Friday, September 16, 2016

Glibenese





Glibenese Tablets



Glipizide




In this leaflet:



  • 1. What Glibenese is and what it is used for

  • 2. Before you take Glibenese

  • 3. How to take Glibenese

  • 4. Possible side effects

  • 5. How to store Glibenese

  • 6. Further information




Important things that you SHOULD know about your medicine:



  • Glibenese is used to treat diabetes and helps lower your blood glucose (sugar) levels, when a change in your diet and exercise is not enough to control your diabetes.


  • Glibenese can cause hypoglycaemia (low blood sugar levels), which is characterised by confusion, faintness, sweating, dizziness, drowsiness, headache, shakiness (tremor) and visual disturbances. (These symptoms may also be unrelated to hypoglycaemia). Low blood sugar levels can be prevented by taking a regular intake of carbohydrates (e.g. bread, or other products containing starch/sugar). You should eat regular meals, and not exercise heavily or for a long period without eating something first.


  • Do not stop taking the tablets or adjust your dosage without seeing your doctor. Stopping the medicine may make the diabetes worse.



Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you.





What Glibenese is and what it is used for



Glibenese is one of a group of medicines called sulphonylureas.



Glibenese is used is used to treat diabetes (Type II, non-insulin-dependent diabetes) and helps to lower your blood glucose (sugar) levels, when a change in diet and exercise is not enough to control the condition.



Diabetics produce too much glucose due to a lack of insulin in the body. This can be controlled by Glibenese, which reduces high blood glucose (sugar) levels by increasing insulin production.





Before you take Glibenese




Do not take Glibenese if you



  • are allergic to glipizide or any of the ingredients in Glibenese.

  • have insulin-dependent diabetes (also called juvenile or Type I diabetes), which would have probably started in your childhood.

  • have ketone bodies and sugar in your urine (this may mean you may have diabetic ketoacidosis).

  • suffer from episodes of unconsciousness (this may mean you may have diabetic coma).

  • have problems with your kidneys or liver.

  • have thyroid problems.

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

  • are currently taking miconazole to treat fungal infections.




Take special care with Glibenese



You should tell your doctor if you;



  • have been told that you have problems with your adrenal or pituitary glands.

  • are about to have major surgery or develop a fever or severe infection. (See Section 3 “If you are going to have an operation” for further information).

  • suffer from G6PD deficiency (a disease that causes abnormal destruction of your red blood cells)

Your blood and urine glucose should be tested regularly. If the results of the tests are outside the limits recommended by your doctor you should contact them immediately.





Taking other medicines



When given with Glibenese, the following medicines may reduce your blood sugar levels too much:



  • Miconazole, fluconazole or voriconazole (used to treat fungal infections)

  • Non steroidal anti-inflammatory agents (used to treat muscle and joint pain e.g. phenylbutazone)

  • Aspirin or aspirin like medicines known as salicylates (usually used as pain killers)

  • Betablockers (used to treat high blood pressure and certain heart conditions e.g. propranolol)

  • Angiotensin converting enzyme (ACE) Inhibitors (used to treat high blood pressure)

  • H2 receptor antagonists, e.g., cimetidine (used to treat stomach and duodenal ulcers, and other digestive disorders)

  • Monoamine oxidase inhibitors (used to treat depression)

  • Sulphonamides or chloramphenicol (used to treat bacterial infections)

  • Probenecid (used to treat gout, or sometimes given with an antibiotic)

  • Coumarins (used to prevent blood clots).

The following medicines may increase your blood sugar levels too much when given with Glibenese:



  • Danazol (a hormone treatment)

  • Phenothiazines (used to treat psychiatric conditions e.g. chlorpromazine)

  • Corticosteroids (used to treat inflammatory conditions)

  • Sympathomimetics, such as nasal decongestants and bronchodilators used to treat asthma(e.g. salbutamol, isoprenaline)

  • Thiazides and other diuretics (water tablets e.g. bendroflumethiazide)

  • Thyroid products (used to treat patients with low production of thyroid hormones).

  • Hormonal agents, oral contraceptives (the Pill) and hormone replacement therapy (HRT)

  • Phenytoin (used to treat epilepsy)

  • Nicotinic acid (used in vitamin supplements and to lower cholesterol and other lipid levels)

  • Calcium channel blocking drugs (used to treat angina and high blood pressure e.g. nifedepine or verampamil)

  • Isoniazid (used to treat tuberculosis)

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





Taking with food and drink



As food may delay absorption of the drug, each dose should be taken 30 minutes before food.



Try to avoid alcohol. Alcoholic drinks (wine, beer, spirits) can further reduce blood sugar levels and could cause a hypoglycaemic coma (unconsciousness).





Pregnancy and breast-feeding



You should not take Glibenese, if you are pregnant, planning to become pregnant or breast-feeding.





Driving and using machines



All diabetic patients who drive need to be particularly careful to avoid hypoglycaemia. Be aware of the symptoms of low blood sugar levels (hypoglycaemia). These are characterised by confusion, faintness, sweating, dizziness, drowsiness, headache shakiness (tremor) and visual disturbances.



If you are affected, do not drive or operate machinery.





Important information about some of the ingredients of Glibenese



Glibenese contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.






How to take Glibenese



Glibenese should only be taken by mouth. It is important that you take your tablets according to the instructions of your doctor. These will be written on the label of the pack. Do not take more Glibenese than your doctor has recommended.



Your dose will be adapted to your individual requirements. Some patients, whose condition is usually controlled by diet alone, may only require Glibenese for a short time.



The following dosage recommendations are only guidelines.




Adults



The usual starting dose is one 5mg tablet taken approximately 30 minutes before breakfast or the midday meal. This dose may be lower for some patients.



If you are elderly, have mild diabetes or suffer from liver or kidney problems you may be started on 2.5mg daily.



If your doctor feels your dose needs to be altered, he will instruct you to adjust the dose in small increments - usually in 2.5 – 5-mg steps.



The maximum recommended dose is 20mg daily.



The label on the pack will tell you what dose YOU should take and how often to take it. If you are still not sure, ask your doctor or pharmacist.



Do not stop taking the tablets or adjust you dosage without seeing your doctor.



Stopping the medicine may make your diabetes worse.





Children



Glibenese is not recommended for use in children.





If you take more Glibenese than you should



  • If you accidentally take too many tablets, seek medical advice immediately.

  • If you suffer faintness, confusion, sweating or shaking, these may be symptoms of low blood sugar. You should eat or drink something sugary.

  • If you suffer fits or loss of consciousness occur, someone should seek urgent medical assistance for you.




If you forget to take Glibenese



If you miss a dose, it is important that you take your medicine as soon as you remember or feel faint, otherwise your blood sugar will become too high and you may go into a coma (or fall unconscious).





If you are going to have an operation



If you are going to have major surgery or you have recently suffered a severe illness or infection, diabetic control may be lost. At such times it may be necessary to temporarily stop Glibenese and administer insulin.






Glibenese Side Effects



Like all medicines, Glibenese can cause side effects, although not everybody gets them. The majority are temporary and disappear on reducing the dose or on stopping treatment.




Reasons for contacting your doctor immediately



Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, these symptoms can be serious.



  • As allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). Allergic reactions (including very rarely, death) have been reported with drugs similar to Glibenese.




Other side effects that may occur are:



  • Effects on your stomach and intestines: feeling sick (nausea), diarrhoea, constipation, stomach or abdominal pain and being sick (vomiting).


  • Effects on your skin: redness (erythema ), itching (pruritus), hives (urticaria), rash (red, bumpy or measle-like), eczema, sensitivity to light


  • Effects on your whole body: malaise (a vague feeling of bodily discomfort, feeling bad).


  • Effects on your mental health: confusion.


  • Effects on your nervous system: dizziness, drowsiness, headache and tremor (shakiness).


  • Effects on your eyes: vision impairment (blurred, double or abnormal vision) and decreased vision.


  • Effects on your liver: inflammation of the liver, jaundice (yellowing of the skin and eyes, itching and dark urine) and other liver problems.


  • Effects on your blood and lymph system: disturbance of blood count e.g. a reduction in the number of white blood cells or red blood cells or platelets in the blood; or deficiency of special blood cells (agranulocytosis).


  • Effects on your nutrition and metabolism: hypoglycaemia (not enough sugar in the blood), reduction in blood sodium (hyponatraemia).



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How to store Glibenese



Keep all medicines out of the reach and sight of children.



Keep your medicine in a cool place (below 25°C).



Do not take this medicine after the date stamped on the pack. The expiry date refers to the last day of that month.



Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.





Further Information




What Glibenese contains



What is in your medicine?



  • The active ingredient is 5mg glipizide

  • The other ingredients are lactose, maize starch, microcrystalline cellulose and stearic acid.




What Glibenese looks like and contents of the pack



Glibenese tablets are white capsular shaped tablets with a score line across them to assist in breaking the tablets should this be necessary.



The tablets come in packs of 56 tablets per carton.





Marketing Authorisation Holder




Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK





Manufacturer




Pfizer PGM

Zone Industrielle

29 Route des Industries

37530 Poce sur Cisse

France




For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.




This leaflet was last updated in October 2008.



Ref: GL10_0






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