Co-fineria

Leaflet attached to the packaging: patient information

Co-Fineria, 50 mg + 500 mg, tablets with modified release

Co-Fineria, 50 mg + 1000 mg, tablets with modified release

Co-Fineria, 100 mg + 1000 mg, tablets with modified release

Sitagliptin + Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Co-Fineria and what is it used for
• 2. Important information before taking Co-Fineria
• 3. How to take Co-Fineria
• 4. Possible side effects
• 5. How to store Co-Fineria
• 6. Contents of the pack and other information

1. What is Co-Fineria and what is it used for

Co-Fineria contains two different active substances called sitagliptin and metformin.

• Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
• Metformin belongs to a group of medicines called biguanides.

The combined action of these medicines leads to the normalization of blood sugar levels in adult patients with diabetes known as "type 2 diabetes". This medicine helps to increase the amount of insulin released after a meal and reduce the amount of sugar produced by the body. The medicine, used in conjunction with diet and exercise, helps to reduce blood sugar levels. This medicine can be used as the only anti-diabetic medicine or in combination with certain other anti-diabetic medicines (insulin, sulfonylurea derivatives, or glitazones). What is type 2 diabetes? In type 2 diabetes, the body does not produce enough insulin, and the insulin produced does not work as it should. The body may also produce too much sugar. If this happens, sugar (glucose) builds up in the blood. This can lead to serious diseases, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Co-Fineria

When not to take Co-Fineria:

• if the patient is allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6)
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, e.g., severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
• if the patient has a severe infection or dehydration
• if the patient is scheduled to undergo a radiological examination with intravenous administration of a contrast agent. Co-Fineria should be discontinued during the radiological examination and for at least 2 days or more, as recommended by the doctor, depending on the patient's kidney function.
• if the patient has recently had a heart attack or has severe circulatory disorders, such as shock or breathing difficulties
• if the patient has liver disease
• if the patient consumes excessive amounts of alcohol (daily or from time to time)
• if the patient is breastfeeding.

Do not take Co-Fineria if any of the above contraindications apply. Consult a doctor to determine other methods of diabetes control. In case of doubts, before taking Co-Fineria, discuss it with a doctor, pharmacist, or nurse.

Warnings and precautions

Patients taking Co-Fineria have reported cases of pancreatitis (see section 4). If the patient develops blisters on the skin, it may be a sign of a disease called bullous pemphigoid. The doctor may recommend discontinuing Co-Fineria.

Risk of lactic acidosis

Co-Fineria may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney problems. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see additional information below), liver disease, or any conditions in which any part of the body is not sufficiently supplied with oxygen (such as acute severe heart disease). If any of the above situations apply to the patient, they should consult a doctor for further instructions.

Discontinue Co-Fineria temporarily if the patient has a condition

that may be associated with dehydration(significant water loss), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Discontinue Co-Fineria and contact a doctor or the nearest hospital immediately if the patient experiences

any symptoms of lactic acidosis, as this condition can lead to coma. Symptoms of lactic acidosis include: nausea and vomiting, abdominal pain, muscle cramps, general feeling of being unwell with severe fatigue, breathing difficulties, low body temperature, and slow heart rate. Lactic acidosis is a life-threatening condition that requires hospital treatment.

Before starting Co-Fineria, discuss with a doctor or pharmacist: if the patient has or has had pancreatitis (e.g., pancreatitis), if the patient has or has had gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such cases, the risk of pancreatitis (see section 4) may increase, if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes, if the patient has currently or has had an allergic reaction to sitagliptin, metformin, or Co-Fineria (see section 4), if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Co-Fineria, as hypoglycemia (low blood sugar) may occur. The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is to undergo major surgery, they must discontinue Co-Fineria during and after the surgery for a certain period. The doctor will decide when the patient must discontinue and resume Co-Fineria. In case of doubts, whether any of the above situations apply to the patient, before taking Co-Fineria, discuss it with a doctor or pharmacist. During Co-Fineria treatment, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age. This medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective in children under 10 years of age.

Co-Fineria and other medicines

If the patient is to receive an intravenous contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they must discontinue Co-Fineria before or at the latest at the time of such administration. The doctor will decide when the patient must discontinue and resume Co-Fineria. Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. The patient may require more frequent blood glucose monitoring and kidney function tests or dose adjustment of Co-Fineria by the doctor. It is especially important to inform about the following medicines: oral, inhaled, or injected medicines used to treat inflammatory diseases, such as asthma and arthritis (corticosteroids), diuretics, medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib), certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists), specific medicines used to treat asthma (beta-sympathomimetics), iodine-containing contrast agents or alcohol-containing medicines, certain medicines used to treat stomach disorders, 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 certain type of thyroid cancer (medullary thyroid cancer), digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Co-Fineria with digoxin, the digoxin blood level should be monitored.

Co-Fineria and alcohol

Avoid consuming excessive amounts of alcohol while taking Co-Fineria, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. This medicine should not be used during pregnancy or breastfeeding. See section 2 "When not to take Co-Fineria".

