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Amaryl 2-4 mg. tablets
glimepiride
The active ingredient in your Amaryl tablets is glimepiride. Each tablet contains 2-4 mg. of glimepiride.
The other ingredients are: lactose, sodium starch glycollate, magnesium stearate, cellulose and povidone 25000, iron oxide yellow (E172) and indigo carmine lake (E132).
WHAT IS AMARYL
Amaryl belongs to the group of medications called Oral Antidiabetic agents, which lower blood glucose to normal levels in patients with adult-onset diabetes (Type II).
It is indicated for the treatment of adult-onset diabetes (Type II), when diet, physical exercise and weight reduction alone are not adequate.
BEFORE TAKING AMARYL
Do not take Amaryl
- If you have Type I (juvenile onset diabetes, that occurs when the pancreas produces too little insulin to regulate blood sugar levels appropriately).
For the treatment of patients with ketoacidosis (abnormally high acidity of blood with an accumulation of ketone bodies).
If you suffer a diabetic coma (a state of unconsciousness caused by ketoacidosis).
If you suffer severe renal or hepatic function disorders.
If you are allergic to this medication or other oral medications used to treat diabetes (other sulphonylureas or sulphonamides) or to any of the excipients in this medication.
If you are pregnant or breastfeeding (see "Use in pregnancy" or "Use in lactation").
Take special care with Amaryl:
If you do not eat regular meals, treatment with Amaryl may lead to a decrease in blood glucose level (hypoglycaemia).
If you can't take Amaryl on a regular basis, as this may lead to a decrease in blood glucose level (hypoglycaemia).
If you experience symptoms of hypoglycaemia (see "Further recommendations for the management of hypoglycaemia") despite having taken sugar. If these symptoms are severe or prolonged, you should consult your doctor immediately.
If you suffer impaired renal function or liver dysfunction, as this may lead to a decrease in blood glucose level (hypoglycaemia). Your doctor will recommend regular monitoring of renal and hepatic function.
If you suffer any metabolic disorder (thyroid, parathyroid function or steroid hormone disorders), as these may lead to a decrease in blood glucose level (hypoglycaemia).
If you are going to have an operation, as your doctor may need to temporarily interrupt treatment and change you over to insulin.
If you have an accident or an infection with fever, your doctor may prescribe a temporary change from this treatment to insulin.
If you take Amaryl concomitantly with insulin or other anti-diabetic agents, as this may lead to a decrease in blood glucose levels (hypoglycaemia) (see "Use of other medications").
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Use of other medications:
Inform your doctor or pharmacist if you are taking or have recently taken any other medication, even those bought without a prescription.
Hypoglycaemia may occur if you take Amaryl concomitantly with the following drugs:
Anti-inflammatory drugs (phenylbutazone, azapropazon and oxyfenbutazone; salicylates and p-amino-salicylic acid).
Anti-diabetic products (oral anti-diabetic products, insulin and metformin).
Anabolic steroids and male sex hormones.
Coumarin anticoagulants
Lipid-lowering agents (fibrates)
Medications used to treat certain heart diseases and high blood pressure.
Some antihypertensive medications (adrenergic type).
Medications used to treat cancer (cyclo-, tro- and iphosphamides).
Uricosuric agents (sulphinpyrazone, allopurinol and probenecid).
Medications used to treat infections (chloramphenicol, certain long acting sulphonamides, tetracyclines, quinolone antibiotics, miconazole, high dose parenteral pentoxifylline).
Medications used to treat depression (fluoxetine).
Tritoqualine.
Fenfluramine.
Hyperglycaemia may occur if you take Amaryl concomitantly with the following drugs:
Oestrogens and progestagens.
Certain antihypertensives (saluretics and thiazide diuretics).
Thyroid stimulating agents.
Glucocorticoids.
Phenothiazine derivatives (chlorpromazine).
Adrenaline and sympathicomimetics.
Nicotinic acid (high dosages) and nicotinic acid derivatives.
Laxatives (long term use).
Barbiturates.
Phenytoin, diazoxide, glucagon, rifampicin and acetozolamide.
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Hypoglycaemia or hyperglycaemia may occur if Amaryl is taken concomitantly with the following drugs:
Proton pump inhibitors
Medications used to treat hypertension, cardiac ischemia and arrhythmias, clonidine, and reserpine. Concomitant treatment with these medications may mask the warning symptoms of a hypoglycaemic attack.
Alcohol.
The effects of oral anticoagulants may be potentiated or weakened if taken concomitantly with Amaryl.
Use in pregnancy
If you are pregnant or think you might be, you should not take Amaryl. Under such circumstances you should consult your doctor who may recommend the use of insulin.
Consult your doctor or pharmacist before taking any medication.
Use in lactation
If you are breastfeeding do not take Amaryl. Under such circumstances you should consult your doctor who may recommend the use of insulin.
Consult your doctor or pharmacist before taking any medication.
Use in children
The safety and efficacy of Amaryl in children have not been studied.
Use in the elderly
There have been no specific studies in the elderly.
Since elderly patients are more likely to have decreased biological functions, greater care should be taken in dosage adjustment, and it may be necessary to monitor these patients closely.
