GLICLAZIDE UXA 30 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Gliclazida Uxa 30 mg Modified Release Tablets EFG

Gliclazida

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the Package Leaflet

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

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

Gliclazida Uxa is a medicine that lowers blood sugar levels (an oral antidiabetic medicine 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 loss alone do not have the desired effect.

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

Do not take Gliclazida Uxa

• If you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines of the same group (sulfonylureas), or to other related medicines (hypoglycemic sulfonamides),
• If you have insulin-dependent diabetes (type 1),
• If you have ketone bodies and sugar in the urine (this may mean you have diabetic ketoacidosis), precoma, or diabetic coma,
• If you have severe liver or kidney disorders,
• If you are receiving treatment for fungal infections (miconazole, see section "Using other medicines and Gliclazida Uxa"),
• If you are breast-feeding.

Warnings and precautions

You should only take this medicine if you have a regular food intake (including breakfast). It is important that your carbohydrate intake is regular, due to the increased risk of low blood sugar (hypoglycemia) if you delay or skip a meal, if you consume an inadequate amount of food, or if your food has a low carbohydrate content.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine) is necessary. Your doctor may ask for blood tests to check your hemoglobin A1c.

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

In the first few weeks of treatment, the risk of low blood sugar (hypoglycemia) may occur. Therefore, it is vital that you are carefully monitored by your doctor.

You may experience low blood sugar (hypoglycemia):

• if you take your meals irregularly or skip a meal,
• if you are fasting,
• if you are malnourished,
• if you change your diet,
• if you increase your physical activity without an adequate increase in carbohydrate intake,
• if you drink alcohol, especially if you also skip a meal,
• if you are taking any other medicine or natural remedies at the same time,
• if you take high doses of gliclazide,
• if you have special hormone-induced disorders (functional disorders 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, pallor, weakness, fatigue, nausea, vomiting, tiredness, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, decreased alertness and reaction time, depression, confusion, speech or visual disorders, tremors, sensory disturbances, dizziness, impotence. The following signs and symptoms may also occur: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and severe and sudden chest pain that may radiate to nearby areas (angina pectoris).

If your blood sugar levels continue to decrease, you may experience considerable confusion (delirium), develop convulsions, lose self-control, have shallow breathing, and a slower heart rate, and you may become unconscious, possibly leading to coma.

In most cases, the symptoms of low blood sugar disappear very quickly when you consume some form of sugar, such as sugar lumps, sweet juices, or sweetened tea. Therefore, you should always have some form of sugar with you (sugar lumps). Remember that sweeteners are not effective. Contact your doctor or the nearest hospital if the symptoms do not improve after taking sugar.

It is possible that the symptoms of low blood sugar may go unnoticed, develop slowly, or that you may not realize in time that your blood sugar level has decreased. This can occur if you are an elderly patient and are taking certain medicines (e.g., those that act on the central nervous system and beta-blockers). It can also happen if you have certain endocrine system disorders (e.g., certain thyroid or pituitary gland disorders or adrenal insufficiency).

If you are in stressful situations (e.g., accidents, operations, infections with fever, etc.), your doctor may temporarily change your therapy to insulin.

The symptoms of high blood sugar (hyperglycemia) may appear when gliclazide has not yet sufficiently lowered your blood sugar, when you have not followed the treatment prescribed by your doctor, or in special stressful situations. The symptoms of high blood sugar may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased performance.

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

If you have a family history or know that you have a hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormal red blood cells), you may experience a decrease in hemoglobin levels and red blood cell breakdown (hemolytic anemia). Contact your doctor before taking this medicine.

Children and adolescents

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

Using Gliclazida Uxa with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or those bought 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 altered if taken at the same time as Gliclazida.

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

The effect of lowering blood sugar of gliclazide may decrease, leading to high blood sugar, when taken with the following medicines:

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

Gliclazide may increase the effect of warfarin (a medicine that inhibits blood clotting).

Consult your doctor before starting to take another medicine. If you are hospitalized, inform the medical staff that you are taking Gliclazida.

Using Gliclazida Uxa with food, drinks, and alcohol

Gliclazide can be taken with food and non-alcoholic drinks.

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

Pregnancy and breast-feeding

Gliclazide is not recommended if you are pregnant.

Do not take Gliclazida Uxa while breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor may prescribe a more suitable treatment for you.

Driving and using machines

Your ability to concentrate or react may be impaired due to symptoms caused by low or high blood sugar, such as vision disturbances. This can be dangerous in situations where these skills are important (e.g., driving or using machines). Therefore, consult your doctor if it is advisable to drive or use machines.

Consult your doctor if you can drive a vehicle if you:

• experience frequent episodes of low blood sugar,
• experience few symptoms of low blood sugar or they go unnoticed.

Gliclazida Uxa contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Gliclazida Uxa

Dose

Follow exactly the administration instructions of this medicine given by your doctor.

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

The recommended initial dose is one tablet (30 mg) once a day. The dose may vary from one to a maximum of four tablets (maximum 120 mg) in a single intake with breakfast. This depends on the response to treatment.

If blood sugar control is not adequate, your doctor may increase the dose in successive steps, usually separated by at least 1 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 correct dose of each medicine for you.

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

Method and route of administration

Oral use.

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

preferably at the same time each day. You should always eat after or while taking your tablets. It is also important not to skip any meals while taking Gliclazida.

Do not crush or chew your tablets.

Use in children and adolescents

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

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

You should ensure that there is always an informed person who can call the doctor in case of 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 used.

If you forget to take Gliclazida Uxa

If you have forgotten 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 forgotten doses.

If you stop taking Gliclazida Uxa

If you stop or interrupt treatment, you should be aware that blood sugar control will worsen. Stopping treatment may cause high blood sugar (hyperglycemia), which increases 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 on the use of this product, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequently observed side effect is low blood sugar (hypoglycemia). 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 with sugar intake.

Liver disorders:

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

Skin disorders: Skin reactions such as rash, erythema, itching, hives, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue, or throat that can cause difficulty breathing), have been reported. The rash may evolve into widespread blistering or peeling of the skin.

Blood disorders: Decreases in blood cell count (e.g., platelets, red or white blood cells) have been reported, which can cause pallor, prolonged bleeding, bruising, sore throat, and fever. These symptoms usually disappear when treatment is discontinued.

Gastrointestinal disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhea, 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 start of treatment. This effect is due to changes in blood sugar levels.

As with other sulfonylureas, the following adverse reactions have been observed: severe changes in blood cell count and allergic inflammation of blood vessel walls, low sodium levels in the blood (hyponatremia), symptoms of liver failure (e.g., jaundice) that in most cases disappeared after withdrawal of the sulfonylurea, but in isolated cases may lead to life-threatening liver failure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Gliclazida Uxa

Keep out of the sight and reach of children.

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

Do not store above 30°C

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

6. Package Contents and Additional Information

Gliclazida Uxa Composition

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

Product Appearance and Package Contents

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

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

Marketing Authorization Holder

UXA FARMA S.A.

Avda. J.V. Foix 62

08034 Barcelona.

Manufacturer

Industria Química y Farmacéutica VIR

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

28923 Alcorcón (Madrid).

or

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas 28108. Madrid

Date of the Last Revision of this Leaflet: December 2015

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es