LONAMO 50 mg Tablets

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.