Effects on ability to drive and use machines:
Alertness and reactions may be impaired due to hypoglycaemia or hyperglycaemia (low blood glucose or high blood glucose levels), especially when beginning or after altering treatment or when Amaryl is not taken regularly. This may, for example, affect the ability to drive or to operate machinery.
Consult your doctor or pharmacist before taking any medication.
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HOW TO TAKE AMARYL
Follow these instructions unless given other indications by your doctor.
Remember to take your medication.
The basis for successful treatment of diabetes is a good diet, regular physical activity, as well as routine checks of blood and urine. Tablets or insulin cannot compensate if the patient does not keep to the recommended diet.
Dosage is determined by the results of blood and urinary glucose determinations.
The starting dose is 1 mg. Amaryl per day. If good control is achieved this dosage should be used for maintenance therapy.
If control is unsatisfactory your doctor will recommend the dosage be increased, in a stepwise manner to 2, 3 or 4 mg. Amaryl per day.
A dosage of more than 4 mg. Amaryl per day should only be recommended in exceptional cases. The maximum recommended dose is 6 mg. Amaryl per day.
If a patient has a hypoglycaemic reaction (see "Further recommendations for the management of hypoglycaemia") on 1 mg. Amaryl daily, he/she should inform their doctor as this indicates that they probably may be controlled by diet alone.
In the course of treatment with Amaryl, the dosage required may decrease. Therefore your doctor may adjust your daily dosage according to your individual needs or even interrupt treatment all together.
In patients not adequately controlled with metformin, concomitant Amaryl therapy can be initiated. Therefore your doctor should determine the dosage of Amaryl which should be taken with metformin.
Your doctor will decide whether Amaryl treatment should be combined with concomitant insulin therapy. In this case your doctor should determine the dosage of insulin which should be taken with Amaryl tablets
If you think that the action of Amaryl is too weak or too strong for you inform your doctor or pharmacist.
Tablets should be swallowed whole, not chewed with some liquid.
Normally a single daily dose of Amaryl is sufficient. It is recommended that this dose be taken shortly before or during a substantial breakfast or -if none is taken -shortly before or during the first main meal.
Your doctor will indicate the duration of your treatment with Amaryl. Do not discontinue treatment before because this may unbalance your blood glucose level again.
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If you take more Amaryl than you should:
After ingestion of an overdosage severe hypoglycaemia may occur (see "Take special care with Amaryl"), lasting from 12 to 72 hours, and may recur after an initial recovery. Symptoms may not be present for up to 24 hours after ingestion. If this occurs consult your doctor or go to the nearest hospital casualty department and take this leaflet with you.
In case of overdosage or accidental ingestion consult your local poison centre (Servicio de Información Toxicológica). Telephone 91 562 04 20.
If you forget to take Amaryl:
Do not take a double dose to make up for the missed doses.
POSSIBLE SIDE EFFECTS
Like all medications, Amaryl may have side effects.
Metabolic reactions
In rare cases hypoglycaemic (reduced blood glucose level) reactions have been observed after administration of Amaryl. These reactions mostly occur immediately, may be severe and are not always easy to correct. The occurrence of such reactions depends, as with other hypoglycaemic therapies, on individual factors such as dietary habits and the dosage (see "Take special care with Amaryl").
Haematologic reactions
In rare cases you may experience fever, sore throat, haemorrhage into skin and mucous membrane, extreme paleness and changes in blood analysis, such as a decrease of red blood cells and / or white blood cells, which may be indicative of a blood disorder (thrombocytopenia, leucopenia, erythrocytopenia, granulocytopenia, agranulocytosis, haemolytic anaemia and pancytopenia), these are usually detected during regular check-ups and are in general reversible upon discontinuation of medication. Inform your doctor immediately if you experience any of these symptoms
Dermatologic reactions
Allergic skin reactions such as red spots on the skin, itching, or rash that is irritating or itchy (urticaria) may occur. In isolated cases hypersensitivity to light or inflammation of blood vessels (allergic vasculitis) may occur.
In isolated cases allergic reactions with breathing difficulties, palpitations, anxiety with intense sweating, chest pain or chest tightness and decreased blood pressure may develop. If you experience any of these symptoms, notify your doctor immediately.
Hepatic reactions
Elevation of liver enzymes may occur. In isolated cases, impairment of liver function may develop; this is manifested by yellow colouring of the skin and mucous membranes (jaundice), and slowing or cessation of the flow of bile (cholestasis), as well as inflammation of the liver (hepatitis), which may progress to decreased liver function (liver failure). If you suffer any hepatic impairment, your doctor will recommend regular hepatic monitoring during treatment with Amaryl (see "Take special care with Amaryl").
Gastrointestinal reactions
In very rare cases nausea, vomiting and diarrhoea, pressure or a feeling of fullness in the stomach or abdominal pain may occur. If you experience any of these symptoms consult your doctor as soon as possible.
Visual reactions
Transient visual disturbances may occur. If this occurs consult your doctor as soon as possible.
If you experience any other reaction not mentioned in this patient information leaflet consult your doctor or pharmacist.
STORAGE OF AMARYL
Do not store Amaryl above 25°C.
Keep Amaryl out of the reach and sight of children.
Expiry:
Do not use Amaryl after the expiry date indicated on the box.
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