Repaglinide Alter 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Repaglinide Alter 1 mg tablets EFG

Repaglinide

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Repaglinide Alter is and what it is used for
2. What you need to know before taking Repaglinide Alter
3. How to take Repaglinide Alter
4. Possible side effects
5. How to store Repaglinide Alter
6. Contents of the pack and other information

1. What is Repaglinide Alter and what is it used for?

Repaglinide Alter is an oral antidiabetic 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.

Repaglinide Alter is used to control type 2 diabetes, as an addition to diet and exercise: treatment should be initiated when diet, physical exercise, and weight reduction alone have not been sufficient to control (or reduce) blood sugar levels.

Repaglinide Alter may also be given in combination with metformin, another antidiabetic medicine.

Repaglinide Alter has been shown to reduce blood sugar levels, thereby helping to prevent diabetes-related complications.

2. What you need to know before taking Repaglinide Alter

Do not take Repaglinide Alter

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

Warnings and precautions

Talk to your doctor before starting to take Repaglinide.

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

Talk to your doctor if any of the above situations apply to you. Repaglinide 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 of age.

If you have hypoglycaemia (low blood sugar)

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

• You take too much Repaglinide.
• 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 Repaglinide Alter).

Warning signs 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 hypoglycaemia coming on: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycaemia have disappeared or when your blood sugar levels have stabilized, continue your treatment with Repaglinide.

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 help. Do not give you anything to eat or drink, as you could choke.

• If severe hypoglycaemia is not treated, it may cause brain damage (temporary or permanent) and even death.
• If severe hypoglycaemia causes you to lose consciousness or if you experience repeated episodes of hypoglycaemia, inform your doctor. Your dose of Repaglinide, diet, or exercise may need adjustment.

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.
• 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 develop gradually and include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. Your dose of Repaglinide, diet, or exercise may need adjustment.

Other medicines and Repaglinide Alter

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

If prescribed by your doctor, you may take Repaglinide together with metformin, another medicine for diabetes.

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

Your body's response to Repaglinide 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 conditions)
• ACE inhibitors (for the treatment of heart conditions)
• Salicylates (e.g. aspirin)
• Octreotide (for the treatment of cancer)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller)
• Steroids (anabolic steroids and corticosteroids, for anaemia 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 (antibiotics)
• Itraconazole, ketoconazole (medicines for fungal infections)
• Gemfibrozil (for treating high blood fat levels)
• Cyclosporine (to suppress the immune system)
• Deferasirox (to reduce chronic iron overload)
• Clopidogrel (to prevent blood clots)
• Phenytoin, carbamazepine, phenobarbital (for treating epilepsy)
• St. John’s wort (herbal remedy)

Taking Repaglinide Alter with food, drinks and alcohol

Alcohol may alter the ability of Repaglinide to lower blood sugar. Be alert for symptoms of hypoglycaemia.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

You must not take Repaglinide if you are pregnant or planning to become pregnant.

You must not take Repaglinide if you are breastfeeding.

Driving and using machines

Your ability to drive or operate machinery may be impaired if your blood sugar level is too low or too high. Be aware that you may put yourself or others at risk. Consult your doctor about whether you may drive if:

• You have frequent episodes of hypoglycaemia.
• You have few or no symptoms of hypoglycaemia or find it difficult to recognize them.

3. How to take Repaglinide Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

Your doctor will calculate your dose.

• Usually the starting dose is 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 the dose up to 4 mg, which should be taken just before, or within the 30 minutes prior to, each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinide than your doctor has prescribed.

If you take more Repaglinide Alter 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 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 missed doses.

If you stop taking Repaglinide Alter

Please note that the desired effect will not be achieved if you stop taking Repaglinide. 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 this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Hypoglycaemia

The most common adverse effect is hypoglycaemia, which may affect up to 1 in 10 people (see If you have hypoglycaemia in section 2). Hypoglycaemic reactions are usually mild or moderate, but occasionally they may lead to loss of consciousness or hypoglycaemic coma. If this occurs, immediate medical assistance is required.

Allergy

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

Other adverse effects

Frequent (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 disorders.
• Serious liver problems, abnormal liver function such as increased liver enzymes in blood.

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

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

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Repaglinide Alter

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

Store in the original packaging to protect it from moisture.

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Repaglinide Alter

• The active substance is repaglinide. Each tablet contains 1 mg of repaglinide.
• The other components are: microcrystalline cellulose (E460), anhydrous calcium diphosphate, corn starch, polacrilin potassium, 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

Repaglinide 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 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

Date of the most recent revision of this leaflet: March 2018.

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