Nocteaze Sr 750mg Prolonged-Release Tablets
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Nocteaze SR 500mg, 750mg, 1000mg Prolonged-release Tablets
Metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor,or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
j What Nocteaze SR is and what it is used for ^ What you need to know before you take Nocteaze SR
^ How to take Nocteaze SR ^| Possible side effects How to store Nocteaze SR ^| Contents of the pack and other information
j What Nocteaze SR is and what it is used for
Nocteaze SR contains the active ingredient metformin hydrochloride and belongs to a group of medicines called biguanides, used in the treatment of diabetes.
Nocteaze SR is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus in adults when diet and exercise changes alone have not been enough to control blood glucose (sugar). Insulin is a hormone that enables body tissues to take glucose from the blood and to use it for energy or for storage for future use. People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms. Nocteaze SR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.
Nocteaze SR is associated with either a stable body weight or modest weight loss.
Nocteaze SR is specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin.
^ What you need to know before you take Nocteaze SR
Do not take Nocteaze SR:
• If you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6).
• If you have ketosis (this is a symptom of uncontrolled diabetes in which substances called 'ketone bodies' accumulate in the blood - you may notice that your breath has an unusual, fruity odour).
• If you have long-term kidney or liver problems.
• If you have had serious complications with your diabetes or other serious conditions which resulted in rapid weight loss, nausea, vomiting or dehydration.
• If you have a severe infection or have recently suffered a severe injury.
• If you have been treated for heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties.
• If you are a heavy drinker of alcohol.
Warnings and precautions
After you have started taking your medicine:
If you have diabetes you should have your blood or urine tested for sugar regularly. You should return to your doctor at least once a year to check the function of your kidneys (more often if you are elderly or if you have kidney problems).
If you start to lose weight unexpectedly or suffer severe nausea or vomiting, uncontrolled rapid breathing, abdominal pains, feeling cold or muscle cramps, stop taking the medicine and tell your doctor straight away. This can be a sign of a rare, but serious, complication with your diabetes called 'lactic acidosis' which means there is too much acid in the blood (see also under '4. Possible side effects').
You may see some remains of the tablets in your stools. Do not worry as this is normal for this type of tablet.
If you need to have an X-ray examination involving the injection of a dye, tell the doctor that you take Nocteaze SR as you may need to stop taking it for a few days after the examination.
Tell your doctor if you are going to have an operation under general anaesthetic, as you may need to stop taking Nocteaze SR for a couple of days before and after the procedure.
You should continue to follow any dietary advice that your doctor has given you and you should make sure that you eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your doctor.
Children and adolescents
Children and adolescents should not use this medicine. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Other medicines and Nocteaze SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, your blood sugar levels may need to be checked more often and your dose adjusted:
• Steroids such as prednisolone, mometasone, beclometasone.
• Diuretics (water tablets) such as furosemide.
• Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics.
You should avoid drinking alcohol and using alcohol-containing medicines as this will increase the risk of lactic acidosis (see under '4. Possible side effects').
Nocteaze SR with food, drink and alcohol
You should take Nocteaze SR with or immediately after food e.g. with your evening meal.
You should avoid drinking alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take this medicine if you are breastfeeding or if you are planning to breast-feed your baby.
Driving and using machines
Nocteaze SR taken on its own does not cause 'hypoglycemia' (symptoms of low blood sugar, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.
You should be aware, however, that Nocteaze SR taken with other antidiabetic medicines can cause low blood sugar, so in this case you should take extra care when driving or operating machinery.
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"3 How to take Nocteaze SR
Your doctor may prescribe Nocteaze SR for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
Usually you will start treatment with 500mg Nocteaze SR daily. After you have been taking Nocteaze SR for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000mg of Nocteaze SR.
How to take the tablets
Normally, you should take the tablets once a day, with your evening meal.
In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with food.
Swallow the tablets whole with a glass of water, do not chew, split or crush the tablets.
Use in children and adolescents
Children and adolescents below 18 years should not use this medicine.
Use in elderly
The dose will be determined after tests have been carried out on your kidney function.
If you take more Nocteaze SR than you should
If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact your doctor. These symptoms may include weakness, confusion, fast breathing and new onset of nausea, vomiting or stomach pain. If the overdose is large, lactic acidosis is more likely and this is a medical emergency requiring treatment in hospital (see also under '4. Possible side effects').
If you forget to take Nocteaze SR
Take it as soon as you remember with some food. Do not take a double dose to make up for a forgotten dose.
If you stop taking Nocteaze SR
You should not stop taking this medicine without talking to your doctor first. If you stop taking Nocteaze SR, your blood sugar may rise again.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking Nocteaze SR and see your doctor immediately:
Very rare (may affect up to 1 in 10,000 people):
• unexpected weight loss, very severe nausea or vomiting, very fast breathing which you cannot stop, stomach pains or feeling cold.
These can be signs of serious problems with your diabetes and may mean you have a very rare side effect called "lactic acidosis” (too much acid in the blood). If this happens, see a doctor as you will need treatment straight away.
Frequency not known (frequency cannot be estimated from the available data)
• Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice. If you develop yellowing of the eyes and/or skin contact your doctor immediately.
Other possible side effects are listed by frequency as follows:
Very common (may affect more than 1 in 10 people):
• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite.
If you get these, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks.
Common (may affect up to 1 in 10 people):
• Taste disturbance
Very rare (may affect up to 1 in 10,000 people):
• Decreased vitamin B12 levels which may result in anaemia
• Skin rashes including redness, itching and hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side affects you can help provide more information on the safety of this medicine.
How to store Nocteaze SR
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 after "EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information What Nocteaze SR contains
• The active substance is metformin (as hydrochloride). Each prolonged-release tablet contains 500mg, 750mg or 1000mg of metformin hydrochloride corresponding to 390mg, 585mg and 780mg metformin base, respectively.
• The other ingredients are magnesium stearate, colloidal anhydrous silica, povidone K30 and hypromellose.
What Nocteaze SR looks like and contents of the pack
Nocteaze SR 500mg prolonged-release tablets are white to off-white, capsule shaped uncoated tablets, 16.50 mm in length,
8.20 mm in width and 6.70 mm in thickness, debossed with 'XR500' on one side and plain on other side.
Nocteaze SR 750mg prolonged-release tablets are white to off-white, capsule shaped, uncoated tablets, 19.60 mm in length, 9.30 mm in width and 7.40 mm in thickness, debossed with 'XR 750' on one side and plain on other side.
Nocteaze SR 1000mg prolonged-release tablets are white to off-white, capsule shaped, uncoated tablets, 21.10 mm in length, 10.10 mm in width and 8.90 mm in thickness, debossed with 'XR 1000' on one side and plain on other side.
Nocteaze SR is available in blister packs containing 28 or 56 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland
Manufacturers
Medicofarma S.A. ul. Kozienicka 97 26-600 Radom Poland
Balkanpharma - Dupnitsa AD 3 Samokovsko Shosse Str Dupnitsa 2600 Bulgaria
This leaflet was last revised in June 2014.
If you would like a leaflet with larger text, please contact 01271 385257.
^actavis
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Actavis, Barnstaple, EX32 8NS, UK