Repaglinide Kern Pharma 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Repaglinide Kern Pharma 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Repaglinide Kern Pharma is and what it is used for
2. Before you take Repaglinide Kern Pharma
3. How to take Repaglinide Kern Pharma
4. Possible side effects
5. How to store Repaglinide Kern Pharma
6. Further information

1. What Repaglinide Kern Pharma is and what it is used for

Repaglinide Kern Pharma is an oral antidiabetic medicine that contains repaglinide, which helps your pancreas produce more insulin and lower your blood sugar (glucose).

Type 2 diabetes is a condition 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 (previously known as non-insulin-dependent diabetes mellitus or adult-onset diabetes).

Repaglinide Kern Pharma is used to control type 2 diabetes as an addition to diet and exercise. Treatment should be initiated when diet, physical activity, and weight reduction alone have not been sufficient to control (or lower) blood sugar levels. Repaglinide Kern Pharma may also be given in combination with metformin, another antidiabetic medicine.

2. Before taking Repaglinide Kern Pharma

Do not take Repaglinide Kern Pharma

• If you are hypersensitive (allergic) to repaglinide or to any of the other components of this medicine
• If you have type 1 diabetes (insulin-dependent diabetes)
• If the acid level in your body has increased (diabetic ketoacidosis)
• If you have severe liver disease
• If you are taking gemfibrozil (a medicine used to lower fat levels in the blood).

If any of the above apply to you, inform your doctor and do not take Repaglinide Kern Pharma.

Take special care with Repaglinide Kern Pharma

• If you have liver problems. Repaglinide Kern Pharma is not recommended for patients with moderate liver disease. Repaglinide Kern Pharma should not be taken if you have severe liver disease (see Do not take Repaglinide Kern Pharma).
• If you have kidney problems. Repaglinide Kern Pharma should be taken with caution.
• If you are undergoing major surgery or have recently had a serious illness or serious infection. In these circumstances, diabetic control may not be achieved.
• If you are under 18 or over 75 years of age, Repaglinide Kern Pharma is not recommended. It has not been studied in these age groups.

Consult your doctor if any of the above apply to you, as Repaglinide Kern Pharma may not be suitable for you. Your doctor will advise you.

If you experience hypoglycaemia

You may experience hypoglycaemia (symptoms of low blood sugar) if your blood sugar level becomes too low. This may happen if:

• You take too much Repaglinide Kern Pharma
• You do more physical exercise than usual
• You take other medicines or have kidney or liver problems (see other sections in 2. Before taking Repaglinide Kern Pharma).

Warning symptoms of hypoglycaemia appear suddenly and may include: cold sweat, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or trembling, anxiety, confusion, and difficulty concentrating.

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

Once the symptoms of hypoglycaemia have subsided or your blood sugar levels have stabilized, continue treatment with Repaglinide Kern Pharma.

Inform others that you are diabetic and that if you lose consciousness due to hypoglycaemia, they should lay you on your side and seek immediate medical assistance. They should not give you anything to eat or drink, as you could choke.

• If severe hypoglycaemia is not treated, it may lead to brain damage (temporary or permanent) or even death.
• If you lose consciousness due to hypoglycaemia or experience repeated episodes of hypoglycaemia, inform your doctor. Your doctor may need to adjust your dose or dosing schedule of Repaglinide Kern Pharma, your diet, or your physical activity.

If your blood sugar level is very high

Your blood sugar level may become very high (hyperglycaemia). This may occur:

• If you take too little Repaglinide Kern Pharma
• If you have an infection or fever
• If you eat more than usual
• If you do less physical exercise than usual.

Warning symptoms develop gradually and may include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your doctor may need to adjust your dose of Repaglinide Kern Pharma, your diet, or your physical activity.

Taking other medicines

Your doctor may prescribe Repaglinide Kern Pharma to be taken together with metformin, another medicine for diabetes. However, you should not take Repaglinide Kern Pharma if you are taking gemfibrozil (used to lower fat levels in the blood).

