Lonamo Duo

Leaflet attached to the packaging: patient information

Lonamo Duo, 50 mg + 1000 mg, coated tablets

Sitagliptin + Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 Lonamo Duo and what is it used for
• 2. Important information before taking Lonamo Duo
• 3. How to take Lonamo Duo
• 4. Possible side effects
• 5. How to store Lonamo Duo
• 6. Contents of the packaging and other information

1. What is Lonamo Duo and what is it used for

Lonamo Duo 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 is used in combination with diet and physical exercise to help reduce blood sugar levels.
This medicine may 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 insulin produced 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 diseases, such as heart disease, kidney disease, vision loss, and limb amputation.

2. Important information before taking Lonamo Duo

When not to take Lonamo Duo

• 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 sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or 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 unusual fruity breath odor.
• 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. The patient should stop taking Lonamo Duo during the radiological examination and for 2 or more days, 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.

You should not take Lonamo Duo if any of the above contraindications occur.
You should consult a doctor to determine other methods of controlling diabetes. In case of doubts, before taking Lonamo Duo, you should discuss it with your doctor, pharmacist, or nurse.

Warnings and precautions

In patients taking Lonamo Duo, cases of pancreatitis (see section 4) have been reported.
If the patient develops blisters on the skin, it may be a sign of a disease called pemphigoid blisters. The doctor may recommend that the patient stop taking Lonamo Duo.

Risk of lactic acidosis

Lonamo Duo may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more information below), liver function disorders, 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 the patient, they should consult their doctor for more detailed instructions.
You should immediately contact your doctor for further instructions if:

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

You should temporarily stop taking Lonamo Duo if you have a condition

that may be associated with 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. You should consult your doctor for more detailed instructions.

You should stop taking Lonamo Duo and immediately contact your doctor or

the nearest hospital 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,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
Before taking Lonamo Duo, you should discuss the following with your 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. These conditions may increase the risk of pancreatitis (see section 4);
• if the patient has type 1 diabetes. It is sometimes called insulin-dependent diabetes;
• if the patient has currently or in the past experienced allergic reactions to sitagliptin, metformin, or Lonamo Duo (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, anti-diabetic medicines, at the same time as Lonamo Duo, as this may lead to excessively low blood sugar levels (hypoglycemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is scheduled to undergo major surgery, they should not take Lonamo Duo during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Lonamo Duo.
If the patient is unsure whether any of the above statements apply to them, they should discuss it with their doctor or pharmacist before taking Lonamo Duo.
During treatment with Lonamo Duo, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has worsening kidney function.

Children and adolescents

Children and adolescents under 18 years of age should not take this medicine. 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.

Lonamo Duo and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Lonamo Duo before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Lonamo Duo.
You should tell your doctor or pharmacist about all medicines you are currently 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 Lonamo Duo 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 diseases). When taking Lonamo Duo with digoxin, the digoxin level in the blood should be monitored.

Lonamo Duo and alcohol

You should avoid consuming excessive amounts of alcohol while taking Lonamo Duo, 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 their doctor or pharmacist before taking this medicine.
This medicine should not be taken during pregnancy or breastfeeding. See section 2, When not to take Lonamo Duo.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. However, dizziness and drowsiness have been reported during sitagliptin treatment, 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.

Lonamo Duo contains sodium

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

3. How to take Lonamo Duo

This medicine should always be taken as directed by the doctor. In case of doubts, you should consult a doctor or pharmacist.

• You should take one tablet: twice a day, orally; during meals to reduce the likelihood of stomach upset.
• To control blood sugar levels, the doctor may increase the dose of the medicine.
• If the patient has kidney function disorders, the doctor may prescribe a lower dose.

While taking this medicine, you should continue to follow the diet and exercise recommended by your doctor.
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 this case, the doctor may reduce the dose of the sulfonylurea derivative or insulin.
The dividing line on the tablet is not intended to break the tablet.

Taking a higher dose of Lonamo Duo than recommended

In case of taking a higher dose of this medicine than recommended, you should immediately contact your doctor.
You should go to the hospital if symptoms of lactic acidosis occur, such as a feeling of cold or discomfort, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Lonamo Duo

In case of missing a dose, you should take it as soon as possible. If it is almost time for the next dose, you should skip the missed dose and continue taking the medicine as usual. You should not take a double dose of this medicine.

Stopping treatment with Lonamo Duo

To maintain control of blood sugar levels, you should take the medicine for as long as your doctor recommends.
You should not stop taking this medicine without consulting your doctor first. Stopping treatment with Lonamo Duo may cause blood sugar levels to rise again.
In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should STOPtaking Lonamo Duo and immediately contact your doctorin case of 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.

Lonamo Duo 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 occurs, you should stop taking Lonamo Duo and immediately contact your doctor or the nearest hospital, 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 breathing or swallowing difficulties, you should stop taking this medicine and immediately contact your doctor. The doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients taking metformin after starting sitagliptin, the following side effects have occurred:
Common (may occur in less than 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting.
Uncommon (may occur in less than 1 in 100 patients): stomach pain, diarrhea, constipation, drowsiness.
In some patients, diarrhea, nausea, bloating, constipation, stomach pain, or vomiting have occurred 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 side effects have occurred:
Very common (may occur in more than 1 in 10 patients): low blood sugar levels
Common: constipation
In some patients taking this medicine in combination with pioglitazone, the following side effects have occurred:
Common: swelling of the hands or feet
In some patients taking this medicine in combination with insulin, the following side effects have occurred:
Very common: low blood sugar levels
Uncommon: dry mouth, headache
In clinical trials, some patients taking sitagliptin (one of the active substances of Lonamo Duo) alone or after marketing authorization, during treatment with Lonamo Duo or sitagliptin alone or with other anti-diabetic medicines, have experienced the following side effects:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sore throat, and joint or limb pain
Uncommon: dizziness, constipation, itching
Rare (may occur in less than 1 in 1,000 patients): 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)
In some patients taking metformin alone, the following side effects have occurred:
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 vitamin B12 levels 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, you should 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lonamo Duo

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lonamo Duo contains

• The active substances of the medicine are sitagliptin and metformin. Each coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 1000 mg of metformin hydrochloride.
• The other ingredients are: Tablet core: povidone (K29/32), microcrystalline cellulose, crospovidone (Kollidon), and sodium stearyl fumarate. Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E172).

What Lonamo Duo looks like and contents of the pack

Red to brown, elongated, oval, coated tablets with a dividing line between the "S" marking and the "B" marking on one side and a dividing line on the other side.
Tablet diameter: 21.3 ± 0.5mm
Blisters of PVC/PVDC/Aluminum in a carton. Packs contain 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168, and 180 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer

SAG Manufacturing S.L.U.
Ctra. N-I, Km 36
San Agustin de Guadalix
28750 Madrid
Spain
Galenicum Health S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Malta
Lonamo Duo 50 mg/ 850 mg, 50 mg /1000 mg film-coated tablets
Bulgaria
Lonamo Duo 50 mg/ 850 mg, 50 mg /1000 mg филмирани таблетки
Czech Republic
Lonamo Duo
Hungary
Lonamo Duo 50 mg/ 850 mg, 50 mg /1000 mg filmtabletta
Poland
Lonamo Duo
Romania
Lonamo Duo 50 mg/ 850 mg, 50 mg /1000 mg comprimate filmate
Slovakia
Lonamo Duo 50 mg/ 850 mg, 50 mg /1000 mg filmom obalené tablety
To obtain more detailed information, you should contact the local representative of the marketing authorization holder at the address:
EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: 12.03.2025