Glimepiride 1 Mg Tablet
120 mm 100 mm
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symptoms:
* Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious 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 bileflow(cholestasis), inflammation of the liver (hepatitis) orliverfailure
* Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to sun. Some mild allergic reactions may develop into serious reactions
* Severe hypoglycaemia including loss of consciousness, seizures or coma
Some patients experienced the following side effects whilst taking Glimepiride:
Rare side effects (may affect up to 1 in 1,000 people)
* Lower blood sugar than normal (hypoglycaemia) (see section 2)
* Decrease in the number of blood cells
* Blood platelets (which increases risk of bleeding or bruising)
* White blood cells (which makes infections more likely)
* Red blood cells (which can make the skin ale and cause weakness or reathlessness)
These problems generally get better after you stop taking Glimepiride
Very rare side effects (may affect up to 1 in
10,000 people)
* Allergic reactions (including inflammation of blood vessels, often with skin rash) which may develop into serious 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
* Abnormal liver function including yellowing of the skin and eyes (jaundice), impairment of the bile flow(cholestasis), inflammation of the liver (hepatitis) or liver failure. If you experience any of these symptoms, tell your doctor immediately
* Feeling or being sick, diarrhoea, feeling full or bloated, and abdominal pain
* Decrease in the amount of sodium level in your blood (shown by blood tests)
Other side effects include:
* Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives ana increased sensitivity to sun. Some
* mild allergic reactions may develop into serious reactions with swallowing or breathing problems, swelling of your
* lips, throat or tongue. Therefore in the event of one of these side effects, tell your doctor immediately
* Allergic reactions with sulfonylureas, sulfonamides, or related medicines 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 liverenzymes
* Severe unusual bleeding or bruising under the skin
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. you can also report side effects directly via the Yellow Card Scheme, website www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Howto store glimepiride tablets
* 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 label after ExP. The expiiy date refers to the last day of that month.
* Do not store the tablets above 25° C
Store in the original package in order to protect from moisture.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist howto throwaway medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other formation
What Glimepiride tablet contains
The active substance is Glimepiride.
The other ingredients are lactose, sodium starch giycolate, povidone, sodium lauryl sulphate, magnesium stearate, microcrystalline cellulose, red iron oxide E172 (1mg tablets), yellow iron oxide E172 (2mg and 3mg tablets) and indigo carmine aluminium lake E132 (2mg and 4mg tablets).
What Glimepiride tablets looks like and contents of the pack
Glimepiride 1mg tablets are Pink coloured capsule shapedtablet with embossing “GM” & 'T with score line on one side and score line on theotherside.
Glimepiride 2mg tablets are Pale green coloured capsule shaped tablet with
embossing “GM” & “2” with score line on one side and score line on the otherside. Glimepiride 3mg tablets are Pale yellow
coloured capsule shaped tablet with
embossing “GM” & “3” with score line on one side and score line on the otherside. Glimepiride 4mg tablets are Light blue coloured capsule shaped tablet with
embossing “GM” & “4” with score line on one side and score line on the otherside.
Pack size: Cartons containing 30 tablets in two blisters, each of 15 tablets.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Limited 5 Marryat Close, Hounslow West Middlesex, TW4 5DQ United Kingdom
This leaflet was last updated in August 2014
Read all of this leaflet carefully
before you start taking this
medicine because it contains
important information foryou.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, asKyourdoctoror 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 Glimepiride is and what it is used for
2. Whatyou need to know before you take Glimepiride
3. Howto take Glimepiride
4. Possible side effects
5. Howto store Glimepiride
6. Contents of the pack and other information
I. What Glimepiride is and what is used for
Glimepiride is one of a group of medicines called oral hypoglycaemics, which are used for treatment of diabetes (a disease where the body does not produce enough insulin to control the level of blooa sugar). Oral hypoglycaemics help control blood sugar level.
The active ingredient in your Glimepiride tablets is Glimepiride.
