Gliclazide Uxa 30 mg modified-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gliclazida Uxa 30 mg modified-release tablets EFG

Gliclazide

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 it may 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.

Contents of the leaflet

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

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

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

Gliclazida Uxa is used to treat a specific type of diabetes (type 2 diabetes mellitus) in adults, when diet, physical exercise, and weight reduction alone do not provide adequate control.

2. What you need to know before starting to take Gliclazida Uxa

Do not take Gliclazida Uxa

• If you are allergic to gliclazide or any of the other components of this medicine (listed in section 6), or to other medicines in the same group (sulfonylureas), or to related medicines (hypoglycemic sulfamides),
• If you have insulin-dependent diabetes (type 1),
• If you have ketones and sugar in your urine (this may indicate diabetic ketoacidosis), pre-coma or diabetic coma,
• If you have severe liver or kidney impairment,
• If you are receiving treatment for fungal infections (miconazole, see section “Use of other medicines and Gliclazida Uxa”),
• If you are breastfeeding.

Warnings and precautions

You should only take this medicine if your meals are taken regularly (including breakfast). It is important that your carbohydrate intake is regular, due to the increased risk of low blood sugar levels (hypoglycemia) if a meal is delayed or skipped, if an inadequate amount of food is consumed, or if the food has a low carbohydrate content.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine) is necessary. Your doctor may request blood tests to monitor your glycated hemoglobin (HbA1c).

You must follow the treatment plan prescribed by your doctor to achieve recommended blood sugar levels. This includes taking the tablets regularly, as well as following a diet and exercise regimen, and, if necessary, losing weight.

During the first weeks of treatment, there is a risk of decreased blood sugar levels (hypoglycemia). Therefore, it is vital that you are carefully monitored by your doctor.

You may experience a drop in blood sugar levels (hypoglycemia):

• if you eat irregularly 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 are taking any other medicines or herbal remedies at the same time,
• if you take high doses of gliclazide,
• if you have specific hormone-related disorders (dysfunction of the thyroid gland, pituitary gland, or adrenal cortex),
• if your kidney or liver function is severely impaired.

If you experience low blood sugar, you may have the following symptoms: headache, intense hunger, paleness, weakness, fatigue, nausea, vomiting, tiredness, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech or visual disturbances, tremor, sensory disturbances, dizziness, impotence. The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and sudden, severe chest pain that may radiate to nearby areas (angina pectoris).

If your blood sugar levels continue to drop, you may experience marked confusion (delirium), seizures, loss of consciousness, shallow breathing, slower heart rate, and possibly fall into a coma.

In most cases, symptoms of low blood sugar resolve quickly when some form of sugar is consumed, for example, sugar lumps, sweet fruit juices, or sweetened tea. Therefore, you should always carry a source of sugar (such as sugar lumps) with you. Remember that sugar substitutes are not effective. Contact your doctor or the nearest hospital if symptoms do not improve after taking sugar.

Symptoms of low blood sugar may go unnoticed, develop slowly, or you may not realize in time that your blood sugar level has dropped. This may occur if you are elderly and taking certain medications (e.g., those acting on the central nervous system and beta-blockers). It may also happen if you have certain endocrine disorders (e.g., certain thyroid or anterior pituitary dysfunction, or adrenal insufficiency).

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

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

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

If you have a family history or know you have an inherited deficiency of glucose-6-phosphate dehydrogenase (G6PD) (abnormal red blood cells), a decrease in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur. Contact your doctor before taking this medicine.

Children and adolescents

Gliclazida must not be used to treat diabetes in children and adolescents under 18 years of age.

Use of Gliclazida Uxa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines or those obtained without a prescription.

The effectiveness and safety of Gliclazida may be altered if taken at the same time as other medicines. Conversely, other medicines may be affected if taken together with Gliclazida.

The blood sugar-lowering effect of gliclazide may increase, leading to signs of low blood sugar, when taken with 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 to treat high blood pressure and heart failure (beta-blockers, angiotensin-converting enzyme (ACE) inhibitors such as captopril or enalapril),
• medicines to treat fungal infections (miconazole, fluconazole),
• medicines to treat dyspepsia and stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine),
• medicines to treat depression (monoamine oxidase inhibitors such as selegiline, phenelzine),
• painkillers or anti-rheumatic drugs (ibuprofen, phenylbutazone),
• medicines containing alcohol.

