Prospect: information for the user

Efficib 50mg/850mg film-coated tablets

Efficib 50mg/1.000mg film-coated tablets

sitagliptin/metformin hydrochloride

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section4.

1.What is Efficib and for what it is used

2.What you need to knowbefore starting to take Efficib

3.How to take Efficib

4.Possible adverse effects

5.Storage of Efficib

6.Contents of the package andadditional information

Efficibcontains two different medications, called sitagliptin and metformin.

• Sitagliptin belongs to a class of medications called DPP‑4 inhibitors (dipeptidyl peptidase‑4 inhibitors)
• Metformin belongs to a class of medications called biguanides.

They work together to control blood sugar levels in adult patients with a form of diabetes called “type 2 diabetes mellitus”.This medication helps to increase insulin levels produced after a meal and reduces the amount of sugar produced by the body.

Along with a diet and exercise, this medication helps to lower blood sugar levels.This medication can be used alone or with certain diabetes medications (insulin, sulfonylureas, or thiazolidinediones).

What is type 2 diabetes?

Type 2 diabetes is a disease in which the body does not produce enough insulin and the insulin produced by the body does not work as well as it should.The body may also produce too much sugar.When this occurs, sugar (glucose) accumulates in the blood.This can lead to serious medical problems, such as heart diseases (cardiovascular), kidney diseases (renal), blindness, and amputations.

Do not take Efficib

• if you are allergic to sitagliptin, metformin, or any of the other ingredients in this medication (listed in section6)
• if you have severe kidney function impairment
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor
• if you have a severe infection or are dehydrated
• if you are scheduled to undergo a radiographythat requires the injection of a contrast agent.You will need to stop taking Efficib at the time of the radiography and for 2 or more days afterwards, as instructed by your doctor, depending on the functioning of your kidneys
• if you have recently had a heart attack or havesevere circulatory problems, such as “shock” or difficulty breathing
• if you have liver problems (hepatic)
• if you drink excessive alcohol (whether daily or occasionally)
• if you are breastfeeding.

Do not take Efficib if any of the above circumstances apply to you and consult your doctor about other ways to control your diabetes. If you are unsure, consult your doctor, pharmacist, or nurse before starting to take Efficib.

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with Efficib (see section4).

If you notice blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Efficib.

Risk of lactic acidosis

Efficib may cause a rare but serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, alcohol consumption, dehydration (see more information below), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Efficib for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Consult your doctor for further instructions.

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

The symptoms of lactic acidosis include:

-vomiting

-stomach pain (abdominal pain)

-muscle cramps

-general feeling of discomfort, with intense fatigue

-difficulty breathing

-reduced body temperature and heart rate

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

Consult your doctor or pharmacist before starting to take Efficib:

• if you have or have had pancreatitis
• if you have or have had gallstones, alcohol addiction, or have very high levels of triglycerides (a type of fat) in your blood. These medical conditions may increase your risk of developing pancreatitis (see section4)
• if you have type1 diabetes. This condition is also known asinsulin-dependent diabetes
• if you have or have had an allergic reaction to sitagliptin, metformin, or Efficib (see section4)
• if you are taking a sulfonylurea or insulin, other diabetes medications, as you may experience low blood sugar (hypoglycemia). Your doctor may need to reduce the dose of the sulfonylurea or insulin you are taking

If you need to undergo major surgery, stop taking Efficib while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Efficib and when to restart it.

If you are unsure whether you are affected by any of the above circumstances, consult your doctor or pharmacist before starting to take Efficib.

During treatment with Efficib, your doctor will check your kidney function at least once a year or more frequently if you are an older person and/or if your kidney function is deteriorating.

Children and adolescents

Children and adolescents under 18years should not use this medication. It is not effective in children and adolescents aged 10 to 17years. The safety and efficacy of this medication in children under 10years are unknown.

Other medications and Efficib

If you need to receive an injection of a contrast agent containing iodine, such as in the context of a radiography or examination, stop taking Efficib before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Efficib and when to restart it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Efficib.

It is especially important to mention the following:

• medications (taken orally, inhaled, or injected) used to treat inflammatory conditions, such as asthma and arthritis (corticosteroids)
• medications that increase urine production (diuretics)
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• specific medications used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• medications specifically used to treat asthma (β-adrenergic agonists)
• iodinated contrast agents or medications containing alcohol
• specific medications used to treat stomach problems, such as cimetidine
• ranolazine, a medication used to treat angina pectoris
• dolutegravir, a medication used to treat HIV infection
• vandetanib, a medication used to treat a specific type of thyroid cancer (medullary thyroid cancer)
• digoxin (to treat irregular heartbeat and other heart problems). You may need to have your digoxin level checked if you are taking Efficib.

Taking Efficib with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.You should not take this medication during pregnancy. Do not take this medication if you are breastfeeding. See section2,Do not take Efficib.