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, during sitagliptin treatment, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines. Taking this medicine in combination with a sulfonylurea derivative or insulin may lead to hypoglycemia, which may affect the ability to drive and use machines or work without safe foot support.

Co-Fineria contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Co-Fineria

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist. The doctor will tell the patient how many Co-Fineria tablets to take and when to take them. The maximum daily dose is 100 mg of sitagliptin and 2000 mg of metformin. The tablets are usually taken once a day with the evening meal. In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with food to reduce the risk of stomach upset. The tablets should be swallowed whole, with a glass of water, without chewing. The doctor may increase the dose of the medicine to control blood sugar levels. If the patient has reduced kidney function, the doctor may prescribe a lower dose. During treatment with this medicine, the patient should continue the diet recommended by the doctor and pay attention to the uniform intake of carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to low blood sugar (hypoglycemia). Low blood sugar may occur when taking this medicine in combination with a sulfonylurea derivative or insulin – in such a case, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Co-Fineria than recommended

If a higher dose of this medicine is taken than recommended, the patient should contact a doctor immediately. The patient should go to the hospital if symptoms of lactic acidosis occur, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Co-Fineria

If a dose is missed, the patient should take it as soon as possible. If the patient does not remember to take the missed dose until it is time for the next dose, they should skip the missed dose and return to the regular dosing schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Co-Fineria treatment

The patient should continue taking this medicine for as long as the doctor recommends to maintain blood sugar control. The patient should not stop taking this medicine without consulting a doctor first. Stopping Co-Fineria treatment may cause blood sugar levels to rise again. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The patient should STOP taking Co-Fineria and contact a doctor immediatelyif they experience any of the following serious side effects: severe and persistent abdominal pain (in the stomach area), which may radiate to the back, with or without nausea and vomiting, as these may be symptoms of pancreatitis.

Co-Fineria may very rarely cause (less than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Co-Fineria and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. In case of a severe allergic reaction (frequency not known, cannot be estimated from the available data), including rash, hives, blisters on the skin, and (or) peeling skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, the patient should stop taking this medicine and contact a doctor immediately. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. Some patients taking metformin have reported the following side effects after starting sitagliptin: common (may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting, uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness. Some patients have experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting sitagliptin in combination with metformin (common). Some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, have reported the following side effects: very common (may affect more than 1 in 10 people): low blood sugar, common: constipation. Some patients taking this medicine in combination with pioglitazone have reported the following side effects: common: swelling of the hands or feet. Some patients taking this medicine in combination with insulin have reported the following side effects: very common: low blood sugar, uncommon: dry mouth, headache. During clinical trials, some patients taking sitagliptin (one of the active substances of Co-Fineria) alone or after marketing authorization, during treatment with Co-Fineria or sitagliptin alone or with other anti-diabetic medicines, have reported the following side effects: common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or sore throat, and joint or muscle pain, uncommon: dizziness, constipation, itching, rare: reduced platelet count, frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blisters on the skin). Some patients taking metformin alone have reported the following side effects: very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms may occur at the start of metformin treatment and usually disappear, common: metallic taste in the mouth, very rare: reduced vitamin B12 levels, liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Co-Fineria

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. There are no special storage precautions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Co-Fineria contains

The active substances of Co-Fineria are sitagliptin and metformin. Co-Fineria, 50 mg + 500 mg: each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin and 500 mg of metformin hydrochloride. Co-Fineria, 50 mg + 1000 mg: each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride. Co-Fineria, 100 mg + 1000 mg: each tablet contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin and 1000 mg of metformin hydrochloride. The other ingredients are: metformin prolonged-release layer: hypromellose K100M CR, hypromellose E50, magnesium stearate, sitagliptin immediate-release layer: calcium phosphate, microcrystalline cellulose, sodium stearyl fumarate, croscarmellose sodium (see section 2 "Co-Fineria contains sodium"), and coating: in 100 mg + 1000 mg and 50 mg + 500 mg doses: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172), in 50 mg + 1000 mg dose: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 4000, talc.

What Co-Fineria looks like and contents of the pack

Co-Fineria, 50 mg + 500 mg: orange, oval, biconvex, film-coated tablets, 17.2 mm/8.4 mm in size. Co-Fineria, 50 mg + 1000 mg: white, oval, biconvex, film-coated tablets, 22.2 mm/10.8 mm in size, with "50" engraved on one side and "1000" on the other. Co-Fineria, 100 mg + 1000 mg: orange, oval, biconvex, film-coated tablets, 22.2 mm/10.8 mm in size, with "100" engraved on one side and "1000" on the other. PVC/PVDC/Aluminum blisters in a carton. Packs of 10, 14, 28, 30, 56, or 60 modified-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MEDICAL PHARMAQUALITY PHARMACEUTICALS S.A., Elaion 54, 145 64 Kifissia, Greece, Tel. +30 210 350 6000

Manufacturer

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice

This medicine is authorized in the Member States of the European Economic Area under the following trade names:

Greece, Co-Fineria

Date of last revision of the leaflet: