REPAGLINIDE ALTER 1 mg TABLETS

2. What you need to know before taking Repaglinida Alter

Do not take Repaglinida Alter

• If you are allergic to repaglinida or any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes.
• If your blood acid level has increased (diabetic ketoacidosis).
• If you have severe liver disease.
• If you are taking gemfibrozil(a medicine that lowers blood fat levels).

Warnings and precautions

Talk to your doctor before starting to take Repaglinida.

• If you have liver problems. Repaglinida is not recommended for patients with moderate liver disease. Repaglinida should not be taken if you have severe liver disease (see Do not take Repaglinida Alter).
• If you have kidney problems. Repaglinida should be taken with caution.
• If you are going to undergo major surgeryor have recently suffered a serious illness or infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18or over 75 years, Repaglinida is not recommended. It has not been studied in these age groups.

Talk to your doctorif any of the above applies to you. Repaglinida may not be suitable for you. Your doctor will advise you.

Children and adolescents

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

If you have hypoglycemia (low blood sugar)

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

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

Warning signs of hypoglycemiaappear suddenly and can be: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, 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 going to have hypoglycemia: take glucose tablets or a sugary product or drink and then rest.

When the symptoms of hypoglycemia disappear or when blood sugar levels stabilize, continue 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 attention. They should not give you anything to eat or drink, as you may choke.

• If severe hypoglycemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• If you experience hypoglycemiathat makes you lose consciousness or if you have repeated hypoglycemic episodes, inform your doctor. You may need to adjust the dose of Repaglinida, diet, or exercise.

If your blood sugar level is too high

Your blood sugar level may be too high (hyperglycemia). This can happen:

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

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

Other medicines and Repaglinida Alter

Tell your doctoror pharmacist if you are taking, have recently taken, or might take any other medicines.

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

If you are taking gemfibrozil (used to lower blood fat levels), you should not take Repaglinida.

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

• Monoamine oxidase inhibitors (MAOIs) (for the treatment of depression)
• Beta-blockers (for the treatment of high blood pressure or heart disease)
• ACE inhibitors (for the treatment of heart disease)
• Salicylates (e.g., aspirin)
• Octreotide (for the treatment of cancer)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of pain reliever)
• Steroids (anabolic steroids and corticosteroids, for anemia or to treat inflammation)
• Oral contraceptives (to prevent pregnancy)
• Thiazides (diuretics)
• Danazol (for the treatment of breast cysts and endometriosis)
• Thyroid products (for the treatment of low thyroid hormone levels)
• Sympathomimetics (for the treatment of asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
• Itraconazole, ketoconazole (medicines for fungal infections)
• Gemfibrozil (to treat high blood fat levels)
• Ciclosporin (to suppress the immune system)
• Deferasirox (to reduce chronic iron overload)
• Clopidogrel (to prevent blood clots)
• Phenytoin, carbamazepine, phenobarbital (to treat epilepsy)
• St. John's Wort (herbal medicinal plant)

Taking Repaglinida Alter with food, drinks, and alcohol

Alcohol can alter Repaglinida's ability to lower blood sugar levels. Be aware of the symptoms of hypoglycemia.

Pregnancy and breastfeeding

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

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

Do not take Repaglinida if you are breastfeeding.

Driving and using machines

Your ability to drive or use machines 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 have frequent hypoglycemic episodes.
• You have few or no symptoms of hypoglycemia or find it difficult to recognize them.

3. How to take Repaglinida Alter

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor again.

Your doctor will calculate your dose.

• The initial doseis usually 0.5 mg taken immediately before each main meal.

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

• The dose may be adjusted by your doctor up to 4 mg, which should be taken immediately 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 level may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the section If you have hypoglycemia.

If you forget to take Repaglinida Alter

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

If you stop taking Repaglinida Alter

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

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

4. Possible side effects

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

Hypoglycemia

The most common side effect is hypoglycemia, which can affect up to 1 in 10 people (see If you have hypoglycemiain section 2). Hypoglycemic reactions are usually mild or moderate but can occasionally lead to loss of consciousness or hypoglycemic coma. If this happens, you need immediate medical attention.

Allergic reactions

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

Other side effects

Common(may affect up to 1 in 10 people)

• Stomach pain.
• Diarrhea.

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

• Acute coronary syndrome (but may not be due to the medicine).

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 the blood.

Frequency not known(frequency cannot be estimated from the available data)

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

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinida Alter

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

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicines to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of packages and unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Repaglinida Alter

• The active substance is repaglinida. Each tablet contains 1 mg of repaglinida.
• The other ingredients are: microcrystalline cellulose (E460), anhydrous calcium phosphate, corn starch, potassium polacrylate, povidone (polyvidone), glycerol 99.5% (E422), magnesium stearate, meglumine, poloxamer, colloidal silicon dioxide (Aerosil), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Repaglinida Alter 1 mg tablets are yellow, round, and biconvex.

Each pack contains 90 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

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

Date of last revision of this package leaflet: March 2018.

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