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Dianben Ū 850 mg. film coated tablets
Metformin hydrochloride
- The active ingredient is metformin (DOE) hydrochloride. Each film coated tablet contains 850 mg. of metformin hydrochloride, corresponding to 662,9 mg. metformin base.
- The excipients are: Povidone K 30, magnesium stearate, hypromellose.
WHAT IS DIANBEN
Dianben 850 mg. comes in the form of film coated tablets. Each pack contains 50 tablets.
Dianben 850 mg. belongs to the group of medications called Oral
Antidiabetics.
It is used for the treatment of adult onset diabetes (type 2), particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
Dianben 850 mg. may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin.
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BEFORE TAKING DIANBEN
Do not take DIANBEN 850 mg.:
You should not take DIANBEN 850 mg. if you:
Are allergic to metformin hydrochloride or to any of the excipients of this product.
Have ketone bodies and sugar in the urine (this may mean you suffer diabetic ketoacidosis), or diabetic pre-coma.
Suffer severe hepatic impairment.
Suffer severe renal impairment or conditions with the potential to alter renal function such as: dehydration, severe infection, shock or intravenous administration of iodinated contrast agents.
Have an acute or chronic disease such as: cardiac or respiratory failure, recent myocardial infarction and shock.
Suffer alcoholism.
Are breastfeeding.
Take special care with DIANBEN 850 mg.:
If you experience symptoms such as: loss of appetite, abdominal pain, nausea and vomiting; these may be a sign of the presence of a disease called lactic acidosis. If you experience any of these symptoms consult your doctor immediately. In this case your doctor will recommend that you have regular hepatic and renal function tests, and blood analysis" done while you are on treatment with this medication.
If you suffer decreased renal function. In this case, your doctor will recommend serum creatinine levels be controlled a few times a year and annually in patients with normal renal function.
If you are going to be treated with an iodinated contrast agent, DIANBEN 850 mg. should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal.
Metformin hydrochloride should be discontinued 48 hours before elective surgery with general anaesthesia.
As with any other medication used to treat diabetes, your blood sugar level may be excessively reduced if you decrease food intake and do not respect regular meal times. You should not skip any meals. Overweight patients should follow a low-calorie diet.
If besides this medication your doctor also prescribes insulin or
sulphonylurea, a decrease in your blood sugar level is likely to occur.
Taking DIANBEN 850 mg. with food and drink:
Dianben 850 mg. should be taken with or immediately after meals in order to minimize the effect of gastrointestinal symptoms.
Never take this medication with alcohol.
Pregnancy
Consult your doctor or pharmacist before taking any medication. You should inform your doctor if you are pregnant or plan to become pregnant, in this case your doctor will indicate which is the appropriate treatment for your diabetes. During pregnancy diabetes should usually be treated with insulin.
Lactation
Consult your doctor or pharmacist before taking any medication.
Breastfeeding is contraindicated while you are taking this medication.
Driving and using machines
Dianben 850 mg. monotherapy does not cause a low concentration of glucose in the blood (hypoglycaemia) and therefore has no effect on the ability to drive or to use machines.
However, patients should be alerted to the risk of hypoglycaemia when
metformin is used in combination with other antidiabetic agents
(sulphonylureas, insulin, repaglinide) and take extreme caution when driving or operating dangerous machinery.
Use in the elderly:
Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Use in children:
Dianben 850 mg. is not recommended for use in children.
Taking other medications:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medications, including those, which you may buy without needing a prescription.
Dianben 850 mg. may interact with other medications such as:
Alcohol and medications that contain alcohol: Their concomitant
administration with Dianben 850 mg. may cause lactic acidosis.
Iodinated contrast agents: substances used to establish a diagnosis; its concomitant use with Dianben 850 mg. may alter the patient's renal function.
Glucocorticoids (intravenous, intramuscular and external administration): medications used as immunosuppressants and anti-inflammatories, their concomitant use with Dianben 850 mg. may increase levels of glucose in the blood (hyperglycaemia).
Beta-2-agonists: its concomitant use with Dianben 850 mg. may increase levels of glucose in the blood (hyperglycaemia).
Diuretics: medications that cause an increased output of urine, its
concomitant use with Dianben 850 mg. may increase levels of glucose in the blood (hyperglycaemia).
Medications used to decrease high blood pressure belonging to the group ACE (angiotensin-converting enzyme) inhibitors; its concomitant use with Dianben 850 mg. may decrease the blood glucose levels.
Anti-inflammatory agents, used to relieve pain called NSAIDs (non-steroidal anti-inflammatory drugs), its concomitant use with Dianben 850 mg. may alter the patient's renal function.
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HOW TO TAKE DIANBEN
Follow these instructions when taking this medication unless advised
otherwise by your doctor. Remember to take your medication.
Your doctor will inform you of the duration of your treatment with Dianben 850 mg. Do not discontinue treatment before the recommended period, as the effect expected may not be achieved.
The tablets should be swallowed whole, without chewing and with a sufficient amount of water.
If you think the action of Dianben 850 mg. is too strong or too weak, inform your doctor or pharmacist.
If you need to take two or more tablets per day, you should take them in two or three divided doses, i.e. in the morning, at midday or in the evening.
The recommended starting daily dose is one tablet (850 mg. metformin
hydrochloride) 2 or 3 times per day, i.e. a maximum of 3 tablets per day (2550 mg. / day) given during or immediately after meals.
If you take more DIANBEN 850 mg. than you should:
Consult your doctor or pharmacist immediately.
In the case of an overdose or accidental ingestion, contact your local poison control centre and indicate the amount taken.
High overdose of metformin may lead to lactic acidosis (see section 2 before you take DIANBEN 850 mg.). Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.
If you forget to take a dose of DIANBEN 850 mg.:
If you forget a dose of Dianben 850 mg. one day take your normal dose on the following day as usual.
Do not take a double dose to make up for the missed dose.
POSSIBLE SIDE EFFECTS
Like all medications, Dianben 850 mg. may cause adverse effects.
Gastrointestinal disorders: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
Renal disorders: lactic acidosis.
Sensory organ disorders: metallic taste.
A decrease of vitamin B12 absorption.
Skin disorders: redness of the skin (mild erythema) in some hypersensitive individuals.
If you notice any other reaction not mentioned in this leaflet, consult your doctor or pharmacist.
STORAGE OF DIANBEN
Keep Dianben 850 mg. out of the reach and sight of children.
No special precautions for storage are necessary.
Expiry
Do not use Dianben 850 mg. after the expiry date printed on the pack.
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Expiry:
Do not use Dianben 850 mg. after the expiry date printed on the pack.
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