PACKAGE LEAFLET: INFORMATION FOR THE USER
LIMEZAPINE 1 mg, 2 mg, 3 mg and 4 mg, tablet glimepiride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What LIMEZAPINE is and what it is used for
2. What you need to know before you take LIMEZAPINE
3. How to take LIMEZAPINE
4. Possible side effects
5. How to store LIMEZAPINE
6. Contents of the pach and other information
1. WHAT LIMEZAPINE IS AND WHAT IT IS USED FOR
LIMEZAPINE is a medicine taken by mouth to help lower blood sugar (sulphonamides, urea derivatives). This medication is indicated for non-insulin-dependent sugar diabetes (type 2), when diet, physical exercise and weight reduction alone are not sufficient to re-establish the glycaemic equilibrium.
In patients not balanced by the maximum doses of metformine, the association of glimepiride and metformine may be initiated under strict medical control.
For patients insufficiently balanced by LIMEZAPINE at the maximum dose, treatment by insulin may be associated under strict medical control.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIMEZAPINE Do not take LIMEZAPINE:
- if you are allergic (hypersensitive) to glimepiride or any of the other ingredients of LIMEZAPINE (listed in section 6),
- if you are allergic (hypersensitive) to other sulphamides and sulphonylureas,
- if you have diabetes requiring a treatment by the insulin (or insulin- dependent), in particular decompensated diabetes,
- if you have renal failure (severe kidney failure), - if you have severe hepatic failure (severe liver failure).
If you are not sure, talk to your doctor or pharmacist before taking LIMEZAPINE. Warnings and precautions :
Talk to your doctor or pharmacist before taking LIMEZAPINE: - if you have a liver, kidney, thyroid glands, adrenal glands disease,
- if you have surgical operation or dental treatment, fever, infection, difficulty feeding, modification of the weight,
- if you are planning to become pregnant,
- if you are taking another medicine in particular: other oral anti-diabetic, anticoagulants (Anti-vitamin K or AVK), anti-inflammatory drug, beta adrenergic blocking agent, contraceptive pill.
- lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase.
Important information about your medicine
This medicine may provoke hypoglycaemia (low blood sugar), which has the following symptoms: headaches, ravenous hunger, nausea, vomiting, tremor, fatigue, sleepiness, paresis, helplessness, dizziness, speech and visual disorders, behavioural disorders (agitation, aggression, depression, confusion, loss of self control, delirium), sleep disorders (somnolence), impaired concentration, sensory disturbances, alertness and reaction time, aphasia, convulsions, loss of consciousness amounting to and including coma, shallow respiration and bradycardia.
In addition, signs of adrenergic counter-regulation may be present such as sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmias.
In cases of occurrence of these symptoms, consume some sugar or some form of sugar (artificial sweeteners are not effective) and contact your doctor.
You are more at risk of experiencing hypoglycaemia (lower blood sugar) if you have any of the following: - undernourishment, irregular meal times, missed or delayed meals or a period of fasting,
- changes to your diet,
- changes to physical exercise,
- drink alcohol (especially when you skip a meal), - impaired renal function,
- severe hepatic impairment, - overdosage of LIMEZAPINE,
- if you have a history of certain hormonal problems (thyroid disorders or adrenal problems), - taking certain other medicines (see section “ Taking other medicines).
The sulphonamide hypoglycaemia (or an oral anti-diabetic) treatment may necessary: - regular meal times,
- regular taking treatment.
In patients not balanced by the maximum doses of metformine, the association of glimepiride and metformine may be initiated under strict medical control, in the following way:
- while maintaining the dose of the metformine, the glimepiride treatment will begin with low doses, then increase gradually up to the maximal doses, according to the popular metabolic balance.
For patients insufficiently balanced by LIMEZAPINE at the maximum dose, treatment by insulin may be associated, in the following way:
- while maintaining the dose of the glimepiride, the insulin-therapy will begin in low doses under strict medical control.
Any taking of LIMEZAPINE must be followed by a meal.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The colouring agents included in LIMEZAPINE 2 mg tablets, Sunset Yellow FCF (E 110) and Tartrazine (E102), may cause allergic reactions.
