INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo DIAPHAGE (Tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

DIAPHAGE (Tablets)

DIAPHAGE 500 (Tablets)
DIAPHAGE 850 (Tablets)
DIAPHAGE 1000 (Tablets)

COMPOSITION:
DIAPHAGE 500:        Each film-coated tablet contains metformin hydrochloride 500 mg.
DIAPHAGE 850:        Each film-coated tablet contains metformin hydrochloride 850 mg.
DIAPHAGE 1000:        Each film-coated tablet contains metformin hydrochloride 1000 mg.
Inactive ingredients are colloidal anhydrous silica, hypromellose, macrogol 6000, magnesium stearate, maize starch, povidone PVP K-30, propylene glycol, purified talc, sodium starch glycolate and titanium dioxide.

PHARMACOLOGICAL CLASSIFICATION:
A 21.2 Oral hypoglycaemic agents.

PHARMACOLOGICAL ACTION:
Pharmacodynamics:
Metformin, a biguanide with antihyperglycaemic effects, reduces both basal and postprandial plasma glucose levels.
Metformin may act via 3 mechanisms:
1. In the liver, by reducing hepatic production of glucose through inhibition of gluconeogenesis and glycogenolysis.
2. In muscle tissue, by increasing sensitivity to insulin with improved peripheral glucose uptake and utilisation.
3. In the gut, by delaying intestinal glucose absorption.
Pharmacokinetics:
Absorption:
Following an oral metformin dose, T
max is reached in 2,5 hours. In healthy subjects, absolute bioavailability of a 500 mg or 850 mg metformin tablet is about 50 –60%. Following oral administration, the non-absorbed fraction recovered in faeces is 20 –30%.
Subsequent to oral administration, absorption of metformin is saturable and incomplete. It is assumed that the pharmacokinetic properties of metformin absorption is non-linear. At the usual metformin doses and dosing schedules, steady state plasma concentrations, which are generally less than 1 microgram/mL, are obtained within 24 to 48 hours. Maximum metformin plasma concentrations (C
max) do not exceed 4 microgram/mL, even at maximum doses.
Food decreases metformin absorption and slightly delays it. After administration of a 850 mg dose, there is a 40% lower peak plasma concentration, a 25% decrease in AUC (area under the curve) and a 35-minute prolongation of time to peak plasma concentration. The clinical significance of these decreases is not known.
Distribution:
Plasma protein binding of metformin is negligible. Metformin partitions into red blood cells. The peak concentration in blood is lower than the plasma peak concentration and occurs at around the same time. Erythrocytes most likely represent a secondary compartment of distribution. The mean volume of distribution varies between 63 276L.
Metabolism:
No metabolites of metformin, which is excreted unchanged in the urine, have been identified in humans.
Elimination:
Renal clearance of metformin is > 400 mL/min. This indicates that metformin is eliminated by both glomerular filtration and tubular secretion. After administration of an oral dose, the apparent terminal elimination half-life is about 6,5 hours.
In the presence of impaired renal function, renal clearance is decreased in proportion to that of creatinine. Therefore, the elimination half-life is prolonged, causing increased levels of metformin in plasma.

Paediatrics:
After administration of single doses of 500 mg metformin, paediatric patients demonstrate similar pharmacokinetic profiles to that observed in healthy adults.

INDICATIONS:
DIAPHAGE
is indicated for the treatment of patients with type 2 diabetes mellitus, particularly overweight individuals, when dietary management and exercise on their own do not result in adequate glycaemic control.
In adults, DIAPHAGE film-coated tablets may be given as monotherapy or in combination with other oral antidiabetic agents or with insulin.
In children over 12 years of age and adolescents with type 2 diabetes, DIAPHAGE film-coated tablets may be given as monotherapy or in combination with insulin.

CONTRAINDICATIONS:
DIAPHAGE
is contraindicated in:
Patients with hypersensitivity to metformin hydrochloride or to any of the excipients of DIAPHAGE.
Patients with diabetic ketoacidosis and diabetic pre-coma.
Renal impairment (e.g., serum creatinine levels >135 micromol/L in males and >110 micromol/L in females).
Acute conditions with the potential to alter kidney function, such as:
  o Dehydration.
  o Severe infection.
  o Shock.
  o Intravascular administration of iodinated contrast agents (see "WARNINGS" and "Special Precautions").
Acute or chronic disease which may induce tissue hypoxia, such as:
  o Cardiac or respiratory failure.
  o Recent myocardial infarction.
  o Shock.
  o Pancreatitis.
Patients with hepatic insufficiency, acute alcohol intoxication, or alcoholism.
Pregnancy and lactation (see "PREGNANCY AND LACTATION").

WARNINGS:
Lactic acidosis:
Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment) metabolic complication that can develop because of DIAPHAGE accumulation. The incidence of lactic acidosis may be reduced by also considering other associated risk factors, such as poorly controlled diabetes mellitus type 2, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia.
Characteristics of lactic acidosis are acidotic dyspnoea, abdominal pain, and hypothermia followed by coma. Diagnostic laboratory findings include decreased blood pH, plasma lactate levels in excess of 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, discontinue DIAPHAGE and hospitalise the patient immediately.
Renal function:
Since DIAPHAGE is excreted via the kidneys, serum creatinine concentrations should be determined before initiation of treatment and regularly thereafter:
At least annually in patients with normal kidney function.
At least two to four times a year in individuals with serum creatinine levels at the upper limit of normal and in the elderly.
Reduced renal function in the elderly is frequent and asymptomatic. Special caution is required in situations where renal function may become impaired, for example when antihypertensive or diuretic therapy is initiated and when therapy with an NSAID is introduced.
Administration of iodinated contrast agents:
As the intravascular administration of iodinated contrast materials in radiological studies may give rise to renal failure, DIAPHAGE should be discontinued prior to, or at the time of, the test. It should not be resumed until 48 hours afterwards, and only after kidney function has been re-assessed and found to be normal.
Surgery:
Treatment with DIAPHAGE should be discontinued 48 hours prior to elective surgery with general anaesthesia and should not be resumed earlier than 48 hours afterwards.
Children and adolescents:
The diagnosis of type 2 diabetes mellitus must be confirmed before treatment with DIAPHAGE commences.
Controlled clinical trials of one-year duration did not demonstrate any effect of DIAPHAGE on growth and puberty; however, no long-term data on these specific points are available. It is therefore recommended that DIAPHAGE-treated children, especially prepubescent children, receive careful follow-up of the effect of DIAPHAGE on these parameters.

INTERACTIONS:
Administration of DIAPHAGE with other medicines that lower blood glucose concentrations increases the risk of hypoglycaemia, while medicines that increase blood glucose may reduce the effect of DIAPHAGE therapy.
Inadvisable combinations:
Alcohol:
There is an increased risk of lactic acidosis with acute alcohol intoxication, particularly in case of:
Fasting or malnutrition.
Liver insufficiency.
Advise patients to avoid consumption of alcohol and alcohol-containing medicines.
Iodated contrast agents:
Intravascular administration of iodinated contrast agents may give rise to kidney failure, resulting in DIAPHAGE accumulation and a risk of lactic acidosis.
DIAPHAGE should be discontinued prior to, or at the time of the test. It should not be resumed until 48 hours afterwards, and only after renal function has been re-assessed and found to be normal.
Combinations requiring precautions for use:
Glucocorticoids (systemic and local routes), beta-2-agonists, and diuretics possess intrinsic hyperglycaemic activity. Medical practitioners should inform the patient and perform more frequent blood glucose monitoring. This is especially important at the beginning of treatment. If necessary, the dosage of DIAPHAGE should be adjusted during treatment with the other medicine and upon its discontinuation.
ACE inhibitors:
ACE inhibitors may decrease blood glucose concentrations. If necessary, adjust the DIAPHAGE dose during treatment with the ACE inhibitor and upon its discontinuation.
Cimetidine:
Reduced renal clearance of DIAPHAGE has been reported during cimetidine therapy, so a dose reduction should be considered.
Sulphonylureas:
Concomitant therapy of DIAPHAGE with sulphonylureas may cause hypoglycaemia.
Vitamins:
Long-term treatment with DIAPHAGE may cause vitamin B12 malabsorption.
Anticoagulants:
An interaction between DIAPHAGE and anticoagulants, such as warfarin, is possible and the dosage of the latter may require adjustment.

PREGNANCY AND LACTATION:
The use of DIAPHAGE in pregnancy and lactation is contraindicated. Safety of metformin in pregnancy and lactation has not been established in humans.
When the patient plans to become pregnant and during pregnancy, diabetes mellitus should not be treated with DIAPHAGE, but with insulin to maintain blood glucose levels as close to normal as possible. This is in order to reduce the risk of foetal malformations associated with abnormal blood glucose concentrations.
Metformin (DIAPHAGE) crosses the placenta and is distributed into breast milk in small amounts. Patients using DIAPHAGE should not breastfeed their infants.

