Sitagliptin/Metformin 50mg/1000mg Film-Coated Tablets – patient leaflet, side effects, dosage

1. What Sitagliptin/Metformin Tablets are and what they are used for

Sitagliptin/Metformin Tablets contains two different medicines called sitagliptin and metformin.

• sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• metformin belongs to a class of medicines called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body.

Along with diet and exercise, this medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones).

What is type 2 diabetes?

Type 2 diabetes 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. This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Sitagliptin/Metformin Tablets

Do not take Sitagliptin/Metformin Tablets

• if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6).
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
• if you have a severe infection or are dehydrated
• if you are going to have an X-ray where you will be injected with a dye. You will need to stop taking Sitagliptin/Metformin Tablets at the time of the X-ray and for 2 or more days after as directed by your doctor, depending on how your kidneys are working
• if you have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or breathing difficulties
• if you have liver problems
• if you drink alcohol to excess (either every day or only from time to time)
• if you are breast-feeding

Do not take Sitagliptin/Metformin Tablets if any of the above apply to you and talk with your doctor about other ways of managing your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking Sitagliptin/Metformin Tablets.

Warnings and precautions

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Sitagliptin/Metformin Tablets (see section 4).

If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop Sitagliptin/Metformin Tablets.

Risk of lactic acidosis

Sitagliptin/Metformin Tablets 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 (see further information below), 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 Tablets 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 Tablets and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

Talk to your doctor or pharmacist before taking Sitagliptin/Metformin Tablets:

• if you have or have had a disease of the pancreas (such as pancreatitis)
• if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood. These medical conditions can increase your chance of getting pancreatitis (see section 4)
• if you have type 1 diabetes. This is sometimes called insulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin, or Sitagliptin/Metformin Tablets (see section 4)
• if you are taking a sulphonylurea or insulin, diabetes medicines, together with Sitagliptin/Metformin Tablets, as you may experience low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of your sulphonylurea or insulin.

If you need to have major surgery you must stop taking Sitagliptin/Metformin Tablets during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Sitagliptin/Metformin Tablets.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sitagliptin/Metformin Tablets.

During treatment with Sitagliptin/Metformin Tablets, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

Talk to your doctor promptly for further instructions if:

• You are known to suffer from a genetically inherited disease affecting mitochondria (the energy-producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD)
• You have any of these symptoms after starting metformin: seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

Children and adolescents

Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.

Other medicines and Sitagliptin/Metformin Tablets

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Sitagliptin/Metformin Tablets before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Sitagliptin/Metformin Tablets.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Sitagliptin/Metformin Tablets. It is especially important to mention the following:

• medicines (taken by mouth, inhalation, or injection) used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
• medicines which increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• specific medicines for the treatment of bronchial asthma (β-sympathomimetics)
• iodinated contrast agents or alcohol-containing medicines
• certain medicines used to treat stomach problems such as cimetidine
• ranolazine, a medicine used to treat angina
• dolutegravir, a medicine used to treat HIV infection
• vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heart beat and other heart problems). The level of digoxin in your blood may need to be checked if taking with Sitagliptin/Metformin Tablets.

Sitagliptin/Metformin Tablets with alcohol

Avoid excessive alcohol intake while taking Sitagliptin/Metformin Tablets since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy or if you are breast-feeding. See section 2, Do not take Sitagliptin/Metformin Tablets.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.

Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.

Sitagliptin/Metformin Tablets contains sodium

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium- free’.

3. How to take Sitagliptin/Metformin Tablets

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

• Take one tablet:
• twice daily by mouth
• with meals to lower your chance of an upset stomach
• Your doctor may need to increase your dose to control your blood sugar
• If you have reduced kidney function, your doctor may prescribe a lower dose.

You should continue the diet recommended by your doctor during treatment with this medicine and take care that your carbohydrate intake is equally distributed over the day.

This medicine alone is unlikely to cause abnormally low blood sugar (hypoglycaemia). When this medicine is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.

The score line is not intended for breaking the tablet.

If you take more Sitagliptin/Metformin Tablets than you should

If you take more than the prescribed dosage of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or uncomfortable, severe nausea or vomiting, stomach ache, unexplained weight loss, muscular cramps, or rapid breathing (see section “Warnings and precautions”).

If you forget to take Sitagliptin/Metformin Tablets

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. Do not take a double dose of this medicine.

If you stop taking Sitagliptin/Metformin Tablets

Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar. You should not stop taking this medicine without talking to your doctor first. If you stop taking Sitagliptin/Metformin Tablets, your blood sugar may rise again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Sitagliptin/Metformin Tablets and contact a doctor immediately if you notice any of the following serious side effects:

• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).

Sitagliptin/Metformin Tablets may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens, you must stop taking Sitagliptin/Metformin Tablets and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away. Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients taking metformin have experienced the following side effects after starting sitagliptin:

Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting

Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness.

Some patients have experienced diarrhoea, nausea, flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common).

Some patients have experienced the following side effects while taking this medicine with a sulphonylurea such as glimepiride:

Very common (may affect more than 1 in 10 people): low blood sugar

Common: constipation

Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:

Common: swelling of the hands or legs

Some patients have experienced the following side effects while taking this medicine in combination with insulin:

Very common: low blood sugar

Uncommon: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Sitagliptin/Metformin Tablets) or during post-approval use of Sitagliptin/Metformin Tablets or sitagliptin alone or with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain

Uncommon: dizziness, constipation, itching

Rare (may affect up to 1 in 1000 people): reduced number of platelets

Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Some patients have experienced the following side effects while taking metformin alone:

Very common: nausea, vomiting, diarrhoea, stomach ache and loss of appetite. These symptoms may happen when you start taking metformin and usually go away

Common:

• a metallic taste
• decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems.

Very rare: hepatitis (a problem with your liver), hives, redness of the skin (rash) or itching

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sitagliptin/Metformin Tablets

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 blister and the carton after 'EXP'. The expiry date refers to the last day of the month.

Store below 30ºC.

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.

6. Contents of the pack and other information

What Sitagliptin/Metformin Tablets contain

The active substances are sitagliptin and metformin.

Each Sitagliptin/Metformin 50mg/850mg film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50mg of sitagliptin and 850mg of metformin hydrochloride.

Each Sitagliptin/Metformin 50mg/1000mg film-coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50mg of sitagliptin and 1000mg of metformin hydrochloride.

The other ingredients in the tablet core are:

povidone K29/32, microcrystalline cellulose, crospovidone type A and sodium stearyl fumarate

The other ingredients in the film coating are:

50/850 tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).

50/1000 tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG (E1521), talc (E553b), iron oxide red (E172) and iron oxide black (E172).

What Sitagliptin/Metformin Tablets looks like and contents of the pack

50/850 tablets are pink, oblong oval-shaped film-coated tablets with a scoreline on one side and ‘SA’ on the other side.

50/1000 tablets are red to brown, oblong oval-shaped film-coated tablets with a scoreline in between ‘S’ and ‘B’ on one side and with a scoreline on the other side.

Available in blister packs of 14, 28, 30, 56, 60 or 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Manufacturer

SAG MANUFACTURING, S.L.U.

Crta. N-I, Km 36, San Agustín de Guadalix, 28750 Madrid, Spain

or

GALENICUM HEALTH, S.L.

Avda. Cornellá, 144 7º, 1ª Edificio Lekla

Esplugues de Llobregat,

Barcelona 08950, Spain

Other sources of information

To listen to or request a copy of this leaflet in Braille, large print or audio please call,

free of charge: 0800 198 5000 (UK only). Please be ready to give the following information:

This leaflet was last revised in 02/2025