What Glimepiride is used for:
Glimepiride is used in the treatment of non-insulin dependent (Type II) diabetes mellitus. you get diabetes if your pancreas does not make enough insulin to control the level of glucose in your blood. Type II diabetes can sometimes be controlled by good diet, physical exercise and weight reduction alone, but where this is not possible, Glimepiride is used in addition.
2. What you need to know before you take Glimepiride.
Do not take Glimepiride:
* if you are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole) or any of the other ingredients of this medicine (listed in section 6)
* if you have insulin dependent diabetes (Type I diabetes mellitus)
* if you have diabetic ketoacidosis (a complication of diabetes when
our acid level is raised in your ody and you may have some of the following signs: fatigue, feeling sick (nausea), frequent urination and muscular stiffness)
* if you are in a diabetic coma
* if you have severe kidney disease
* if you have a severe liver disease
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Glimepiride.
Warnings and precautions:
Talk to vour doctor pharmacist before taking vour medicine if:
* You are recovering from an injury, operation, infections with fever, or from other forms of stress, inform your doctor as temporary change of treatment may be necessary.
* You have a severe liver or kidney disotoer.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Glimepiride.
Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur in atients missing the enzyme glucose-phosphate dehydrogenase.
The information available on the use of Glimepiride in people under 18 years of age is limited. Therefore, its use in these patients is not recommended.
Important Information about hypoglycaemia (low blood sugar!
When you take Glimepiride, ^ou ma^
^leasl* see below for additional information about hypoglycaemia, its signs and treatment.
Following factors could increase the risk of you getting hypoglycaemia:
* Undernourishment, irregular meal time, missed or delayed meal or period of fasting
* Changes to your diet
* Taking more Glimepiride than needed
* Having kidneys that do not work properly
* Having severe liver disease
* If you suffer from particular hormone-induced disorders (disotoers of the thyroid glands, of the pituitary gland or adrenal cortex)
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* Drinking alcohol (especially when you skip a meal)
* Taking certain other medicines (see below “Other medicines and Glimepiride”)
* If you increase the amount of exercise you do and you don't eat enough food or eat food containing less carbohydrate than usual.
Signs of hvooglvcaemia include:
Hunger pangs, headache, nausea, vomiting, sluggishness, sleepiness, problems sleeping, restlessness, aggression, problems with concentration, reduced alertness and reaction time, depression, confusion, problems with your speech and sight, slurred speech, shakiness, partial paralysis, dizziness, helplessness
* The following signs may also occur; sweating, clammy skin, anxiety, fast or increased heart beat, high blood pressure, awareness of your heart beat, sudden strong pain in the breast that may radiate into neighbouring areas (angina pectoris and cardiac arrhythmias)
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop fits, lose seif control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness.
The clinical picture of a severe reduced blood sugar level may resemble that of a stroke.
Treating hvDoalvcaemia:
In most cases the signs of reduced blood sugar vanish veiy quickly when you consume some form of sugar, e.g. sugar cubes, sweet juice, sweetened tea.
You should therefore always take some form of sugar with you (e.g. sugar cubes). 'Remember that artificial sweeteners are not effective. Please contact your doctor or go to the hospital if taxing sugar does not help or if the symptoms recur.
Laboratory tests
The level of sugar in your blood or urine should be checked regularly. Your doctor may also take blood tests to monitor your blood cell levels and liver function.
Children and adolescents
Glimepiride is not recommended for use in children under18years of age.
Other medicines and Glimepiride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may wish to change your dose of Glimepiride if you are taxing other medicines, which may weaken or strengthen the effect of Glimepiride on the level of sugar in your blood.