DOSAGE AND DIRECTIONS FOR USE:
It is important that patients take DIAPHAGE tablets in divided doses with meals.
Adults:
Initially, administer one 500 mg tablet two to three times daily; or one 850 mg or 1000 mg tablet twice daily, with or after food.
After 10 to 15 days, the dose should be adjusted based on blood glucose readings. A slow dose increase may improve gastrointestinal tolerability. Good glycaemic control may be obtained within a few days, but it is not unusual for the full benefit to be delayed for up to two weeks. If control is inadequate, a cautious dose increase to a maximum of 2550 mg per day is justified. Once control has been achieved, it may be possible to reduce the DIAPHAGE dosage.
Children and adolescents:
DIAPHAGE
can be given to children from 12 years of age and adolescents.
Usually, the starting dose is 500 mg or 850 mg once daily, taken during meals or after meals.
After 10 to 15 days, the dose should be adjusted according to blood glucose measurements. A slow dose increase may improve gastrointestinal tolerability. The maximum recommended DIAPHAGE dose is 2000 mg daily, given in 2 or 3 divided doses.
Elderly:
DIAPHAGE
dose in elderly patients should be adjusted based on kidney function. Combination therapy: See "Special Precautions".

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects
:
The following side-effects may occur while using DIAPHAGE:
Blood and lymphatic system disorders:
Less frequent:        Megaloblastic anaemia.
Immune system disorders:
Less frequent:         Hypersensitivity.
Metabolic and nutrition disorders:
Less frequent:         Hypoglycaemia, lactic acidosis (see "Special Precautions").
Frequency unknown:        Decreased vitamin B12 and folic acid absorption (see "Special Precautions").
Nervous system disorders:
Frequent:         Headache.
Gastrointestinal system disorders:
Frequent:         Nausea, vomiting, diarrhoea, loss of appetite (anorexia), flatulence, dyspepsia and metallic taste.
Frequency unknown:        Abdominal pain, constipation.
Hepato-biliary disorders:
Frequency unknown:        Liver function abnormalities, severe cholestatic hepatitis.
Skin and subcutaneous tissue disorders:
Frequency unknown:         Mild erythema in some hypersensitive individuals.
General disorders:
Frequent:        Weight loss.
Special Precautions:
Lactic acidosis is associated with the use of DIAPHAGE (see "WARNINGS"). In patients presenting with a metabolic acidosis with lack of evidence of ketoacidosis (ketonuria and ketonaemia), lactic acidosis should be suspected and DIAPHAGE treatment stopped. Lactic acidosis is a medical emergency which requires treatment in hospital.
DIAPHAGE’s undesirable gastrointestinal effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that DIAPHAGE be taken in 2 or 3 daily doses during or after meals. A slow increase in the dose may also improve gastrointestinal tolerability.
DIAPHAGE is renally excreted and regular monitoring of kidney function is advised in all patients with type 2 diabetes mellitus.
DIAPHAGE treatment should be stopped 2 –3 days prior to surgery and clinical investigations, such as intravenous urography and intravenous angiography. Treatment with DIAPHAGE should be resumed only after control of renal function has been regained.
It is advised that DIAPHAGE not be used in conditions which may cause dehydration or in patients suffering from trauma, serious infections, or on low calorie intake.
Patients receiving continuous DIAPHAGE treatment should have an annual assessment of vitamin B12 levels, due to reports of decreased vitamin B
12 and folic acid absorption. This change in serum levels is generally without clinical significance (see "Side-Effects"). During concomitant treatment with a sulphonylurea, blood glucose levels should be monitored, since combined therapy may cause hypoglycaemia. It may be necessary to carry out stabilisation of diabetic patients with DIAPHAGE and insulin in hospital until the correct ratio of the two medicines has been obtained, because of the possibility of hypoglycaemia.
Other precautions:
Advise all patients to continue their diet with a regular distribution of carbohydrate intake during the day. Overweight individuals should continue their energy-restricted diet.
The usual laboratory tests for the monitoring of diabetes should regularly be performed.
In combination with insulin or other oral antidiabetics, hypoglycaemia can occur.

