2 mg repaglinide tablets
What Repaglinide Sandoz is and what it is used for
Repaglinide Sandoz contains repaglinide and is an oral tablet for the treatment of diabetes. Repaglinide Sandoz helps your pancreas to produce more insulin and lower your blood sugar ( glucose ).
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of sugar in your blood or where your body does not respond normally to the insulin it produces.
Repaglinide Sandoz is used to controlling type 2 diabetes in adults as a supplement to diet and exercise. Treatment is usually started if diet, exercise, and weight loss alone are not enough to control (or lower) your blood sugar. Repaglinide Sandoz can also be given with metformin, another diabetes medicine.
Repaglinide Sandoz lowers blood sugar, which helps prevent complications of your diabetes.
Repaglinide contained in Repaglinide Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Repaglinide Sandoz
Do not take Repaglinide Sandoz
- if you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6).
- if you have type 1 diabetes
- if the acid level in the blood is elevated ( diabetic ketoacidosis )
- if you have severe liver disease
- if you are taking gemfibrozil (a medicine used to treat high blood fats).
Warnings and cautions
Talk to your doctor before taking Repaglinide Sandoz:
- if you have liver problems. Repaglinide Sandoz 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 Sandoz).
- if you have kidney problems. Repaglinide Sandoz should be used with caution.
- if you are going to have major surgery or have recently had a serious illness or infection. In such cases, diabetes control may be insufficient.
- if you are under 18 or over 75 years of age. Repaglinide Sandoz is then not recommended as studies in these age groups are lacking.
Talk to your doctor if any of the above apply to you. Then you may not be treated with Repaglinide Sandoz, but your doctor will advise you.
Children and young people
Do not take this medicine if you are under 18 years of age.
If you get an insulin sensation (low blood sugar)
You may experience insulin (hypoglycemia) if your blood sugar gets too low. It could happen:
- if you take more Repaglinide Sandoz than you should
- if you exercise more than usual
- if you are taking other medicines or have kidney or liver problems (see the second section under 2. What you need to know before taking Repaglinide Sandoz).
The warning signs of low blood sugar can come on suddenly and manifest themselves as: cold sweat; cold and pale skin; headache; palpitation; nausea; strong hunger; temporary vision changes; drowsiness; unusual fatigue and weakness; nervousness or tremors; feelings of anxiety; confusion; concentration difficulties.
If your blood sugar is low or you get an insulin sensation: eat glucose tablets or a snack or a drink that contains a lot of sugar and then rest.
When the symptoms of hypoglycemia have disappeared or your blood sugar level has stabilized, you can continue treatment with Repaglinide Sandoz.
Tell people around you that you have diabetes and that if you become unconscious due to an insulin sensation, they should put you on the sidelines and get medical attention immediately. They must not give you anything to eat or drink. Then there is a risk that you will suffocate.
- If severe insulin sensitivity is not treated, it can cause brain damage (temporary or permanent) and even death.
- If you get an insulin sensation and lose consciousness, or if you get a lot of insulin sensations, talk to your doctor. Dosage of Repaglinide Sandoz, diet, or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may become too high (this is called hyperglycemia). It could happen:
- if you take too little Repaglinide Sandoz
- whether you have an infection or fever
- if you have eaten more than usual
- if you have exercised less than usual.
The warning signs of high blood sugar gradually appear. They manifest as: increased urine output; thirst; dry skin and dry mouth. Talk to your doctor. Dosage of Repaglinide Sandoz, diet, or exercise may need to be adjusted.
Other medicines and Repaglinide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can take Repaglinide Sandoz together with metformin, another diabetes medicine if your doctor tells you to.
If you are taking gemfibrozil (for the treatment of high blood fats), do not take Repaglinide Sandoz.
Your body may react differently to Repaglinide Sandoz if you are taking other medicines, especially these:
- 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 (eg acetylsalicylic acid)
- Octreotide (used to treat cancer)
- Non-steroidal anti-inflammatory drugs ( NSAIDs ) (a kind of painkiller)
- Steroids (anabolic steroids and corticosteroids – used in anemia or treatment of inflammation )
- Oral contraceptives ( birth control pills )
- Thiazides ( diuretics or diuretics)
- Danazol (used to treat breast cysts and endometriosis )
- Thyroid drugs (used to treat low levels of thyroid hormones)
- Agents that affect the involuntary nervous system ( sympathomimetics, used to treat asthma )
- Clarithromycin, trimethoprim, rifampicin ( antibiotics )
- Itraconazole, ketoconazole (medicine for fungal infections)
- Gemfibrozil (used to treat high blood fats)
- Ciclosporin (used to inhibit the immune system)
- Deferasirox (used to remove a chronic excess of iron from the body)
- Clopidogrel (prevents the formation of blood clots)
- Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy )
- St. John’s wort (herbal medicine).
Repaglinide Sandoz with alcohol
Alcohol may alter the ability of Repaglinide Sandoz to lower blood sugar. Pay attention to signs of insulin sensation.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Repaglinide Sandoz if you are pregnant or planning to become pregnant.
You should not take Repaglinide Sandoz if you are breastfeeding.
Driving and using machines
Your ability to drive or use machines may be affected if your blood sugar is too high or too low. Remember that you can put yourself and others at risk. Talk to your doctor if you can drive if you:
- often have insulin sensations
- receive few or no warning signs of low blood sugar.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Repaglinide Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Your doctor will determine your dose.
The usual starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
- Your doctor may increase the dose to one up to 4 mg to be taken immediately before or up to 30 minutes before each main meal. The highest recommended daily dose is 16 mg.
Do not take more Repaglinide Sandoz than your doctor has prescribed.
If you take more Repaglinide Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you take too many tablets, your blood sugar may become too low and lead to insulin sensation. See If you get an insulin sensation for more information on what this is and how it is treated.
If you forget to take Repaglinide Sandoz
Do not take a double dose to make up for a forgotten dose, take the next dose as usual.
If you stop taking Repaglinide Sandoz
Keep in mind that you will not get the desired effect if you stop taking Repaglinide Sandoz. Your diabetes may worsen. If your treatment needs to be changed, always consult your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood sugar (hypoglycemia)
The most common side effect is low blood sugar, which may affect up to 1 in 10 people (see If you get an insulin sensation in section 2). Reactions to low blood sugar are generally mild/moderate but may temporarily develop into hypoglycaemic unconsciousness or coma. If this happens, seek immediate medical attention.
Allergy
Allergies are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness, and sweating may be signs of an anaphylactic reaction. Contact a doctor immediately.
Other side effects ar
Common (may affect up to 1 in 10 people)
- Abdominal pain
- Diarrhea.
Rare (may affect up to 1 in 1,000 people)
- Acute coronary heart disease (does not need to be related to the drug).
Very rare (may affect up to 1 in 10,000 people)
- Vomiting
- Constipation
- Visual disturbances
- Severe liver problems, and abnormal liver function such as an increase in liver enzymes in your blood.
No known frequency
- Hypersensitivity (such as rash, itchy skin, redness of the skin, swelling of the skin)
- Nausea.
How to store Repaglinide Sandoz
Keep this medicine out of the sight and reach of children.
No special storage instructions.
For HDPE tablet can: Use no later than 6 months after opening the can.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is repaglinide.
One tablet contains 2 mg repaglinide.
Other ingredients are:
Repaglinide Sandoz 2 mg tablets
Glycerol 85%, meglumine, maize starch, anhydrous calcium hydrogen phosphate, hydroxypropylcellulose, poloxamer type 188, colloidal anhydrous silica, magnesium stearate, potassium polarizing USP / NF, microcrystalline cellulose, red iron oxide (E 172).
What the medicine looks like and the contents of the pack
Repaglinide Sandoz 2 mg tablets
Light red, slightly spotted, round tablet with a notch. The notch is not intended for splitting the tablet.
Repaglinide Sandoz is available in pressure packs of 30, 60, 90, 120, or 270 tablets and tablet cans of 30, 60, 90, or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
LEK Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia
or
LEK SA, Ul. Domaniewska 50 C, 02-672 Warsaw, Poland
or
SC Sandoz SRL, 7A Livezeni Street, 540472, Targu Mures, Jud Mures, Romania