JANUMET®

Sitagliptin phosphate monohydrate/metformin hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about JANUMET. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking JANUMET against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What JANUMET is used for

JANUMET helps to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise.

Type 2 diabetes mellitus
Type 2 diabetes mellitus is a condition in which your body does not make enough insulin and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood resulting in high blood sugar (hyperglycaemia). This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar to a normal level. Lowering and controlling blood sugar may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness and foot amputation.

High blood sugar can be lowered by diet and exercise and by certain medicines.

How JANUMET works

JANUMET contains two active ingredients, sitagliptin (as phosphate monohydrate) and metformin hydrochloride. Sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin belongs to a class of medicines called biguanides. Sitagliptin and metformin work together to control blood sugar levels in patients with type 2 diabetes mellitus.

• JANUMET helps to improve the levels of insulin after a meal.
• JANUMET decreases the amount of sugar made by the body.
• JANUMET works when blood sugar is high, especially after a meal. This is when the body needs the greatest amount of help in lowering blood sugar. JANUMET also lowers blood sugar between meals.
• JANUMET by itself is unlikely to cause low blood sugar (hypoglycaemia) because it does not work when your blood sugar is low.

Before you take JANUMET

When you must not take it

Do not take JANUMET if:

• you have an allergy to sitagliptin or metformin or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips, mouth, tongue or throat.

• the packaging is torn or shows signs of tampering.
• the expiry date on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking JANUMET, talk to your doctor.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to become pregnant.

JANUMET is not recommended for use during pregnancy.

2. you are breastfeeding or plan to breastfeed.

JANUMET should not be used while breastfeeding or if planning to breastfeed.

3. you have or have had type 1 diabetes mellitus or a condition called diabetic ketoacidosis (increased ketones in the blood or urine).

JANUMET should not be used for the treatment of these conditions.

4. you have any kidney or liver problems or any past or present medical problems.

JANUMET should not be used in individuals with certain kidney or liver problems.

5. you have or have had an allergic reaction to sitagliptin (JANUVIA), metformin, or JANUMET, or you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
6. you drink excessive alcohol (all the time or short term "binge" drinking).
7. you are going to get or receive an injection of dye or contrast agent for an X-ray procedure, or if you plan to have surgery.

Talk to your doctor about when to stop JANUMET and when to start again.

If you have not told your doctor about any of the above, tell him/her before you take any JANUMET.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines and herbal supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

JANUMET may affect how well other drugs work and some drugs can affect how well JANUMET works.

How to take JANUMET

Take JANUMET only when prescribed by your doctor.

Your doctor will tell you how many JANUMET tablets to take and how often you should take them.

Take JANUMET with meals to lower your chance of an upset stomach.

Follow all directions given to you by your doctor and pharmacist carefully.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How long to take it

Continue to take JANUMET as long as your doctor prescribes it so you can continue to help control your blood sugar.

Diet and exercise can help your body use its blood sugar better. It is important to stay on your doctor's recommended diet, exercise and weight loss program while taking JANUMET.

If you forget to take it

If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose of JANUMET to make up for the dose that you missed.

If you have trouble remembering to take your tablet, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much JANUMET. Do this even if there are no signs of discomfort or poisoning.

While you are using JANUMET

Things you must do

If you become pregnant while taking JANUMET, tell your doctor immediately.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking JANUMET.

Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them.

HYPOGLYCAEMIA
JANUMET does not normally cause hypoglycaemia, although you may experience it if you take certain other medicines.

Signs of hypoglycaemia may include:

• weakness, trembling or shaking
• sweating
• light-headedness, dizziness, headache or lack of concentration
• irritability, tearfulness or crying
• hunger
• numbness around the lips and tongue.

If not treated quickly, these symptoms may progress to:

• loss of co-ordination
• slurred speech
• confusion
• fits or loss of consciousness

At the first signs of hypoglycaemia, you need to raise your blood glucose quickly.

You can do this by taking one of the following:

• 5 -7 jelly beans
• 3 teaspoons of sugar or honey
• half a can of non-diet soft drink
• 2-3 concentrated glucose tablets

Unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates such as plain biscuits, fruit or milk.

Taking this extra carbohydrate will prevent a second drop in your blood glucose level.

