Repaglinide Alter 2 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: Information for the patient

Repaglinide Alter 2 mg tablets EFG

Repaglinide

Read all of this 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 they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 adverse effects
5. How to store Repaglinide Alter
6. Contents of the pack and other information

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

Repaglinide Alter is an oral antidiabetic medicine containing repaglinide that 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 manage 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 together with metformin, another diabetes medicine.

Repaglinide Alter has been shown to reduce blood sugar levels, thereby helping to prevent diabetes 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 used 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 of age, 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 experience hypoglycemia (low blood sugar)

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

• You take too much Repaglinide.
• You exercise more 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).

Symptoms warning of hypoglycemia 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 hypoglycemic episode coming on: take glucose tablets or a sugary drink or food, and then rest.

Once the symptoms of hypoglycemia have subsided 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 hypoglycemia, 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 hypoglycemia is not treated, it may cause brain damage (temporary or permanent) and even death.
• If hypoglycemia causes you to lose consciousness or if you experience repeated episodes, inform your doctor. You may need to adjust your dose of Repaglinide, your diet, or your physical activity.

If your blood sugar level is very high

Your blood sugar level may become very high (hyperglycemia). This may happen:

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

Symptoms warning of high blood sugar develop gradually. These include: frequent urination, thirst, dry skin, and dry mouth. Inform your doctor. You may need to adjust your dose of Repaglinide, your diet, or your physical activity.

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.

The response of your body to Repaglinide may change if you take other medicines, especially:

• Monoamine oxidase inhibitors (MAOIs) (for treatment of depression)
• Beta-blockers (for treatment of high blood pressure or heart conditions)
• ACE inhibitors (for treatment of heart conditions)
• Salicylates (e.g., aspirin)
• Octreotide (for treatment of cancer)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (a type of painkiller)
• Steroids (anabolic steroids and corticosteroids, for anemia or to treat inflammation)
• Oral contraceptives (to prevent pregnancy)
• Thiazides (diuretics)
• Danazol (for treatment of breast cysts and endometriosis)
• Thyroid products (for treatment of low thyroid hormone levels)
• Sympathomimetics (for treatment of asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
• Itraconazole, ketoconazole (medicines for fungal infections)
• Gemfibrozil (to treat 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 treatment of 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 levels. Remain alert for symptoms of hypoglycemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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. Bear in mind that you could endanger yourself or others. Consult your doctor about whether you may drive 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 Repaglinide Alter

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

Your doctor will calculate your dose.

• Normally, 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 daily dose is 16 mg.

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 forgotten 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 may 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 disturbances.
• Severe liver problems, abnormal liver function such as increased liver enzymes in 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 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 Medicinal Products: 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 container 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE 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. Package contents and additional information

Composition of Repaglinide Alter

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

Appearance of the product and contents of the pack

Repaglinide Alter 2 mg tablets are pink-colored, round, and biconvex.

Each package 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 the most recent review 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 Health Products (AEMPS) http://www.aemps.gob.es/.