Asitalip Combo

Leaflet accompanying the packaging: patient information

Asitalip Combo, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• 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 Asitalip Combo and what is it used for
• 2. Important information before taking Asitalip Combo
• 3. How to take Asitalip Combo
• 4. Possible side effects
• 5. How to store Asitalip Combo
• 6. Contents of the pack and other information

1. What is Asitalip Combo and what is it used for

Asitalip Combo 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". Asitalip Combo helps achieve higher insulin levels after meals and reduces the amount of sugar produced by the body. The medicine is used in combination with diet and exercise to reduce blood sugar levels. Asitalip Combo 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 health problems, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Asitalip Combo

When not to take Asitalip Combo:

• 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, such as severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis.

Ketoacidosis is a disease in which substances called "ketone bodies" accumulate in the blood and can lead to diabetic pre-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. Asitalip Combo should be discontinued during the radiological examination and for at least 2 days after the examination, 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 (either daily or from time to time);
• if the patient is breastfeeding.

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

Warnings and precautions

There have been reports of pancreatitis in patients taking Asitalip Combo (see section 4). If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid. The doctor may recommend discontinuing Asitalip Combo.

Risk of lactic acidosis

Asitalip Combo 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 increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see below), liver disease, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease). If any of these situations apply to the patient, they should consult a doctor for more detailed instructions.

Discontinue taking Asitalip Combo temporarily 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 more detailed instructions.

Discontinue taking Asitalip Combo and seek medical attention immediately 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 malaise with severe fatigue;
• breathing difficulties;
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Before starting Asitalip Combo, discuss it 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 may increase (see section 4);
• if the patient has type 1 diabetes (insulin-dependent diabetes);
• if the patient has currently or has had allergic reactions to sitagliptin, metformin, or Asitalip Combo (section 4);
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Asitalip Combo, as this may lead to excessive reduction of blood glucose levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

In case of surgery, discontinue taking Asitalip Combo during and after the surgery for a certain period. The doctor will decide when to discontinue and resume treatment with Asitalip Combo. In case of doubts, before taking Asitalip Combo, consult a doctor or pharmacist. During treatment with Asitalip Combo, the doctor will monitor 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 the medicine is safe and effective when used in children under 10 years of age.

Asitalip Combo with 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 should discontinue taking Asitalip Combo before or at the latest at the time of administration. The doctor will decide when to discontinue and resume treatment with Asitalip Combo. Tell the 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 or dose modification of Asitalip Combo by the doctor. It is especially important to inform about the following medicines:

• medicines (taken orally, by inhalation, or by injection) used to treat inflammatory diseases, such as asthma or 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-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 carcinoma);
• digoxin (used to treat heart rhythm disorders and other heart diseases). When taking Asitalip Combo with digoxin, monitor digoxin levels in the blood.

Asitalip Combo with alcohol

Avoid consuming excessive amounts of alcohol while taking Asitalip Combo, 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. Do not take this medicine during pregnancy or breastfeeding. See section 2. When not to take Asitalip Combo.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, when driving and using machines, consider that dizziness and drowsiness have been reported with sitagliptin, which may affect the ability to drive and use machines. Taking Asitalip Combo 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.

Asitalip Combo contains sodium

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

3. How to take Asitalip Combo

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist. Take one Asitalip Combo tablet:

• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.

To control blood sugar levels, the doctor may increase the dose of the medicine. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. If the patient has kidney problems, the doctor may prescribe a lower dose. During treatment with Asitalip Combo, continue the diet recommended by the doctor and pay attention to the uniform intake of carbohydrates throughout the day. It is unlikely that taking Asitalip Combo alone will lead to abnormally low blood glucose levels (hypoglycemia). Hypoglycemia may occur when taking Asitalip Combo 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 Asitalip Combo than recommended

If a higher dose of Asitalip Combo than recommended is taken, contact a doctor immediately. In case of symptoms of lactic acidosis, such as feeling cold or discomfort, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing, go to the hospital (see "Warnings and precautions").

Missing a dose of Asitalip Combo

If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue taking the medicine as usual. Do not take a double dose to make up for the missed dose.

Stopping treatment with Asitalip Combo

To maintain control of blood sugar levels, take the medicine for as long as the doctor recommends. Do not stop taking this medicine without consulting a doctor first. Stopping Asitalip Combo may cause blood sugar levels to rise. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. STOPtaking Asitalip Combo and contact a doctor immediately if 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 - these may be symptoms of pancreatitis.

Asitalip Combo may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). In such cases, stop taking Asitalip Combo 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), including rash, hives, blisters on the skin, or peeling of the skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, 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 after starting sitagliptin experienced the following side effects:

Frequent (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 experienced diarrhea, nausea, bloating, constipation, stomach pain, or vomiting after starting treatment with sitagliptin in combination with metformin (frequent). Some patients taking this medicine in combination with a sulfonylurea derivative, such as glimepiride, 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 experienced the following side effects: Common: swelling of the hands or feet. Some patients taking this medicine in combination with insulin experienced the following side effects: Very common: low blood sugar. Uncommon: dry mouth, headache. In clinical trials, some patients taking sitagliptin (one of the active substances in Asitalip Combo) alone or after marketing authorization, during treatment with Asitalip Combo or sitagliptin alone, or with other anti-diabetic medicines, experienced the following side effects: Common: low blood sugar, headache, upper respiratory tract infection, stuffy nose or runny nose and sore throat, osteoarthritis, pain in the arms or legs. Uncommon: dizziness, constipation, itching. Rare (may affect up to 1 in 1,000 people): decreased platelet count. Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, pemphigoid (a type of blistering skin disease). Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, stomach pain, and loss of appetite. These symptoms may occur after starting metformin and usually disappear. Common: metallic taste, decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, or pallor or yellowing of the skin). The doctor may order certain tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems. Very rare: liver inflammation (liver disease), hives, skin redness (rash), or itching.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration 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, you can help provide more information on the safety of this medicine.

5. How to store Asitalip Combo

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. Store in a temperature below 30°C. 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. Contents of the pack and other information

What Asitalip Combo contains

The active substances are sitagliptin and metformin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride. The other ingredients are: Tablet core: povidone (K 29/32), microcrystalline cellulose, crospovidone, sodium stearyl fumarate. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide red (E 172), iron oxide black (E 172).

What Asitalip Combo looks like and contents of the pack

The tablets are red to brown, oval, with a score line between the embossed letters "S" and "B" on one side, and a score line on the other side. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses. PVC/PVDC/Aluminum blister pack in a cardboard box with a patient leaflet. The pack contains 28 or 56 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno, Poland, Tel.: +48 24 357 44 44, Fax: +48 24 357 45 45, e-mail: [email protected]

Manufacturer

Galenicum Health, S.L., Avda. Cornellá 144, 7º-1ª, Edificio LEKLA, Esplugues de Llobregat, Barcelona, 08950, Spain

Manufacturer

SAG Manufacturing, S.L.U, Crta. N-I, Km 36, San Agustin de Guadalix, Madrid, 28750, Spain

Date of last revision of the leaflet: