Repafix 1 mg. 90 tablets

What Repaglinide Accord and what it is used
Repaglinide Accord is oral antidiabetic medicine containing repaglinide which helps your pancreas to produce more insulin and thus lower your blood sugar (glucose).
Type 2 diabetes is a disease in which your pancreas does not produce enough insulin to control the sugar in your blood or your body does not respond normally to the insulin it produces.
Repaglinide Accord is used to control type 2 diabetes in adults as an adjunct to diet and exercise, treatment is usually started if diet, exercise and weight loss can be achieved control (or lower) your blood sugar . Repaglinide Accord can also be administered in combination with metformin, another medicine for diabetes.
It was found that Repaglinide Accord reduces blood sugar levels, which helps to prevent complications from your diabetes.
 
2. What you need to know before you take Repaglinide accord
Do not take Repaglinide Accord:
If you are allergic to repaglinide or any of the other ingredients of the medicine (listed in section 6).
 
If you have type 1 diabetes
If the acidity in your body is increased (diabetic ketoacidosis).
If you suffer from severe liver disease.
If you are taking gemfibrozil (a medicine for lowering elevated levels of lipids in the blood).
 
Warnings and Precautions
Talk to your doctor before taking Repaglinide Accord.
If you have liver problems, Repaglinide Accord is not recommended in patients with moderate liver disease. Repaglinide Accord should not be taken in severe liver disease.
If you have kidney problems, Repaglinide Accord should be taken with caution.
If you have major surgery or have recently suffered a severe illness or infection. In such cases, the control of diabetes may suffer.
If you are under 18 or over 75 years, Repaglinide Accord is not recommended. It has not been studied in these age groups.
Tell your doctor if any of the above applies to you, probably treatment Repaglinide Accord is not suitable for you. Your doctor will advise you.
Children and adolescents
Do not take this medicine if you are under the age of 18 years.
If you get hypoglycemia (decrease in blood sugar levels)
You can get hypoglycemia (symptoms of low blood sugar) if your blood sugar gets too low. This can happen:
If you take too much Repaglinide Accord
Larger than usual
If you take other medicines or suffer from liver or kidney problems
The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; hunger; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty in concentrating.
If your blood sugar is low or you feel a hypo coming on:
eat glucose tablets or a high sugar snack or drink and rest.
When symptoms of hypoglycaemia have disappeared or when blood glucose level is stabilized continue treatment Repaglinide Accord.
Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help. You should not give anything to eat or drink. This could choke you.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
If you have hypoglycemia, leading to unconsciousness or recurrent hypoglycemia, talk to your doctor. The amount Repaglinide Accord, food or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may get too high (hyperglycaemia). This can happen:
If you take too little Repaglinide Accord
If you have an infection or fever
If you eat more than usual
In less than usual.
The warning signs of excessively high blood sugar in gradually. These include: frequent urination; thirst; dry skin; dry mouth.
Check with your doctor. The amount Repaglinide Accord, food 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 take any other medicines.
You can take Repaglinide Accord in combination with metformin, another medicine for diabetes. If you are taking gemfibrozil (used to lower elevated levels of lipids in the blood) should not take Repaglinide Accord.
Your body's response to Repaglinide Accord may change if you take other medicines, especially these:
- Monoamine oxidase (MAO) inhibitors (used to treat depression)
Beta-blockers (used to treat high blood pressure or heart disease)
- ACE inhibitors (used to treat heart disease)
- Salicylates (eg. Aspirin)
- Octreotide (used to treat cancer)
- Non-steroidal anti-inflammatory drugs (NSAIDs) (type painkillers)
- Steroids (anabolic steroids and corticosteroids - used in the treatment of anemia or inflammation)
- Oral contraceptives (birth control)
- Thiazides (diuretics or 'water resources)
- Danazol (used to treat breast cysts and endometriosis)
- Thyroid hormones (used for the treatment of low levels of thyroid hormone)
- Sympathomimetics (used to treat asthma)
- Clarithromycin, trimethoprim, rifampicin (antibiotic drugs)
- Itraconazole, ketoconazole (antifungal medicines)
- Gemfibrozil (used to treat high levels of lipids in the blood)
- Ciclosporin (used to suppress the immune system)
- Deferasiroks (izpolzvanza reduce chronic iron overload in the body)
- Phenytoin, carbamazepine, phenobarbital (used for the treatment of epilepsy)
- St. John's Wort (herbal medicine)
 
