Act Repaglinide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ACT REPAGLINIDE is used:

• To lower blood sugar in patients with type 2 diabetes mellitus

  whose blood sugar levels cannot be controlled by diet and exercise alone (monotherapy)

• In combination with metformin to lower blood sugar in

  patients whose blood sugar levels cannot be controlled by diet and exercise only plus metformin alone.

• In combination with rosiglitazone in patients who cannot take

  metformin and whose blood sugar levels cannot be controlled by diet and exercise plus ACT REPAGLINIDE or rosiglitazone alone.

What it does:

ACT REPAGLINIDE is an oral anti-diabetic agent used for the treatment of diabetes mellitus. It helps your body release more insulin when your blood sugar is high. This helps improve your blood sugar control.

When it should not be used:

Do not use ACT REPAGLINIDE if you:

• Have a known hypersensitivity to repaglinide tablets or any of the other ingredients in ACT REPAGLINIDE

• Have diabetic ketoacidosis (accumulation of

  ketones in the blood and urine).

• Have type 1 diabetes.
• Have severe liver disease.

• Are taking gemfibrozil (a medicine used to lower

  increased fat levels in the blood).

• Are taking clopidogrel (a medicine used to prevent blood

  clots).

What the medicinal ingredient is:

repaglinide

What the nonmedicinal ingredients are:

Calcium hydrogen phosphate, croscarmellose sodium, glycerol, iron oxide red (2 mg tablet only), iron oxide yellow (1 mg tablet only), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, poloxamer and povidone.

What dosage forms it comes in:

0.5 mg, 1 mg, 2 mg Tablets are available d bottles of 100 tablets.

WARNINGS AND PRECAUTIONS

To help avoid side effects and ensure proper use, talk to you healthcare professional before you take ACT REPAGLINIDE. Talk about any health conditions or problems you may have, including if you:

• Have a history of allergy or intolerance to any medications or other substances
• Have a history of liver or kidney problems

• Are or think you may be pregnant

• Are breastfeeding
• Are over 75 years of age

Other warnings you should know about:

ACT REPAGLINIDE is not recommended for use in children and adolescents less than 18 years of age.

The treatment with insulin secretagogues (drugs that stimulate insulin secretion from the pancreas) in general has been associated with more heart-related deaths as compared to treatment with diet alone or diet plus insulin.

ACT REPAGLINIDE may cause low blood sugar (hypoglycemia), especially if you miss a meal, exercise for a long time, drink alcohol or use another anti-diabetic medication with ACT REPAGLINIDE.

You should ask your doctor or pharmacist or diabetes educator about symptoms of low blood sugar and what to do if you experience these symptoms. You should also test your blood sugar as instructed by your doctor.

The warnings signs of hypoglycemia may come on suddenly and can include:

• cold sweat
• cool pale skin
• headache
• rapid heart beat
• feeling sick
• difficulty in concentrating

Severe hypoglycemia can cause loss of consciousness, seizure, brain damage and even death.

Your blood sugar may get too high (hyperglycemia) if you have fever, infection, surgery or trauma (stress conditions). In such cases, contact your doctor as your medication may need to be adjusted.

Driving and Operating Machinery:

Alertness and reactions may be impaired due to low blood sugar (hypoglycemia), especially when beginning or changing treatment

or when ACT REPAGLINIDE is not taken regularly. This may affect you ability to drive or to operate machinery.

INTERACTIONS WITH THIS MEDICATION

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious Drug Interactions

Many medicines affect the way glucose works in your body and this may influence your ACT REPAGLINIDE dose. Listed below are the most common medicines which may affect your treatment with ACT REPAGLINIDE:

• Other anti-diabetic agents (used to lower blood sugar)
• Monoamine oxidase inhibitors (used to treat depression)

• Beta-blocking agents (used to treat high blood pressure

  and certain heart conditions)

• Angiotensin converting enzyme (ACE)-inhibitors (used

  to treat high blood pressure and certain heart conditions)

• Salicylates (e.g. acetylsalicylic acid)
• Octreotide

• Non-steroidal anti-inflammatory agents (NSAIDS) (a

  type of painkiller)

• Anabolic steroids and corticosteroids (used for anemia or

  to treat inflammation)

• Oral contraceptives (used for birth control)
• Thiazides (diuretics or ‘water pills’)
• Danazol (used to treat breast cysts and endometriosis)

• Thyroid hormones (used to treat patients with low levels

  of thyroid hormones)

• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (anti-fungal drug)

• Phenytoin, carbamazepine, phenobarbital (used to treat

  epilepsy/seizures)

• Cyclosporine (used to supress the immune system)
• Deferasirox (used to reduce chronic iron overload)

• Non-prescription and over the counter drugs such as

  drugs for appetite control, asthma, colds, cough, hay fever or sinus problems.

Alcohol may increase the effect of ACT REPAGLINIDE on lowering your blood sugar and therefore impair you ability to concentrate. Avoid drinking alcohol while you are taking ACT REPAGLINIDE.

Grapefruit juice may increase the effect of ACT REPAGLINIDE.

PROPER USE OF THIS MEDICATION

How to take ACT REPAGLINIDE:

Your doctor will prescribe ACT REPAGLINIDE according to your needs. Take ACT REPAGLINIDE exactly as prescribed by your doctor.

Usual dose:

ACT REPAGLINIDE tablets should be taken with meals, usually 15 minutes before the meal. However, ACT REPAGLINIDE tablets may be taken 30 minutes before a meal or right before a meal.

Overdose:

If you take more ACT REPAGLINIDE than you should, your blood sugar may become too low leading to a hypoglycemic event.The symptoms of such an event include: headache, dizziness, tiredness, rapid heartbeat, nervousness, shakiness, nausea and sweating.

Discuss with your healthcare professional about how to treat low blood sugar.

Missed Dose:

If you miss a dose of ACT REPAGLINIDE do not take the missed dose. Wait and take your usual dose before your next meal.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

What are the possible side effects from using ACT

REPAGLINIDE?

These are not all the possible side effects you may feel when taking ACT REPAGLINIDE. If you experience any side effects not listed here, contact your healthcare professional. Please also see WARNINGS AND PRECAUTIONS.

The following side effects may occur during your treatment with ACT REPAGLINIDE:

Common

• Visual disturbance
• Abdominal pain
• Nausea
• Constipation

Uncommon

• Liver dysfunction

Do not use ACT REPAGLINIDE (repaglinide) with gemfibrozil (used to treat high blood fats).

Do not use ACT REPAGLINIDE (repaglinide) with clopidogrel (a medicine used to prevent blood clots).

If you think you have taken too much ACT REPAGLINIDE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

• Itching
• Redness
• Vomiting
• Rash
• Hives
• Abnormal blood test results

If you have troublesome symptom or side effects that is not listed here or becomes bad enough to interfere with your daily activities, talk to you healthcare professional.

This is not a complete list of side effects. For any unexpected effects while taking ACT REPAGLINIDE, contact your doctor or pharmacist.

HOW TO STORE IT

Keep out of reach and sight of children.

ACT REPAGLINIDE should be stored at 15°C to 30°C. Protect from moisture and light. Do not store ACT REPAGLINIDE in moist areas, like bathroom medication cabinet or other damp places. Always store it in the bottle it came in, with the lid on tight.

Do not use ACT REPAGLINIDE after the expiry date on the package.

Medicines should not be disposed of down the drain or in household garbage. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Reporting Side Effects

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the Teva Canada Limited by:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last revised: April 3, 2020