GLIMEPIRIDE DENK 2 Tablet

In the treatment of a certain type of diabetes (type 2 diabetes mellitus) when diet, physical exercise and weight reduction alone are not sufficient.

The basis for treatment of diabetes is the diet recommended by doctor which should be strictly adhered to When taking this tablet, patients must still observe the dietary instructions, as medicine cannot compensate for diet.

Dosage

See the package insert about the details.

The usual starting dose for an adults is 1mg/day. If this treatment is successful, this dosage can be used for maintenance therapy.

If the daily needs to be raised, based on glycaemic control, this should be done gradually to 2,3mg or 4mg/day at intervals of about 1-2 weeks.

A dosage of more than 4mg glimepiride/day gives better results only in exceptional cases. The maximum daily dose is 6mg.

If patients are not adequately controlled with the maximum daily dose of metformin, concomitant therapy with Glimepiride Denk 2 can be initiated under careful medical supervision.

If patients are not adequately controlled with the maximum daily dose of Glimepiride Denk 2, concomitant therapy with insulin can be initiated under careful medical supervision.

In cases such as these your attending doctor will decide what dose of Glimepiride Denk 2, metformin or insulin you individually require.

How should it be taken?

The tablets are swallowed whole with sufficient fluids (e.g, a glass of water).

Your doctor will decide about the time of intake and the distribution of doses taking your lifestyle into consideration (dietary habits).

Normally the entire daily dose of glimepiride is taken once shortly before or during a substantial breakfast. If no breakfast is taken, then Glimepiride Denk 2 should be taken shortly before or during the first main meal.

It is important to take Glimepiride Denk 2 on schedule at the times suggested by your doctor. You mustn’t skip meals if you have taken Glimepiride Denk 2.

- if you are allergic (hypersensitive) to glimepiride, certain other drugs (sulfonylureas or sulfonamides) or any of the other ingredients of Glimepiride Denk 2,

- in insulin-dependent diabetics (type 1 diabetes mellitus),

- in cases of clouding or loss of consciousness caused by very high blood sugar levels (diabetic precoma and coma),

- in diabetic metabolic decompensation (e.g. ketoacidosis or history of it),

- in cases of severe renal or hepatic impairment.

Experience gained to date concerning the use of Glimepiride Denk 2 in patients with severe renal impairment (dialysis patients) or severe hepatic impairment is not sufficient. Treatment with insulin is therefore indicated in these patients.

Blood and lymphatic system disorders

Rare: Blood count changes are rare. They are generally reversible upon discontinuation of treatment. However, they may also be severe in individual cases, there occurred reduced platelet count, reduced red and white blood cell count and sometimes life-threatening reduction of all blood cells, anemia (haemolytic anaemia).

Immune system disorders

In very rare cases, hypersensitivity reactions (e.g. of the skin) may develop into life-threatening reactions associated with dyspnoea, fall in blood pressure and sometimes shock. Please therefore inform your attending doctor immediately if skin reactions occur. Allergic inflammation of the blood vessels (allergic vasculitis) may occur and is also very rare.

Cross-allergenicity with other medicines such as sulfonylureas (hypoglycaemic agents), sulfonamides (antibiotics) or related substances is possible.

Metabolic and nutrition disorders

A severe drop in blood sugar (hypoglycaemia) is rare.

Eye disorders

Transient visual disturbances may also occur, particularly on initiation of treatment.

Gastrointestinal disorders

Nausea, vomiting, diarrhoea, epigastric fullness and abdominal pain are very rare. In rare cases, these may necessitate discontinuation of therapy.

Hepatobiliary disorders

There may be an increase in hepatic enzymes.

Very rarely hepatic impairment (e.g. obstruction of biliary drainage and jaundice), hepatitis and sometimes life-threatening liver failure are possible.

Hepatobiliary disorders

There may be an increase in hepatic enzymes.

Very rarely hepatic impairment (e.g obstruction of biliary drainage and jaundice), hepatitis and sometimes life-threatening liver failure are possible.

Skin and subcutaneous tissue disorders

Hypersensitivity reactions of the skin such as pruritus, rash and urticaria are rare.

Photosensitivity has been observed in very rare instances.

Investigations

Very rare: Blood sodium decrease.

Some medicine-induced adverse drug reactions (e.g. hypoglycaemia, liver failure, certain blood count changes, hypersensitivity reactions) may be life-threatening. Please therefore inform your doctor immediately if an adverse drug reaction develops suddenly or gets rapidly worse. On no account should you continue to take the medicine without a doctor’s instructions.

If Glimepiride Denk 2 is taken simultaneously with certain other medicinal products, both undesired increases and decreases in the hypoglycaemic action of Glimepiride Denk 2 may occur.

Hypoglycaemia caused by an increase in the hypoglycaemic effect of Glimepiride Denk 2 may occur when one or more of the following medicines are taken simultaneously:

- other antidiabetic drugs, including insulin,

- anti-infective agents (antibiotics such as chloramphenicol, quinolone derivatives, tetracyclines, sulfonamides),

- analgesics or antirheumatic agents (pyrazolone derivatives such as phenylbutazone, azopropazone, oxyphenbutazone),

- analgesics (salicylates),

- antituberculosis agents (p-amino salicylic acid),

- muscle building drugs (anabolic substances and male sex hormones),

- anticoagulants (coumarin),

- antifungal agents (miconazole, fluconazole),

- antihypertensive agents or drugs that slow the heart rate (ACE inhibitors, beta-receptor blockers, sympatholytics),

- mood elevating agents( fluoxetine, MAO inhibitors),

- appetite suppressants (fenfluramine),

- lipid lowering medications (fibrates),

- certain medicines used in the treatment of cancer (cyclo-, tro- and iphosphamide),

- medicines to treat allergies (tritoqualine),

- high dose medicine to enhance blood flow administered as an infusion (pentoxifylline),

- medicines to treat gout (probenecide, allopurinol, sulfinpyrazone).

An increase in blood sugar caused by a decrease in the hypoglycaemic effect to Glimepiride Denk 2 ay occur when one or more of the following medicines are taken simultaneously with Glimepiride Denk 2:

- female sex hormones (oestrogen and progestogen),

- diuretics (saluretics, thiazide diuretics),

- thyroid hormones,

- anti-inflammatory agents (corticoids),

- medicines to treat seizures or schizophrenia (phenytoin, phenothiazine derivatives),

- antihypertensive agents (diazoxide),

- medicine to treat tuberculosis (rifampicin),

- medicine to treat hypoglycaemia (glucagon),

- sleeping pill (barbiturate),

- medicine to treat certain eye diseases (acetazolamide),

- medicines that increase the heart rate (adrenaline and sympathomimetics),

- lipid lowering medicines (nicotinate),

- prolonged use of laxatives.

Medicines to treat gastric or duodena ulcers (H2 receptor antagonists) or antihypertensive medicines (beta-receptor blockers, clonidine and reserpine) may lead to either potentiation or weakening of the blood-glucose-lowering effect of Glimepiride Denk 2.

Alcohol consumption may potentiate or weaken the hypoglycaemic effect of Glimepiride Denk 2.

Certain medicines that affect the central nervous system such as beta-receptor blockers, clonidine, guanethidine and reserpine can mask or suppress the symptoms of hypoglycaemia.

Glimepiride Denk 2 may potentiate or weaken the effects of anticoagulants such as coumarin derivatives.

Please see the package insert about the details below:

Taking this tablet with food and drink.

Contraindicated (See the package insert about the details.)

Patients receiving treatment with this tablet require regular medical supervision: Treatment with Glimepiride Denk 2 requires regular monitoring of your glucose levels in blood and urine. In addition, determination of glycosylated haemoglobin (HbA1, or HbA1c) is recommended. Furthermore, your blood count, in particular the white blood cell count (leukocytes) and platelet count (thrombocytes), and your hepatic function should be checked.

In order to achieve satisfactory metabolic control (e.g. stable blood sugars within the normal range) you must adhere strictly to your doctor’s prescribed treatment plan.

Keeping to a diet, physical exercise and, if necessary, weight reduction are just as important as taking tablets on a regular basis. It is also important to regularly attend the appointments arranged by your doctor to have your glucose levels in blood and urine checked.

There may be an increased risk of developing low blood glucose levels (hypoglycaemia) on initiation of treatment. Especially careful medical supervision is therefore required during this period.

Hypoglycaemia may also occur:

- if you take your meals at irregular hours or skip them altogether,

- if you fast,

- if you are undernourished,

- if you alter your diet,

- if you exercise more than usual and there is an imbalance between physical exertion and carbohydrate intake,

- if you consume alcohol, especially in combination with skipped meals,

- if you are taking other medicines or natural remedies at the same time,

- if you are taking too high a dose of Glimepiride Denk 2,

- if you suffer from certain hormonal disorders (as for example function disorders of thyroid gland, pituitary gland or adrenal cortex),

- if you have renal impairment,

- if you have severe hepatic impairment,

- if you do not follow your doctor’s instructions and the instructions contained in this package leaflet.

Possible symptoms of hypoglycaemia, which could draw your or someone else’s attention to a pronounced drop in blood sugar, are as follows: headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, impairment of speech and visual disorders that are sometimes severe, aphasia, tremor, paresis, sensory disturbances, dizziness and helplessness. In addition, sweating, clammy skin, anxiety, tachycardia (“racing heart”), hypertension, palpitations, sudden severe chest pain that may radiate to surrounding areas (angina pectoris) and cardiac arrhythmias may occur.

If your hypoglycaemia progresses you may become delirious, develop seizure, loose your self-control. have shallow breathing and slowed heart beat and become unconscious.

The clinical picture of severe shock caused by hypoglycaemia may resemble that of a stroke.

Symptoms of hypoglycaemia can almost always be promptly controlled by immediate intake of carbohydrates (sugar as for example in dextrose bars, sugar cubes, sweet fruit juices, sugared tea). For this reason you should always carry some dextrose bars (at least 20g) with you. Please note that artificial sweeteners have no effect. If taking sugar has no effect or if the symptoms recur, consult your doctor immediately or go to the nearest hospital.

Warning symptoms of hypoglycaemia may be absent reduced or develop gradually. You do not notice in time that you are hypoglycaemic. This is possible in elderly patients, if you are taking certain medicines (those acting on the central nervous system or beta-receptor blockers) or if you suffer from a certain form of neuropathy (autonomic neuropathy). The counter regulation may be impaired in case of impaired hepatic function.

In stress situations such as accidents, surgeries or fever, a temporary switch to insulin may be required.

Clinical symptoms of raised blood sugar (hyperglycaemia due, for example, to still insufficient blood sugar reducing effect of Glimepiride Denk 2, not adhering to the treatment plan prescribed by the doctor or in particularly stressful situations) may be as follows: severe thirst, dry mouth, frequent urination, itchy and/or dry skin, fungal or skin infections as well as reduced achievement potential.

Particular caution is advised if you suffer from a particular disease of the red blood cells, as so-called treatment with glimepiride may damage deficiency, as blood cells and reduce your haemoglobin level (haemolytic anaemia).

See the package insert about the details below:

Children

The elderly

Hypoglycaemic drug (oral antidiabetic belonging to the class of sulfonylurea agents).