The effect of Repaglinide Kern Pharma in your body may change if you take other medicines, especially:

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

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

Taking Repaglinide Kern Pharma with food and drink

Take Repaglinide Kern Pharma before main meals. Alcohol may affect the ability of Repaglinide Kern Pharma to lower blood sugar levels. Be alert for symptoms of hypoglycaemia.

Pregnancy and breastfeeding

You must not take Repaglinide Kern Pharma if you are pregnant or planning to become pregnant. Consult your doctor as soon as possible if you become pregnant or plan to become pregnant during treatment.

You must not take Repaglinide Kern Pharma if you are breastfeeding.

Driving and using machines

Your ability to concentrate and react may be impaired due to symptoms caused by hypoglycaemia or hyperglycaemia, such as vision problems. This could be dangerous in situations where these skills are important (e.g. driving or operating machinery). Therefore, consult your doctor to determine whether it is safe for you to drive or operate machinery.

3. How to use Repaglinide Kern Pharma

Your doctor will calculate your dose.

• The starting dose is usually 0.5 mg taken just before each main meal. The tablets should be taken with a glass of water just before, or within the 30 minutes prior to, each main meal.
• Your doctor may adjust your dose up to 4 mg, which should be taken just before, or within the 30 minutes prior to, each main meal. The maximum recommended daily dose is 16 mg.

Do not take more Repaglinide Kern Pharma than your doctor has prescribed. Always take Repaglinide Kern Pharma exactly as your doctor has instructed. If you are unsure, consult your doctor.

If you take more Repaglinide Kern Pharma than you should

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

If you forget to take Repaglinide Kern Pharma

If you forget to take a dose, take your next dose as usual. Never take a double dose.

If you stop taking Repaglinide Kern Pharma

Please note that the desired effect will not be achieved if you stop taking Repaglinide Kern Pharma. Your diabetes may worsen. If any change in your treatment is needed, consult your doctor first.

If you have any further questions about the use of Repaglinide Kern Pharma, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Repaglinide Kern Pharma may have adverse effects, although not everyone experiences them.

Possible adverse effects

Frequent: affect between 1 and 10 out of every 100 patients

• Hypoglycaemia (see section If you have hypoglycaemia). The risk of experiencing hypoglycaemia may increase if you are taking other medicines.
• Stomach pain.
• Diarrhoea.

Rare: affect between 1 and 10 out of every 10,000 patients

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

Very rare: affect less than 1 out of every 10,000 patients

• Allergic reaction (such as swelling, difficulty breathing, palpitations, dizziness and sweating which may be symptoms of an anaphylactic reaction). Consult your doctor immediately.
• Vomiting.
• Constipation.
• Visual disturbances.
• Serious liver problems, abnormal liver function, and increased liver enzymes in the blood.

Frequency unknown: frequency cannot be estimated from available data

• Hypoglycaemic coma or loss of consciousness (very severe hypoglycaemic reactions, see section If you have hypoglycaemia). Contact your doctor immediately.
• Hypersensitivity (such as rash, itching, redness, and swelling).
• Nausea.

If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor.

5. Storage of Repaglinide Kern Pharma

Keep out of the reach and sight of children.

Do not use Repaglinide Kern Pharma after the expiry date stated on the carton and the blister. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Additional Information

Composition of Repaglinide Kern Pharma

• The active substance is repaglinide. Each Repaglinide Kern Pharma 1 mg tablet contains 1 mg of repaglinide.
• The other components are: microcrystalline cellulose (E460), calcium hydrogen phosphate, corn starch, amberlite (polacrilin potassium), povidone K30 (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, and yellow iron oxide (E172).

Appearance of the medicinal product and contents of the container

Repaglinide Kern Pharma 1 mg tablets are yellow, round, biconvex, and have a score line on one side. The tablets may be divided into two equal parts.

Repaglinide Kern Pharma is available in four blister pack presentations. Each package contains 30, 90, 120 or 270 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

PharmaPath S.A.

1, 28 Octovriou str., Ag. Varvara, 12351 Athens

Greece

This patient information leaflet was approved in April 2013.

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