Lonamo

Package leaflet: Information for the patient

Lonamo, 50 mg, film-coated tablets
Lonamo, 100 mg, film-coated tablets
Sitagliptinum
Please read all of this leaflet carefully before taking this medicine, because 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 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, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Lonamo is and what it is used for

Lonamo contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), that reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps increase the amount of insulin released after meals and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower high blood sugar levels caused by type 2 diabetes. This medicine may be used alone or in combination with other antidiabetic medicines (such as insulin, metformin, sulfonylureas, or glitazones) that you may already be taking, along with diet and exercise.

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 sugar. As a result, sugar (glucose) builds up 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

When not to use Lonamo

• if the patient is allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Lonamo (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease known as bullous pemphigoid. The doctor may advise the patient to stop taking sitagliptin.
Inform the doctor if the patient has had or currently has:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high blood triglyceride (a type of fat) levels. These conditions may increase the risk of developing pancreatitis (see section 4);
• type 1 diabetes;
• diabetic ketoacidosis (a diabetes complication characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
• any kidney disease in the past or currently;
• an allergic reaction to sitagliptin (see section 4).

Since this medicine does not act when blood glucose levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is used together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea or insulin.
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 with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Lonamo with digoxin, blood digoxin levels should be monitored.
Lonamo with food and drink
Lonamo can be taken with or without food and drink.
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.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or if breastfeeding is planned.
Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, when driving and using machines, it should be noted that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which in turn may affect the ability to drive and use machines or to work without secure foot support.
Lonamo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Lonamo

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual recommended dose is:

• one 100 mg coated tablet;
• once daily;
• taken orally.

If the patient has impaired kidney function, the doctor may prescribe a lower dose of sitagliptin
(e.g. 25 mg or 50 mg).
A 25 mg dose cannot be obtained using Lonamo medicine. Tablets containing sitagliptin at a lower dose (25 mg) are available on the market.
This medicine can be taken regardless of meals or drinks.
The doctor may recommend taking only this medicine or this medicine together with other medicines that
lower blood sugar levels.
Diet and physical exercise help the body to use blood sugar more effectively.
While taking Lonamo, it is important to follow the diet and perform the physical exercises
recommended by your doctor.
Taking more Lonamo than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately.
Missing a dose of Lonamo
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 with your regular dosing schedule.
Do not take a double dose of this medicine.
Stopping Lonamo
To maintain control of blood sugar levels, the medicine should be taken for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first.
If you have any further doubts 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 everybody gets them.
You should DISCONTINUE Lonamo and contact your doctor immediately if any of the following severe 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.

In case of a severe allergic reaction (frequency not known), including rash, urticaria, skin blisters or skin peeling, and swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing, treatment with the 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.

The following adverse effects have been reported in some patients when sitagliptin was added to metformin:

Common (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.

Gastrointestinal disorders of various kinds have occurred in some patients after starting treatment with sitagliptin in combination with metformin (common).

The following adverse effects have been reported in some patients when sitagliptin was used in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar levels.

Common: constipation.

The following adverse effects have been reported in some patients when sitagliptin was used with pioglitazone:

Common: flatulence, swelling of hands or feet.

The following adverse effects have been reported in some patients when sitagliptin was used in combination with pioglitazone and metformin:

Common: swelling of hands or feet.

The following adverse effects have been reported in some patients when sitagliptin was used in combination with insulin (with or without metformin):

Common: influenza-like illness.

Uncommon: dry mouth.

In clinical trials, the following adverse effects have been observed in some patients treated with sitagliptin alone or after marketing authorization with sitagliptin alone or in combination with other antidiabetic medicines:

Common: low blood sugar levels, headache, upper respiratory tract infections, nasal congestion or runny nose, sore throat, bone and joint inflammation, pain in arm or leg.

Uncommon: dizziness, constipation, itching.

Rare: 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 blistering).

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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 marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Lonamo

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.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Lonamo contains

• The active substance is sitagliptin.

Lonamo 50 mg:
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.
Lonamo 100 mg:
Each film-coated tablet contains sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

• Other ingredients are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (PH 102), sodium croscarmellose, colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172).

What Lonamo looks like and contents of the pack
Lonamo 50 mg:
Round, light beige film-coated tablet with a diameter of approximately 8 mm, engraved with the letter "S" on one side.
Lonamo 100 mg:
Round, beige film-coated tablet with a diameter of approximately 10 mm.

Blister packs made of PVC/PE/PVDC/Aluminium in cardboard boxes.
Pack contents: 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168, or 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 European Economic Area countries under the following names:
Malta: Lonamo 50 mg film-coated tablets, Sitagliptin 100 mg film-coated tablets
Czech Republic: Lonamo
Poland: Lonamo
Romania: Lonamo 50 mg comprimate filmate, Sitagliptin 100 mg comprimate filmate
Slovakia: Lonamo 50 mg filmom obalené tablety, Sitagliptin 100 mg filmom obalené tablety
Hungary: Sitagliptin Galenicum 50 mg filmtabletta, Sitagliptin Galenicum 100 mg filmtabletta