructions given to you by your doctor and pharmacist carefully, even if they are different from what is in this leaflet.
if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Trazec.
if you have type 1 diabetes (i.e. your body does not produce any insulin).
if you know that you have a severe liver problem.
if you are pregnant or planning to become pregnant.
if you are breast-feeding.
Talk to your doctor if you have any further questions or you think that any of these may apply to you.
People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia). Medicines, including Trazec, may also produce symptoms of low blood sugar.
If you get any of these symptoms – feeling dizzy, light-headed, hungry, shaky or any of the other signs in section 4, “Possible side effects” – eat or drink something containing sugar.
Some people are more likely to get symptoms of low blood sugar than others. Take care
if you are over 65 years of age.
if you are undernourished.
if you have another medical condition that may cause low blood sugar (e.g. an under-active pituitary or adrenal gland).
If any of these apply to you, monitor your blood sugar levels more carefully.
if you know that you have a liver problem.
if you have a severe kidney problem.
if you have problems of drug metabolism.
if you are due to have an operation.
if you have suffered a fever, an accident or an infection. Your treatment may need to be adjusted.
Medicinal product no longer authorised
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The amount of Trazec that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
It is especially important that you tell your doctor or pharmacist if you are taking:
Beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high blood pressure and certain heart conditions).
Diuretics (used in the treatment of high blood pressure).
Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).
Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout).
Your doctor may adjust the dose of these medicines.
Take Trazec before meals (see section 3, “How to take Trazec”). Its effect may be delayed if it is taken during or after meals.
Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise your doctor has recommended for you.
Watch carefully for signs of low blood sugar, especially
if you have exercised more strenuously than usual.
if you have drunk alcohol.
Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Trazec. If you do get symptoms of low blood sugar, eat or drink something containing sugar and talk to your doctor.
Trazec can be used by people over 65 years of age. Take special care to avoid low blood sugar.
Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Do not take Trazec if you are pregnant or planning to become pregnant. See your doctor as soon as possible if you become pregnant during treatment.
Do not breast-feed during treatment with Trazec.
Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast- feeding.
You are advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
Trazec tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Medicinal product no longer authorised
Always take Trazec exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take Trazec before the three main meals, usually:
1 dose before breakfast
1 dose before lunch
1 dose before dinner
It is best to take it right before a main meal but you can take it up to 30 minutes before.
Do not take it if you are not going to eat a main meal. If you miss a meal, skip that dose of Trazec and wait until your next meal.
Take Trazec as your doctor told you to. Your doctor will determine the dosage you require.
The usual dose of Trazec to start with is 60 mg before the three main meals. In some cases your doctor may prescribe higher doses. The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.
Swallow the tablets whole with a glass of water before the meal.
Take Trazec daily until your doctor tells you to stop.
If you have accidentally taken too many tablets, talk to a doctor straight away. If you experience symptoms of low blood sugar – if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, “Possible side effects” – eat or drink something containing sugar.
If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help – or make sure that someone else does this for you.
If you forget to take a tablet simply take the next one before your next meal. Do not take a double dose of Trazec to make up for the one that you missed.
Like all medicines, Trazec can cause side effects, although not everybody gets them. The side effects caused by Trazec are usually mild to moderate.
The most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually mild. These include
sweating,
dizziness,
shaking,
weakness,
hunger,
feeling your heart beating fast,
tiredness,
feeling sick (nausea).
Medicinal product no longer authorised
They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking. If you do get symptoms of low blood sugar, eat or drink something containing sugar.
Abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported.
Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such as rash and itching.
A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, fever and/or diarrhoea.
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 pharmacist.
Keep out of the reach and sight of children. Store in the original package.
Do not use Trazec after the expiry date stated on the carton after EXP. The expiry date refers to the
last day of that month.
Do not use any Trazec pack that is damaged or shows signs of tampering. Do not store above 30°C.
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 nateglinide.
The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60
and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
Trazec 60 mg film-coated tablets are pink, round tablets with “NVR” marked on one side and “TS” on the other.
Trazec 120 mg film-coated tablets are yellow, ovaloid tablets with “NVR” marked on one side and “TSL” on the other.
Trazec 180 mg film-coated tablets are red, ovaloid tablets with “NVR” marked on one side and “TSX” on the other.
Each blister pack contains 12, 60, 84, 120 or 360 tablets. Not all pack sizes or tablet strengths may be available in your country.
Horsham
Medicinal product no longer authorised
West Sussex, RH12 5AB United Kingdom
Novartis Farma S.p.A.
Via Provinciale Schito, 131
I-80058 Torre Annunziata - Napoli Italy
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Novartis Pharma Services Inc.
Тел.: +359 2 489 98 28
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Novartis s.r.o.
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Vistor hf.
Sími: +354 535 7000
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Tel: +421 2 5542 5439
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Novartis Pharma Services Inc. Tel: +370 5 269 16 50