Co-fineria

Leaflet accompanying 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 packaging 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 is used in combination with diet and exercise 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 properly. 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:

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

Warnings and precautions

In patients taking Co-Fineria, cases of pancreatitis (see section 4) have been reported. 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.

Temporarily discontinue Co-Fineria if the patient has a condition

that may lead to dehydration(significant water loss from the body), 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 immediately contact a doctor or the nearest hospital if the patient experiences

any symptoms of lactic acidosis, as this condition can lead to coma. Symptoms of lactic acidosis include:

• 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 it with a doctor or pharmacist:

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 should 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 administration. The doctor will decide when the patient should 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 need more frequent blood glucose monitoring and kidney function tests or dose adjustments of Co-Fineria by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, inhaled, or injected) used to treat inflammatory diseases, such as asthma and arthritis (corticosteroids)
• medicines that increase urine production (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)
• contrast agents containing iodine or medicines containing alcohol
• certain medicines used to treat stomach disorders, 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 certain type of thyroid cancer (medullary thyroid cancer)
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Co-Fineria with digoxin, the patient's digoxin levels should be monitored.

Co-Fineria and alcohol

Avoid excessive alcohol consumption 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 sulfonylurea derivatives 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

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. The doctor will inform the patient how many Co-Fineria tablets to take and when to take them. The maximum daily dose is 100 milligrams of sitagliptin and 2000 milligrams of metformin. Usually, the tablets should be taken once a day with an 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 abnormally low blood sugar levels (hypoglycemia). Hypoglycemia may occur when taking this medicine in combination with a sulfonylurea derivative or insulin - in such cases, the doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Co-Fineria than recommended

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

Missing a dose of Co-Fineria

In case of missing a dose, the patient should take it as soon as possible. If the patient does not remember the missed dose until the next dose is due, 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 control of blood sugar levels. The patient should not stop taking this medicine without consulting a doctor first. Stopping Co-Fineria treatment may lead to increased blood sugar levels again. In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Fineria can cause side effects, although not everybody gets them. The patient should STOPtaking Co-Fineria and IMMEDIATELYcontact a doctor if 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 it may be a sign 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 STOPtaking Co-Fineria and IMMEDIATELYcontact a doctor or the nearest hospital, 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 of the 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 immediately contact a doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. In some patients taking metformin, after starting sitagliptin, the following side effects have occurred: Common (may affect up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting Uncommon (may affect up to 1 in 100 people): abdominal pain, diarrhea, constipation, drowsiness Some patients experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting sitagliptin in combination with metformin (common). In some patients taking this medicine with a sulfonylurea derivative, such as glimepiride, the following side effects have occurred: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred: Common: swelling of the hands or feet In some patients taking this medicine in combination with insulin, the following side effects have occurred: Very common: low blood sugar Uncommon: dry mouth, headache During clinical trials, in some patients taking sitagliptin alone (one of the active substances of Co-Fineria) or after marketing authorization, during the use of Co-Fineria or sitagliptin alone or with other anti-diabetic medicines, the following side effects have occurred: Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or runny nose and sore throat, osteoarthritis, pain in the hands or feet Uncommon: dizziness, constipation, itching Rare: decreased 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) In some patients taking metformin alone, the following side effects have occurred: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms may occur at the beginning of metformin treatment and usually disappear. Common: metallic taste in the mouth Very rare: decreased 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 Adverse Reaction 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

The medicine should be stored out of 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 precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 500 mg of metformin hydrochloride. Co-Fineria, 50 mg + 1000 mg: Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. Co-Fineria, 100 mg + 1000 mg: Each tablet contains sitagliptin phosphate 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").
• Additionally, the coating contains: o in doses 100 mg + 1000 mg and 50 mg + 500 mg: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172). o in dose 50 mg + 1000 mg: partially hydrolyzed polyvinyl alcohol, 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 with dimensions 17.2 mm/8.4 mm. Co-Fineria, 50 mg + 1000 mg: white, oval, biconvex, film-coated tablets with dimensions 22.2 mm/10.8 mm with a score line and "50" engraved on one side and "1000" on the other side. Co-Fineria, 100 mg + 1000 mg: orange, oval, biconvex, film-coated tablets with dimensions 22.2 mm/10.8 mm with a score line and "100" engraved on one side and "1000" on the other side. 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: