Lonamo duo

Patient Information Leaflet

Lonamo Duo, 50 mg + 1000 mg, film-coated tablets
Sitagliptin + Metformin hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not share it with others. This medicine may harm others, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Lonamo Duo 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 known as biguanides.

The combined action of these two medicines helps regulate blood glucose levels in adult patients with a condition known as "type 2 diabetes." This medicine helps increase the amount of insulin released after meals and reduces the amount of glucose produced by the body.
Used together with diet and exercise, this medicine helps lower blood glucose levels.
This medicine may be used as the only antidiabetic treatment or in combination with certain other antidiabetic medicines (insulin, sulfonylureas, or glitazones).

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work properly, or the body produces too much glucose. When this happens, sugar (glucose) accumulates in the blood. This may lead to serious health problems such as heart disease, kidney disease, vision loss, and limb amputations.

2. Important information before using Lonamo Duo

When not to use Lonamo Duo

• if the patient is allergic to sitagliptin or metformin, or to 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, for example 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 ketone bodies accumulate in the blood and which may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath.
• if the patient has severe infection or dehydration,
• if the patient is scheduled for a radiological procedure involving intravascular administration of contrast agents. The use of Lonamo Duo should be discontinued during the radiological procedure and for 2 or more days afterwards, according to the physician's instructions, depending on the patient's kidney function.
• if the patient has recently experienced 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 occasionally),
• if the patient is breastfeeding.

Do not take Lonamo Duo 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 using Lonamo Duo.
Warnings and precautions
Cases of pancreatitis have been reported in patients taking Lonamo Duo (see section 4).
If the patient develops blisters on the skin, this may be a symptom of a disease known as bullous pemphigoid. The doctor may advise the patient to stop taking Lonamo Duo.
Risk of lactic acidosis
Lonamo Duo may cause a very rare but serious adverse effect called lactic acidosis, particularly if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited disorder affecting mitochondria (cellular structures producing energy), such as MELAS (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 Lonamo Duo if the patient develops a medical condition
that may lead to 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 Lonamo Duo and contact a 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,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Before starting Lonamo Duo, 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). These conditions may increase the risk of pancreatitis (see section 4);
• if the patient has type 1 diabetes. This is sometimes referred to as insulin-dependent diabetes;
• if the patient currently has or has previously experienced allergic reactions to sitagliptin, metformin, or Lonamo Duo (see section 4).
• if the patient is taking a sulfonylurea derivative or insulin, along with other antidiabetic medicines and Lonamo Duo, as this may lead to excessively low blood sugar levels (hypoglycaemia). The doctor may reduce the dose of the sulfonylurea derivative or insulin.

If the patient is undergoing major surgery, Lonamo Duo must not be taken during the procedure and for some time afterwards. 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, they should discuss this with their doctor or pharmacist before using Lonamo Duo.
While being treated 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 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.
Lonamo Duo and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, they must stop taking Lonamo Duo before or at the latest at the time of injection. 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 currently taking or has recently taken, as well as any medicines they plan to take. The patient may require more frequent monitoring of blood glucose levels 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 conditions 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),
• iodine-containing contrast agents or medicines containing alcohol,
• some medicines used to treat stomach problems, 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 levels of digoxin should be monitored when taking Lonamo Duo with digoxin. Lonamo Duo and alcohol Avoid consuming excessive amounts of alcohol while taking Lonamo Duo, 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 is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or while breastfeeding. See section 2, When not to use Lonamo Duo.
Driving and operating machinery
This medicine has no effect or 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 together 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.
Lonamo Duo 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 Lonamo Duo

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• Take one tablet: o twice daily, orally; o with meals to reduce the likelihood of stomach upset.
• To control blood sugar levels, your doctor may increase the dose of this medicine.
• If you have impaired kidney function, your doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by your doctor and ensure an even intake of carbohydrates 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 derivative or insulin – in such cases, your doctor may reduce the dose of the sulphonylurea or insulin.
The break-line on the tablet is not intended for splitting the tablet.

Taking more Lonamo Duo 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 discomfort, severe nausea or vomiting, stomach pain, unexplained weight loss, muscle cramps or rapid breathing (see section "Warnings and precautions").

If you forget to take Lonamo Duo
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 with your regular dosing schedule. Do not take a double dose of this medicine.

Stopping Lonamo Duo
To maintain control of your blood sugar levels, take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor. Discontinuing treatment with Lonamo Duo may result in a recurrence of high blood sugar levels.

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 Lonamo Duo and contact your doctor immediately if any of the following serious adverse effects occur:

• Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting – these may be symptoms of pancreatitis.

Lonamo Duo may very rarely (may occur in no more than 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acidosis occurs, STOP taking Lonamo Duo and contact your doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
If a severe allergic reaction occurs (frequency unknown), including rash, hives, skin blisters 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 another medicine to treat diabetes.
In some patients taking metformin, the following adverse effects occurred after starting sitagliptin:

Frequent (may affect up to 1 in 10 patients): low blood sugar levels, nausea, bloating, vomiting.
Uncommon (may affect up to 1 in 100 patients): stomach pain, diarrhoea, constipation, drowsiness.

Diarrhoea, nausea, bloating, constipation, stomach pain or vomiting occurred in some patients after starting treatment with sitagliptin in combination with metformin (frequent).

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

Very frequent (may affect more than 1 in 10 patients): low blood sugar levels
Frequent: constipation

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

Frequent: swelling of hands or feet

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

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

In clinical studies, the following adverse effects occurred in some patients taking sitagliptin alone (one of the active substances in Lonamo Duo) or after marketing authorization of Lonamo Duo or sitagliptin alone or in combination with other antidiabetic medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, blocked or runny nose and sore throat, bone and joint inflammation, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare (may affect up to 1 in 1,000 patients): 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 skin blister)

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

Very frequent: nausea, vomiting, diarrhoea, stomach pain and loss of appetite. These symptoms may occur after starting metformin and usually resolve over time.
Frequent: metallic taste, reduced or low blood levels of vitamin B12 (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 or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported directly to the marketing authorization holder.
Reporting adverse effects helps provide 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 cardboard box and blister pack following
"EXP". The expiry date refers to the last day of the specified month.
Store 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Lonamo Duo contains

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

What Lonamo Duo looks like and contents of the pack
Reddish-brown, elongated, oval film-coated tablets, with a break line between the mark "S" and the mark "B" on one side and a break line on the other side.
Tablet diameter: 21.3 ± 0.5 mm
Blister packs made of PVC/PVDC/Aluminum in cardboard boxes. Pack sizes containing 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168 and 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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

For further information, please contact the local representative of the Marketing Authorisation Holder at the following address:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Telephone: +48 22 417 92 00