Sitagliptin/Metformin Zentiva 50 mg/1000 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sitagliptin/Metformin is and what it is used for
2. What you need to know before you take Sitagliptin/Metformin
3. How to take Sitagliptin/Metformin
4. Possible side effects
5. How to store Sitagliptin/Metformin
6. Contents of the pack and other information

• are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6),
• have severely reduced kidney function,
• 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.
• have a severe infection or are dehydrated,
• are going to have an X-ray where you will be injected with a dye. You will need to stop taking Sitagliptin/Metformin 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,
• have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or breathing difficulties,
• have liver problems,
• drink alcohol to excess (either every day or only from time to time),
• are breast-feeding.

Do not take Sitagliptin/Metformin 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 or pharmacist before taking Sitagliptin/Metformin.

Talk to your doctor or pharmacist before taking Sitagliptin/Metformin.

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

Sitagliptin/Metformin 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 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 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 if you:

• have or have had a disease of the pancreas (such as pancreatitis),
• 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),
• have type 1 diabetes. This is sometimes called insulin-dependent diabetes,
• have or have had an allergic reaction to sitagliptin, metformin, or Sitagliptin/ Metformin (see section 4),
• are taking a sulphonylurea or insulin, diabetes medicines, together with Sitagliptin/Metformin, 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 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.

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

During treatment with Sitagliptin/Metformin, 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.

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.

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 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.

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. 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.

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

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. Do not take this medicine if you are breast-feeding. See section 2 “Do not take Sitagliptin/Metformin“.

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.

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

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 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.

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, your blood sugar may rise again.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

• The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
• The other ingredients are:
  Core - cellulose microcrystalline (Avicel PH 102), povidone, sodium laurylsulfate, magnesium stearate.
  Film coating (Opadry QX Brown) - macrogol (PEG) polyvinyl alcohol graft copolymer (E1209), talc (E553b), titanium dioxide (E171), iron oxide red (E172), mono- and diglycerides of fatty acids (E471), polyvinyl alcohol (E1203), iron oxide black (E172).

Sitagliptin/Metformin 50 mg/1000 mg film-coated tablets are oval-shaped, biconvex, approximately 21.5 mm x 10.0 mm, brown, debossed with “S477” on one side and plain on the other.

PVC/PVdC-Aluminium blisters.

Pack sizes: 14, 28, 56, 60 and 196 film-coated tablets.

HDPE bottle with PP cap containing silica gel desiccant.

Pack size: 196 film-coated tablets.

Not all pack sizes may be marketed.

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