Glimepiride 1 Mg Tablets

Document: leaflet MAH GENERIC_PL 00289-0943 change

Tr^rW7l 231-30-88374-C LEA GLIMEPIRIDE A/S TAB TUK Ref 22 November 2013

TEVA UK LIMITED

I Trackwise Parent:

224822

Child

240368

PL Number(s), PL 00289/0943-6, Teva UK Limited Licence (Post Licence Regulatory Team).

MA Holder & Packer: Packed at Teva UK Limited, Eastbourne. Packing Line: B1260.

Reason for revision: Leaflet text update. V2: Alterations in response to an RFI from the MHRA.

F. P. Code:

Pharma Code: Third party code: Fonts:

Base Font Size:

231-10-03141, 231-10-03171 231-10-03181, 231-10-03191 415 (10100000)

N/A

Univers.

9.7 Pt

Dimensions:
L: 323 mm
W: 160 mm	Please refer to the latest version of the full base material specification: 92653, 92655, 92651

ceptions to this are: beeds, chokes, spreads or other print related adjustments required for reproduction by the supplier

text and content must not be reset, remade, emended or atered. me only

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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 -Warnings and precautions)

• 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 pale and cause weakness or breathlessness).

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 discomfort or pain

• Decrease in the amount of sodium level in your blood (shown by blood tests).

Not known (frequency cannot be estimated from the available data)

• Allergy (hypersensitivity) of the skin may occur such as itching, rash, hives and 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 drugs may occur

• Problemswithyoursightmayoccur when beginning treatment with Glimepiride.This is due to changes in blood sugar levels and should soon improve.

• Increasedliverenzymes

• Severe decrease in the number of blood platelets (thrombocytopenia) and unusual bleeding or bruising under the skin (thrombocytopenic purpura).

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ HOW TO STORE GLIMEPIRIDE

Keep this medicine out of the sight and reach of children. Do not store above

25°C. Do not use Glimepiride after the expiry date which is stated on the outer packaging.The expiry date refers to the last day of that month.

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 protect the environment.

©CONTENTS OF THE PACK AND OTHER INFORMATION

What Glimepiride 1, 2, 3 & 4 mg Tablets contain

• The active substance is glimepiride. Each tablet contains either 1, 2, 3 or 4 mg of glimepiride.

• The other ingredients are lactose monohydrate, sodium starch glycolate, povidone, microcrystalline cellulose, magnesium stearate and the following colouring agents:

• 1 mg tablets - red iron oxide (E172)

• 2 mg tablets - yellow iron oxide (E172) and indigo carmine (E132)

• 3mg tablets - yellow iron oxide (E172) • 4mg tablets - indigo carmine (E132).

What Glimepiride looks like and contents of the pack:

• Glimepiride 1 mgTablets are mottled pink, round tablets, bisected on both sides. One side of the tablet is debossed with "9" on one side of the score and "3" on the other. The other side of the tablet debossed with "72" on one side of the score and "54" on the other.

• Glimepiride 2 mgTablets are mottled green, round tablets, bisected on both sides. One side of the tablet is debossed with "9" on one side of the score and "3" on the other. The other side ofthe tablet is debossed with "72" on one side of the score and "55" on the other.

• Glimepiride 3 mgTablets are light yellow to yellow, round tablets, bisected on both sides. One side of the tablet is debossed with "G" on one side of the score and "3" on the other.

• Glimepiride 4 mgTablets are mottled light blue, round tablets, bisected on both sides. One side of the tablet is debossed with "9" on one side of the score and "3" on the other. The other side ofthe tablet is debossed with "72" on one side of the score and "56" on the other.

• Glimepiride is available in pack sizes of 20, 28, 30, 50, 60, 90, 120 and 200 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised:

November 2013.

PL 00289/0943 PL 00289/0944 PL 00289/0945 PL 00289/0946

88374-C

TEVA UK LIMITED 320x 323

GLIMEPIRIDE 1, 2, 3 AND 4 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 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 INTHIS LEAFLET:

1. What Glimepiride is and what it is used for

2. What you need to know before you take Glimepiride

^m 3.How to take Glimepiride

4. Possible side effects

5. How to store Glimepiride

6. Contents of the pack and other information

OWHAT GLIMEPIRIDE IS AND WHAT IT IS USED FOR

• Glimepiridecontainstheactive substance glimepiride • Glimepiride is a medicine to reduce blood sugar levels (antidiabetic medicine taken orally)

• Glimepiride is used in a certain form of diabetes (type 2 diabetes mellitus), when diet, exercise and weight loss alone do not have an adequate effect.

OWHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIMEPIRIDE

Do not take Glimepiride

• Ifyouare allergic toglimepirideor other drugs of the same group (sulfonylureas and sulfonamides) or any of the other ingredients of GlimepirideTablets (listed in section 6)

• Ifyourkidneyorliverfunctionis severely impaired

• Ifyou have insulin-dependent (type 1) diabetes

• Ifyou have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, nausea or vomiting)

• In the case of somnolence and loss of consciousness due to a strongly increased blood sugar level (diabetic coma).

In cases of severe renal or hepatic functional disorders, a change-over to insulin is required.

Warnings and precautions

Talk to your doctor or pharmacist before taking Glimepiride

During Glimepiride treatment regular monitoring of your blood sugar level is necessary.Your doctor may also take blood tests to monitor your blood cell levels and liver function.

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels.This means that, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight. Also take care that you

have your blood (and possibly urine) sugar levels determined regularly as prescribed by your doctor.

In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased, therefore it is vital that you are carefully monitored by your doctor.

Reduced blood sugar may occur if:

• You take meals irregularly or skip meals altogether

• You are fasting

• You are malnourished

• You change your diet

• You increase your physical activity and your carbohydrate intake is not increased to match this

• You consume alcohol, especially in combination with skipped meals

• You take other medicines or natural remedies at the same time

• You take high doses of Glimepiride

• You suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex)

• Your renal function is decreased

• Your liver function is seriously decreased

• You do not observe the instructions given by your doctor or in this patient package leaflet.

Please inform your doctor of such risks so that he/she can either adjust the dosage of Glimepiride or revise the entire treatment plan to change it where necessary.

If you suffer from low blood sugar (hypoglycaemia) you may have the following signs:

headache, hunger, exhaustion, nausea, vomiting, weariness, sleepiness, sleep disorders, restlessness, aggressiveness, impaired concentration, reduced alertness and reaction time, depression, confusion, speech and visual disorders, difficulty using or understanding language (aphasia), shaking, slight paralysis, sensory disturbances, dizziness, and helplessness.

The following signs may also occur: sweating, clammy skin, anxiety, accelerated heart beat, high blood pressure, a feeling of an abnormally strong or irregular heartbeat (palpitations), 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 cerebral convulsions, lose self control, breathing may be shallow and your heart beat slowed down, you may fall into unconsciousness.The symptoms of a severe reduced blood sugar level may resemble that of a stroke.

In most cases the signs of reduced blood sugar vanish very quickly when you consume some form of sugar, e.g. grape sugar, sugar cubes, sweet juice, sweetened tea.

You should therefore always take some form of sugar with you (grape sugar, sugar cubes). Remember that sweeteners are not effective. Please contact your doctor or the next hospital if taking sugar does not help or if the symptoms recur.

Signals of reduced blood sugar may be

Peel HereTo Open

Version: 2

I Trackwise Parent:

224822

Chile

240368

PL Number(s), PL 00289/0943-6, Teva UK Limited Licence (Post Licence Regulatory Team).

MA Holder & Packer: Packed at Teva UK Limited, Eastbourne. Packing Line: B1260.

Reason for revision: Leaflet text update. V2: Alterations in response to an RFI from the MHRA.

F. P. Code:	231-10-03141,231-10-03171
	231-10-03181,231-10-03191
Pharma Code:	415 (10100000)
Third party code:	N/A
Fonts:	Univers.
Base Font Size:	9.7 Pt

Dimensions

IMPORTANT: Artwork, text and content must not be reset, remade, amen

We must receive acopv ot any 3rd Party Supplier's Proot before approval

323 mm 160 mm

Colours:

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Please refer to the latest version of the full base material specification: 92653, 92655, 92651

or aterea. me any exceptions to this are: bleeds, chokes, spreads or other print related adjustments required tor reproduction by the rlnt wll be granted.

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absent or less pronounced or develop very slowly.You are not aware in time that your blood sugar level has dropped. This may happen in elderly patients taking certain medicinal products (e.g. those acting on the central nervous system and beta-blockers). It may also happen when you suffer from certain disorders of the endocrine system (e.g. certain disorders of thyroid function and anterior pituitary or adreneocortical insufficiency). Impaired liver function may affect counter regulation.

In stress-situations (e.g. accidents, acute operations, infections with fever, etc.) a temporary switch to insulin may be indicated.

Signs of raised blood sugar (hyperglycaemia) - this may occur when Glimepiride has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor or in special stress situations may include thirst, frequent urination, dry mouth and dry itching skin, fungal or skin infections and reduced performance.

In such a case, you must contact your doctor.

If you have a deficiency in the enzyme glucose-6-phosphate dehydrogenase, or G6PD, glimepiride could cause a decrease in your blood haemoglobin levels, which might lead to low red blood cell levels (haemolytic anaemia). You should tell your doctor if you have G6PD deficiency.

Children and adolescents

There is not enough information on efficacy and safety of glimepiride in children and adolescents. Glimepiride tablets are not recommended in children and adolescents.

Other medicines and Glimepiride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The activity and safety of this treatment may be affected if this medicine is taken at the same time as certain other medicines. Conversely, other medicines may be affected if they are taken at the same time as Glimepiride. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription.

