SITAGLIPTIN/ METFORMIN SANDOZ ®
sitagliptin hydrochloride monohydrate/metformin hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Sitagliptin/Metformin Sandoz. 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 Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz is used for
Sitagliptin/Metformin Sandoz helps to lower blood sugar levels in patients with type 2 diabetes mellitus along with diet and exercise. Sitagliptin/Metformin Sandoz can be used alone, or in combination with ertugliflozin, insulin, or sulfonylurea medicines such as glimepiride, gliclazide and glibenclamide.
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 Sitagliptin/Metformin Sandoz works
Sitagliptin/Metformin Sandoz contains two active ingredients, sitagliptin (as hydrochloride 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.
- Sitagliptin/Metformin Sandoz helps to improve the levels of insulin after a meal.
- Sitagliptin/Metformin Sandoz decreases the amount of sugar made by the body.
- Sitagliptin/Metformin Sandoz 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. Sitagliptin/Metformin Sandoz also lowers blood sugar between meals.
Before you take Sitagliptin/Metformin Sandoz
When you must not take it
Do not take Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz, talk to your doctor.
Before you start to take it
Tell your doctor if:
- you are pregnant or intend to become pregnant.
Sitagliptin/Metformin Sandoz is not recommended for use during pregnancy.
- you are breastfeeding or plan to breastfeed.
Sitagliptin/Metformin Sandoz should not be used while breastfeeding or if planning to breastfeed.
- you have or have had type 1 diabetes mellitus or a condition called diabetic ketoacidosis (increased ketones in the blood or urine).
Sitagliptin/Metformin Sandoz should not be used for the treatment of these conditions.
- you have severe kidney problems
Sitagliptin/Metformin Sandoz should not be used in individuals with severe kidney problems.
- you have any liver or heart problems including congestive heart failure or any past or present medical problems.
Sitagliptin/Metformin Sandoz should not be used in individuals with certain liver or heart problems
- you have or have had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin, or you have any allergies to any other medicines or any other substances such as foods, preservatives or dyes.
- you drink excessive alcohol (all the time or short term “binge” drinking).
- 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 Sitagliptin/Metformin Sandoz and when to start again.
If you have not told your doctor about any of the above, tell him/ her before you take any Sitagliptin/Metformin Sandoz.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Sitagliptin/Metformin Sandoz may affect how well other drugs work and some drugs can affect how well Sitagliptin/Metformin Sandoz works.
How to take Sitagliptin/Metformin Sandoz
Take Sitagliptin/Metformin Sandoz only when prescribed by your doctor.
Your doctor will tell you how many Sitagliptin/Metformin Sandoz tablets to take and how often you should take them.
Take Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz.
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 Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz. Do this even if there are no signs of discomfort or poisoning.
While you are using Sitagliptin/Metformin Sandoz
Things you must do
If you become pregnant while taking Sitagliptin/Metformin Sandoz, tell your doctor immediately.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Sitagliptin/Metformin Sandoz.
Make sure that you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and hyperglycaemia and know how to treat them.
Sitagliptin/metformin does not normally cause hypoglycaemia, although you may experience it if you take certain other medicines.
When sitagliptin/metformin is used with insulin, low blood sugar (hypoglycaemia) due to the insulin, can occur. Lower doses of insulin may be required.
Signs of hypoglycaemia 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 Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz with insulin.
Things you must not do
Do not give Sitagliptin/Metformin Sandoz to anyone else, even if they have the same condition as you.
Do not skip meals while taking Sitagliptin/Metformin Sandoz.
Do not stop taking Sitagliptin/Metformin Sandoz or change your dose without checking with your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sitagliptin/Metformin Sandoz.
Like all prescription medicines, Sitagliptin/Metformin Sandoz may cause side effects. In studies, side effects usually were mild and did not cause patients to stop taking sitagliptin/metformin.
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
- Cases of skin reaction called bullous pemphigoid that can require treatment in a hospital have been reported in patients receiving sitagliptin/metformin. Tell your doctor if you develop blisters or the breakdown of your skin (erosion). Your doctor may tell you to stop taking Sitagliptin/Metformin Sandoz.
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 Sitagliptin/Metformin Sandoz 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 Sitagliptin/Metformin Sandoz and call your doctor right away if you experience these symptoms.
RISK OF LACTIC ACIDOSIS
Sitagliptin/Metformin Sandoz may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Sitagliptin/Metformin Sandoz for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
STOP TAKING SITAGLIPTIN/METFORMIN SANDOZ IF YOU GET ANY OF THE FOLLOWNIG 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 sitagliptin/metformin or sitagliptin, one of the medicines in Sitagliptin/Metformin Sandoz. These side effects have been reported when sitagliptin/metformin or sitagliptin have been used by themselves and/or with other diabetes medicines:
- Kidney problems (sometimes requiring dialysis)
- Joint pain
- Muscle aches
- Arm or leg pain
- Back pain
Common side effects in patients taking metformin alone include diarrhoea, nausea/vomiting, flatulence, weakness, indigestion, abdominal discomfort and headache. Diarrhoea and nausea/vomiting were seen in patients treated with modified release metformin products
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 Sitagliptin/Metformin Sandoz
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 Sitagliptin/Metformin Sandoz in a cool dry place where the temperature stays below 30°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 Sitagliptin/Metformin Sandoz or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
What it looks like
Sitagliptin/Metformin Sandoz comes as three strengths of tablets:
- 50 mg/500 mg tablet – A pink, oval, film coated tablet debossed with “SM1” on one side and plain on the other.
- 50 mg/850 mg tablet – A light orange, oval, film coated tablet debossed with “SM2” on one side and plain on the other.
- 50 mg/1000 mg tablet – A light red, oval, film coated tablet debossed with “SM3” on one side and plain on the other.
A box of Sitagliptin/Metformin Sandoz contains 56 tablets.
- Sitagliptin 50 mg per tablet (as free base)
- Metformin hydrochloride 500, 850 or 1000 mg per tablet
- Microcrystalline cellulose
- Sodium lauryl sulfate
- Sodium stearylfumarate
- Croscarmellose sodium
Ingredients of film-coating:
- Triethyl citrate
- Titanium Dioxide
- Iron oxide yellow
- Iron oxide red
Sitagliptin/Metformin Sandoz does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
Sitagliptin/Metformin Sandoz is supplied in Australia by:
Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369
This leaflet was prepared in September 2021.
Australian Register Numbers:
Sitagliptin/Metformin Sandoz 50/500 – AUST R 326502
Sitagliptin/Metformin Sandoz 50/850 – AUST R 326501
Sitagliptin/Metformin Sandoz 50/1000 – AUST R 326500
Published by MIMS November 2022