REPAGLINIDA COMBIX 1 mg TABLETS

2. What you need to know before you take Repaglinida Combix

Do not take Repaglinida Combix

• if you are allergicto repaglinide or any of the other ingredients of this medicine (listed in section 6)
• if you have type 1 diabetes
• if your body's acid levels have increased (diabetic ketoacidosis)
• if you have a severe liver disease
• if you are taking gemfibrozil(a medicine that lowers blood fat levels)

Warnings and precautions

Talk to your doctor or pharmacist before taking Repaglinida Combix:

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

Talk to your doctor ifany of the above applies to you. Repaglinida Combix 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 low blood sugar (hypoglycaemia)

You may have hypoglycaemia if your blood sugar levels are too low. This can happen if:

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

Warning signs of hypoglycaemiacan appear suddenly and can be: cold sweat, cool pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual weakness and tiredness, nervousness or tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar levels are low or you feel like you are going to have a hypoglycaemic attack: take glucose tablets or a sugary product or drink, and then rest.

When the symptoms of hypoglycaemia disappear or when your blood sugar levels stabilize, continue treatment with Repaglinida Combix.

Tell others that you are diabetic and that if you lose consciousnessdue to hypoglycaemia, 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 hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• if you have a hypoglycaemic attackthat makes you lose consciousness or if you have repeated hypoglycaemic attacks, tell your doctor. You may need to adjust the dose or administration schedule of Repaglinida Combix, your diet, or exercise.

If your blood sugar levels are very high

Your blood sugar levels may be too high (hyperglycaemia). This can happen:

• if you take too little Repaglinida Combix
• 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 sugar levelsappear gradually. These include: excessive urination, thirst, dry skin, and a dry mouth feeling. Tell your doctor. You may need to adjust the dose of Repaglinida Combix, your diet, or exercise.

Taking Repaglinida Combix with other medicines

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

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

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

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

• Monoamine oxidase inhibitors (MAOIs) (for depression treatment)
• Beta-blockers (for high blood pressure or heart disease treatment)
• Angiotensin-converting enzyme (ACE) inhibitors (for heart disease treatment)
• Salicylates (e.g., aspirin)
• Octreotide (for cancer treatment)
• 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 breast cysts and endometriosis treatment)
• Thyroid medicines (for low thyroid hormone levels treatment)
• Sympathomimetics (for asthma treatment)
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
• Itraconazole, ketoconazole (medicines for fungal infections)
• Gemfibrozil (to treat high blood fat levels)
• Cyclosporin (to suppress the immune system)
• Deferasirox (to reduce chronic iron overload)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's Wort (herbal medicine)
• Clopidogrel (to prevent blood clots formation)

Taking Repaglinida Combix with alcohol

Alcohol may alter Repaglinida Combix's ability to lower your blood sugar levels.

Be aware of the warning signs of hypoglycaemia.

Pregnancy and breast-feeding

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

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

Do not take Repaglinida Combix if you are breast-feeding.

Driving and using machines

Your ability to drive or use machines may be affected if your blood sugar levels are too low or too high. Be aware that you may put yourself or others at risk. Talk to your doctor about the possibility of driving a car if:

• you have frequent hypoglycaemic attacks

you have few or no symptoms of hypoglycaemia or find it difficult to recognize them.

3. How to take Repaglinida Combix

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

Your doctor will determine your dose.

• The initial doseis usually 0.5 mg taken just before each main meal. The tablets should be taken with a glass of water just 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 just before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinida Combix than your doctor has recommended.

If you take more Repaglinida Combix than you should

If you take too many tablets, your blood sugar levels may become too low and cause hypoglycaemia. Please read what hypoglycaemia is and how to treat it in the section If you have low blood sugar (hypoglycaemia).

In case of overdose or accidental ingestion, talk to your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Repaglinida Combix

If you forget to take a dose, take the next dose when it is due. Do not take a double dose to make up for forgotten doses.

If you stop taking Repaglinida Combix

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

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.

Hypoglycaemia

The most common side effect is hypoglycaemia, which can affect up to 1 in 10 people (see If you have low blood sugar (hypoglycaemia)in section 2). Hypoglycaemic reactions are usually mild or moderate but can occasionally lead to loss of consciousness or hypoglycaemic coma. If this happens, seek immediate medical attention.

Allergic reactions

Cases of allergic reactions are very rare (may affect up to 1 in 10,000 people). Symptoms such as swelling, difficulty breathing, palpitations, dizziness symptoms, and 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
• Diarrhoea

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)
• Nausea

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinida Combix 1 mg tablets

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Repaglinida Combix composition

• The active substance is repaglinide. Each tablet contains 1 mg of repaglinide.
• The other ingredients are: microcrystalline cellulose (E460i), calcium hydrogen phosphate, maize starch without gluten, potassium acrylate, povidone K30, glycerol 99.5% (E422), magnesium stearate (E470b), poloxamer 188, meglumine, and yellow iron oxide (E172).

Appearance and packaging of the product

The tablets are yellow, round, biconvex, approximately 6 mm in diameter, and have a score line on one side.

The tablets can be divided into equal doses.

Repaglinida Combix is available in packs of 30, 90, 120, and 270 tablets in blisters and in packs of 90 and 270 tablets in bottles.

Not all pack sizes may be marketed.

Marketing authorisation holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Manufacturer

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Repaglinida Combix 1 mg tablets EFG

This leaflet was approved in February 2016

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