0.5 mg, 1 mg, 2 mg tablets
Repaglinide
What Repaglinide Accord is and what it is used for
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 Accord contains repaglinide and is an oral tablet for the treatment of diabetes. Repaglinide Accord helps your pancreas to produce more insulin and lower your blood sugar (blood glucose).
Repaglinide Accord is used to control 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 Accord can also be given with metformin, another diabetes medicine.
Repaglinide Accord lowers blood sugar, which helps prevent complications of your diabetes.
What you need to know before using Repaglinide Accord
Do not take Repaglinide Accord:
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 your blood is elevated ( diabetic ketoacidosis )
• if you have a severe liver disease
• if you are taking gemfibrozil (for the treatment of high blood fats).
Warnings and cautions
Talk to your doctor before taking Repaglinide Accord:
• if you have liver problems. Repaglinide Accord is not recommended for patients with moderate liver disease. Repaglinide Accord should not be taken if you have severe liver disease (see Do not take Repaglinide Accord ).
• if you have kidney problems. Repaglinide Accord should then be used with caution.
• if you are having 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 Accord can then not be recommended, as studies in these age groups are lacking.
Talk to your doctor if any of the above apply to you. You may not be treated with Repaglinide Accord, 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 get insulin sensation (hypoglycemia) if your blood sugar gets too low. This may happen:
• if you take too much Repaglinide Accord
• if you exercise more than usual
• if you are taking other medicines or have kidney or liver problems (see other sections under 2. What you need to know before taking Repaglinide Accord ).
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 Accord.
Tell people around you that you have diabetes and that if you become unconscious, 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 untreated 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. Dose a Repaglinide Accord, diet or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may get too high (this is called hyperglycemia ). It can have the following causes:
• You have taken too little Repaglinide Accord
• You have an infection or fever
• You have eaten more than usual
• 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. Dose a Repaglinide Accord, diet or exercise may need to be adjusted.
Other medicines and Repaglinide Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can take Repaglinide Accord 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 Accord.
• Your body may react differently to Repaglinide Accord if you are taking other medicines, especially these:
• MAO inhibitors (used to treat depression)
• Beta-receptor blockers (used to treat high blood pressure or heart disease)
• ACE inhibitors (used to treat heart disease)
• Salicylates (included in some painkillers)
• Octreotide (used to treat cancer)
• Non-steroidal anti-inflammatory drugs ( NSAIDs ) (painkillers)
• 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 endometrial tissue outside the uterus, so-called endometriosis )
• Thyroid drugs ( used to treat low levels of thyroid hormones)
• Adrenergic agents (used to treat asthma )
• Clarithromycin, trimethoprim, rifampicin ( antibiotics )
• Itraconazole, ketoconazole (antifungal)
• Gemfibrozil (used to treat high blood fats)
• Ciclosporin (used to suppress the immune system)
• Deferasirox (used to remove excess iron from the body )
• Clopidogrel (prevents blood clots)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy )
• St. John’s wort (herbal medicine).
Repaglinide Accord with food, drink, and alcohol
Alcohol may alter the ability of Repaglinide Accord to lower blood sugar. Pay attention to signs of insulin sensation.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
You should not take Repaglinide Accord if you are pregnant or planning to become pregnant.
You should not take Repaglinide Accord 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 a car if you:
• often have insulin sensations
• have few or no warning signs of low blood sugar.
How to use Repaglinide Accord
Always take this medicine exactly as your doctor has told you. Consult a doctor 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 by up to 4 mg immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.
Do not take more Repaglinide Accord than your doctor has prescribed.
If you use more Repaglinide Accord than you should
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 use Repaglinide Accord
If you miss a dose, take the next dose as usual – do not take a double dose.
If you stop using Repaglinide Accord
Keep in mind that you will not get the desired effect if you stop taking Repaglinide Accord. 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 Repaglinide Accord, 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 medical attention immediately.
Allergy
Allergies 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 anaphylactic reaction. Contact a doctor immediately.
Other side effects 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 (need not be associated with the medicine).
Very rare (may affect up to 1 in 10,000 people)
• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function, increase in liver enzymes in your blood.
Unknown frequency
• Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)
• Nausea.
Reporting of side effects If
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help increase information on the safety of medicines.
How to store Repaglinide Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, bottle label, and blister after “EXP”. The expiration date is the last day of a specified month. This is stated on the outer carton and blister foil.
No special storage instructions apply to the medicine.
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.
Repaglinide Accord 0.5 mg: Each tablet contains 0.5 mg repaglinide
Repaglinide Accord 1 mg: Each tablet contains 1 mg repaglinide
Repaglinide Accord 2 mg: Each tablet contains 2 mg repaglinide
The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, meglumine, poloxamer 188, povidone, glycerin, magnesium stearate, yellow iron oxide (E172) only in 1 mg tablets, and red iron oxide (E172) only in 2 mg tablets.
What the medicine looks like and the contents of the pack
The Repaglinide Accord 0.5 mg tablet is white to off-white, round, biconvex, with a beveled edge and marked with “R” on one side and unmarked on the other side.
The tablet Repaglinide Accord 1 mg is light yellow to yellow, round, biconvex, with a beveled edge and marked with “R” on one side and unmarked on the other side, and maybe marbled.
The tablet Repaglinide Accord 2 mg is peach-colored, round, biconvex, with a beveled edge and marked with “R” on one side and unmarked on the other side, maybe marbled.
The tablets are available in the following pack sizes:
Blister of 30, 90, 120, 180, or 270 tablets.
HDPE bottle with 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
Winthontlaan 200,
3526 VK Utrecht,
Netherlands