Package Insert: Information for the Patient

Repaglinide Alter 2 mg Tablets

Repaglinide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Repaglinida Alter is aoral antidiabetic that contains repaglinidewhich helps your pancreas to produce more insulin and lower your blood sugar (glucose) levels.

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin to control blood sugar levels or in which the body does not respond normally to the insulin it produces.

Repaglinida Alter is used to control type 2 diabetes, as a complement to diet and exercise: treatment should begin if diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels.

Repaglinida Alter may also be administered with metformin, another diabetes medication.

It has been shown that Repaglinida Alter reduces blood sugar levels, which contributes to preventing diabetes complications.

Do not take Repaglinida Alter

• If you are allergic to repaglinide or any of the other components of this medication (listed in section 6).
• If you havetype 1 diabetes.
• If your blood acid level has increased (diabetic ketoacidosis).
• If you havesevere liver disease.
• If you takegemfibrozil(a medication that lowers blood lipid levels).

Warnings and precautions

Consult your doctor before starting to take Repaglinida.

• If you haveliver problems. Repaglinida is not recommended for patients with moderate liver disease. Repaglinida should not be taken if you have severe liver disease (seeDo not take Repaglinida Alter).
• If you havekidney problems. Repaglinida should be taken with caution.
• If you are about to undergo amajor surgical procedureor have recently had aserious illness or infection. In these circumstances, blood sugar control may not be achieved.
• If you areunder 18orover 75 years, Repaglinida is not recommended. It has not been studied in these age groups.

Consult your doctorif any of the above cases occur. Repaglinida may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medication if you are under 18 years old.

If you have a hypoglycemia (low blood sugar)

You may experience hypoglycemia if your blood sugar level is too low. This can occur if:

• You take too much Repaglinida.
• You engage in more physical exercise than usual.
• You take other medications or have kidney or liver problems (see other sections of section 2. What you need to know before starting to take Repaglinida Alter).

Warning signs of hypoglycemiaappear suddenly and may include: cold sweat, pale and cold skin, headache, palpitations, nausea, excessive appetite, temporary visual disturbances, fatigue, unusual weakness and tiredness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or if you feel you are about to have a hypoglycemia: take glucose tablets or a sugary product or drink, and then rest.

When the symptoms of hypoglycemia disappear or when blood sugar levels stabilizecontinue treatment with Repaglinida.

Inform others that you are diabetic and that if you lose consciousnessdue to hypoglycemia, they should lay you on your side and seek immediate medical assistance. Do not give you anything to eat or drink, as you may choke.

• If severe hypoglycemia is not treatedit can cause brain damage (temporary or permanent) and even death.
• If hypoglycemia causes you to lose consciousness or if you experience repeated hypoglycemiainform your doctor. Your doctor may need to adjust your Repaglinida dose, diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycemia). This can occur:

• If you take too little Repaglinida.
• If you have an infection or fever.
• If you eat more than usual.
• If you engage in less physical exercise than usual.

Warning signs of high blood sugarappear gradually and may include: frequent urination, thirst, dry skin, and a sensation of dryness in the mouth. Inform your doctor. Your doctor may need to adjust your Repaglinida dose, diet, or exercise.

Other medications and Repaglinida Alter

Inform your doctoror pharmacist if you are taking, have taken recently, or may need to take any other medication.

If your doctor prescribes it, you can take Repaglinida with metformin, another diabetes medication.

If you take gemfibrozil (used to lower blood lipid levels), do not take Repaglinida.