Adoption of Repaglinide Accord with food, beverages and alcohol
Alcohol can change the ability of Repaglinide Accord to reduce the blood sugar. Watch for signs of hypoglycemia.
Pregnancy and lactation
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
Repaglinide Accord should not be taken if you are pregnant or planning a pregnancy.
You should not take Repaglinide Accord, if you are breastfeeding.
Driving and using machines
Your ability to drive or use machines may be impaired if your blood sugar is low or high. Note that you can put yourself or others at risk. Please ask your doctor whether you can drive if:
Frequent hypos
Receive little or no warning signs of hypoglycemia.
 
3. How to take Repaglinide accord
Always take this medicine exactly as prescribed by your doctor or pharmacist.
If you are not sure, ask your doctor or pharmacist your doctor will determine your dose.
The usual starting dose is 0,5 mg, taken before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
The dose may be adjusted by your doctor up to 4 mg, to be taken 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 you recommend your doctor.
Consult your doctor if you are unsure.
If you take more than the amount of Repaglinide Accord
If you take too many tablets, your blood sugar may be too low, causing hypoglycemia. Please see If you get a hypo on what a hypo is and how to treat it.
If you forget to take Repaglinide Accord
If you miss a dose, take your next dose as usual - do not double the dose.
If you stop taking Repaglinide Accord
Note that if you stop taking Repaglinide Accord, the desired effect is not achieved. Your diabetes may get worse. If you have any change in your treatment, first contact your doctor.
If you have any questions about using this medicine, ask your doctor or pharmacist.
 
4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
hypoglycaemia
The most common adverse reaction was hypoglycaemia, which may affect up to 1 in 10 patients (see. If you get a hypo in section 2). Reactions of hypoglycemia were generally mild / moderate, but can in some cases develop into hypoglycaemic unconsciousness or coma. If this happens, seek medical advice immediately.
allergy
An allergy is a very rare (may affect up to 1 in 10,000 patients). signs of
anaphylactic reaction can be swelling, difficulty breathing, accelerated
heart beat, feeling dizzy and sweating. Contact a doctor immediately.
Other side effects
Common (may affect up to 1 in 10 patients)
- Stomach pain
- Diarrhoea
Rare (may affect up to 1 in 1,000 patients)
- Acute coronary syndrome (but may not be due to the drug).
Very rare (may affect up to 1 in 10,000 patients)
- Vomiting
- Constipation
- Visual disturbances
- Severe liver problems, abnormal liver function, increased liver enzymes in the blood.
Not known
- Hypersensitivity (such as rash, itching, redness, swelling of the skin)
- Feeling sick (nausea).
If you get any side effects, tell your doctor or pharmacist. This includes any not listed in this leaflet
 
5. How to store Repaglinide Accord
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label of the carton bottle and blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. Contents of the pack and further information
What Repaglinide Accord
The active ingredient 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
Other ingredients are:
Microcrystalline cellulose, anhydrous calcium hydrogen phosphate, corn starch, meglumine, poloxamer 188, povidone, glierin, yellow iron oxide (E172) only in the 1 mg tablets and iron oxide red (E172) only in the tablets of 2 mg.
 
Repaglinide Accord looks like and contents of the pack
Repaglinide Accord 0,5 mg tablets are white to off-white, round, biconvex with beveled edge, uncoated, marked "R" on one side and plain on the other.
Repaglinide Accord 1 mg tablets are light yellow to yellow, round, biconvex with beveled edge, uncoated, marked "R" on one side and plain on the other, may have spots.
Repaglinide Accord 2 mg tablets are peach-colored, round, biconvex with beveled edge, uncoated, marked "R" on one side and plain on the other, may have spots.