Oseni: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

OSENI^TM is used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes:

• who are not controlled on pioglitazone alone; OR who are currently on alogliptin (NESINA™) and pioglitazone and who can’t take metformin; OR
• in combination with metformin, in patients who are not controlled on metformin and pioglitazone

What it does:

OSENI^TM is used when your blood sugar cannot be adequately controlled by diet, exercise and other oral anti-diabetic medicines such as pioglitazone; or pioglitazone and metformin taken together.

It is important that you continue to follow the advice on diet and exercise that your nurse or doctor has given you.

When it should not be used:

You should not take OSENI^TM if you:

• have type 1 diabetes (your body does not produce insulin).
• have or have had heart problems or heart failure
• are allergic to alogliptin, pioglitazone or any of the other ingredients of this medicine
• have serious liver damage

• are pregnant or planning to become pregnant

• are breast-feeding
• have or have had bladder cancer
• have blood or a red colour in your urine

What the medicinal ingredient is:

Alogliptin benzoate and pioglitazone hydrochloride

What the nonmedicinal ingredients are:

mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose 2910, talc, titanium dioxide, yellow and/or red iron oxide, macrogol 8000, and printing ink (Red A1 or Gray F1).

What dosage forms it comes in:

OSENI^TM is available in tablets of 12.5 mg/15 mg, 12.5 mg/30 mg, 12.5 mg/45 mg, 25 mg/15 mg, 25 mg/30 mg,

25 mg/45 mg.

WARNINGS AND PRECAUTIONS

Before you take OSENI™, tell your doctor if you:

• are taking an anti-diabetic medicine known as sulfonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.
• have kidney disease.
• suffer from heart failure or fluid retention (edema). Symptoms of heart failure include shortness of breath, weakness, tiredness, swelling (edema), or unusual weight gain.
• have liver disease. Symptoms of liver problems include tiredness, lack of appetite, dark urine, yellowing of the skin or the white part of the eye.
• bladder cancer. Symptoms of bladder cancer include blood or a red colour in your urine, an increased need to urinate, or pain while you urinate.
• have any allergies, especially to the ingredients in OSENI^TM.

• have a special type of diabetic eye disease called macular edema (swelling of the back of the eye).

  • You may become pregnant unless you use an effective method of birth control. Pioglitazone, like other drugs in this class, may cause women with insulin resistance to ovulate again.
• are breastfeeding.
• are pregnant or planning to become pregnant

If you are taking OSENI^TM with a sulfonylurea, you may develop low blood sugar. Make sure to ask your doctor, pharmacist, or diabetes educator what to do if your blood sugar is low. Teach your friends, coworkers, and family members what they can do to help you if you have low blood sugar.

Consult your doctor promptly during periods of stress, such as fever, trauma, infection or surgery, since your medication requirements may change during these times.

Fractures, usually in the hand, upper arm or foot, have been seen with pioglitazone use in women. Talk to your doctor about the risk of fracture.

OSENI^TM should not be used in children under 18 years of age.

Monitoring:

• Fasting blood glucose: Test your blood sugar levels with your personal glucose meter as often as your doctor recommends.
• Glycosylated hemoglobin (HbA1c): This blood test is done periodically to determine the average control of your blood sugar levels.
• Liver Enzymes: Your doctor may recommend a blood test to monitor your liver function before you start OSENI^TM and may repeat this test occasionally while you take OSENI^TM.
• Eye: should be checked regularly. Rarely, some patients have experienced vision changes due to swelling in the back of the eye while taking OSENI^TM.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Drugs that interact with OSENI^TM include:

Oral Contraception. Women using oral birth control should check with their doctor about the possible need to adjust the dose or use alternative methods of contraception when taking OSENI^TM. Women should also inform their doctors of any changes in their monthly cycle.

Pioglitazone may also interact with some other drugs such as gemfibrozil, rifampicin, nifedipine and atorvastatin calcium. Tell your doctor if you are taking these medicines.

Talk to your doctor before starting any new medicine.

PROPER USE OF THIS MEDICATION

Usual dose:

The usual dose is one tablet once a day.

The maximum recommended dose of OSENI^TM is 25 mg/45 mg tablet once a day.

Swallow your tablet(s) whole with water. You can take this medicine with or without food.

If you have kidney disease your doctor may prescribe you a reduced dose.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

If you take more tablets than you should, or if someone else or a child takes your medicine, contact or go to your nearest emergency centre straight away. Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.

Missed Dose:

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, OSENI^TM may cause unwanted reactions, so called side effects.

The common side effects that may occur are:

• cold or flu like symptoms such as sore throat, stuffy or blocked nose, feeling tired, fever, chills, body ache, dry cough
• itchy skin with or without hives
• blisters
• skin infection
• sensitive skin
• ingrowing nail
• nail infection
• headache
• shortness of breath
• nose bleed
• stomach pain, constipation
• intestinal gas (flatulence)
• nausea, vomiting
• indigestion, heartburn
• feeling hot
• inflamed nose or throat (nasopharyngitis)
• pneumonia
• road traffic accident
• scratch, fall, wrist fracture, tennis elbow
• high cholesterol or fat in blood
• urinary tract infection
• blood in urine
• feeling sick
• back pain
• muscle and bone pain
• joint pain
• muscle spasms
• difficulty sleeping, feeling depressed
• feeling numb in any part of your body
• blurred or distorted vision
• anemia (low red blood cell count) which may make you

feel very weak or tired

• heart disorders
• high blood pressure (hypertension)
• sudden and severe bone pain or immobility (particularly in women) Edema (fluid retention or swelling) which could lead to heart failure. If you notice swelling in
• extremities (arms and legs, hands and feet), unusually rapid increase in weight, tiredness, trouble breathing or shortness of breath, call your doctor. These symptoms, although not specific, may signal heart problems or heart failure.
• low blood sugar (hypoglycemia) if you are taking OSENI^TM in combination with another diabetes medicine (e.g., metformin or a sulfonylurea). Dizziness, lack of energy, drowsiness, headache, trembling, sweating, or hunger may mean that your blood sugar is too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if you feel that your symptoms of low blood sugar are uncomfortable. If you are using OSENI™ by itself, there is less risk of having low blood sugar.
• increased weight. Tell your doctor if you gain a lot of weight in a short period of time.

The uncommon side effects that may occur are:

• rash
• allergic reaction
• low blood sugar (hypoglycemia)
• inflammation of the pancreas (pancreatitis)

The following side effects have been reported rarely with pioglitazone, a component of OSENI^TM, (could affect up to 1 in 1000 patients):

• Liver problems. If you experience nausea, vomiting, stomach pain, lack of appetite, tiredness, dark urine, or yellowing of the skin, stop taking OSENI^TM and call your doctor right away.
• Breakthrough bleeding (unexpected vaginal bleeding or spotting) while using oral contraceptives, or generally, if you experience any symptoms that persist or become troublesome, these should be discussed with your doctor.
• Blurred vision due to swelling (or fluid) in the back of the eye.
• Fractures, usually in the hand, upper arm or foot, have been seen with pioglitazone use in women. Talk to your doctor about the risk of fracture.
• Bladder cancer. If you experience blood or a red colour in your urine, an increased need to urinate, or pain while you urinate, stop taking OSENI^TM and call your doctor right away.

The following side effects have been reported very rarely with pioglitazone (could affect up to 1 in 10,000 patients):

• Heart failure or pulmonary edema (fluid accumulation in the lungs). Symptoms of heart failure include shortness of breath, getting tired easily after light physical activity such as walking, waking up short of breath at night and swollen ankles or feet. Symptoms of fluid in the lungs are breathlessness, which may be very severe and usually worsens on lying down. Stop taking OSENI^TM and call your doctor right away if you experience these symptoms.

  • Swelling of the face, lips, mouth, tongue or throat (which may cause difficulty in swallowing or breathing); hives or rash (which may be itchy). Stop taking OSENI^TM and call your doctor right away if you experience these symptoms.

There are other less common side effects. For more information ask your doctor or pharmacist.

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

HOW TO STORE IT

Store OSENI^TM in its bottle with the cap tightly closed at room temperature (15 -30 C). Protect from moisture.

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 bottle after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.takedacanada.com/

or by contacting the sponsor, Takeda Canada Inc. at:

1-866-295-4636.

OSENI^TM is a trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Canada Inc.

Last revised: January 16, 2014