Simetlip

Package Leaflet: Information for the Patient

Symetlip, 50 mg + 850 mg, film-coated tablets

Symetlip, 50 mg + 1000 mg, film-coated tablets

Sitagliptin + Metformin hydrochloride

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

• 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 you only. Do not pass it on to others. It may harm them, 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.

Table of Contents of the Leaflet

• 1. What Symetlip is and what it is used for
• 2. Important information before taking Symetlip
• 3. How to take Symetlip
• 4. Possible side effects
• 5. How to store Symetlip
• 6. Contents of the pack and other information

1. What Symetlip is and what it is used for

Symetlip 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 achieve higher insulin levels after meals and reduces the amount of sugar produced by the body. The medicine, used in conjunction with diet and physical exercise, helps 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? Type 2 diabetes is a disease in which the body does not produce enough insulin, and the produced insulin does not work as it should. The body may also produce too much sugar. If 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 amputation.

2. Important information before taking Symetlip

When not to take Symetlip

if you have a severe infection or dehydration;

Do not take Symetlip if any of the above contraindications apply to you. Consult your doctor to determine other methods of controlling diabetes. In case of doubt, before taking Symetlip, discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Symetlip, cases of pancreatitis (see section 4) have been reported. If you experience blisters on the skin, it may be a sign of a disease called pemphigoid blisters. Your doctor may advise you to stop taking Symetlip.

Risk of lactic acidosis

Symetlip 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 in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more detailed information below), liver problems, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease). If any of the above situations apply to you, consult your doctor for more detailed instructions.

You should temporarily stop taking Symetlip if you have a condition that may lead to dehydration

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

You should stop taking Symetlip and immediately contact your doctor or the nearest hospital if you experience any symptoms of lactic acidosis

because this condition can lead to coma. Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell along with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. You should immediately contact your doctor to receive further instructions if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• after starting metformin, you experience any of the following symptoms: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Before taking Symetlip, discuss it with your doctor or pharmacist:

If you are going to have a major surgical procedure, you should not take Symetlip during the procedure and for some time after it. Your doctor will decide when you should stop and resume treatment with Symetlip. If you are unsure whether any of the above statements apply to you, discuss it with your doctor or pharmacist before taking Symetlip. During treatment with Symetlip, 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.

Symetlip with other medicines

If you are going to have a contrast agent injected into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Symetlip before or at the latest at the time of the injection. Your doctor will decide when you should stop and resume treatment with Symetlip. 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 a dose adjustment of Symetlip by your 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 cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). When taking Symetlip with digoxin, digoxin blood levels should be monitored.

Symetlip with alcohol

Avoid excessive alcohol consumption while taking Symetlip, 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, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine during pregnancy or while breastfeeding. See section 2. "When not to take Symetlip".

Driving and using machines

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

Symetlip 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 Symetlip

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Take one tablet:
• twice a day, orally;
• with meals to reduce the likelihood of stomach upset.
• Your doctor may increase the dose of Symetlip to control your blood sugar levels.
• If you have kidney problems, your doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by your doctor and pay attention to evenly distributing carbohydrates throughout the day. It is unlikely that taking this medicine alone will lead to abnormally low blood sugar levels (hypoglycemia). Low blood sugar levels may occur when taking this medicine with a sulfonylurea derivative or insulin - in such cases, your doctor may reduce the dose of the sulfonylurea derivative or insulin.

Taking a higher dose of Symetlip than recommended

If you take more Symetlip 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").

Missing a dose of Symetlip

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

Stopping treatment with Symetlip

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

4. Possible side effects

Like all medicines, Symetlip can cause side effects, although not everybody gets them. STOP taking Symetlip 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 - these may be symptoms of pancreatitis.

Symetlip may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Symetlip and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Symetlip may very rarely cause (may occur in less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Symetlip and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

In the event 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 Symetlip and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes. Some patients taking metformin after starting sitagliptin experienced the following side effects: 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): abdominal pain, diarrhea, constipation, drowsiness. Some patients experienced diarrhea, nausea, bloating, constipation, abdominal pain, or vomiting after starting treatment with sitagliptin in combination with metformin (common). Some patients taking Symetlip 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 levels. Common: constipation. Some patients taking Symetlip with pioglitazone experienced the following side effects: Common: swelling of the hands or feet. Some patients taking Symetlip with insulin experienced the following side effects: Very common: low blood sugar levels. Uncommon: dry mouth, headache. In clinical trials, some patients taking sitagliptin alone (one of the active substances of Symetlip) or after marketing authorization, when taking Symetlip or sitagliptin alone or with other anti-diabetic medicines, experienced the following side effects: Common: low blood sugar levels, headache, upper respiratory tract infection, stuffy or runny nose, and sore throat, joint or muscle pain. 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, pemphigoid blisters (a type of blisters on the skin). Some patients taking metformin alone experienced the following side effects: Very common: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur after starting metformin and usually disappear. Common: metallic taste, reduced or low vitamin B levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness and tingling). Your doctor may order certain tests to find the cause of the symptoms you are experiencing, 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 not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Symetlip

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 blister and carton after "EXP". The expiry date refers to the last day of that month. There are no special storage precautions 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Symetlip contains

• The active substances of Symetlip are sitagliptin and metformin.
• Each film-coated tablet of Symetlip 50 mg + 850 mg contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride.
• Each film-coated tablet of Symetlip 50 mg + 1000 mg contains sitagliptin phosphate monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.
• Other ingredients are:
• Tablet core: microcrystalline cellulose PH 101, microcrystalline cellulose PH 102, povidone K-90, sodium stearyl fumarate, sodium lauryl sulfate.
• Tablet coating: Opadry II White 85F18422 (50 mg + 850 mg) contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, 4000, talc. Opadry II Yellow 85F520153 (50 mg + 1000 mg) contains: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, 4000, talc, and yellow iron oxide (E172).

What Symetlip looks like and contents of the pack

Symetlip 50 mg + 850 mg, film-coated tablets White to off-white capsule-shaped film-coated tablets, approximately 20.2 mm in length and 9.8 mm in width, and 6.6 mm ± 0.4 mm in thickness, with "S18" and a break line on one side and "H" on the other side. Symetlip 50 mg + 1000 mg, film-coated tablets Yellow film-coated tablets, capsule-shaped, approximately 21.4 mm in length and 10.4 mm in width, and 7.0 mm ± 0.4 mm in thickness, with "S19" and a break line on one side and "H" on the other side. The break line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses. PVC/Aluminum/OPA/Aluminum blisters, in a cardboard box. Packs containing 14, 28, 50, 56, 60, 112, 168, 180, or 196 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o. ul. Koszykowa 65 00-667 Warsaw tel.: +48 22 822 93 06 e-mail: biuro@farmakinternational.pl

Manufacturer/Importer

Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park, Paola PLA3000, Malta Farmak International Sp. z o.o. ul. Chełmżyńska 249 04-458 Warsaw Date of last revision of the leaflet:May 2025