Document: leaflet MAH GENERIC_PL 04569-0308 change

• leaflet MAH GENERIC_PL 04569-0308
• leaflet TEVA UK_PL 04569-0308

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Package leaflet: Information for the patient

Glipizide 5 mg Tablets

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 Glipizide is and what it is used for

2.    What you need to know before you take Glipizide

3.    How to take Glipizide

4.    Possible side effects

5.    How to store Glipizide

6.    Contents of the pack and other information

1.    What Glipizide is and what it is used for

Glipizide is one of a group of medicines called sulfonylureas. Glipizide is used to reduce blood sugar levels (antidiabetic medicine taken by mouth).

Glipizide 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.

2.    What you need to know before you take Glipizide

Do not take Glipizide if you:

•    are allergic to glipizide, other sulfonylureas or any of the other ingredients of this medicine (listed in section 6)

•    suffer from kidney or liver disease

•    suffer from thyroid problems

•    have insulin-dependent diabetes (also called "juvenile onset" or "Type I" diabetes)

•    have diabetic ketoacidosis (a complication of diabetes with rapid weight loss, feeling or being sick), especially if this has ever led to unconsciousness or a coma

•    are taking miconazole to treat a fungal infection

•    are pregnant, are planning to become pregnant or are breast feeding

Warnings and precautions

Talk to your doctor or pharmacist before

taking Glipizide if:

•    it is planned that you will have surgery in the near future

•    you are suffering from stress or have an infection or fever

•    you have recently had a traumatic injury (if you are receiving treatment for an accident tell your doctor you have been given these tablets)

•    you have been told that your adrenal or pituitary glands are not working properly

In the above cases, your doctor may change the number of tablets you should take or he/she may revise your entire treatment plan.

Lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur in patients missing the enzyme glucose-6-phosphate dehydrogenase (G6PD).

Control of your blood sugar levels

During Glipizide treatment, regular checking of your blood (or urine) sugar levels is necessary. Your doctor may also perform certain blood tests to monitor your progress. You should follow the treatment plan prescribed by your doctor in order to control your blood sugar levels. This means that you should continue with your diabetic diet, take regular exercise and if necessary, lose weight.

In the first few weeks of treatment, there is a greater risk of having low blood sugar levels (hypoglycaemia). Your doctor will therefore monitor your progress closely.

Low blood sugar levels may occur if:

•    you have meals irregularly or you skip meals altogether

•    you are fasting

•    you are elderly or in poor health

•    you change your diet

•    you increase your physical activity without increasing your carbohydrate intake

•    you drink alcohol (especially if you also skip meals)

•    you take certain other medicines at the same time (see "Other medicines and Glipizide")

If you suffer from low blood sugar levels, you may have the following symptoms:

•    headache

•    hunger

•    exhaustion

•    feeling or being sick

•    weariness

•    sleepiness

•    problems sleeping

•    restlessness

•    aggressiveness

•    difficulty concentrating

•    feeling less alert

•    having slower reactions than normal

•    depression

•    confusion

•    speech problems

•    eyesight problems

•    dizziness

•    helplessness

•    sweating

•    clammy skin

•    anxiety

•    faster heart beat

•    high blood pressure

•    feeling of an abnormally strong, racing or irregular heartbeat (palpitations)

•    sudden strong pain in the chest (angina)

If your blood sugar levels continue to drop, you may suffer from considerable confusion (delirium), you may develop "fits" (convulsions), have breathing difficulties, your heartbeat may slow down and you may fall unconscious.

In most cases, the signs of reduced blood sugar vanish very quickly when you eat or drink something sugary e.g. sugar cubes, sweet juice, sweetened tea. You should always carry some form of sugar with you. Remember that artificial sweeteners are not effective. Please contact your doctor or hospital if taking sugar does not help or if any of these symptoms return.

Other medicines and Glipizide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Taking the following medicines with Glipizide may reduce your blood sugar levels too much:

•    Insulin or another medicine to control your diabetes

•    Antibiotics to treat an infection (e.g. sulfonamides, chloramphenicol)

•    NSAIDs (non-steroidal anti-inflammatory medicines e.g. aspirin or ibuprofen), used to treat pain and/or inflammation

•    Medicines to thin the blood (e.g. warfarin and other coumarins)

•    Medicines to treat fungal infections (e.g. fluconazole or voriconazole)

•    Certain medicines to treat high blood pressure called beta-blockers (e.g. atenolol, propranolol)

•    Monoamine oxidase inhibitors (MAOIs, e.g. moclobemide, used to treat depression)

•    Medicines to treat gout (e.g. probenecid)

•    Angiotensin converting enzyme (ACE) inhibitors (e.g. captopril used to treat high blood pressure)

•    Cimetidine (used to treat stomach or duodenal ulcers and other digestive disorders)

•    Fibrates (e.g. clofibrate used to treat high cholesterol)

Taking the following medicines with Glipizide may increase your blood sugar levels:

•    Oral contraceptives ("the pill") and medicines containing oestrogen or progesterone

•    "Water tablets" (also known as diuretics)

•    Medicines to treat thyroid disorders

•    Medicines to treat inflammation called corticosteroids

(e.g. hydrocortisone, prednisolone)

•    Medicines called phenothiazines (e.g. chlorpromazine), used to treat sickness or some mental illnesses

•    Medicines to treat tuberculosis (e.g. isoniazid)

•    Certain medicines to treat high blood pressure and heart problems, called calcium channel blocking drugs (e.g. verapamil, nifedipine, diltiazem)

•    Medicines to lower fat levels in the blood (e.g. nicotinic acid)

•    Certain medicines for treating asthma (e.g. salbutamol) and blocked nose (e.g. ephedrine)

•    Phenytoin (used to treat epilepsy)

•    Danazol (a hormone treatment)

Glipizide with alcohol You should not drink alcohol while being treated with this medicine. Drinking alcohol can upset the control of your diabetes.

