Zicron Pr 30 Mg Prolonged-Release Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zicron® PR 30 mg prolonged-release tablets
Gliclazide
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.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
_1. What this medicine is and what it is used for_
The name of your medicine is Zicron® PR30 mg prolonged-release tablets. The active ingredient is Gliclazide. It reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).
This medicine is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
2. What you need to know before you take this medicine Do NOT take this medicine
• if you are allergic to gliclazide or any of the other ingredients of this medicine, or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides);
• if you have insulin-dependent diabetes (type 1);
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma;
• if you have severe kidney or liver disease;
• if you are taking medicines to treat fungal infections (miconazole, see "Taking other medicines");
• if you are breastfeeding (see "Pregnancy, breastfeeding and Fertility").
Warnings and precautions
You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, you observe the dietary regimen, have physical exercise and, where necessary, reduce weight.
During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary.
In the first few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
• if you take meals irregularly or skip meals altogether
• if you are fasting
• if you are malnourished
• if you change your diet
• if you increase your physical activity and carbohydrate intake does not match this increase
• if you drink alcohol, especially in combination with skipped meals
• if you take other medicines or natural remedies at the same time
• if you take too high doses of gliclazide
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex)
• if your kidney function or liver function is severely decreased.
If you have low blood sugar you may have the following symptoms:
headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, e.g. glucose tablets, sugar cubes, sweetjuice, sweetened tea. You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta blockers). If you are in stress-situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide 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. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
If these symptoms occur, you must contact your doctor or pharmacist.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product. This medicine is not recommended for use in children due to a lack of data.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they may interact with this medicine.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics or GLP-1 receptor agonists or insulin),
- antibiotics (e.g. sulphonamides, clarithromycin),
- medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril),
- medicines to treat fungal infections (miconazole, fluconazole),
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors),
- painkiller or antirheumatics (phenylbutazone, ibuprofen),
- medicines containing alcohol.
The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:
- medicines to treat disorders of the central nervous system(chlorpromazine),
- medicines reducing inflammation (corticosteroids),
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
This medicine may increase the effects of medicines which reduce blood clotting (e.g. warfarin). Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking this medicine.
Taking this medicine with food, drink and alcohol
This medicine can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Pregnancy, breast-feeding and fertility
This medicine is not recommended for use during pregnancy. If you are, pregnant or breast-feeding, think you may be pregnant or are planning to have a baby while taking this medicine inform your doctor so that he may prescribe a more suitable treatment for you.
You must not take this medicine while you are breastfeeding.
Driving and using machines
Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (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 low blood sugar (hypoglycaemia),
• have few or no warning signals of low blood sugar (hypoglycaemia). |
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This medicine 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.
_3. How to take this medicine_
Always take this medicine as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage
The dose is determined by the doctor, depending on your blood and possibly urine sugar levels.
Change in external factors (e.g. weight reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The usual dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment.
If a combination therapy of this medicine with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidvl peptidase-4 inhibitor, a GIP-1 agonist receptor or insulin (other medicines to treat high blood sugar) is initiated your doctor will determine the proper dose of each medicine individually for you.
If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
Methods and routes of administration
Oral use.
Swallow your tablets whole. Do not chew them.
Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day).
You must always eat a meal after taking your tablet(s).
If you take more tablets than you should
If you take too many tablets, contact your doctor or the nearest hospital Accident &Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in Section 2. The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, e.g. a child, has taken the product unintentionally. Unconscious patients must not be given food or drink.
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 this medicine
It is important to take your medicine every day as regular treatment works better.
However, if you forget to take a dose of this medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia).
If you have any further questions on the use of this product, ask your doctor or pharmacist
4. Possible side effects
Like all medicines this medicine, can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see "Warnings and Precautions" in "Section 2 ".
If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Blood disorders:
Decrease in the number of cells in the blood has been reported (e.g. platelets, red and white blood cells).
This may cause:
• Paleness
• Prolonged bleeding
• Bruising
• Sore throat
• Fever
These symptoms usually vanish when the treatment is discontinued.
Liver disorders:
There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders:
Skin reactions have been reported such as:
• Rash
• Redness
• Itching
• Hives
• Angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty). The rash may progress to widespread blistering or peeling of the skin.
Digestive disorders:
• Abdominal pain
• Nausea, vomiting
• Indigestion
• Diarrhoea
• Constipation
These effects are reduced when this medicine is taken with a meal as recommended, See Section 3 Eye disorders:
Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for other sulphonylureas, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (e.g. jaundice) which in most cases disappeared after withdrawal of the sulphonylurea, but may lead to life threatening liver failure in isolated cases.
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
| 5. How to store this medicine |
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the blister strip after (EXP.). The expiry date refers to the last day of that month.
• Do not store above 250C.
• 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 this medicine contains
• The active substance is gliclazide. One tablet contains 30 mg of gliclazide, in a prolonged-release formulation.
• The other ingredients are: Lactose monohydrate, Maize starch, Povidone, Hypromellose, Colloidal anhydrous silica and Magnesium stearate.
What these tablets look like
• The tablets are white to off white, capsule shaped, biconvex tablets debossed with 'C12' on one side and plain on the other side.
• The tablets are available in blisters packed in cartons of 7, 10, 14, 28, 20, 30, 56, 60, 84, 90, 100,112, 120, 180 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717
Email: info@hristol-lahs.co.uk
Zicron® PR 30mg prolonged-release tablets; PL 17907/0398 This leaflet was last revised in September 2014.
To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.
V4 29-09-2014 DO S
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