Lonamo
Ask a doctor about a prescription for Lonamo
How to use Lonamo
Package Leaflet: Information for the Patient
Lonamo, 50 mg, Film-Coated Tablets
Lonamo, 100 mg, Film-Coated Tablets
Sitagliptin
Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Table of Contents of the Leaflet
- 1. What is Lonamo and What is it Used For
- 2. Important Information 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 is Lonamo and What is it Used For
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which may already be taken for diabetes, along with diet and exercise.
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, loss of vision, and limb amputation.
2. Important Information Before Taking Lonamo
When Not to Take Lonamo
- if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
In patients taking Lonamo, cases of pancreatitis (see section 4) have been reported.
If you experience blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking sitagliptin.
Tell your doctor if you have or have had:
- pancreatic disease (such as pancreatitis);
- gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These conditions may increase the risk of pancreatitis (see section 4);
- type 1 diabetes;
- diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
- any kidney disease, past or present;
- allergic reaction to sitagliptin (see section 4).
Since this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels. However, if this medicine is taken with a sulfonylurea or insulin, low blood sugar levels (hypoglycemia) may occur. Your 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 if this medicine is safe and effective when used in children under 10 years of age.
Lonamo and Other Medicines
Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Lonamo with digoxin, your doctor may need to check your digoxin blood levels.
Lonamo with Food and Drink
Pregnancy and Breast-Feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy.
It is not known if this medicine passes into breast milk. This medicine should not be used during breast-feeding or if you are planning to breast-feed.
Driving and Using Machines
This medicine has no or negligible influence on the ability to drive and use machines. However, when driving or using machines, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which may affect your ability to drive and use machines or work without safe foot support.
Lonamo Contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.
3. How to Take Lonamo
This medicine should always be taken exactly as your doctor has instructed. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
- one 100 mg film-coated tablet;
- once a day;
- taken orally.
If you have kidney problems, your doctor may prescribe a lower dose of sitagliptin (e.g., 25 mg or 50 mg).
A 25 mg dose cannot be obtained with Lonamo. Tablets containing sitagliptin 25 mg are available on the market.
This medicine can be taken with or without food and drinks.
Your doctor may advise you to take this medicine alone or with certain other medicines that lower blood sugar levels.
Diet and exercise help your body use blood sugar better. When taking Lonamo, it is important to follow the diet and exercise plan recommended by your doctor.
What to Do if You Take More Lonamo Than You Should
If you take more Lonamo than you should, contact your doctor immediately.
What to Do if You Miss a Dose of Lonamo
If you miss a dose, take it as soon as you remember. 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.
What to Do if You Stop Taking Lonamo
To maintain control of your blood sugar levels, you should continue to take this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first.
If you have any further questions on the use of this product, ask 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 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 - this may be a sign of pancreatitis.
If you experience 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 difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients, when sitagliptin was added to metformin, the following side effects were reported:
Common (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting.
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness.
In some patients, gastrointestinal symptoms were reported when sitagliptin was started in combination with metformin (common).
In some patients, when sitagliptin was taken in combination with a sulfonylurea and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation
In some patients, when sitagliptin and pioglitazone were taken, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin, pioglitazone, and metformin were taken, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin and insulin (with or without metformin) were taken, the following side effects were reported:
Common: flu
Uncommon: dry mouth
In clinical studies, when sitagliptin was taken alone or with other anti-diabetic medicines, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, sore throat, and joint pain or muscle pain
Uncommon: dizziness, constipation, itching
Rare: reduced platelet count
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).
Reporting Side Effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to Store Lonamo
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.
There are no special storage requirements for this medicine.
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 Pack and Other Information
What Lonamo Contains
- The active substance is sitagliptin.
- The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (PH 102), croscarmellose sodium, 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
PVC/PE/PVDC/Aluminum blisters in a cardboard box.
The pack contains 28, 30, 56, 60, 84, 90, 112, 120, 140, 150, 168, 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 Member States of the European Economic Area 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 film-coated tablets, Sitagliptin 100 mg film-coated tablets
Slovakia: Lonamo 50 mg film-coated tablets, Sitagliptin 100 mg film-coated tablets
Hungary: Sitagliptin Galenicum 50 mg film tablet, Sitagliptin Galenicum 100 mg film tablet
Date of Last Revision of the Leaflet: 14.05.2024
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterGalenicum Health S.L.U. SAG Manufacturing S.L.U.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to LonamoDosage form: Tablets, 25 mgActive substance: sitagliptinManufacturer: Lek Pharmaceuticals d.d. LEK S.A.Prescription requiredDosage form: Tablets, 50 mgActive substance: sitagliptinManufacturer: Lek Pharmaceuticals d.d. LEK S.A.Prescription requiredDosage form: Tablets, 100 mgActive substance: sitagliptinManufacturer: Lek Pharmaceuticals d.d. LEK S.A.Prescription required
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