0.5 mg / 1 mg / 2 mg tablet
repaglinide
What Repaglinide Actavis is and what it is used for
Repaglinide Actavis is a diabetes medicine that contains repaglinide and is taken orally. Repaglinide Actavis helps the pancreas to produce more insulin, thereby lowering 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 the blood or the body does not respond normally to the insulin it produces.
Repaglinide Actavis 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 have not been enough to control (or lower) blood sugar. Repaglinide Actavis can also be given with metformin, another diabetes medicine.
Repaglinide Actavis lowers blood sugar, which helps protect against sequelae of your diabetes.
What you need to know before using Repaglinid Actavis
Do not take Repaglinide Actavis:
- 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 lower high blood lipid levels).
If any of the above applies to you, tell your doctor and do not take Repaglinide Actavis.
Warnings and cautions
Talk to your doctor or pharmacist before taking Repaglinide Actavis:
- if you have liver problems. Repaglinide Actavis is not recommended for patients with moderate liver disease. Repaglinide Actavis should not be taken if you have severe liver disease (see Do not take Repaglinide Actavis).
- if you have kidney problems. Repaglinide Actavis should then be taken 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 Actavis is not recommended as it has not been studied in these age groups.
Talk to your doctor if any of the above apply to you. Repaglinide Actavis may not be for you. 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 get an insulin sensation (hypoglycemia) if your blood sugar gets too low. This can happen:
- if you take more Repaglinide Actavis than you should
- if you exercise more than usual
- if you are taking other medicines or have liver or kidney problems (see other sections under 2. What you need to know before taking Repaglinide Actavis).
The warning signs for insulin sensation may come on suddenly and may consist of cold sweats, cold and pale skin, headaches, palpitations, nausea, severe hunger, temporary vision changes, drowsiness, unusual tiredness and weakness, nervousness, or tremors, anxiety, confusion, and difficulty concentrating.
If your blood sugar is low or you are feeling insulin, take 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, continue treatment with Repaglinide Actavis.
Tell other people that you have diabetes and that if you become unconscious due to an insulin sensation, they should put you on the side 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 hypoglycemia 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. The amount of Repaglinide Actavis, diet, or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may become too high (hyperglycemia). This can happen:
- if you take too little Repaglinide Actavis
- whether you have an infection or fever
- if you eat more than usual
- if you exercise less than usual.
The warning signs of high blood sugar gradually appear. They consist of increased urine output, thirst, dry skin, and dry mouth. Talk to your doctor if you experience these symptoms. The amount of Repaglinide Actavis, diet, or exercise may need to be adjusted.
Other medicines and Repaglinide Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can take Repaglinide Actavis together with metformin, another diabetes medicine if your doctor prescribes it for you. If you are taking gemfibrozil (used to lower high blood lipid levels), you should not take Repaglinide Actavis.
Your body may react differently to Repaglinide Actavis 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 (included in some painkillers)
- octreotide (used to treat cancer)
- non-steroidal anti-inflammatory drugs ( NSAIDs ), (a type 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 endometrial tissue outside the uterus, called endometriosis )
- thyroid drugs (used to treat low levels of thyroid hormones)
- sympathomimetics (used to treat asthma )
- clarithromycin, trimethoprim, rifampicin ( antibiotics )
- itraconazole, ketoconazole (antifungal drug)
- gemfibrozil (used to treat high blood fats)
- cyclosporine (used to inhibit the immune system)
- deferasirox (used to reduce chronic iron deficiency)
- clopidogrel (prevents blood clots)
- phenytoin, carbamazepine, phenobarbital (used to treat epilepsy )
- St. John’s wort (herbal medicine).
Repaglinide Actavis with food, drink, and alcohol
Alcohol may alter the ability of Repaglinide Actavis 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 Actavis if you are pregnant or planning to become pregnant.
You should not take Repaglinide Actavis if you are breastfeeding.
Driving and using machines
Your ability to drive or use machines may be affected if your blood sugar is low or high. Remember that you can put yourself and others at risk. Talk to your doctor if you can drive if you:
- often have insulin sensations
- may receive few or no warning signals in case of insulin sensations.
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 use Repaglinid Actavis
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 (equivalent to 1 tablet of Repaglinide Actavis 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.
- Dose one can be adjusted by the doctor up to 4 mg 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 Actavis than your doctor advised.
If you take more Repaglinide Actavis 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 an insulin sensation is and how it is treated.
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 forget to use Repaglinid Actavis
If you miss a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Repaglinide Actavis
Keep in mind that you will not get the desired effect if you stop taking Repaglinide Actavis. Your diabetes may worsen. If your treatment needs to be changed, contact 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 occur in up to 1 in 10 patients (see If you get an insulin sensation in section 2). Reactions to low blood sugar are generally mild/moderate but may temporarily develop into unconsciousness caused by low blood sugar or coma. If this happens, seek medical attention immediately.
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 a severe allergic reaction ( 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 have to depend on 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 the blood.
Has been reported (occurs in an unknown number of patients)
- Hypersensitivity (such as rash, itchy skin, redness of the skin, swelling of the skin)
- Nausea.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
How to store Repaglinide Actavis
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 outer carton, blister, and can after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 0.5 mg, 1 mg, and 2 mg repaglinide respectively.
- Other ingredients are Microcrystalline cellulose (E 460), calcium hydrogen phosphate, poloxamer, povidone, glycerol 85%, meglumine, polacril potassium, maize starch, and magnesium stearate. Repaglinide Actavis 1 mg tablet also contains yellow iron oxide (E 172). Repaglinide Actavis 2 mg also contains red iron oxide (E 172).
What the medicine looks like and the contents of the pack
Repaglinide Actavis 0.5 mg tablets are white, round, and biconvex with RE punched on one side.
Repaglinide Actavis 1 mg tablets are bright yellow, round, and biconvex with RE1 punched on one side.
Repaglinide Actavis 2 mg tablets are bright pink, round and biconvex with RE2 punched on one side.
Blister (Aluminum / Aluminum)
Pack sizes: 30, 60, 90, 100, 120 and 180 tablets.
Plastic container (polyethylene)
Pack size: 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd
BLB015-16 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta