Package Leaflet: Information for the User

Gliclazide Normon 30 mg Modified Release Tablets EFG

Gliclazide

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Gliclazida Normon 30 mg modified-release tablets are a medication used to reduce blood sugar levels (oral antidiabetic medication).

Gliclazida Normon 30 mg modified-release tablets are used for the treatment of a type of diabetes (type 2 diabetes) in adults, when diet, physical exercise and weight loss alone do not have an adequate effect.

Do not take Gliclazida Normon 30 mg modified-release tablets

• If you are allergic to gliclazide, other sulfonylureas, sulfonamides, or any of the other ingredients of this medicine (listed in section 6).
• If you have insulin-dependent diabetes (type 1).
• If you have ketone bodies and sugar in your urine (which may mean you have ketoacidosis), precoma, or diabetic coma.
• If you have severe liver or kidney damage.
• If you are receiving treatment for fungal infections (miconazole).
• If you are breastfeeding.

If you think you are affected by any of the above situations, inform your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gliclazida Normon 30 mg modified-release tablets.

You should only take this medicine if you have a regular intake of food (including breakfast). It is essential that your carbohydrate intake is regular, as there is an increased risk of low blood sugar (hypoglycemia) if you delay a meal or skip one, if you consume an inadequate amount of food, or if the food is low in carbohydrates.

During treatment with gliclazide, regular monitoring of blood sugar levels (and possibly urine) is required. Your doctor may want to do blood tests to control your hemoglobin A1c (HbA1c, fasting plasma glucose).

You must monitor the treatment prescribed by your doctor to achieve the recommended blood sugar level. This means taking the tablets regularly, as well as following a diet and exercising.

During the first weeks of treatment, there is an increased risk of low blood sugar (hypoglycemia). Therefore, it is essential that your doctor closely monitors you.

Hypoglycemia can occur:

• If you take meals irregularly or skip them
• If you are fasting
• If you are malnourished
• If you change your diet
• If you increase your physical activity without an appropriate increase in carbohydrate intake
• If you consume alcohol, especially if you have skipped a meal
• If you take other medicines or natural remedies at the same time
• If you take high doses of gliclazide
• If you have endocrine disorders (thyroid, pituitary, or adrenal gland disorders)
• If you have severely impaired renal or hepatic function.

If you are experiencing low blood sugar, you may have the following symptoms: headache, intense hunger, pallor, weakness, fatigue, nausea, vomiting, drowsiness, sleep disturbances, nervousness, irritability, decreased concentration, decreased alertness and reaction time, depression, confusion, speech and visual disturbances, tremors, sensory disturbances, dizziness, and a feeling of uselessness. You may also experience the following signs and symptoms: sweating, moist skin, anxiety, rapid or irregular heartbeat, high blood pressure, and severe and sudden chest pain that may spread to adjacent areas (angina pectoris).

If your blood sugar levels continue to drop, you may feel a significant confusion (delirium), develop seizures, lose control, have shallow breathing, and a slower heart rate, which may lead to loss of consciousness and coma. The clinical profile of severe low blood sugar may resemble a heart attack.

In most cases, the symptoms of low blood sugar disappear quickly when you take sugar in any form, e.g., sugar cubes, sugary drinks, or sweet tea. You should always carry some form of sugar (sugar cubes) with you. Remember that artificial sweeteners (saccharin) are not effective. Contact your doctor or the nearest hospital if taking sugar does not work or if symptoms recur.

You may not experience symptoms of low blood sugar, or they may appear slowly, or you may not realize in time that your blood sugar has dropped.

This can happen if you are an elderly patient taking certain medications (e.g., central nervous system-acting drugs and beta-blockers). It can also happen when you have some endocrine disorders (e.g., certain thyroid function disorders, anterior pituitary gland disorders, or adrenal insufficiency).

Your doctor may change your treatment temporarily to insulin if you are experiencing stress (e.g., accidents, surgery, infections with fever, etc.).

The symptoms of high blood sugar (hyperglycemia) may include thirst, frequent urination, dry mouth, dry skin with itching, skin infections, and decreased activity. This may be due to inadequate control of blood sugar levels due to poor adherence to treatment or stressful situations such as an infection. Contact your doctor in this case.

Children and adolescents

Gliclazida Normon 30 mg modified-release tablets should not be used to treat diabetes in children or adolescents under 18 years old.

Other medicines and Gliclazida Normon 30 mg modified-release tablets

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including those purchased without a prescription.

The efficacy and safety of this medicine may be affected if taken at the same time as other medicines. Similarly, the action of other medicines may be affected if taken at the same time as Gliclazida Normon.

The hypoglycemic effect (ability to lower blood sugar) of gliclazide may be increased, 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) or insulin.
• Antibiotics (e.g., sulfonamides).
• 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 indigestion and stomach or duodenal ulcers (H2 receptor antagonists such as ranitidine).
• Medicines to treat depression (monoamine oxidase inhibitors).
• Analgesics (for pain) or antirheumatics (ibuprofen, phenylbutazone).
• Medicines containing alcohol.

The hypoglycemic effect of gliclazide may be decreased, and blood sugar levels may increase when taking any of the following medicines:

• Medicines to treat central nervous system disorders (chlorpromazine).
• Medicines to inhibit inflammation (glucocorticoids).
• Medicines to treat asthma (salbutamol administered by injection).
• Medicines used when there is a risk of premature birth (ritodrine and terbutaline intravenously).
• Medicines to treat chest diseases, heavy menstrual bleeding, and endometriosis (danazol).

Gliclazide may potentiate the anticoagulant effect during simultaneous treatment with warfarin (a medicine that inhibits blood clot formation).

Consult your doctor before starting to take another medicine. If you visit the hospital, inform the doctor and nurses that you are taking Gliclazida Normon 30 mg modified-release tablets.