Your body's response to Repaglinida may change if you take other medications, especially:

• Monamine oxidase inhibitors (MAOIs) (for depression treatment)
• Beta-blockers (for hypertension or heart disease treatment)
• Angiotensin-converting enzyme inhibitors (ACE inhibitors) (for heart disease treatment)
• Salicylates (e.g. aspirin)
• Octreotide (for cancer treatment)
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic)
• Glucocorticoids (anabolic steroids and corticosteroids, for anemia or inflammation treatment)
• Oral contraceptives (to prevent pregnancy)
• Thiazides (diuretics)
• Danazol (for breast cysts and endometriosis treatment)
• Thyroid products (for hypothyroidism treatment)
• Sympathomimetics (for asthma treatment)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (antifungal medications)
• Gemfibrozil (to treat high blood lipid levels)
• Cyclosporine (to suppress the immune system)
• Deferasirox (to reduce chronic iron overload)
• Clopidogrel (to prevent blood clot formation)
• Phenytoin, carbamazepine, phenobarbital (for epilepsy treatment)
• St. John's Wort (herbal medicine)

Taking Repaglinida Alter with food, drinks, and alcohol

Alcohol can alter Repaglinida's ability to lower blood sugar levels. Remain alert to hypoglycemia symptoms.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Do not take Repaglinida if you are pregnant or planning to become pregnant.

Do not take Repaglinida if you are breastfeeding.

Driving and operating machinery

Your ability to drive cars and operate machinery may be affected if your blood sugar level is low or high. Be aware that you may put yourself or others at risk. Consult your doctor about the possibility of driving a car if:

• You experience frequent hypoglycemia.
• You have few or no hypoglycemia symptoms or find it difficult to recognize them.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will calculate your dose.

• Normallythe initial doseis 0.5 mg taken exactly before each main meal.

The tablets should be taken with a glass of water just before or within 30 minutes before each main meal.

• Your dose may be adjusted by your doctor up to 4 mg, which should be taken just before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinida than your doctor has recommended.

If you take more Repaglinida Alter than you should

If you take too many tablets, your blood sugar may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the sectionif you have hypoglycemia.

If you forgot to take Repaglinida Alter

If you forget to take a dose, take the next dose as you normally do, do not take a double dose to make up for the missed doses.

If you interrupt treatment with Repaglinida Alter

Be aware that the desired effect will not be achieved if you stop taking Repaglinida. Your diabetes may worsen. If any changes to your treatment are necessary, consult your doctor first.

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

ALike all medications, this medication may produce adverse effects, although not all people will experience them.

Hypoglycemia

The most frequent adverse effect is hypoglycemia, which may affect up to 1 in 10 people (seeif you have hypoglycemiain section 2). Hypoglycemic reactions are usually mild or moderate but occasionally may lead to loss of consciousness or hypoglycemic coma. If this occurs, you need immediate medical assistance.

Allergy

Allergic reactions are very rare (may affect up to 1 in 10,000 people). Symptoms such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating, may be signs of anaphylactic reaction. Contact your doctor immediately.

Other Adverse Effects

Frequent(may affect up to 1 in 10 people)

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

Very Rare(may affect up to 1 in 10,000 people)

• Vomiting.
• Constipation.
• Visual disturbances.
• Severe liver problems, abnormal liver function such as increased liver enzymes in blood.

Frequency Not Known(the frequency cannot be estimated from available data)

• Hypersensitivity (such as hives, itching, redness, and swelling of the skin).
• Nausea.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Repaglinida Alter

• The active ingredient is repaglinide. Each tablet contains 2 mg of repaglinide.
• The other components are: microcrystalline cellulose (E460), anhydrous calcium di phosphate, cornstarch, potassium polacrilinate, povidone (polyvidone), 99.5% glycerol (E422), magnesium stearate, meglumine, poloxamer, colloidal silicon dioxide (Aerosil), and red iron oxide (E172).

Appearance of the product and contents of the packaging

Repaglinida Alter 2 mg tablets are pink, round, and biconvex.

Each package contains 90 tablets.

Holder of the marketing authorization

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Pharmathen S.A.

6 Dervenakion Str.

153 51 Pallini, Attiki

Greece

or

Pharmathen International S.A.

Industrial Park Sapes Rodopi Prefecture

Block No. 5

Rodopi 69 300

Greece

Last review date of this leaflet: March 2018.

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