Gliclazide Stada 30 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazida Stada 30 mg modified-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Gliclazida Stada is and what it is used for
2. What you need to know before taking Gliclazida Stada
3. How to take Gliclazida Stada
4. Possible side effects
5. How to store Gliclazida Stada

Pack contents and other information

1. What Gliclazida Stada is and what it is used for

Gliclazida Stada is a medicine that lowers blood sugar levels (an oral antidiabetic medicine belonging to the sulfonylurea group).

Gliclazida Stada is used in a certain type of diabetes in adults (type 2 diabetes mellitus), when diet, physical exercise, and weight loss alone are not sufficient to ensure normal blood sugar levels.

2. What you need to know before taking Gliclazida Stada

DO NOT take Gliclazida Stada:

• If you are allergic to gliclazide or to any of the other ingredients of this medicine (listed in section 6) or to any medicine in the same group (sulfonylureas), or to other related medicines (hypoglycemic sulfonamides).
• If you have insulin-dependent diabetes (Type 1).
• If you have ketones and sugar in your urine (which may indicate diabetic ketoacidosis), pre-coma, or diabetic coma.
• If you suffer from severe kidney or liver disease.
• If you are taking medicines for fungal infections (miconazole – see section: “Other medicines and Gliclazida Stada”).
• If you are breastfeeding (see section: “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor before starting to take Gliclazida Stada.

You must follow your doctor's prescribed treatment to achieve appropriate blood sugar levels. This means, in addition to regularly taking the tablets, you should control your diet, exercise, and, if necessary, lose weight.

During treatment with gliclazide, it is necessary to monitor your blood sugar levels (and possibly urine sugar) and also your glycated hemoglobin (HbA1c).

During the first weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Therefore, careful medical monitoring is required.

Low blood sugar levels (hypoglycemia) may occur:

• if you do not maintain regular meal times or skip meals.
• if you are fasting.
• if you are malnourished.
• if you change your diet.
• if you increase your physical activity without a corresponding increase in carbohydrate intake.
• if you drink alcohol, especially if you also skip meals.
• if you take other medicines or herbal remedies at the same time.
• if you take very high doses of gliclazide.
• if you have certain hormonal disorders (dysfunctions of the thyroid gland, pituitary gland, or adrenal cortex).
• if your liver or kidney function is severely impaired.

If your blood sugar drops, you may experience the following symptoms:

Headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, visual and speech disturbances, tremors, sensory disturbances, dizziness, and weakness. The following signs and symptoms may also appear: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, severe sudden chest pain that may radiate to nearby areas (angina pectoris).

If blood sugar levels continue to fall, you may experience severe confusion (delirium), seizures, loss of coordination, shallow breathing, and slowed heartbeat, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar disappear quickly when you consume any form of sugar, e.g., glucose tablets, sugar cubes, sugary 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. Contact your doctor or the nearest hospital if sugar intake does not help or if symptoms reappear.

Symptoms of low blood sugar may not appear, may be mild or develop slowly, or you may not notice in time that your blood sugar has dropped. This may happen if you are an elderly patient and are taking certain medicines (e.g., those acting on the central nervous system and beta-blockers).

If you are under stress (accidents, surgery, fever, etc.), your doctor may temporarily switch your treatment to insulin.

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazida has not sufficiently lowered your blood sugar, if you have not followed your prescribed treatment, if you take St. John's wort (Hypericum perforatum) preparations (see section "Other medicines and Gliclazida Stada"), or during special stress situations. These may include thirst, frequent urination, dry mouth, dry and itchy skin, skin infections, and reduced performance.

If these symptoms appear, contact your doctor or pharmacist.

Changes in blood glucose (low blood sugar and high blood sugar) may occur when gliclazida is prescribed together with medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history or know you have hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell abnormality), a reduction in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Children and adolescents

Gliclazida Stada is not recommended for use in children and adolescents due to lack of data.

Other medicines and Gliclazida Stada

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

The hypoglycemic effect of gliclazide may increase and signs of low blood sugar may appear when taking any of the following medicines:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists) or insulin.
• antibiotics (e.g., sulfonamides, clarithromycin).
• medicines for treating hypertension or heart failure (beta-blockers, angiotensin-converting enzyme inhibitors such as captopril or enalapril).
• medicines for treating fungal infections (miconazole, fluconazole).
• medicines for treating stomach or duodenal ulcers (H2-receptor antagonists).
• medicines for treating depression (monoamine oxidase inhibitors).
• medicines containing alcohol.

The hypoglycemic effect of gliclazida may decrease, causing an increase in blood sugar levels, when taking any of the following medicines:

• medicines for treating disorders of the central nervous system (chlorpromazine).
• medicines to reduce inflammation (corticosteroids).
• medicines for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline).
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).
• St. John's wort preparations (Hypericum perforatum).

Changes in blood glucose (low blood sugar and high blood sugar) may occur when taking a medicine belonging to a class of antibiotics called fluoroquinolones at the same time as Gliclazida Stada, especially in elderly patients.

Gliclazida may increase the effects of medicines that reduce blood clotting (e.g., warfarin).

