Metsigletic 50 mg/1000 mg. 56 tablets

1. What Metsigletic is and what it is used for

Metcigletic 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 biguanidines.

They work together to control blood sugar levels in adult patients with a form of diabetes called 'type 2 diabetes'. This medicine increases the levels of insulin produced after a meal and reduces the amount of sugar produced 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 diabetes medicines (insulin, sulphonylureas or glitazones).

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin, and the insulin produced does not work as well as it should. Also, your body may produce too much sugar.

In this situation, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

2. What you need to know before you take Metsigletic

Do not take Metsigletic:

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, for example with severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see 'Risk of lactic acidosis' below) or ketoacidosis. Ketoacidosis is a condition where substances called 'ketone bodies' build up in the blood and this can lead to diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity smell on your breath.

if you have a severe infection or are dehydrated;

if you are about to have an X-ray examination where you will be injected with a contrast agent. You should stop taking Metsigletic during the X-ray test and for 2 or more days afterwards, as prescribed 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 problems;

if you have liver problems;

if you drink alcohol in large quantities (every day or only occasionally);

if you are breastfeeding.

Do not take Metsigletic if any of the above apply to you and talk to your doctor about other ways to treat your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking Metsigletic.

Warnings and precautions

Talk to your doctor or pharmacist before taking Metsigletic.

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Metsigletic (see section 4).

If you get blisters on your skin, it could be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Metsigletic.

Risk of lactic acidosis

Metsigletic can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems and any condition where part of the body has a reduced supply of oxygen ( such as acute severe heart disease).

If any of the above applies to you, talk to your doctor for further guidance.

Stop taking Metsigletic for a short time if you have an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal.

Talk to your doctor for further instructions.

Stop taking Metsigletic and contact a doctor or the nearest hospital immediately if you have any of the symptoms of lactic acidosis, as this condition can lead to coma.

Symptoms of lactic acidosis include:

vomiting;

stomach pain (abdominal pain);

muscle cramps;

a general feeling of malaise, accompanied by severe fatigue;

difficulty breathing;

decreased body temperature and heart activity.

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

Talk to your doctor or pharmacist before taking Metsigletic:

if you have or have had pancreatic disease (such as pancreatitis);

if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a type of fat) in your blood. These diseases can make you more likely to get pancreatitis (see section 4); if you have type 1 diabetes. Sometimes called insulin-dependent diabetes;

if you have or have had an allergic reaction to sitagliptin, metformin or Metcigletic (see section 4);

if you are taking a sulphonylurea or insulin, anti-diabetic medicines together with Metsigletic, as a condition of low blood sugar (hypoglycaemia) may occur. Your doctor may reduce the dose of the sulphonylurea or insulin.

If you have to undergo a major operation, you must stop taking Metsigletic during and for some time after the procedure. Your doctor will decide when to stop and when to resume treatment with Metsigletic.

If you are not sure if any of the above apply to you, ask your doctor or pharmacist before taking Metsigletic.

During treatment with Metsigletic, your doctor will check your kidney function at least once a year, or more often if you are elderly and/or if you have impaired kidney function.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not known if this medicine is safe and effective for use in children and adolescents under 18 years of age.

Other medicines and Metsigletic

If you are to have an injection of iodinated contrast material into your bloodstream, for example in the context of an X-ray or scan, you should stop taking Metsigletic before or during the injection. Your doctor will decide when to stop and when to resume treatment with Metsigletic.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your blood glucose and kidney function may need to be checked more often, or your doctor may adjust the dose of Metsigletic. It is extremely important that you mention the following:

medicines (taken by mouth, inhaled or injected) used to treat inflammatory diseases such as asthma and arthritis (corticosteroids);

drugs that increase urine output (diuretics);

medicines used to treat pain and inflammation (NSAIDs 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 drugs for the treatment of bronchial asthma (r-si m pati com im epici);

iodinated contrast agents or drugs containing alcohol;

certain medicines used to treat stomach problems, such as cimetidine;

ranolazine, a medicine used to treat angina pectoris;

dolutegravir, a medicine used to treat HIV infection;

vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid carcinoma);

digoxin (to treat irregular heartbeat and other heart problems). Your blood level of digoxin may need to be checked if you are taking it at the same time as Metsigletic.

Metsigletic with alcohol

Avoid excessive alcohol consumption while taking Metsigletic, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. You should not take this medicine during pregnancy or if you are breast-feeding. See section 2 Do not take Metsigletic.

Driving and using machines

This medicine does not affect or has a negligible effect on the ability to drive and use machines. However, cases of dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or operate machinery.

Taking this medicine in combination with medicines called sulphonylureas or insulin may cause hypoglycaemia, which may affect your ability to drive or operate machinery, or to work without a secure footrest.

Metsigletic contains sodium

Metsigletic 50 mg/850 mg film-coated tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.

Metsigletic 50 mg/1000 mg film-coated tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it can be said to be practically sodium-free.

3. How to take Metsigletic

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Take one tablet:

twice daily orally

with food to reduce the risk of stomach upset.

Your doctor may 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 make sure that your carbohydrate intake is evenly distributed throughout the day.

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

If you have taken more Metsigletic than you should

If you have taken more than the prescribed dose of this medicine, tell your doctor immediately. Go to hospital if you get symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section "Warnings and precautions").

If you forget to take Metsigletic

If you miss a dose, take it as soon as you remember. If you don't remember before it's time for the next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose of this medicine.

If you have stopped taking Metsigletic

Keep taking this medicine for as long as your doctor tells you to so that you can continue to control your blood sugar. You should not stop taking this medicine without first talking to your doctor. If you stop taking Metsigletic, 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 Metsigletic and contact your doctor immediately if you notice any of the following serious side effects:

severe and persistent pain in the abdomen (stomach area) that may radiate to the back, with or without nausea and vomiting, as these may be signs of an inflamed pancreas (pancreatitis).

Metsigletic can 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 Metsigletic and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you get a serious allergic reaction (not known), including rash, hives, blistering/peeling of the skin and swelling of the face, lips, tongue and throat which may cause difficulty in breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe medicine to treat the allergic reaction and another medicine for your diabetes.

Some patients taking metformin experience the following side effects when sitagliptin is added:

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

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

Some patients experience diarrhoea, nausea, gas, constipation, stomach pain or vomiting when they start taking the combination of sitagliptin and metformin (the frequency

5. How to store Metsigletic

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP and EXP. The expiration date corresponds to the last day of the specified month.

Do not store above 25°C.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Metsigletic contains

Metsigletic 50 me/850 mg film-coated tablets

The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg sitagliptin and 850 mg metformin hydrochloride.

Excipients are: In the core of the tablet: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium stearyl fumarate.

In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc, titanium dioxide (E 171), black iron oxide (E 172) and red iron oxide (E 172).

Metsigletic 50 te/1000 mg film-coated tablets

The active substances are sitagliptin and metformin hydrochloride. Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg sitagliptin and 1000 mg metformin hydrochloride.

The other ingredients are: In the core of the tablet: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium stearyl fumarate.

In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc, titanium dioxide (E171), black iron oxide (E172) and red iron oxide (E172).

What Metsigletic looks like and contents of the pack

Metsigletic 50 mg/850 mg film-coated tablets: oval, biconvex pink film-coated tablets, debossed with “850” on one side. The length of the tablet is between 19.9 and 20.4 mm and the width is between 9.7 and 10.2 mm.

Metsigletic 50 mg/1000 mg film-coated tablets: oval, biconvex red film-coated tablets, debossed with “1000” on one side. The length of the tablet is between 21.1 and 21.6 mm and the width is between 10.3 and 10.8 mm.

Aluminum/PVC/PVDC blisters in outer packaging.

Packs of 14, 28, 30, 56, 60, 90, 112, 168, 180, 196 film-coated tablets, multipacks containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets. Packages of 50 x 1 film-coated tablets in perforated single-dose blisters.