LONAMO 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lonamo, 50 mg, Film-Coated Tablets
3. Lonamo, 100 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
4. What is Lonamo and What is it Used For
5. Important Information Before Taking Lonamo
   1. When Not to Take Lonamo
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Lonamo and Other Medications
   5. Lonamo with Food and Drink
   6. Pregnancy and Breastfeeding
   7. Driving and Using Machines
   8. Lonamo Contains Sodium
6. How to Take Lonamo
   1. What to Do if You Take More Lonamo Than You Should
   2. What to Do if You Miss a Dose of Lonamo
   3. What to Do if You Stop Taking Lonamo
7. Possible Side Effects
   1. Reporting Side Effects
8. How to Store Lonamo
9. Package Contents and Other Information
   1. What Lonamo Contains
   2. What Lonamo Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:
   6. Date of Last Revision of the Package Leaflet: 14.05.2024

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 Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• This Medication Has Been Prescribed for You Only. 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 Those Not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 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. Package Contents and Other Information

1. What is Lonamo and What is it Used For

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 Medication (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 the 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 (e.g., Pancreatitis);
• Gallstones, Alcohol Dependence, or Very High Triglyceride Levels 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;
• An Allergic Reaction to Sitagliptin (See Section 4).

Since this Medication Does Not Work When Blood Sugar Levels are Low, it is Unlikely to Cause Hypoglycemia (Low Blood Sugar). However, if this Medication is Taken with a Sulfonylurea Derivative or Insulin, Hypoglycemia May Occur. Your Doctor May Reduce the Dose of the Sulfonylurea Derivative or Insulin.

Children and Adolescents

Do Not Use this Medication in Children and Adolescents Under 18 Years of Age. This Medication is Not Effective in Children and Adolescents Aged 10 to 17 Years. It is Not Known if this Medication is Safe and Effective When Used in Children Under 10 Years of Age.

Lonamo and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Plan to Take.
In Particular, Tell Your Doctor if You are Taking Digoxin (a Medication Used to Treat Heart Rhythm Disorders and Other Heart Conditions). When Taking Lonamo with Digoxin, