Patient leaflet - Glydex 160 mg tablets

1. What Glydex tablets are and what are they used for

Glydex tablets contain the active substance gliclazide, one of a group of medicines called sulfonylureas. It is an oral hypoglycaemic medicine (blood sugar lowering drug). Glydex tablets are used to keep blood sugar at the correct level in adults with non-insulin dependent diabetes when it is not controlled by diet, physical exercise and weight loss alone.

2. What you need to know before you take Glydex tablets

Do not take Glydex tablets

if you are allergic to gliclazide or any of the other ingredients of Glydex tablets (listed in section 6), or 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 and coma;
if you have severe kidney or liver disease;
if you are taking miconazole (a treatment for fungal infections) (see section Other medicines and Glydex tablets) • if you are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions

Talk to your doctor or pharmacist before taking Glydex tablets. 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, 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. 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, if you take St John’s Wort (Hypercium perforatum) preparations (see section “other medicine and Glydex tablets”) 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.

While taking Glydex tablets 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 Glydex tablets),
check your blood glucose regularly as recommended by your doctor.

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide is prescribed at the same time as medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you the importance of monitoring your blood glucose.

Children and Adolescents

Glydex tablets are not recommended for use in children.

Other medicines and Glydex tablets

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 (e.g. sulfonamides, 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),
painkillers 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.

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as Glydex 160mg, especially in elderly patients. Glydex tablets may increase the effects of medicines which reduce blood clotting (e.g. warfarin). Gliclazide

Package leaflet: Information for the patient

Glydex 160 mg Tablets

121XXXX-V1

6 mm

Marketing Authorisation Holder and Manufacturer

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, United Kingdom.

E-mail : info@medreich.co.uk

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 02088311580 (UK only)

Please be ready to give the following information:

Product name Reference number

Glydex 160mg Tablets PL 21880/0204

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

Glydex tablets with food, drink and alcohol

Glydex tablets 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 and breastfeeding

Glydex tablets are 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 ask your doctor for advice before taking this medicine. You must not take Glydex tablets while you are breastfeeding.

Driving and using machines

Provided your blood glucose levels are satisfactorily controlled on Glydex tablets, 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)

Glydex tablets contain lactose

Glydex tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars (for instance glucose, lactose or galactose) or 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.

3. How to take Glydex tablets

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 dose is from 40mg to 320mg. This depends on the response to treatment. When the total daily dose exceeds one tablet, it should be divided into two equal doses taken morning and evening. 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.

If a combination therapy of Glydex tablets 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.

Use in children and adolescents

The safety and efficacy of Glydex tablets in children and adolescents have not been established. No data is available.

Routes and method of administration

Glydex tablets are for oral use.

Swallow your tablets whole (and preferably at the same time each day). Do not chew them. Take your tablet(s) with a glass of water before a meal.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. If you take more Glydex 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.

If you forget to take Glydex tablets

It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Glydex tablets, 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 Glydex tablets

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.

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

4. Possible Side effects of Glydex tablets

Like all medicines this medicine can cause side effects, although not everybody gets them. Low blood sugar (Hypoglycaemia)

The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs see Section (Warnings and Precautions).

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.

Other side effects

Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Glydex tablets are taken with a meal as recommended.

Skin disorders: Skin reactions 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) have been reported. The rash may progress to widespread blistering or peeling of the skin. 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 (e.g. 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 (e.g. jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Glydex tablets

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 and the blister strip. The expiry date refers to the last day of that month.

Store below 25°C

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 Glydex tablets contain

The active substance is gliclazide. Each tablet contains 160 mg of gliclazide.

The other ingredients are: Lactose Monohydrate, Cellulose, microcrystalline, Povidone, Sodium Starch Glycolate (Type A), Talc and Magnesium Stearate.

What Glydex tablets look like and contents of the pack

Glydex 160mg Tablets are 12.5mm x 7.2mm, white to off white, flat-faced, oval-shaped, bevelled-edged, uncoated tablets, debossed “160” on one side with a score line on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Glydex tablets are supplied in blister packs of 10, 14, 28, 56, 60, 112 tablets.

Not all pack sizes may be marketed.

This leaflet was last revised in 08/2018