Pregnancy and breast-feeding Glipizide must not be taken during pregnancy or if you are breast-feeding (see section 2, "Do not take Glipizide"). If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines Do not drive or operate machinery if you feel dizzy, drowsy, suffer from headaches or have difficulty concentrating after taking this medicine.

Glipizide contains lactose. If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3.    How to take Glipizide

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

Glipizide should be taken about 30 minutes before a meal.

Adults

The recommended dose is one tablet (5 mg) before breakfast or one tablet (5 mg) before the midday meal. Depending on how your blood sugar level responds, your doctor may gradually increase your dose by half to one tablet up to a maximum of four tablets (20 mg) a day. The tablets can be divided into equal doses. If you are taking more than three tablets (15 mg) a day, your doctor will split your dose so that you take your tablets twice a day.

Elderly patients, patients with poor diets and patients with kidney or liver disease

Your doctor may start you on the lower dose of half a tablet (2.5 mg) a day before gradually increasing your dose, as you may be more sensitive to the effects of Glipizide.

If you are already taking a medicine to treat your diabetes (e.g. tolbutamide) or more than 20 units of Insulin a day, and your doctor wants to change your medicine to Glipizide Tablets, your blood sugar level will need to be closely monitored.

This is to ensure that you do not suffer the unwanted effects of low blood sugar levels (hypoglycaemia).

If your doctor feels that Glipizide Tablets are not sufficiently controlling your blood sugar levels, he may also prescribe another medicine (e.g. metformin) for you to take as well.

Use in children

Glipizide is not recommended for use in children.

If you take more Glipizide than you should

If you have taken too many tablets, this will cause your blood sugar level to drop too low (hypoglycaemia - for signs of hypoglycaemia see section 2).

If left untreated, this can lead to fainting and coma.

You should eat or drink something sugary as soon as you can (e.g. sugar cubes, sweet juice, sweetened tea) and tell your doctor immediately.

If you forget to take Glipizide

Take the next dose as soon as you remember or feel faint, otherwise your blood sugar level will become too high and you may go into a coma (unconscious).

Do not take a double dose to make up for a forgotten dose.

If you stop taking Glipizide

This will make your diabetes worse.

Talk to your doctor before you stop taking Glipizide.

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 any of the following symptoms after taking this medicine:

•    An allergic reaction such as wheeziness, difficulty breathing or swelling of the eyelids, face or lips

•    Allergic skin reactions including rashes, eczema, hives (nettle rash) and red, itchy skin

•    Reductions in blood cells and blood platelets. This can make the skin pale yellow, cause weakness or breathlessness, or make bruising, bleeding or infections more likely.

•    Liver inflammation which can cause nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, light coloured bowel movements, dark coloured urine and jaundice which causes yellowing of the skin and whites of the eyes.

•    A blood pigment disorder. This can cause blistering or peeling of skin exposed to sunlight, skin darkening or excessive hair growth

In some people, a sudden, severe reaction to alcohol can occur. You may experience a sudden 'hangover' feeling with a throbbing headache, flushed skin, increased heart rate, shortness of breath, feeling or being sick, vision problems, confusion and low blood pressure which may make you dizzy especially on standing up from lying or sitting.

Other side effects that may occur include:

Common (may affect up to 1 in 10 people)

•    Low blood sugar (hypoglycaemia - for signs of hypoglycaemia see section 2)

•    Feeling sick, diarrhoea or stomach pains. These side effects usually improve if your doctor divides up your dosage during the day

Uncommon (may affect up to 1 in 100 people)

•    Dizziness, drowsiness/sleepiness

•    Shakiness (tremor) Blurred vision Being sick

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

•    Headache

•    A reduction in your blood sodium. This can occur if you are dehydrated.

•    Confusion

•    Double vision, changes in vision (you may it more difficult to focus or see clearly)

•    Constipation

•    General feeling of being unwell

•    Increased sensitivity of the skin to sunlight

The results of some laboratory tests have been affected by this medicine but it is rare for patients to have any symptoms.

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

5.    How to store Glipizide

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 carton after "EXP". The expiry date refers to the last day of that month.

Store below 25°C and keep in the original package in order to protect from light.

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.

6.    Contents of the pack and other information

What Glipizide contains

The active substance is glipizide. Each tablet contains 5 mg of glipizide.

The other ingredients are lactose monohydrate (see section 2, 'Glipizide contains lactose'), maize starch, pregelatinised maize starch and stearic acid.

What Glipizide looks like and contents of the pack

Tablets are white, oval, uncoated and marked "GP" breakline "5" on one side and "G" on the other side.

Glipizide Tablets are available in bottles of 20, 30, 50, 60, 100, 250 and 500 tablets and blister packs of 20, 28 30, 50, 56, 60 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

Manufacturer

Gerard Laboratories,

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13,

Ireland

Generics [UK] Ltd. Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

This leaflet was last revised in    _LT1324AI

March 201 5.    598525