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 + Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Co-Fineria is and what it is used for
2. What you need to know 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 Co-Fineria is and what it is used for

Co-Fineria contains two different active substances: 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 two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes." This medicine helps increase insulin release after meals and reduces the amount of glucose produced by the body. When used together with diet and exercise, it helps lower blood glucose levels. This medicine may be used as the only antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?
In type 2 diabetes, the body does not produce enough insulin, and the insulin that is produced does not work properly. The body may also produce too much glucose. When this happens, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Co-Fineria

When not to use 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 hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour on the breath.
• if the patient has a severe infection or dehydration,
• if the patient is scheduled to undergo a radiological procedure with intravascular administration of contrast agents. Treatment with Co-Fineria must be discontinued before and for 2 or more days after the procedure, as advised by the physician, depending on the patient's kidney function.
• if the patient has recently experienced 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 occasionally),
• if the patient is breastfeeding.

Do not take Co-Fineria if any of the above contraindications apply.
Consult your doctor to determine alternative methods of diabetes management. If in doubt, discuss this with your doctor, pharmacist, or nurse before using Co-Fineria.
Warnings and precautions
Cases of pancreatitis have been reported in patients taking Co-Fineria (see section 4).
If the patient develops skin blisters, this may be a sign of a disease called bullous pemphigoid. The doctor may advise the patient to discontinue treatment with Co-Fineria.
Risk of lactic acidosis
Co-Fineria may cause a very rare but serious adverse effect known as lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see additional information below), liver dysfunction, and any medical conditions in which any part of the body is inadequately oxygenated (such as acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Temporarily discontinue Co-Fineria if the patient develops any illness associated with dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
Discontinue Co-Fineria immediately and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general malaise with profound fatigue
• difficulty breathing
• low body temperature and slowed heart rate

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
Before starting treatment with Co-Fineria, discuss the following with your doctor or pharmacist:

• if the patient has or has had pancreatic disease (e.g. pancreatitis),
• if the patient has or has had gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). In such cases, the risk of pancreatitis may be increased (see section 4),
• if the patient has been diagnosed with type 1 diabetes. This is sometimes called insulin-dependent diabetes,
• if the patient currently has or has previously experienced an allergic reaction to sitagliptin, metformin, or Co-Fineria (see section 4),
• if the patient is taking a sulphonylurea derivative or insulin along with Co-Fineria, as this may lead to excessively low blood sugar levels (hypoglycaemia). The doctor may reduce the dose of the sulphonylurea derivative or insulin.

If the patient is to undergo major surgery, treatment with Co-Fineria must be discontinued during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Co-Fineria.
If in doubt whether any of the above situations apply, discuss this with your doctor or pharmacist before using Co-Fineria.
While being treated with Co-Fineria, 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. The medicine is not effective in children and adolescents aged 10 to 17 years. It is not known whether this medicine is safe and effective for use in children under 10 years of age.
Co-Fineria and other medicines
If the patient is to receive an intravenous iodinated contrast agent, for example for an X-ray or CT scan, treatment with Co-Fineria must be stopped before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart treatment with Co-Fineria.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Co-Fineria by the doctor. It is especially important to inform about the following medicines:

• medicines (oral, inhaled, or injected) used to treat inflammatory conditions 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 (β-sympathomimetic agents),
• iodinated contrast agents or medicines containing alcohol,
• certain medicines used to treat gastrointestinal 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 specific type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored when Co-Fineria is taken with digoxin.

Co-Fineria and alcohol
Avoid consuming excessive amounts of alcohol while taking Co-Fineria, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy or breastfeeding. See section 2 "When not to use Co-Fineria".
Driving and operating machinery
This medicine has no or negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported with sitagliptin, which may affect the ability to drive and operate machinery.
Taking this medicine in combination with medicines called sulphonylurea derivatives or insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without secure foot support.
Co-Fineria contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Co-Fineria

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Your doctor will inform you 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 daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily.
The tablets should always be taken with food to reduce the risk of stomach upset.
The tablets must be swallowed whole with a glass of water and must not be chewed.
Your doctor may increase the dose of this medicine to help control your blood sugar levels.
If you have reduced kidney function, your doctor may prescribe a lower dose.
While taking this medicine, you should continue following the diet recommended by your doctor and pay attention to evenly distributing carbohydrate intake throughout the day.
It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycaemia). Low blood sugar may occur if this medicine is taken together with a sulfonylurea derivative or insulin – in such cases, your doctor may reduce the dose of the sulfonylurea derivative or insulin.
Taking more Co-Fineria than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately. Go to hospital if symptoms of lactic acidosis occur, such as feeling cold or unwell, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see section "Warnings and precautions").
Missing a dose of Co-Fineria
If you miss a dose, take it as soon as possible. If you do not remember the missed dose until it is time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Co-Fineria
You should continue taking this medicine for as long as your doctor recommends in order to maintain control of your blood sugar levels. Do not stop taking this medicine without first consulting your doctor. Stopping treatment with Co-Fineria may cause your blood sugar levels to rise again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should STOP taking Co-Fineria and immediately contact your doctor if any of the following serious adverse reactions occur:

• Severe and persistent stomach pain (in the abdominal 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 (in no more than 1 in 10,000 people) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acidosis occurs in a patient, treatment with Co-Fineria must be stopped and immediate contact made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency unknown, cannot be estimated from available data), including rash, urticaria, skin blisters and/or skin peeling, and swelling of the face, lips, tongue, or throat which may cause difficulty in breathing or swallowing, you must stop taking this medicine and contact your doctor immediately. Your doctor may prescribe medication to treat the allergic reaction and another medicine (a different medicine) for the treatment of diabetes.
In some patients taking metformin, the following adverse reactions occurred after starting treatment with sitagliptin:

Frequent (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness

In some patients, diarrhoea, nausea, bloating, const游戏副本

6. Contents of the pack and other information

What Co-Fineria contains
The active substances in 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.
Other ingredients are:

• Metformin extended-release layer: hypromellose K100M CR, hypromellose E50, magnesium stearate
• Sitagliptin immediate-release layer: calcium hydrogen phosphate, microcrystalline cellulose, sodium stearyl fumarate, sodium croscarmellose (see section 2 "Co-Fineria contains sodium")
• Additionally, the coating contains:
  • For strengths 100 mg + 1000 mg and 50 mg + 500 mg: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172)
  • For strength 50 mg + 1000 mg: partially hydrolysed 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, elongated, biconvex film-coated tablets, 17.2 mm × 8.4 mm in size.
Co-Fineria 50 mg + 1000 mg: White, elongated, biconvex film-coated tablets, 22.2 mm × 10.8 mm in size, engraved with "50" on one side and "1000" on the other.
Co-Fineria 100 mg + 1000 mg: Orange, elongated, biconvex film-coated tablets, 22.2 mm × 10.8 mm in size, engraved with "100" on one side and "1000" on the other.
Blister packs made of PVC/PVDC/Aluminium in cardboard cartons. Pack sizes contain 10, 14, 28, 30, 56 or 60 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following trade names:
Greece: Co-Fineria