Gliclazide Combix 60 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazida Combix 60 mg modified-release tablets EFG

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

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it 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 these are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

l

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

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

Gliclazida Combix 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 maintain normal blood sugar levels.

2. What you need to know before taking Gliclazida Combix

Do not take Gliclazida Combix

• if you are allergic to gliclazide or to any of the other ingredients of this medicine (listed in section 6), or to other medicines in the same group (sulfonylureas), or to 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 have severe renal or hepatic impairment;
• if you are receiving antifungal medications (miconazole); see section “Use of other medicines”;
• if you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor before starting to take Gliclazida Combix.

You must follow your doctor's prescribed treatment to achieve appropriate blood glucose levels.

This means that, in addition to taking the tablets regularly, you should control your diet, engage in physical exercise, and, if necessary, lose weight.

During treatment with gliclazide, periodic monitoring of your blood glucose levels (and possibly urine glucose) and also your glycated hemoglobin (HbA1c) is required.

In the first weeks of treatment, the risk of low blood sugar levels (hypoglycemia) may increase. Close clinical supervision is therefore especially necessary.

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 skip meals,
• if you take other medicines or herbal remedies simultaneously,
• if you take excessively high doses of gliclazida,
• if you have certain hormonal disorders (dysfunction of the thyroid gland, pituitary gland, or adrenal cortex),
• if you have severely impaired renal or hepatic function.

If you experience low blood sugar, you may have the following symptoms: headache, intense hunger, nausea, vomiting, fatigue, sleep disturbances, agitation, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, visual disturbances, and speech difficulties, tremors, sensory disturbances, dizziness, and weakness.

The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, sudden severe chest pain that may radiate to nearby areas (angina pectoris).

If blood sugar levels continue to drop, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, and slowed heart rate, potentially leading to unconsciousness.

In most cases, symptoms of low blood sugar resolve quickly after consuming sugar, for example glucose tablets, sugar lumps, sugary juice, or sweetened tea.

Therefore, you should always carry some form of sugar with you (glucose tablets, sugar lumps). Remember that artificial sweeteners are not effective. If sugar intake does not help or symptoms recur, please contact your doctor or the nearest hospital.

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

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

Symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently reduced blood glucose, when you have not followed your prescribed treatment, or during special stress situations. These may include thirst, dry mouth, dry and itchy skin, skin infections, reduced performance, and frequent urination.

If these symptoms occur, you should contact your doctor or pharmacist.

Blood glucose disturbances (low blood sugar and high blood sugar) may occur when gliclazida is prescribed together with other 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 a hereditary deficiency of glucose-6-phosphate dehydrogenase (G6PD) (a red blood cell disorder), a decrease in hemoglobin levels and destruction of red blood cells (hemolytic anemia) may occur. Consult your doctor before taking this medicine.

Children and adolescents

Gliclazida Combix is not recommended for use in children due to lack of data.

Other medicines and Gliclazida Combix

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

The hypoglycemic effect of gliclazida may be enhanced, leading to signs of low blood sugar, when taken with any of the following drugs:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists, or insulin),
• antibiotics (e.g., sulfonamides, clarithromycin),
• medicines for treating high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril),
• antifungal medicines (miconazole, fluconazole),
• medicines for treating stomach or duodenal ulcers (H2 receptor antagonists),
• medicines for treating depression (monoamine oxidase inhibitors),
• painkillers or anti-rheumatic drugs (phenylbutazone, ibuprofen),
• medicines containing alcohol,
• preparations containing St. John’s wort (Hypericum perforatum).

The hypoglycemic effect of gliclazida may be reduced, increasing blood sugar levels, when taken with any of the following drugs:

• medicines for treating disorders of the central nervous system (chlorpromazine),
• anti-inflammatory medicines (corticosteroids),
• medicines for treating asthma or used during childbirth (intravenous salbutamol, ritodrine, terbutaline),
• medicines for treating breast disorders, heavy menstrual bleeding, and endometriosis (danazol).

When a medicine belonging to the class of antibiotics called fluoroquinolones is taken at the same time as Gliclazida Combix, disturbances in blood glucose (low and high blood sugar) may occur, especially in elderly patients.

Gliclazida Combix may enhance the effect of medicines that reduce blood clotting (warfarin).

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

Taking Gliclazida Combix with food, drinks, and alcohol

Gliclazida Combix can be taken with meals and non-alcoholic drinks.

Alcohol consumption is not recommended, as it may unpredictably affect your diabetes control.

Pregnancy and breastfeeding

The use of Gliclazida Combix during pregnancy is not recommended.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

You must not use Gliclazida Combix if you are breastfeeding.

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycemia or hyperglycemia, such as vision problems. This may be dangerous in situations where these skills are important (e.g., driving or operating machinery). Therefore, consult your doctor about whether it is advisable to drive or use machines.

Consult your doctor about whether you may drive in the following cases:

• if you have frequent episodes of low blood sugar (hypoglycemia),
• if you have mild or no warning signs of low blood sugar (hypoglycemia).

Gliclazida Combix contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Gliclazida Combix

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

The dose will be determined by your doctor, depending on your blood sugar levels and possibly on sugar in the urine.

Dosage adjustments of gliclazide may be required due to changes in external factors (weight loss, changes in lifestyle, stress) or improvements in blood sugar control. The recommended daily dose is 30 to 120 mg (maximum 120 mg), taken as a single dose with breakfast. This depends on the response to treatment.

Gliclazida Combix is for oral use. Take the tablet(s) with a glass of water at breakfast (preferably at the same time each day). Swallow the tablets whole. Do not chew or crush. You must always eat after taking the tablet(s).

If combination therapy with Gliclazida Combix and metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist, or insulin is initiated, your doctor will individually determine the appropriate dose of each medicine for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels are high despite taking this medicine as prescribed by your doctor.

If you take more Gliclazida Combix than you should

If you take too many tablets, contact your doctor immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

Symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may be relieved by immediately taking sugar (4 to 6 sugar lumps) or sugary drinks, followed by a substantial snack or meal. If the patient is unconscious, inform the doctor immediately and call emergency services. The same should be done if someone, for example a child, has accidentally taken the medicine. Do not give food or drink to unconscious persons.

You must ensure that there is always an informed person available who can call the doctor in an emergency.

If you forget to take Gliclazida Combix

It is important that you take your medicine every day, as regular treatment is more effective.

However, if you forget to take a dose of Gliclazida Combix, 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 Combix

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

If you have any further questions about the use of this product, 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 symptoms and signs, see section “Warnings and precautions”.

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

Hepatic disorders

Isolated cases of abnormal liver function have been reported, which may cause yellowing of the skin and eyes. If you experience this, consult your doctor immediately. These symptoms usually resolve upon discontinuation of treatment. Your doctor will decide whether it is necessary to stop your treatment.

Skin disorders

Skin reactions such as rash, erythema, itching, hives, and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat, which may cause difficulty breathing) have been reported. Skin rash may progress to the formation of widespread blisters or skin peeling.

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

initially as flu-like symptoms and a rash on the face, followed by generalized rash with high fever.

Blood disorders

Decreases in blood cell counts (e.g. platelets, red and white blood cells) have been reported, which may cause paleness, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually resolve when treatment is discontinued.

Gastrointestinal disorders

Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazida Combix is taken with meals, as recommended.

Eye disorders

Your vision may be temporarily affected, especially at the beginning of treatment. This effect is due to changes in blood sugar levels.

As with other sulphonylureas, the following adverse reactions have been observed: cases of severe changes in blood cell counts and allergic inflammation of blood vessel walls, decreased sodium levels in blood (hyponatraemia), symptoms of liver failure (e.g. jaundice), which in most cases resolved after discontinuation of the sulphonylurea, but in isolated cases may lead to life-threatening liver failure.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gliclazide Combix

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 outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly 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 Combix 60 mg

• The active substance is gliclazide. Each modified-release tablet contains 60 mg of gliclazide.
• The other components are: monohydrate lactose, anhydrous sodium carbonate, hypromellose, anhydrous colloidal silica and magnesium stearate.

Appearance of the product and contents of the pack

Gliclazida Combix is a white or off-white, modified-release, oblong tablet, uncoated, marked with '60' on one side and smooth on the other. The tablets come in blisters packed in containers of 60 and 100 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: February 2018

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/