The blood sugar lowering effect of glimepiride may be strengthened and signs of low blood sugar levels may occur when one of the following drugs is taken:

• Other oral antidiabetic drugs (e.g. metformin), and insulin

• Antibiotics (e.g. chloramphenicol, or clarithromycin, quinolones, tetracyclines, sulfonamides)

• Painkillersorantirheumatics (pyrazolone-derivatives, e.g. phenylbutazone, azapropazone, oxyfenbutazone)

• Painkillers (salicylates)

• Productstotreattuberculosis (p-amino-salicylic acid)

• Products supporting muscle build-up (anabolics and male sex hormones)

• Products inhibiting blood clotting (coumarin)

• Productsto treatfungal infections (miconazole, fluconazole)

• Products lowering blood pressure or heart beat (ACE-inhibitors, beta-blockers, sympatholytics)

• Products elevating mood/antidepressants (fluoxetine, MAO-inhibitors)

• Productssuppressingappetite (fenfluramine)

• Products lowering increased fat levels in the blood (fibrates)

• Certain products to treat cancer (cyclo-tro- and iphosphamides)

• products to treat allergies (tritoqualine)

• Infusion of high dose of products to increase blood flow (pentoxiphylline)

• Products to treat gout (probenecid, allopurinol, sulphinpyrazone)

• Disopyramide which is used to treat irregular heart rhythm.

The blood glucose lowering effect of Glimepiride may be weakened and raised blood sugar levels may occur when one of the following drugs is taken:

• Female sex hormones (oestrogens and progestagens)

• Products supporting urine production (saluretics, thiazide diuretics)

• Thyroid hormones

• Products inhibiting inflammation (glucocorticoids)

• Products to treat cramps or schizophrenia (phenytoin, phenothiazine derivatives)

• Products lowering blood pressure (diazoxide)

• Productsto treattuberculosis (rifampicin)

• Products to treat low blood sugar (glucagon)

• Sleeping pills (barbiturate)

• Products to treat certain eye diseases (acetazolamide)

• Products to raise heart beat (adrenaline and sympathicomimetics)

• Products lowering increased fat levels in the blood (nicotinic acid derivatives)

• Long term use of products relieving evacuation (laxatives).

Products to treat ulcers in the stomach or duodenum (H2 receptor-antagonists) or blood pressure lowering products (beta-blockers, clonidine and reserpine) may either strengthen or weaken the blood sugar lowering effect of Glimepiride.

Medicinal products with effects on the central nervous system (beta-blockers, clonidine, guanethidine or reserpine) may mask or totally suppress the signs of reduced blood sugar.

Glimepiride may either strengthen or weaken the effect of products inhibiting blood clotting (coumarin derivatives).

Glimepiride with food, drink and alcohol

Alcohol can enhance or diminish the ability of Glimepiride to reduce blood sugar in an unpredictable manner.

Pregnancy and breast-feeding Pregnancy

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.

Glimepiride should not be taken during

pregnancy. If pregnancy is planned you should discuss the treatment plan with your doctor. If you become pregnant during Glimepiride treatment you should inform your doctor immediately.

Breast-feeding

Glimepiride may pass into breast milk. Glimepiride should not be taken during breast-feeding.

Driving and using machines

Your ability to concentrate or react may be impaired 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:

• Havefrequentepisodesof hypoglycaemia

• Have fewer or no warning signals of hypoglycaemia.

Glimepiride 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.

^ HOW TO TAKE GLIMEPIRIDE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The dose is fixed by the doctor, depending on your blood and urine sugar levels.

Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the disease may require changed Glimepiride doses.

The recommended starting dose for adults is 1 mg of Glimepiride per day. If good blood sugar control is achieved the dosage should be used for maintenance therapy. Doses of more than 4 mg of Glimepiride per day give better results only in exceptional cases.The maximum recommended dose is 6 mg Glimepiride per day.

A combination therapy of Glimepiride plus metformin, or of Glimepiride plus insulin may be initiated. In such a case your doctor will determine the proper doses of Glimepiride, metformin or insulin individually for you.

Glimepiride must be swallowed with at least half a glass of water. Usually the entire daily dose is taken all at once directly before or during a substantial breakfast. If you do not have breakfast you should take the product on schedule as prescribed by your doctor. It is important not to leave out any meal when you are on Glimepiride.

Use in children

Glimepiride is not recommended for use in children.

Please speak with your doctor or pharmacist if you have the impression that Glimepiride is acting too strongly or not strongly enough.

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 low sugar levels, (for signs of hypoglycaemia see section 2) and therefore you should instantly consume enough sugar (e.g. a small bar of grape sugar cubes, sugar cubes, sweet juice, sweetened tea) and inform a doctor immediately.The same should be done if somebody, e.g. a child, has taken the product unintentionally. Persons in a state of unconsciousness must not be given food or drink.

Since the state of low sugar levels may last for some time it is very 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. Severe cases of low blood sugar accompanied by loss of consciousness and severe neurological failure are cases of medical emergency requiring immediate medical treatment and admission into hospital. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take Glimepiride

If you forget to take a dose, do not take the missed dose, just take the next dose on time. Do not take a double dose to make up for a forgotten dose.

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 the disease will deteriorate again. If any change is necessary it is absolutely important for you to contact your doctor first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Glimepiride can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms:

• 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

• 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

• Severe decrease in the number of blood platelets (thrombocytopenia) and unusual bleeding or bruising under the skin (thrombocytopenic purpura).