Ability to drive or operate machinery:
Patients should be alerted to the risk of hypoglycaemia when DIAPHAGE is used in combination with other antidiabetic agents.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Hypoglycaemia can develop when DIAPHAGE is administered concomitantly with a sulphonylurea, insulin or alcohol. In excessive doses, and particularly if there is a possibility of accumulation, patients may develop lactic acidosis. Lactic acidosis is a medical emergency and necessitates treatment in hospital. Haemodialysis is the most effective method to remove lactate and DIAPHAGE. Intense symptomatic and supportive therapy, which should particularly be directed at rectifying fluid loss and correcting blood glucose levels, is recommended.

IDENTIFICATION:
DIAPHAGE
500: White-coloured, film-coated, round, biconvex tablets scored on one side and ‘500’embossed on the other side.
DIAPHAGE 850: White-coloured, film-coated, round, biconvex tablets plain on one side and ‘850’embossed on the other side.
DIAPHAGE 1000: White, capsule-shaped, biconvex, film-coated tablets having central breakline on one side and plain on the other side.

PRESENTATION:
DIAPHAGE 500: 10 tablets per transparent/colourless PVC/aluminium blister packed in a carton. Each carton contains 9 blisters (90 tablets).
DIAPHAGE 850: 10 tablets per transparent/colourless PVC/aluminium blister packed in a carton. Each carton contains 6 blisters (60 tablets).
DIAPHAGE 1000: 10 tablets per transparent/colourless PVC/aluminium blister packed in a carton. Each carton contains 6 blisters (60 tablets).

STORAGE INSTRUCTIONS:
Store at or below 25ºC.
Protect from light and moisture.
The blisters should not be removed from the carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
DIAPHAGE
500: 44/21.2/0771
DIAPHAGE 850: 44/21.2/0772
DIAPHAGE 1000: 44/21.2/0773

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATES OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Parc du Cap, Building 9
Mispel Street, Bellville 7530 South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 April 2013

© 2013 CIPLA MEDPRO (PTY) LTD

PATIENT INFORMATION LEAFLET
Information for the Patient about
DIAPHAGE 500 / 850 / 1000 (TABLETS)

Read all of this leaflet carefully before you start taking DIAPHAGE.
• Keep this leaflet; you may need to read it again. ·
• If you have further questions, please ask your doctor or your pharmacist. ·
• DIAPHAGE has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS:
S3

PROPRIETARY NAME (AND DOSAGE FORM):
DIAPHAGE 500 (Tablets)
DIAPHAGE 850 (Tablets)
DIAPHAGE 1000 (Tablets)

WHAT DIAPHAGE CONTAINS:
The active substance in DIAPHAGE tablets is metformin hydrochloride.
Inactive ingredients are colloidal anhydrous silica, hypromellose, macrogol 6000, magnesium stearate, maize starch, povidone PVP K-30, propylene glycol, purified talc, sodium starch glycollate and titanium dioxide.

WHAT DIAPHAGE IS USED FOR:
DIAPHAGE is indicated for the treatment of type 2 diabetes mellitus. Metformin, the active ingredient in DIAPHAGE, helps to bring your blood glucose levels down by making your cells more sensitive to insulin and also possibly by delaying absorption of glucose from your gut and by decreasing your liver’s production of glucose.
DIAPHAGE can be used by adults with type 2 diabetes mellitus as single agent to control their disease, or in combination with other oral antidiabetic medicines or injectable insulin. Children older than 12 years and teenagers with type 2 diabetes may also use DIAPHAGE as single agent or in combination with insulin.

BEFORE YOU TAKE DIAPHAGE:
Do NOT take DIAPHAGE if you:
Are hypersensitive (allergic) to metformin or any of the other ingredients of DIAPHAGE.
Have kidney failure or abnormal kidney function. Please discuss with your doctor if you are unsure.
Suffered from serious complications from your diabetes previously, especially if you had a condition known as diabetic ketoacidosis. Please discuss with your doctor if you are unsure.
Suffer from any of the following conditions:
  o Dehydration.
  o Severe infection.
  o Shock (poor blood circulation with very low blood pressure).
  o Heart or lung failure.
  o Recent heart attack.
  o Any disease of your pancreas.
  o Liver disease.
  o Alcoholism, or if you are a heavy drinker of alcohol.
Are scheduled for X-ray, CT-scan or MRI-scan examinations that require the use of intravenous dye (contrast agent) that contains iodine. Please discuss with your doctor if you are unsure.
Are pregnant or breastfeeding, or if you are planning to become pregnant.

