Co-fineria

Package Leaflet: Information for the Patient

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

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

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

Sitagliptin + Metformin hydrochloride

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

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 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. Package contents 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 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. When taken in combination with diet and exercise, this medicine helps to reduce blood sugar levels. This medicine can be used alone or in combination with other anti-diabetic medicines (insulin, sulfonylureas, 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 to you. Consult your doctor to determine other methods of controlling diabetes. If in doubt, consult your doctor, pharmacist, or nurse before taking Co-Fineria.

Warnings and precautions

Patients taking Co-Fineria have reported cases of pancreatitis (see section 4). If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking Co-Fineria.

Risk of lactic acidosis

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

Temporarily stop taking Co-Fineria if you have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, high temperature, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking Co-Fineria and contact your doctor or the nearest hospital immediately if you experience

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 with your doctor or pharmacist: if you have or have had pancreatitis (e.g., pancreatitis), if you have or have had gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase. if you have type 1 diabetes. It is sometimes called insulin-dependent diabetes. if you have or have had an allergic reaction to sitagliptin, metformin, or Co-Fineria (see section 4). if you are taking a sulfonylurea or insulin, anti-diabetic medicines, at the same time as Co-Fineria, as this may lead to low blood sugar (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

If you are going to have a major surgical procedure, you must stop taking Co-Fineria during the procedure and for some time after it. Your doctor will decide when you should stop and restart Co-Fineria. If in doubt, consult your doctor or pharmacist before taking Co-Fineria. During treatment with Co-Fineria, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have 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 when used in children under 10 years of age.

Co-Fineria with other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example, for an X-ray or CT scan, you must stop taking Co-Fineria before or at the latest at the time of injection. Your doctor will decide when you should stop and restart Co-Fineria. Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests or dose adjustments of Co-Fineria by your 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, your doctor will monitor your digoxin blood levels.

Co-Fineria with 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Do not take this medicine during pregnancy or breastfeeding. See section 2 "Do not 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 sulfonylureas or insulin may lead to hypoglycemia, which can 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 it is essentially "sodium-free".

3. How to take Co-Fineria

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will tell you 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. You should usually take the tablets once a day with your evening meal. In some cases, your doctor may advise you to take the tablets twice a day. You should always take the tablets with food to reduce the risk of stomach upset. Swallow the tablets whole with a glass of water; do not chew. Your doctor may increase the dose of Co-Fineria to control your blood sugar levels. If you have reduced kidney function, your doctor may prescribe a lower dose. While taking this medicine, continue to follow the diet and exercise regimen recommended by your doctor. It is unlikely that taking this medicine alone will cause low blood sugar (hypoglycemia). Low blood sugar can occur when this medicine is taken with a sulfonylurea or insulin - in this case, your doctor may reduce the dose of the sulfonylurea or insulin.

If you take more Co-Fineria than you should

If you take more Co-Fineria than you should, contact your doctor immediately. Go to the hospital if you experience symptoms of lactic acidosis, such as feeling cold or uncomfortable, severe nausea or vomiting, abdominal pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

If you forget to take Co-Fineria

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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Co-Fineria treatment

Continue to take this medicine for as long as your doctor recommends to maintain control of your blood sugar levels. Do not stop taking Co-Fineria without consulting your doctor first. Stopping Co-Fineria may cause your blood sugar levels to rise again. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Fineria can cause side effects, although not everybody gets them. STOP taking Co-Fineria and contact your doctor immediatelyif you 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 happens to you, stop taking Co-Fineria and contact your doctor or the nearest hospital immediately, as lactic acidosis 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. In the event 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, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine (change the medicine) to treat diabetes. Some patients taking metformin after starting sitagliptin have experienced the following side effects: 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, such as glimepiride, have experienced 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 experienced the following side effects: Common: swelling of the hands or feet. Some patients taking this medicine in combination with insulin have experienced 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 in combination with other anti-diabetic medicines have experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy or runny nose, 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 blistering skin disease). Some patients taking metformin alone have experienced the following side effects: 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: reduced vitamin B12 levels, liver inflammation (liver disease), hives, skin rash, or itching.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 requirements for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Co-Fineria contains

The active substances 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: in the 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 the 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 package leaflet: