Metphar XR 750

Metphar XR 750

metformin

Manufacturer:

PT Novell

Distributor:

Primal
Full Prescribing Info
Contents
Metformin hydrochloride.
Description
Each extended-release tablet contains 750 mg of the active ingredient metformin hydrochloride.
Excipients/Inactive Ingredients: The other ingredients are carboxymethylcellulose sodium, microcrystalline cellulose, hypromellose, magnesium stearate, and purified water.
Action
Metphar XR extended-release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of Type 2 (non-insulin dependent) diabetes mellitus.
Indications/Uses
Metphar XR is used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults, when diet and exercise alone for 3 to 6 months have not been enough to control blood glucose (sugar). Patients are at high risk of developing Type 2 diabetes if they have additional conditions like high blood pressure, aged above 40 years, an abnormal amount of lipids (fat) in the blood or a history of diabetes during pregnancy.
The medicine is particularly effective if patients are aged below 45 years, are very overweight, have high blood glucose levels after a meal or developed diabetes during pregnancy.
Metphar XR is used for the treatment of Type 2 diabetes 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 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 patients continue to take the medicine, even though they may not have any obvious symptoms. Metphar XR makes the body more sensitive to insulin and helps return to normal the way the body uses glucose.
Metphar XR is associated with either a stable body weight or modest weight loss.
Metphar XR extended-release tablets are specially made to release the drug slowly in the body and therefore are different to many other types of tablet containing metformin.
Dosage/Direction for Use
The doctor may prescribe Metphar XR to be taken on its own, or in combination with other oral antidiabetic medicines or insulin.
Always take Metphar XR exactly as advised by the doctor.
Patients should check with the doctor or pharmacist if unsure.
Swallow the tablets whole with a glass of water, do not chew.
Recommended dose: Usually patients will start treatment with 500 milligrams of Metformin HCl extended-release tablets daily. After patients have been taking Metformin HCl extended-release tablets for about 2 weeks, the doctor may measure the blood sugar and adjust the dose. The maximum daily dose is 2000 milligrams of Metformin HCl extended-release tablets.
If patients have reduced kidney function, the doctor may prescribe a lower dose.
Normally, patients should take the tablets once a day, with the evening meal.
In some cases, the doctor may recommend to take the tablets twice a day. Always take the tablets with food.
Please note that only Metphar XR 750 extended-release tablets 750 mg are available. Please consider other suitable oral preparation for recommended dosages other than 750 mg.
Posology and Renal Impairment: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3 - 6 months. (See table.)