Other medicines and LIMEZAPINE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Because they can modify in an important way your glycaemia, certain combination therapies must be avoided. You should not set of your own initiative of medicines.
The following medicines can increase the blood sugar lowering effect of LIMEZAPINE. This can lead to a risk of hypoglycaemia (low blood sugar):
- Other medicines to treat diabetes mellitus (such as insulin or metformin),
- Medicines to treat pain and inflammation (phenylbutazone, azopropazone, oxyphenbutazone, aspirin-like medicines),
- Medicines to treat urinary infections (such as some long acting sulfonamides),
- Medicines to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin),
- Medicines to inhibit blood clotting (coumarin derivatives), - Medicines to support muscle build up (anabolics),
- Medicines used for replacement therapy by male sex hormones, - Medicines to treat depression (fluoxetine, MAO-inhibitors), - Medicines lowering high cholesterol level (fibrates), - Medicines lowering high blood pressure (ACE inhibitors),
- Medicinal products called anti-arrhythmic agents used to control abnormal heart beat (disopyramide), - Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone),
- Medicines to treat cancer (cyclophosphamide, iphosphamide, trophosphamide), - Medicines used to reduce weight (phenfluramine),
- Medicines to increase circulation when given in a high dose intravenous infusion (pentoxifylline), - Medicines to treat nasal allergies such as hay fever (tritoqualine),
- Medicines (called sympatholytics) to treat blood pressure, heart failure, or prostate symptoms.
The following medicines may decrease the blood sugar lowering effect of LIMEZAPINE. This can lead to a risk of hyperglycaemia (high blood sugar level):
- Medicines containing female sex hormones (oestrogens, progestogens), - Medicines to treat high blood pressure (thiazide diuretics, saluretics), - Medicines used to stimulate the thyroid gland (such as levothyroxine), - Medicines used to treat allergies and inflammation (glucocorticoids),
- Medicines to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives),
- Medicines used to raise heart beat, to treat asthma or nasal congestion, coughs and colds, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics),
- Medicines to treat high cholesterol level (nicotinic acid and nicotinic acid derivatives), - Medicines to treat constipation when they are used long term (laxatives),
- Medicines used to treat fits (phenytoin),
- Medicines used to treat nervousness and sleep problems (barbiturates), - Medicines used to treat increased pressure in the eye (acetazolamide), - Medicines to treat high blood pressure or lowering blood sugar (diazoxide), - Medicines to treat infections, tuberculosis (rifampicine),
- Medicines to treat severe low blood sugar levels (glucagon).
The following medicines can increase or decrease the blood sugar lowering effect of LIMEZAPINE: - medicines for stomach ulcers (called H2 antagonists),
- medicines to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine and reserpine.
These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines. LIMEZAPINE may either increase or weaken the effects of the following medicines:
- medicines inhibiting blood clotting (coumarin derivatives).
LIMEZAPINE with food, drink and alcohol
Alcohol intake may increase or decrease the blood sugar lowering action of LIMEZAPINE in an unpredictable way.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- This medicine should not be taken during pregnancy.
- The treatment of the diabetes during the pregnancy requires insulin treatment. Contact your doctor if you are planning to become pregnant.
- If you are pregnant, tell your doctor so that he prescribes you an adapted treatment. - This medicine should not be taken during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Your ability to concentrate or react and your vision, when you drive or operate machines, may be reduced when diabetes treatment is not balanced or in case of hypoglycaemia.
LIMEZAPINE contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
LIMEZAPINE 2 mg, tablet contains sunset yellow FCF (E110) and tartrazin (E102) which may cause allergic reactions.
Always take this medecine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine - Oral route.
- The tablets are to be swallowed whole with a little liquid, just before, or with the first main meal of the day (usually breakfast).
- Take LIMEZAPINE exactly as your doctor has told you.
- The level of sugar in your blood or urine should be checked regularly. Your doctor may adapt your treatment based on these results.
- While being treated with LIMEZAPINE (or other oral anti-diabetic medications) it is necessary to keep regular meal times and take the medication at the same time everyday.
How much to take
- The usual dose is 1 mg to 4 mg once a day.
- The maximum recommended dose is 6 mg glimepiride per day.
