Lonamo duo

Package leaflet: Information for the patient

Lonamo Duo, 50 mg + 850 mg, film-coated tablets
Sitagliptin + Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet. 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Lonamo Duo is and what it is 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 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 called biguanides.

The combined action of these two medicines helps regulate blood glucose levels in adult patients with diabetes known as "type 2 diabetes." This medicine helps increase insulin release 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, sulfonylurea derivatives, 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 may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid deep breathing, drowsiness or unusual fruity odour on the breath.
• if the patient has a severe infection or dehydration,
• if the patient is scheduled for a radiological procedure involving intravascular administration of contrast medium. Treatment with 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 problems 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. In case of
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 skin blisters, this may be a sign of a condition called bullous pemphigoid. The doctor may advise the patient to discontinue treatment with 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 a 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.
Seek immediate medical advice if:

• the patient has a genetically inherited mitochondrial disorder (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 develops any of the following symptoms after starting metformin: seizures, worsening cognitive ability, 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 body water), 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 treatment with Lonamo Duo, discuss the following with your doctor or pharmacist:

• if the patient has or has had pancreas 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 sulphonylurea derivative or insulin, antidiabetic medicines together with Lonamo Duo, as this may lead to excessively low blood glucose levels (hypoglycaemia). The doctor may reduce the dose of the sulphonylurea 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 restart 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 declining 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 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 medium, for example for an X-ray or CT scan, treatment with Lonamo Duo must be stopped before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart treatment with Lonamo Duo.
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used. The patient may require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Lonamo Duo.
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 bronchial asthma (β-sympathomimetics),
• iodine-containing contrast agents or medicines containing alcohol,
• some medicines used to treat gastrointestinal 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 specific type of thyroid cancer (medullary thyroid cancer),
• digoxin (used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels 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.
This medicine should not be used during pregnancy or while breastfeeding. See section 2, When not to use Lonamo Duo.
Driving and operating machinery
This medicine has no effect or negligible effect on the ability to drive and operate machinery. However, dizziness and somnolence have been reported with sitagliptin, which may affect the ability to drive and operate machinery.
Taking this medicine together with medicines called sulphonylurea derivatives or insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and operate machinery or work without safe 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 use Lonamo Duo

This medicine should always be taken as directed by the doctor. If in doubt, consult
the 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, the doctor may increase the dose of this medicine.
• If the patient has impaired kidney function, the doctor may prescribe a lower dose.

While taking this medicine, continue to follow the diet recommended by the doctor and pay attention to
consuming carbohydrates evenly 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 when this
medicine is taken together with a sulphonylurea derivative or insulin – in such a case, the doctor may reduce the dose of
the sulphonylurea derivative or insulin.
The break line on the tablet is not intended for splitting the tablet.
Taking more Lonamo Duo than prescribed
If you have taken 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”). Missing a dose of Lonamo Duo
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 with the regular dosing schedule. Do
not take a double dose of this medicine.
Stopping Lonamo Duo treatment
To maintain control of blood sugar levels, the medicine should be taken for as long as directed by the doctor.
Do not stop taking this medicine without first consulting your doctor. Discontinuing treatment with Lonamo Duo may result in a recurrence of elevated 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 cause (may occur in no more than 1 in 10,000 patients) a very serious adverse effect known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Lonamo Duo must be discontinued and immediate contact made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or peeling skin, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, treatment with this medicine should be stopped and immediate medical advice sought. The doctor may prescribe a medicine 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 people): low blood sugar levels, nausea, flatulence, vomiting.
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness.

Some patients experienced diarrhoea, nausea, flatulence, constipation, stomach pain or vomiting 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 people): 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 trials, the following adverse effects occurred in some patients taking sitagliptin alone (one of the active substances in Lonamo Duo), or after marketing of Lonamo Duo or sitagliptin alone or in combination with other antidiabetic medicines:

Frequent: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare (may affect up to 1 in 1,000 people): 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 blistering skin condition)

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 levels of vitamin B12 in blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling or numbness (paraesthesiae), or pallor or yellowing of the 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 to the responsible entity.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Lonamo Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and blister after "EXP". The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must 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 are sitagliptin and metformin. Each coated tablet (tablet) contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin and 850 mg of metformin hydrochloride.
• Other ingredients:
  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), yellow iron oxide (E 172).

What Lonamo Duo looks like and contents of the pack
Pink, elongated, oval film-coated tablets with a score line on one side and the imprint "SA" on the other side.
Tablet diameter: 19.5 ± 0.5 mm.
Blister packs made of PVC/PVDC/Aluminum in cardboard boxes. Packs 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 following 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 film-coated tablets
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