Click on icon to see table/diagram/image

If patients forget to take Metphar XR, it should be taken as soon as remembered with some food. Do not take a double dose to make up for a forgotten dose.
Overdosage
If patients take extra tablets by mistake, there is no need to worry, but if patients have unusual symptoms, contact the doctor. If the overdose is large, lactic acidosis is more likely. Symptoms of lactic acidosis are non-specific, such as vomiting, bellyache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heartbeat. If patients experience some of these symptoms, they should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Metphar XR immediately and contact a doctor or the nearest hospital straightaway.
Contraindications
Do not take Metphar XR if: Allergic to metformin or to any of the other ingredients of this medicine (listed in Description). An allergic reaction may cause a rash, itching or shortness of breath.
There are liver problems.
There is severely reduced kidney function.
There is uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see Risk of lactic acidosis under Precautions) or ketoacidosis. Ketoacidosis is a condition in which substances called 'ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or breath developing an unusual, fruity smell.
Have lost too much water from the body (dehydration). Dehydration may lead to kidney problem, which can put patients at risk for lactic acidosis (see Risk of lactic acidosis under Precautions).
There is a severe infection, such as an infection affecting the lung or bronchial system or the kidney. Severe infections may lead to kidney problems, which can put patients at risk for lactic acidosis (see Risk of lactic acidosis under Precautions).
Have been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put patients at risk for lactic acidosis (see Risk of lactic acidosis under Precautions).
A heavy drinker of alcohol.
Under 18 years of age.
Warnings
Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Metformin should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable.
Special Precautions
If patients need to have major surgery, they must stop taking Metphar XR during and for some time after the procedure. The doctor will decide when patients must stop and when to restart the treatment with Metphar XR.
During treatment with Metphar XR, the doctor will check the kidney function at least once a year or more frequently if the patient is an elderly and/or if there is worsening kidney function.
Patients may see some remains of the tablets in the stools. No need to worry - this is normal for this type of tablet.
Patients should continue to follow any dietary advice that the doctor has given and should make sure to eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to the doctor.
Risk of lactic acidosis: Metphar XR may cause a very rare, but very serious side effect called lactic acidosis, particularly if the kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information as follows), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the previously mentioned applies, talk to the doctor for further instructions.
Stop taking Metphar XR for a short time if a condition that may be associated with dehydration (significant loss of body fluids) is present such as severe vomiting, diarrhea, fever, exposure to heat or if drinking less fluid than normal. Talk to the doctor for further instructions.
Stop taking Metphar XR and contact a doctor or the nearest hospital immediately if experiencing some of the symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include: vomiting; stomach ache (abdominal pain); muscle cramps; a general feeling of not being well with severe tiredness; difficulty in breathing; reduced body temperature and heartbeat.
Lactic acidosis is a medical emergency and must be treated in a hospital.
Metphar XR with alcohol: Avoid excessive alcohol intake while taking Metphar XR since this may increase the risk of lactic acidosis (see Risk of lactic acidosis as previously mentioned).
Driving and using machines: Metphar XR taken on its own does not cause 'hypos' (symptoms of low blood sugar or hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect the ability to drive or use machinery.
Patients should be aware, however, that Metphar XR taken with other antidiabetic medicines can cause hypos, so in this case they should take extra care when driving or operating machinery.
Use in Elderly: If the patient is older than 75 years, treatment with Metphar XR should not be started to lower the risk of developing type 2 diabetes.
Use In Pregnancy & Lactation
Do not take Metphar XR if pregnant or breast feeding.
Ask the doctor or pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, Metphar XR can cause side effects, although not everybody gets them. The following side effects may occur: Metphar XR may cause a very rare (may affect up to 1 user in 10,000) but very serious side effect called lactic acidosis (see Risk of lactic acidosis under Precautions). If this happens, patients must stop taking Metphar XR and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Metphar XR may cause abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice (may affect up to 1 user in 10,000). If yellowing of the eyes and/or skin develops, contact the doctor immediately.
Other possible side effects are listed by frequency as follows: Very common (affects more than 1 person in 10): Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If these are experienced, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks. It helps if the tablets are taken with or immediately after a meal.
Common (affects less than 1 person in 10, but more than 1 person in 100): Taste disturbance.
Very rare (affects less than 1 person in 10,000): Decreased vitamin B12 levels; Skin rashes including redness, itching and hives.
Reporting of side effects: If any side effects are experienced, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Drug Interactions
If patients need to have an injection of a contrast medium that contains iodine into the bloodstreams, in the context of an X-ray or scan, they must stop taking Metphar XR before or at the time of injection. The doctor will decide when patients must stop and when to restart the treatment with Metphar XR.
Tell the doctor if taking, have recently taken or might take any other medicines. Patients may need more frequent blood glucose and kidney function tests, or the doctor may need to adjust the dosage of Metphar XR. It is especially important to mention the following: Medicines which increase urine production (diuretics (water tablets) such as furosemide).
Medicines used to treat pain and inflammation (NSAID and COX-2 inhibitors, such as ibuprofen and celecoxib).
Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Steroids such as prednisolone, mometasone, beclomethasone.
Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthethics.
Medicines that may change the amount of Metphar XR in the blood, especially if patients have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
Caution For Usage
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
This medicinal product does not require any special storage conditions.
MIMS Class
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Presentation/Packing
XR tab 750 mg (white, oblong, convex, breakline on one side and embossed "NPL" on another side) x 10 x 10's.
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