The blood sugar-lowering effect of gliclazide may be weakened, thereby increasing blood sugar levels, when taken with any of the following medicines:

• medicines to treat central nervous system disorders (chlorpromazine),
• medicines that reduce inflammation (glucocorticoids such as hydrocortisone, prednisolone),
• medicines to treat asthma (salbutamol, when administered by injection),
• medicines used during childbirth (ritodrine and terbutaline when administered by injection),
• medicines to treat breast disorders, heavy menstrual bleeding, and endometriosis (danazol).

Gliclazida may enhance the effect of warfarin (a medicine that inhibits blood clotting).

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

Use of Gliclazida Uxa with food, drinks, and alcohol

Gliclazida may be taken with food and non-alcoholic drinks.

Alcohol consumption is not recommended, as it may unpredictably affect your diabetes control and may even lead to coma.

Pregnancy and breastfeeding

Gliclazida is not recommended if you are pregnant.

You must not take Gliclazida Uxa while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor may prescribe a more suitable treatment for you.

Driving and use of machines

Your ability to concentrate or react may be affected 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 to determine whether it is advisable to drive or use machines.

Consult your doctor about whether you may drive a vehicle if:

• you experience frequent episodes of hypoglycemia,
• you have few symptoms of hypoglycemia or they go unnoticed.

Gliclazida Uxa contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Gliclazida Uxa

Dosage

Follow exactly the instructions for use of this medicine provided by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The dose of Gliclazida is determined by your doctor, depending on your blood sugar levels and possibly on sugar in your urine. Changes in external factors (for example, weight loss, changes in lifestyle, stress) or improvements in blood sugar control may require adjustments in the dose of gliclazida.

The recommended starting dose is one tablet (30 mg) once daily. The dose may range from one to a maximum of four tablets (maximum 120 mg) taken as a single dose with breakfast. This depends on your response to treatment.

If blood glucose control is not adequate, your doctor may increase the dose in successive steps, usually separated by at least one month.

If combination therapy with gliclazida 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 determine the appropriate dose of each medication for you.

Contact your doctor or pharmacist if you notice that your blood sugar levels remain high or have dropped too low despite taking this medicine as prescribed.

Administration route and method

Oral use.

Swallow the tablets whole with a glass of water during breakfast,

preferably at the same time each day. You must always eat a meal after or while taking your

tablets. It is also important not to skip any meals while taking Gliclazida.

Do not crush or chew the tablets.

Use in children and adolescents

Gliclazida Uxa is not recommended for use in children and adolescents, as no data are available.

If you take more Gliclazida Uxa than you should

If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. Symptoms of overdose are those of low blood sugar (hypoglycemia) described in section 2. Symptoms may improve by immediately taking sugar (4 to 6 sugar cubes) 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 applies if someone else, e.g., a child, has accidentally taken the medicine. Do not give food or drink to unconscious persons.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Gliclazida Uxa

If you forget to take a dose, take the next dose the following day at the usual time.

Do not take a double dose to make up for missed doses.

If you stop taking Gliclazida Uxa

If you interrupt or stop treatment, be aware that blood sugar control will worsen. Stopping treatment may cause an increase in blood sugar (hyperglycemia), increasing the risk of developing diabetes complications. If any change is necessary, it is very important that you contact your doctor.

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 it is temporarily controlled by sugar intake.

Liver disorders:

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

Skin disorders: Skin reactions have been reported, 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). The skin rash may progress to the formation of widespread blisters or skin peeling.

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 gliclazide 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 serious changes in blood cell counts and allergic inflammation of the blood vessel wall, decreased sodium levels in blood (hyponatraemia), symptoms of liver failure (e.g., jaundice), which in most cases resolved after discontinuation of the sulphonylurea, but which in isolated cases may lead to life-threatening liver failure.

Reporting of adverse effects

If you experience any type of 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 Uxa

Keep out of sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Gliclazida Uxa

• The active substance is gliclazide. Each tablet contains 30 mg of gliclazide.
• The other components are: lactose (see section 2, “Gliclazida Uxa contains lactose”), corn starch, povidone, hypromellose, anhydrous colloidal silica, magnesium stearate.

Appearance of the medicine and contents of the pack

The modified-release tablets are white or almost white, capsule-shaped, biconvex, marked with C12 on one side.

They are packaged in PVDC/PVC/Aluminum blisters, in boxes containing 60 tablets.

Marketing Authorization Holder

UXA FARMA S.A.

Avda. J.V. Foix 62

08034 Barcelona, Spain.

Manufacturer

Industria Química y Farmacéutica VIR

C/ Laguna 66-70. P.I. URTINSA II

28923 Alcorcón (Madrid), Spain.

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas 28108, Madrid, Spain

Date of the most recent review of this leaflet: December 2015

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