Take special care with DIAPHAGE:
Before using DIAPHAGE you should speak to your doctor if you:
Suffer from impaired kidney function or any kidney disease. Your doctor may need to test your kidney function while you are taking DIAPHAGE.
Are scheduled for surgery. Inform your doctor at least 48 hours before going for surgery as your doctor may need to temporarily stop your treatment until/after the surgery.
DIAPHAGE may cause a condition known as lactic acidosis, which may be life-threatening (see "POSSIBLE SIDE-EFFECTS"). Lactic acidosis is a medical emergency. It is characterised by unexpected weight loss, nausea and vomiting, rapid breathing and stomach pains. If you suffered from this condition previously, you should tell your doctor before you start taking DIAPHAGE. If you develop these symptoms while using DIAPHAGE, please inform your doctor immediately.
Children older than 12 years and adolescents who use DIAPHAGE will have to undergo periodic examinations to ensure that they are growing and developing normally.
All patients on DIAPHAGE require regular clinical and blood examinations to ensure that their condition is well-controlled. All patients should continue their diabetic diet with regular meals during the day. Overweight patients should continue their energy-restricted diet.
You will have to undergo periodic blood tests to ensure that your blood glucose levels are within normal limits and that your kidneys are still functioning properly.
When DIAPHAGE is combined with other medicines that lower blood glucose levels, there is a risk that blood glucose levels may fall too low (a condition known as hypoglycaemia). Please see "Taking other medicines with DIAPHAGE".

Taking DIAPHAGE with food and drinks:
DIAPHAGE should be taken with or after meals.
You should eat carbohydrates regularly throughout the day.
You should not skip meals.
You need to follow your doctor’s/nutritionist’s advice regarding your diet very carefully.
Please discuss the use of alcohol with your doctor, pharmacist or other healthcare professional.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding your baby, you should not use DIAPHAGE (please see "Do NOT take DIAPHAGE if you"). Please inform your doctor or pharmacist if you are planning to become pregnant. DIAPHAGE is excreted in small quantities in breast milk.
If you are pregnant or breastfeeding your baby while taking DIAPHAGE, please consult your doctor, pharmacist, or other healthcare professional for advice.

Driving or using machinery:
When your blood glucose levels fall too low, you may feel faint, dizzy, confused, sweaty and nauseous. You should not drive or use tools or machines if your blood glucose levels are too low. This can sometimes happen when DIAPHAGE is combined with other medicines or with insulin (please see "Taking other medicines with DIAPHAGE"). Do not drive or operate machinery before you know how DIAPHAGE will affect you.

Taking other medicines with DIAPHAGE:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, concomitant use of such medicines with DIAPHAGE may cause undesirable interactions. Please consult your doctor or pharmacist, or other healthcare professional for advice.
In particular tell your doctor if you are taking:
Alcohol or medicines that contain alcohol, as this may increase your risk of developing hypoglycaemia (low blood glucose levels) or lactic acidosis (see "Take special care with DIAPHAGE").
Glucocorticosteroids, such as hydrocortisone or betamethasone, because this may make DIAPHAGE less effective.
Beta-2-agonists for the treatment of asthma or chronic obstructive pulmonary (lung) disease (COPD), as this may negatively impact on the efficacy of DIAPHAGE.
Diuretics (water tablets), since this may make DIAPHAGE less effective.
ACE inhibitors, since these medicines may lower blood glucose levels and combined use may therefore increase your risk of hypoglycaemia.
Cimetidine, as this may affect your kidney’s excretion of DIAPHAGE.
Anticoagulant ("blood thinning") medicines, such as warfarin, as an interaction between DIAPHAGE and these medicines is possible and the dosage of your anticoagulant may need adjustment.

HOW TO TAKE DIAPHAGE:
Always take DIAPHAGE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Do not share medicines prescribed for you with others.
DIAPHAGE
should be taken in divided doses with meals.
Adults:
Initially, one 500 mg tablet two to three times a day; or one 850 mg or 1000 mg tablet twice a day (mornings and evenings), with or after food.
After 10 to 15 days your doctor may change the dose based on measurements of your blood glucose levels.
Children >12 years and adolescents:
Initially, one 500 mg or one 850 mg tablet once daily, with or after meals.
After 10 to 15 days your doctor may change the dose based on measurements of your blood glucose levels.
You should continue to take DIAPHAGE for as long as your doctor considers necessary.
If you have the impression that the effect of DIAPHAGE is too strong or too weak, talk to your doctor or pharmacist.
Elderly patients:
Your doctor will change your dose depending on your kidney function.