The following medicines can increase the blood sugar lowering effect of Glimepiride. 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 such as warfarin)
* Medicines supporting muscle build up (anabolics)
* Medicines used for male sex hormone replacement therapy
* Medicines to treat depression (fluoxetine, MAOinhibitors)
* Medicines lowering high cholesterol level (fibrates) Medicines lowering high blood pressure (ACE inhibitors)
* Medicines called anti-arrhythmic agents used to control abnormal heart beat (disopyramide)
* Medicines to treat gout (allopurinol, probenecid, sulfinpyrazone)
* Medicines to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
* Medicines used to reduce weight (fenfluramine)
* 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 high blood pressure, heart failure, or prostate symptoms
The following medicines may decrease the blood sugar lowering effect of Glimepiride. 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 called thiazide diuretics (water tablets)
* Medicines used to stimulate the thyroid gland (such as levothyroxine)
* Medicines 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 ana sympatnomimetics)
* Medicines to treat high cholesterol level (nicotinic acid)
* Medicines to treat constipation when they are used long term (laxatives)
* Medicines to treat fits (phenytoin)
* Medicines to treat nervousness and sleep problems (barbiturates)
* Medicines to treat increased pressure in the eye (azetazolamide)
* Medicines to treat high blood pressure or low 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
Glimepiride:
* Medicines to treat 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:
* Glimepiride may either increase or weaken the effects of the following medicines:
* Medicines inhibiting blood clotting (coumarin derivatives such as warfarin).
* Colesevelam, a medicine used to reduce cholesterol, has an effect on the absorption of Glimepiride. To avoid this effect, you should be advised to take Glimepiride at Ieast4 hours before colesevelam
Glimepiride tablets contains lactose
If you have been told by yourdoctor that you cannot tolerate some sugars, contact your doctor before taking this medicinal product.
3. How to take Glimepiride tablets.
Always take Glimepiride tablets exactly as your doctor has tola you. You should check with your doctor if you are not sure.
Taking this medicine
* Take this medicine by mouth, just before or with the first main meal of the day (usually breakfast). If you do not have breakfast you should take the medicine on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Glimepiride
* Swallow the tablets with at least half glass of water. Do not crush or chew the tablets.
If you take more Glimepiride than you should
If you happen to have taken too much Glimepiride or an additional dose there is a danger of hypoglycaemia (signs of hypoglycaemia see section 2) ana therefore you should instantly consume enough sugar (e.g. a small bar of sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately. When treating hypoglycaemia due to accidental intake in children, the quantity of sugar given must be carefully controlled to avoid the possibility of producing dangerous hyperglycaemia. Persons in a state of unconsciousness must not be given food or drink.
Glimepiride with food, drink and alcohol
Alcohol intake may increase or decrease the blood sugar lowering action of Glimepiride in an unpredictable way.
Pregnancy and breast-feeding
Pregnancy
Glimepiride should not be taken during pregnancy. Tell your doctor if you are, you think you might be or are planning to become pregnant.
Breast-feeding
Glimepiride may pass into breast milk. Glimepiride should not betaken during breast feeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your ability to concentrate or react may be reduced if your blood sugar is lowered (hypoglycaemia), or raised (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (e.g. when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
* have frequent episodes of hypoglycaemia,
* have fewer or no warning signals of hypoglycaemia.
Since the state of hypoglycaemia may last for some time it is veiy important that the patient is carefully monitored until there is no more danger. Admission into hospital may be necessary, also as a measure of precaution. Show the doctor the package or remaining tablets, so the doctor knows what has been taken.
Severe cases of hypoglycaemia accompanied by loss of consciousness and coma are cases of medical emergency requiring immediate medical treatment ana admission into hospital. It may be helpful to tell your family ana friends to call a doctor immediately if this happens to you.
If you forget to take Glimepiride
If you forget to take a tablet, do not take a double dose to make up for forgotten doses.
If you stop taking Glimepiride
If you interrupt or stop the treatment you should be aware that the desired blood sugar lowering effect is not achieved or that fne disease will get worse again. Keep taking Glimepiride until yourdoctortells you to stop.
4. Possible side effects
Like all medicines, Glimepiride can cause side effects, although not eveiybody gets them.
Tell your doctor immediately if you experience any of the following
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