Janumet 50/1000mgTablets 56


Drug Name: sitagliptin + metformin
Private Price $56.69
PBS $37.30
Concession $5.20
Safety Net $0.00

S8 Note - This prescription item is Schedule 8 and can only be supplied on a script from a registered doctor in Queensland. Any prescriptions from any other state cannot be filled and will be returned in the mail

Note: Private, PBS and our prices are available to the general public. Concession and Safety Net prices are only available to people with the appropriate concession or Safety Net cards. See Prescriptions for more details.


This prescription item requires a pre approved authority from the Government in order to get this item at the quoted price. Authority prescriptions need to be applied for by the doctor writing the script and can include reasons such as increased quantities due to dosage, increased repeats, use for a pre determined specified use, or the nature of the medication itself requiring specialist interaction. In the event that an authority is not granted on the script, the price will revert to the private price quoted for that item


This item contains more than one pack of a prescription product. Before this can be dispensed the doctor has to give approval. The prescription must be written for the total quantity or the prescription must be endorsed by your doctor "Regulation 24" otherwise we will be unable to dispense the increased amount. If you proceed with the order without approval, we will only send out one pack at the single pack price and refund the difference. Eg If your prescription is written out for 30 Tablets with 5 repeats and it does not have “Regulation 24 “ written on the script, the ONLY quantity we can dispense is 30 at one time. Further dispensing of this product could only occur after an appropriate length of time - usually 21 days but depends on dosage. In this example if you would like to obtain 180 Tablets then the doctor must endorse the prescription “Regulation 24” or the quantity must be written out for 180 and not 30. NB Conditions apply on the writing of a Regulation 24 prescription. Ask your doctor or pharmacist for details.

We can no longer accept signed authority forms from your doctor as permission to dispense more than one pack. Please contact our pharmacist for more information.

If you order this item as Private, NO PBS stickers will be issued. Once any prescription order has been sent the product cannot be returned for a refund even if your doctor changes your medication or you have an adverse reaction.

Janumet 50/1000mgTablets 56

Janumet 50/1000mgTablets 56

Product ID: 58237

Pharmacist Only Medicine

This product is a Pharmacist Only Medicine and requires pharmacist advice before we can dispatch this product. You must first place the order and then contact our pharmacists within 48 hours on 1300 367 283. The pharmacist will determine if this product is appropriate for you and if so, approve the order. In the event that you do not do this, the product will be deleted from your order and the balance of your order will be dispatched. This is not required if you have a doctor's prescription.


General Information

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.


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
light-headedness, dizziness, headache or lack of concentration
irritability, tearfulness or crying
numbness around the lips and tongue.
If not treated quickly, these symptoms may progress to:

loss of co-ordination
slurred speech
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.


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
Tell your doctor immediately if you notice any of the following:

Symptoms of kidney problems including passing little or no urine, drowsiness, nausea, vomiting or breathlessness.
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.


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.
Additionally, the following side effect has been reported in general use with JANUMET:

Inflammation of pancreas
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
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.

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.

Active ingredients:

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

Microcrystalline cellulose
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.

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

This leaflet was prepared in April 2010

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

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.

®Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, New Jersey, USA
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