If you take more DIAPHAGE than you should:
In the event of an overdosage, or if someone else has taken your medicine by mistake, you, or this other person, may experience side-effects such as those listed below.
The most dangerous side-effect from overdosage is lactic acidosis, which can be life-threatening. In the event of overdosage, consult your doctor or pharmacist immediately. If neither is available, immediately seek help at the nearest hospital or poison control centre.

If you forget to take DIAPHAGE:
Always take DIAPHAGE as prescribed. If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to compensate for the forgotten individual dose. It is important to take DIAPHAGE regularly, because irregular intake may increase the risk of developing too high blood glucose levels with all its associated complications.

POSSIBLE SIDE-EFFECTS:
DIAPHAGE may have side-effects.
Not all side-effects reported for DIAPHAGE are included in this leaflet. Should your general health worsen while taking DIAPHAGE, please consult your doctor, pharmacist or other healthcare professional for advice.
Check with your doctor immediately if you develop a combination of the following symptoms:
Stomach discomfort, unexpected weight loss, nausea and vomiting, very rapid breathing that you cannot control, and stomach pain, as these are symptoms associated with the development of lactic acidosis (see "Take special care with DIAPHAGE"). You should report these symptoms to your doctor as a matter of urgency.
Check with your doctor or pharmacist as soon as possible if any of the following side-effects continue or become bothersome:
•Headache, diarrhoea, loss of appetite, flatulence (gas), stomach discomfort, and a metallic taste in the mouth. These side-effects occur most frequently during initiation of therapy. Other side-effects include skin rash, weight loss, and low red blood cell counts (anaemia). Some patients may experience low blood glucose levels (hypoglycaemia), especially when DIAPHAGE is combined with other medicines that lower blood glucose concentrations. Symptoms of hypoglycaemia include faintness, dizziness, confusion, sweating and palpitations. You may also develop reduced absorption of vitamin B12 and folic acid from your gut during long-term use of DIAPHAGE. Your doctor will monitor you for this.
Not all side-effects reported for DIAPHAGE are included in this leaflet.
Please tell your doctor or pharmacist of any undesirable effects you think may be due to DIAPHAGE, especially if not mentioned in this leaflet.

STORAGE AND DISPOSING OF DIAPHAGE:
Store at or below 25°C. Protect from light and moisture.
The blisters should not be removed from the carton until required for use.
Do not use the medication after the expiry date stated on the packaging material.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems, for example toilets.
KEEP THIS MEDICINE OUT OF REACH OF CHILDREN.

PRESENTATION OF DIAPHAGE:
DIAPHAGE 500:        10 tablets per transparent/colourless PVC/aluminium blister packed in a carton. Each carton contains 9 blisters (90 tablets).
DIAPHAGE 850:        10 tablets per transparent/colourless PVC/aluminium blister packed in a carton. Each carton contains 6 blisters (60 tablets).
DIAPHAGE 1000:         10 tablets per transparent/colourless PVC/aluminium blister packed in a carton. Each carton contains 6 blisters (60 tablets).

IDENTIFICATION OF DIAPHAGE:
DIAPHAGE 500:        White-coloured, film-coated, round, biconvex tablets scored on one side and ‘500’embossed on the other side.
DIAPHAGE 850:        White-coloured, film-coated, round, biconvex tablets plain on one side and ‘850’embossed on the other side.
DIAPHAGE 1000:         White, capsule-shaped, biconvex, film-coated tablets having central breakline on one side and plain on the other side.

REGISTRATION NUMBERS:
DIAPHAGE 500: 44/21.2/0771
DIAPHAGE 850: 44/21.2/0772
DIAPHAGE 1000: 44/21.2/0773

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATES OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Parc du Cap, Building 9
Mispel Street, Bellville 7530 South Africa

DATE OF PUBLICATION OF THIS PATIENT LEAFLET:
19 April 2013

© 2013 CIPLA MEDPRO (PTY) LTD

New addition to this site: December 2016.
Source: http://www.cipla.co.za/wp-content/uploads/2013/10/diaphage.pdf

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