Taking Gliclazida Normon 30 mg modified-release tablets with food, drinks, and alcohol

Gliclazida Normon 30 mg modified-release tablets can be taken with food and non-alcoholic drinks.

Avoid consuming alcohol as it may unpredictably alter blood sugar control and even lead to coma.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Gliclazida Normon is not recommended during pregnancy.

You should not take this medicine while breastfeeding.

Driving and operating machinery

Your ability to concentrate or react may be impaired if your blood sugar level is too low (hypoglycemia), too high (hyperglycemia), or if you develop visual problems due to these conditions. Be aware that you may put yourself or others at risk (e.g., when driving or operating machinery). Ask your doctor if you can drive if:

• You have frequent episodes of hypoglycemia
• You have a fever or do not have symptoms of hypoglycemia.

Gliclazida Normon 30 mg modified-release tablets contain sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Gliclazida Normon 30 mg modified-release tablets as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the dose of Gliclazida Normon 30 mg modified-release tablets based on your blood sugar and urine levels. Changes in external factors (e.g., weight loss, lifestyle changes, stress) or improvements in blood sugar control may require a change in the gliclazide dose.

The recommended starting dose is one tablet per day. The usual dose may vary from one to four tablets at most, taken once a day, depending on the response to treatment.

If blood sugar levels are not adequately controlled, your doctor may increase the dose in successive steps, leaving at least one month between adjustments.

This medication may be used to replace another oral antidiabetic, exactly as your doctor has informed you. If treatment is started with Gliclazida Normon 30 mg modified-release tablets combined with metformin, an alpha-glucosidase inhibitor, or insulin, your doctor will determine the individual appropriate dose for each medication.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Swallow the tablets whole with a glass of water during breakfast, preferably at the same time every day. It is essential not to skip any meals while taking gliclazide.

If you take more Gliclazida Normon 30 mg modified-release tablets than you should

In case of overdose or taking an additional dose of gliclazide, there is a risk of hypoglycemia (see signs of hypoglycemia in section 2) and you should take sugar immediately (e.g., glucose tablets, sugar cubes, sweetened juice, sweet tea) and consult your doctor immediately. You should act in the same way if someone, for example, a child, has taken the medication unintentionally. Unconscious people should not be given food or drink.

Since hypoglycemia can last for some time, it is essential to monitor the patient until the risk has passed. Hospital admission may be necessary as a precautionary measure. Severe cases of hypoglycemia accompanied by loss of consciousness and severe neurological failure are emergency cases that require immediate medical treatment and hospital admission.

Ensure that there is always an informed person who can notify your doctor in case of an emergency.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Gliclazida Normon 30 mg modified-release tablets

If you forget to take your tablet(s) one day, continue with the treatment as usual the next day.

Do not increase the next dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Gliclazida Normon 30 mg modified-release tablets

If you interrupt treatment, be aware that blood sugar control may worsen. If any changes are needed, it is essential to contact your doctor first.

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

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

The following side effects have been reported at the indicated frequencies:

Frequent (may affect up to 1 in 10 people):

• Hypoglycemia (low blood sugar). Symptoms include sweating, paleness, intense hunger, palpitations, and loss of consciousness, and others (see section 2: “What you need to know before starting to take Gliclazida Normon 30 mg modified-release tablets”). Symptoms improve by taking glucose (sugar) or sweetened drinks, followed by a large meal. If the patient does not respond to sugar or is unconscious, notify the nearest hospital's Emergency Service. Do not introduce anything into the mouth of an unconscious person.

Uncommon (may affect up to 1 in 100 people):

• Abdominal pain
• Nausea
• Vomiting
• Indigestion
• Diarrhea
• Constipation

These side effects decrease when Gliclazida Normon 30 mg modified-release tablets are taken with a meal, as recommended.

Rare (may affect up to 1 in 1,000 people):

• Decrease in the number of blood cells (anemia).
• Changes in blood values (may cause paleness, prolonged bleeding, bruising, sore throat, and fever) that usually disappear when treatment is discontinued.
• Skin reactions such as redness, itching, and rash formation. Severe skin reactions may occur.
• Abnormal liver function tests, changes in the liver (may cause yellowing of the skin and eyes).
• Your vision may be affected for a short period, especially at the beginning of treatment.

This effect is due to the change in blood sugar levels.

These usually disappear if treatment is discontinued.

With other sulfonylureas, very rare changes in the number of blood cells and allergic inflammatory reactions of the blood vessel walls have been described. Rarely, signs and symptoms of liver insufficiency (e.g., jaundice) have been observed with other sulfonylureas, which in most cases disappear when treatment with them is discontinued, but may cause severe liver failure in isolated cases.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special conditions for conservation.

Store in the original packaging.

Do not use Gliclazida Normon 30 mg Modified Release Tablets after the expiration date that appears on the blister pack and the box. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Deposit the packaging and medicines that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Gliclazida Normon 30 mg modified-release tablets

• The active ingredient is gliclazide. Each modified-release tablet contains 30 mg of gliclazide.
• The other components are: Mannitol (E-421), Stearic acid, Carnauba wax, Sodium phosphate, Hypromellose, Magnesium stearate, Anhydrous colloidal silica (E-551), Macrogol 4000, Talc, Titanium dioxide (E-171).

Appearance of the product and content of the packaging

The modified-release tablets are white, oval, and biconvex.

Gliclazida Normon 30 mg modified-release tablets are available in boxes of 60 tablets.

Holder of the marketing authorization:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Responsible for manufacturing:

VALPHARMA INTERNATIONAL S.p.A.

Via G. Morgagni, 2

61016 Pennabilli

Pesaro Italy

or

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Spain

F resh date of the last review of this leaflet: February 2012

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