Lonamo Duo

Leaflet accompanying the packaging: patient information

Lonamo Duo, 50 mg + 850 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, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• 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 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) builds up 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

Do not take Lonamo Duo if any of the above contraindications occur.
Consult your doctor to determine other methods of controlling diabetes. In case of doubts, before taking Lonamo Duo, 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 cases 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.
Consult your doctor immediately 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 maternally inherited diabetes and deafness (MIDD).
• the patient has experienced any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Temporarily discontinue use of Lonamo Duo if the patient has 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. Consult your doctor for more detailed instructions.

Discontinue use of Lonamo Duo and immediately consult a doctor or

the nearest hospital 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 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 starting Lonamo Duo, consult your doctor or pharmacist:

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 frequently if the patient is elderly and/or has deteriorating 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 receive an intravenous 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 administration. The doctor will decide when the patient should stop and resume treatment with Lonamo Duo.
Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. The patient may require more frequent blood glucose monitoring and kidney function assessments or dose adjustments of Lonamo Duo 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 Lonamo Duo with digoxin, the digoxin blood level should be monitored.

Lonamo Duo and alcohol

Avoid excessive alcohol consumption 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.
Do not take this medicine 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 it is considered "sodium-free".

3. How to take Lonamo Duo

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

• 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 Lonamo Duo.
• If the patient has kidney function disorders, the doctor may prescribe a lower dose.

During treatment with this medicine, continue to follow the diet and pay attention to evenly distributed carbohydrate intake 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 this case, the doctor may reduce the dose of the sulfonylurea derivative or insulin.
The dividing line on the tablet is not intended for breaking the tablet.

Taking a higher dose of Lonamo Duo than recommended

If you have taken more than the recommended dose of this medicine, 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, stomach pain, unexplained weight loss, muscle cramps, or rapid breathing (see "Warnings and precautions").

Missing a dose of Lonamo Duo

If you miss a dose, 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 of this medicine.

Stopping treatment with Lonamo Duo

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Lonamo Duo and contact your 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.

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, stop taking Lonamo Duo 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 can cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. 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, 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 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
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
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, 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lonamo Duo

Keep this medicine out of the 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 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 packaging and other information

What Lonamo Duo contains

• The active substances of Lonamo Duo are sitagliptin and metformin. Each film-coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin, and 850 mg of metformin hydrochloride.
• 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 (E 172), iron oxide yellow (E 172)

What Lonamo Duo looks like and contents of the pack

Pink, elongated, oval film-coated tablets with a dividing line on one side and "SA" marking on the other side.
Tablet diameter: 19.5 ± 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 film-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 European Economic Area countries 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, contact the local representative of the marketing authorization holder at:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00

Date of last revision of the leaflet: 12.03.2025