Depepsit met

Package leaflet: Information for the patient

Depepsit Met, 50 mg + 500 mg, modified-release tablets
Depepsit Met, 50 mg + 1000 mg, modified-release tablets
Depepsit Met, 100 mg + 1000 mg, modified-release tablets
Sitagliptin + Metformin hydrochloride
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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Depepsit Met is and what it is used for
2. What you need to know before taking Depepsit Met
3. How to take Depepsit Met
4. Possible side effects
5. How to store Depepsit Met
6. Contents of the pack and other information

1. What Depepsit Met is and what it is used for

Depepsit Met 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 adults 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 physical exercise, it helps lower blood glucose levels. This medicine may be used alone as an antidiabetic treatment or in combination with certain other antidiabetic 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 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 can lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Depepsit Met

When not to use Depepsit Met:

• 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 ketones accumulate in the blood and which 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 examination with intravascular administration of contrast medium. Treatment with Depepsit Met must be discontinued during the radiological examination and for a period of 2 or more days, as directed by the physician, depending on the patient's kidney function,
• if the patient has recently suffered 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 Depepsit Met if any of the above contraindications apply.
Consult your doctor to determine alternative methods of diabetes control. If in doubt, discuss this with your doctor, pharmacist, or nurse before taking Depepsit Met.
Warnings and precautions
Talk to your doctor or pharmacist before starting treatment with Depepsit Met.
Cases of pancreatitis have been reported in patients taking Depepsit Met (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease called bullous pemphigoid. The doctor may advise the patient to discontinue treatment with Depepsit Met.
Risk of lactic acidosis
Depepsit Met may cause a very rare but serious adverse effect called 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), impaired liver function, and any medical conditions in which any part of the body is inadequately supplied with oxygen (such as acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Contact your doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
• the patient experiences any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

Temporarily discontinue use of Depepsit Met if the patient has a medical condition that may involve 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 use of Depepsit Met and contact your 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 severe 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 Depepsit Met, discuss 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 increase (see section 4),
• if the patient has been diagnosed with type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes,
• if the patient currently has or has previously had an allergic reaction to sitagliptin, metformin, or Depepsit Met (see section 4),
• if the patient is taking a sulfonylurea derivative or insulin together with Depepsit Met, as this may lead to excessive lowering of blood sugar (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled for major surgery, treatment with Depepsit Met must be discontinued during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Depepsit Met.
If in doubt whether any of the above situations apply, discuss this with your doctor or pharmacist before taking Depepsit Met.
While being treated with Depepsit Met, 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 unknown whether this medicine is safe and effective in children under 10 years of age.
Depepsit Met and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example during an X-ray or CT scan, treatment with Depepsit Met must be discontinued before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Depepsit Met.
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 the doctor may need to adjust the dose of Depepsit Met. It is especially important to inform about the following medicines:

• medicines (taken orally, 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 bronchial asthma (β-sympathomimetics),
• iodine-containing 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 Depepsit Met is used concomitantly with digoxin.

Depepsit Met and alcohol
Avoid consuming excessive amounts of alcohol while taking Depepsit Met, 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. Do not use this medicine during pregnancy or breastfeeding. See section 2 "When not to use Depepsit Met".
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery. However, dizziness and drowsiness have been reported during treatment with sitagliptin, which may affect the ability to drive and operate machinery.
Taking this medicine in combination with medicines called sulfonylurea 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.
Depepsit Met 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 take Depepsit Met

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will inform you how many tablets of Depepsit Met 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 advise taking the tablets twice daily.
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 them.
Your doctor may increase the dose to help control your blood sugar levels.
If you have reduced kidney function, your doctor may prescribe a lower dose.
While taking this medicine, 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 sulphonylurea or insulin – in such cases, your doctor may reduce the dose of the sulphonylurea or insulin.

Taking more Depepsit Met than prescribed
If you take more than the prescribed dose of this medicine, 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 Depepsit Met
If you miss a dose, take it as soon as possible. However, 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 Depepsit Met
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 Depepsit Met 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 effects

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

• 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.

Depepsit Met may very rarely (in no more than 1 in 10,000 people) cause a very serious adverse effect known as lactic acidosis (see section “Warnings and precautions”). If lactic acidosis occurs, treatment with Depepsit Met must be stopped and medical help must be sought immediately from 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 may also prescribe another medicine (switch the medicine) for the treatment of diabetes.

In some patients taking metformin, adverse effects listed below occurred after starting treatment with sitagliptin:

Common (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

Some patients experienced diarrhoea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common).

In some patients taking this medicine in combination with a sulfonylurea derivative such as glimepiride, the following adverse effects occurred:

Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation

In some patients taking this medicine in combination with pioglitazone, the following adverse effects occurred:

Common: swelling of hands or feet

In some patients taking this medicine in combination with insulin, the following adverse effects occurred:

Very common: low blood sugar levels
Uncommon: dry mouth, headache

During clinical trials and post-marketing experience with Depepsit Met, sitagliptin (one of the active substances in Depepsit Met), or sitagliptin in combination with other antidiabetic medicines, the following adverse effects were observed in some patients:

Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, sore throat, bone and joint pain, pain in hands or feet
Uncommon: dizziness, constipation, itching
Rare (may affect up to 1 in 1,000 people): decreased platelet count
Frequency not known: kidney disorders (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)

In some patients taking metformin alone, the following adverse effects occurred:

Very common: nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These symptoms may occur at the beginning of treatment with metformin and usually resolve over time.
Common: metallic taste in the mouth, reduced or low levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness sensations (paraesthesiae), or pale or yellowish skin). Your doctor may order certain tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other unrelated health problems.
Very rare: hepatitis (liver disease), urticaria, skin redness (rash), or itching.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Depepsit Met
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after the abbreviation “EXP”. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Depepsit Met contains
The active substances in this medicine are sitagliptin and metformin.
Depepsit Met, 50 mg + 500 mg: Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 500 mg of metformin hydrochloride.
Depepsit Met, 50 mg + 1000 mg: Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 1000 mg of metformin hydrochloride.
Depepsit Met, 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 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, "Depepsit Met contains sodium")

• In addition, the film coating contains:

  • For the 100 mg + 1000 mg and 50 mg + 500 mg strengths: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide (E 172), red iron oxide (E 172)
  • For the 50 mg + 1000 mg strength: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc

What Depepsit Met looks like and contents of the pack
Depepsit Met, 50 mg + 500 mg: Orange, elongated, biconvex film-coated tablets measuring 17.2 mm x 8.4 mm.
Depepsit Met, 50 mg + 1000 mg: White, elongated, biconvex film-coated tablets measuring 22.2 mm x 10.8 mm, engraved with "50" on one side and "1000" on the other.
Depepsit Met, 100 mg + 1000 mg: Orange, elongated, biconvex film-coated tablets measuring 22.2 mm x 10.8 mm, engraved with "100" on one side and "1000" on the other.
Blister packs made of PVC/PVDC/Aluminium in cardboard cartons. Pack sizes: 28, 30, 56, and 60 modified-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

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

This medicinal product is authorised in the Member States of the European Economic Area under the following trade names:
Spain: Metsunix
Latvia: TIXULDA
Germany: Metsunix
Poland: Depepsit Met
Italy: Metsunix