• 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.

Diamicron 80 mg Tablets will be referred as to Diamicron 80 mg throughout.

1. What Diamicron 80 mg is and what it is used for
2. What you need to know before you take Diamicron 80 mg
3. How to take Diamicron 80 mg
4. Possible side effects
5. How to store Diamicron 80 mg
6. Contents of the pack and other information

• if you are allergic to gliclazide or any of the other ingredients of Diamicron 80 mg (listed in section 6), to other medicines of the same group (sulfonylureas), to other related medicines (hypoglycaemic sulfonamides),
• If you have insulin-dependent diabetes (type 1),
• if you have ketone bodies and sugar in your urine (this may mean you have keto-acidosis), a diabetic pre-coma or coma,
• if you have severe kidney or liver disease,
• if you are taking miconazole (a treatment for fungal infections) or antibiotics (quinolones) (see section Other medicines and Diamicron 80mg),
• if you are breastfeeding (see section Pregnancy and breastfeeding).

Diamicron 80 mg is not recommended for use in children.

If you have been told by your doctor that you have an intolerance to some sugars (for instance glucose, lactose, galactose), contact your doctor before taking this medicinal product.

Follow your doctor's advice about diet and treatment. This is to reduce the chances of very low blood sugar (hypoglycaemia). Make sure your doctor knows:

• if you have an operation, a serious injury, fever or infection,
• difficulty in eating,
• if you plan a pregnancy or become pregnant,
• if you are taking any of the medicines listed in Other medicines and Diamicron 80mg.
• Tell your dentist about your treatment.

Dietary advice

This medicine may cause episodes of low blood sugar (hypoglycaemia). This is more likely if:

• you are on a strict diet,
• your diet is poorly balanced,
• you are taking prolonged or strenuous exercise,
• you drink alcohol,
• you are taking several medicines for high blood sugar (See Other medicines and Diamicron 80mg).

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 heart beat, 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, for instance glucose tablets, sugar cubes, sweet juice, 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.

While taking Diamicron 80 mg you should:

• follow a regular diet: it is important to eat regular meals, including breakfast and never to miss or delay a meal,
• take your medicine regularly (see How to take Diamicron 80 mg),
• check your blood glucose regularly as recommended by your doctor.

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), contact your doctor before taking this medicinal product.

Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria (inherited genetic disorders with accumulation in the body of porphyrins or porphyrin precursors).

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

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, GLP-1 receptor inhibitors or insulin),
• antibiotics (sulfonamides, clarithromycin, quinolones),
• 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),
• St John's Wort — Hypericum perforatum — preparations to treat mild to moderate depressive episodes.

Diamicron 80 mg may increase the effects of medicines which reduce blood clotting (warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking Diamicron 80 mg.

Diamicron 80 mg can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes.

Diamicron 80 mg is not recommended for use during pregnancy. If you are pregnant or breastfeeding, 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 Diamicron 80 mg while you are breastfeeding.

Provided your blood glucose levels are satisfactorily controlled on Diamicron 80 mg, your ability to drive or use machines should not be affected. However, if your blood glucose levels become too low, this could adversely affect your concentration, and therefore your ability to perform these tasks.

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).

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended daily dose is from one half to four tablets. This depends on the response to treatment. When the total daily dose exceeds two tablets, it should be divided into two equal doses taken morning and evening.

Diamicron 80 mg is for oral use. Take your tablet(s) with a glass of water (and preferably at the same time each day). Swallow your tablets whole. Do not chew them. You must always eat a meal after taking your tablet(s).

If a combination therapy of Diamicron 80 mg with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin 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.

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.

It is important to take your medicine every day as regular treatment works better.

However, if you forget to take a dose of Diamicron 80 mg, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

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) which increases the risk of developing complications of diabetes.

• Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Diamicron 80 mg is taken with a meal as recommended.
• Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking Diamicron 80 mg, seek urgent advice from a doctor and tell him that you are taking this medicine.
  Exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
• Blood disorders: Decrease in the number of cells in the blood for instance platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever. These symptoms usually stop 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 drug is stopped. Your doctor will decide whether to stop your treatment.
• 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 sulfonylureas, 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 (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life threatening liver failure in isolated cases.

If you get any side effects, talk to your doctor or 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is gliclazide. Each tablet contains 80 mg of gliclazide. The other ingredients are: lactose monohydrate, maize starch, pregelatinised maize starch, talc, magnesium stearate.

Diamicron 80 mg is a white, circular tablet with flat bevelled edges and cross scoring on one face and come in cartons of 28, 56, 60 and 112 tablets. Not all pack sizes may be marketed.

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