HYPERGLYCAEMIA
If you notice the return of any signs of hyperglycaemia, contact your doctor immediately.

The risk of hyperglycaemia is increased in the following situations:

• uncontrolled diabetes
• illness, infection or stress
• taking less JANUMET than prescribed
• taking certain other medicines
• too little exercise
• eating more carbohydrates than normal.

Tell your doctor if you:

• become ill
• become dehydrated
• are injured
• have a fever
• have a serious infection
• plan to have surgery

Your blood glucose may become difficult to control at these times. You may also be at greater risk of developing a serious condition called lactic acidosis. During these times, your doctor may temporarily replace JANUMET with insulin.

Things you must not do

Do not give JANUMET to anyone else, even if they have the same condition as you.

Do not skip meals while taking JANUMET.

Do not stop taking JANUMET or change your dose without checking with your doctor.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking JANUMET.

Like all prescription medicines, JANUMET may cause side effects. In studies, side effects were usually mild and did not cause patients to stop taking JANUMET.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice or have any of the following and they worry you:

• signs of an infection of the breathing passages, including runny nose, sore throat, cough
• upper respiratory tract infection
• nausea and vomiting
• headache
• diarrhoea

Tell your doctor immediately or go to the accident and emergency at your nearest hospital if you notice any of the following:

• Allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking JANUMET and call your doctor right away. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.
• Severe and persistent stomach pain, often with nausea and vomiting. These may be symptoms of pancreatitis. Pancreatitis can be a serious, potentially life-threatening medical condition. Stop taking JANUMET and call your doctor right away if you experience these symptoms.

IN RARE CASES, METFORMIN, ONE OF THE MEDICINES IN JANUMET, CAN CAUSE A SERIOUS SIDE EFFECT CALLED LACTIC ACIDOSIS. LACTIC ACIDOSIS IS A MEDICAL EMERGENCY THAT CAN CAUSE DEATH AND MUST BE TREATED IN THE HOSPITAL. LACTIC ACIDOSIS IS CAUSED BY A BUILD-UP OF LACTIC ACID IN YOUR BLOOD.

STOP TAKING JANUMET IF YOU GET ANY OF THE FOLLOWING SYMPTOMS OF LACTIC ACIDOSIS AND SEE YOUR DOCTOR IMMEDIATELY:

• You feel very weak and tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting, or diarrhoea.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You have a slow or irregular heart beat
• Your medical condition suddenly changes.

Additional side effects have been reported in general use with JANUMET or sitagliptin, one of the medicines in JANUMET. These side effects have been reported when JANUMET or sitagliptin have been used by themselves and/or with other diabetes medicines:

• Kidney problems (sometimes requiring dialysis)
• Constipation

Tell your doctor if you notice any other effects.

Other side effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After using JANUMET

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep JANUMET in a cool dry place where the temperature stays below 30 degrees C. Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking JANUMET or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

JANUMET comes as three strengths of tablets:

• 50mg/500mg tablet - A light pink, film coated tablet with "575" on one side and plain on the other.
• 50mg/850mg tablet - A pink, film coated tablet with "515" on one side and plain on the other.
• 50mg/1000mg tablet - A red, film coated tablet with "577" on one side and plain on the other.

A box of JANUMET contains 56 tablets. JANUMET tablets may also be supplied in packs of 14 tablets to start treatment.

Ingredients

Active ingredients:

• Sitagliptin 50 mg per tablet (as free base)
• Metformin 500, 850, or 1000 mg

Inactive ingredients:

• Microcrystalline cellulose
• Povidone
• Sodium lauryl sulfate
• Sodium stearylfumarate

Ingredients of film-coating:

• polyvinyl alcohol,
• macrogol 3350
• talc purified
• titanium dioxide
• iron oxide red CI77491
• iron oxide black CI77499

JANUMET does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

JANUMET is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
54-68 Ferndell Street
SOUTH GRANVILLE NSW 2142

This leaflet was prepared in October 2010

Australian Register Numbers:
50mg/500mg - AUST R 149014
50mg/850mg - AUST R 149021
50mg/1000mg - AUST R 149023

WPC-MK0431A-T-092010S

This CMI leaflet was current at the time of printing. To check if it has been updated, please view our website www.janumet.com.au or ask your pharmacist.

Published by MIMS/myDr December 2010

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