Your dose may need to be adjusted by your doctor if according to your state. If you take more LIMEZAPINE than you should
If you take too much LIMEZAPINE or an additional dose, there is a danger of hypoglycaemia and therefore you should instantly consume enough sugar (4 to 6 sugar cubes).
If the patient has a loss of consciousness, immediately consult your doctor or your pharmacist. If you forget to take LIMEZAPINE
If you forget to take a dose, do not take a double dose to make up for forgotten doses. If you stop taking LIMEZAPINE
Your diabetes will be at risk of becoming unbalanced (hyperglycemia or an increase of the glycemia). Always take LIMEZAPINE exactly as your doctor has told you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience the following symptoms:
- Allergic reactions which may develop into severe reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock.
- Abnormal liver function including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure.
- Allergic skin reactions (hypersensitivity) of the skin such as itching, rash, urticaria and increased sensitivity to sun.
- Severe hypoglycaemia with loss of consciousness, convulsions or coma. Some patients experienced the following side effects whilst taking glimepiride: Rare side effects (affects from 1 patient in 10,000 to 1 patient in 1,000):
- Decrease in the number of blood cells:
o Blood platelets (which increases risk of bleeding or bruising). o White blood cells (which makes infections more likely).
o Red blood cells (which can make the skin pale and cause weakness or breathlessness). These problems generally get better after you stop taking glimepiride.
Very rare side effects (affects less than 1 patient in 10,000):
- Allergic reactions which may develop into severe reactions with difficulty in breathing, fall in blood pressure and sometimes progressing to shock. If you experience any of these symptoms, tell your doctor immediately.
- Liver problems including yellowing of the skin and eyes (jaundice), problems with the bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately.
- Nausea, vomiting, diarrhoeas, feeling full or bloated, abdominal pains.
- Decrease in the amount of sodium level in your blood (shown by blood tests). Other side effects (incidence cannot be estimated from the available data):
- Allergic skin reactions (hypersensitivity) of the skin may occur such as itching, rash, urticaria and increased sensitivity to sun (very rare effect). Some mild allergic reactions may develop into serious reactions, therefore in the event of one of these side effects, tell your doctor immediately.
- Allergic reactions with sulfonylureas, sulfonamides, or related drugs may occur.
- Problems with your sight may occur when beginning treatment with glimepiride. This is due to changes in blood sugar levels and should soon improve.
- Increased liver enzymes. - Decreased number of platelets. - Bruising under the skin.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE LIMEZAPINE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the after ‘EXP’ on the blister and carton. The expiry date refers to the last day of that month.
Do not store above +30º C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What LIMEZAPINE contains The active substance is glimepiride.
Each tablet contains 1 mg, 2 mg, 3 mg or 4 mg of glimepiride depending on the strength indicated on the blister.
The other ingredients are: Monohydrated lactose
Sodium carboxymethylamidon (type A) Povidone K29-K32
Microcrystalline cellulose (E460) Magnesium stearate (E572)
In addition the tablets contain colouring agents: 1 mg tablets contain red iron oxide (E172)
2 mg tablets contain yellow iron oxide (E172), sunset yellow FCF (E110), tartrazin (E102), brilliant blue FCF (E133)
3 mg tablets contain yellow iron oxide (E172) 4 mg tablets contain Indigotine I (E132)
What LIMEZAPINE looks like and contents of the pack 1 box contains 10 tablets.
1 box contains 20 tablets 1 box contains 30 tablets 1 box contains 50 tablets 1 box contains 60 tablets 1 box contains 90 tablets 1 box contains 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
RANBAXY PHARMACIE GENERIQUES 11-15 Quai de Dion Bouton
92800 PUTEAUX France Manufacturer ACTAVIS hf. Reykjavikurvegur 76-78 222 HAFNARFJORDUR ISLAND or ACTAVIS Ltd.
B16 Bulebel Industrial Estate Zejtun ZTN 08
or
BALKANPHARMA – DUPNITSA AD 3 Samokovsko Shosse Str.
Dupnitsa 2600 BULGARIA
This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State} > < {Name of the medicinal product}
This leaflet was last approved in {MM/YYYY}. [To be completed nationally]