Driving and operating machinery

This medication has no or insignificant effect on your ability to drive and operate machinery.However, cases of dizziness and somnolence have been reported during treatment with sitagliptin, which may affect your ability to drive and operate machinery.

Taking this medication with sulfonylureas or insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work without a secure support.

Efficib contains sodium

This medication contains less than 23mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt,consult your doctor or pharmacist again.

• Take a tablet:
• • twice a day by mouth
  • with food to reduce the likelihood of stomach discomfort

• Your doctor may need to increase the dose to control blood sugar levels.

• If you have reduced renal function, your doctor may prescribe a lower dose.

You must continue with the diet recommended by your doctor during treatment with this medication and be careful to distribute carbohydrate intake evenly throughout the day.

It is unlikely that treatment withonly this medicationwill cause an abnormal drop in blood sugar (hypoglycemia). A drop in blood sugar may occur whenthis medicationis taken with a medication containing sulfonylurea or with insulin, so it is likely that your doctor will consider reducing the dose of your sulfonylurea or insulin.

If you take more Efficib than you should

If you take more than the prescribed dose of this medication, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis such as feeling cold or unwell, intense nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or agitated breathing (see section “Warnings and precautions”).

If you forget to take Efficib

If you forget to take a dose, take it as soon as you remember.If you do not remember until your next scheduled dose, skip the missed dose and continue with your regular treatment.Do not take a double dose of this medication.

If you interrupt treatment withEfficib

Continue taking this medicationfor as long as your doctor tells you to, to help control your blood sugar levels. Do not stop taking this medication without first consulting your doctor. If you stop taking Efficib, your blood sugar levels may increase again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking Efficib and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent abdominal pain (stomach area) that can reach the back with or without nausea and vomiting, as these can be signs of pancreatitis (pancreas inflammation).

Efficib can cause a rare but serious side effect (can affect up to 1 in 10,000 people), called lactic acidosis (see "Warnings and precautions" section). If this happens to you, you should stop taking Efficib and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, blisters on the skin/skin peeling and swelling of the face, lips, tongue, and throat that can cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change the medicine for diabetes treatment.

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

Frequent (can affect up to 1 in 10 people):low blood sugar levels,nausea, gas, vomiting

Infrequent (can affect up to 1 in 100 people):stomach pain, diarrhea, constipation, drowsiness

Some patients have experienced diarrhea, nausea, gas, constipation, stomach pain, or vomiting when starting treatment with the combination of sitagliptin and metformin (classified as frequent).

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

Very frequent (can affect more than 1 in 10 people):low blood sugar levels

Frequent:constipation

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

Frequent: swelling of hands or feet

Some patients presented the following side effects while takingthis medicinein combination with insulin:

Very frequent:low blood sugar levels

Infrequent: dry mouth, headache

Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines contained in Efficib)or during use after Efficib or sitagliptin alone or with other diabetes medicines:

Frequent:low blood sugar levels, headache,upper respiratory tract infection,nasal congestion or mucous, and sore throat, arthritis, arm or leg pain

Infrequent:dizziness, constipation, itching

Rare: reduction in platelet count

Unknown frequency: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blister on the skin)

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

Very frequent:nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms can appear when you start taking metformin and usually disappear

Frequent:metallic taste, decrease or low levels of vitamin B12 in the blood (symptoms can include extreme fatigue, pain and redness of the tongue (glossitis), tingling (paresthesia) or pale or yellowish skin). Your doctor may request tests to determine the cause of your symptoms because some of them can also be caused by diabetes or other unrelated health problems.

Very rare:hepatitis (liver problem), urticaria, skin redness (rash) or itching

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the container after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Efficib

• The active principles are sitagliptina and metformina.

• Each film-coated tablet of Efficib 50 mg/850 mg contains sitagliptina phosphate monohydrate equivalent to 50 mg of sitagliptina and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Efficib 50 mg/1.000 mg contains sitagliptina phosphate monohydrate equivalent to 50 mg of sitagliptina and 1.000 mg of metformin hydrochloride.

• The other components are:

• Core tablet: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium lauryl sulfate and sodium stearate fumarate.
• Film coating: polyvinyl alcohol, macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).

Appearance of the product and contents of the package

• The film-coated tablets of Efficib 50 mg/850 mg are oval-shaped, pink in color, and have the inscription “515” on one face.
• The film-coated tablets of Efficib 50 mg/1.000 mg are oval-shaped, red in color, and have the inscription “577” on one face.

Blister packs (PVC/PE/PVDC and aluminum). Packages of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multiple pack containing 196 (2 boxes of 98) and 168 (2 boxes of 84) film-coated tablets. Package of 50 x 1 film-coated tablets in a pre-cut single-dose blister pack.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:{MM/AAAA}.

For detailed information about this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.