Consult your doctor before using any other medicine. If you are admitted to hospital, inform the healthcare staff that you are taking Gliclazida Stada.

Taking Gliclazida Stada with food, drinks, and alcohol

Gliclazida Stada may be taken with meals and non-alcoholic drinks. It is recommended not to drink alcohol during treatment with gliclazide, as it may unpredictably affect your diabetes control.

Pregnancy and breastfeeding

Gliclazida Stada is not recommended during pregnancy. If you plan to become pregnant or become pregnant, consult your doctor before taking this medicine, as they may prescribe a more suitable treatment for you.

You must not take Gliclazida Stada if you are breastfeeding.

Driving and using machines

Your ability to concentrate and react may be affected if your blood sugar is too low (hypoglycemia), too high (hyperglycemia), or if you experience visual disturbances due to these conditions. Be aware that you may put yourself or others at risk (e.g., when driving or operating machinery).

Consult your doctor if you can drive if:

• you have frequent episodes of low blood sugar (hypoglycemia).
• you do not experience warning signs of low blood sugar (hypoglycemia) or these signs are mild.

3. How to take Gliclazida Stada

Dosage

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The dosage is determined by your doctor, depending on your blood and possibly urine glucose levels.

Changes in external factors (e.g., weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the dose of gliclazide.

The recommended daily dose is 1 to 4 tablets (maximum 120 mg), taken as a single dose at breakfast time. This depends on your response to treatment.

If your doctor initiates combination therapy with gliclazide and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin, your doctor will determine the appropriate individualized dose for each medication.

If you notice that your blood glucose levels remain high despite taking the medicine as prescribed, you should contact your doctor or pharmacist.

Route and method of administration

Gliclazida is for oral use.

Take your medicine with a glass of water at breakfast time (and preferably at the same time each day). Swallow the tablet whole. Do not crush or chew it.

You must always eat a meal after taking your tablet(s).

If you take more Gliclazida Stada than you should

If you have taken too many tablets, contact your doctor or the nearest emergency hospital immediately. Signs of overdose are those described for low blood sugar (hypoglycemia) in section 2. Symptoms may improve by taking sugar (4 to 6 sugar cubes) or sugary drinks, followed by a substantial snack or meal.

If the patient is unconscious, call emergency services and inform the doctor immediately. The same applies if someone, e.g., a child, takes the medicine unintentionally. Do not give food or drink to unconscious patients. Ensure that there is always an informed person available who can call the doctor in case of emergency.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Gliclazida Stada

It is important to take your medicine regularly every day for it to work effectively.

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

If you stop taking Gliclazida Stada

Since diabetes treatment is usually lifelong, you must consult your doctor before stopping this medicine. Discontinuing treatment may cause an increase in blood sugar (hyperglycemia), increasing the risk of developing diabetes complications.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most frequently observed adverse effect is low blood sugar (hypoglycaemia). For signs and symptoms, see "Warnings and precautions".

If symptoms are not treated, they may progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if temporarily controlled by sugar intake, seek immediate medical attention.

Liver disorders

Isolated cases of abnormalities in liver function have been reported, which may cause yellowing of the skin and eyes. If this occurs, consult your doctor immediately. These symptoms usually resolve if the medicine is discontinued. Your doctor will decide whether treatment should be stopped.

Skin disorders

Skin reactions have been reported, such as:

• Rash.
• Redness.
• Itching.
• Urticaria.
• Angioedema (rapid swelling of tissues such as eyelids, face, lips, tongue or throat, which may cause breathing difficulties). The rash may progress to the formation of generalized blisters or skin peeling.

Rarely, signs of severe hypersensitivity reactions (DRESS) have been reported:

Initially presenting as flu-like symptoms and later as a facial rash with widespread rash and high fever.

Blood disorders

A reduction in blood cells (e.g. platelets, white and red blood cells) has been reported. This may cause:

• Pallor.
• Prolonged bleeding.
• Bruising.
• Sore throat.
• Fever.

These symptoms usually resolve upon discontinuation of treatment.

Gastrointestinal disorders

• Abdominal pain.
• Nausea.
• Indigestion.
• Diarrhoea.
• Constipation.

These effects are reduced if Gliclazida Stada is taken with a meal as recommended.

Eye disorders

Your vision may be affected for a short period of time, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylureas, the following adverse effects have been observed: cases of serious changes in blood cell counts and allergic inflammation of blood vessel walls, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (e.g. jaundice), which in most cases resolved after discontinuation of sulphonylureas, but which in isolated cases may lead to liver failure that can be fatal.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the blister, after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Stada

The active substance is gliclazide.

Each modified-release tablet contains 30 mg of gliclazide.

The other components are:

Calcium hydrogen phosphate dihydrate, povidone K30, hypromellose and magnesium stearate (E470b).

Appearance of the product and contents of the pack

Gliclazida Stada 30 mg are white or almost white, capsule-shaped, biconvex tablets, 9.8 mm x 4.3 mm in size, engraved with "30" on one side and plain on the other.

Gliclazida Stada 30 mg modified-release tablets are available in blisters packed in boxes containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180 and 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel,

Co. Tipperary

Ireland

Date of the most recent review of this leaflet: March 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es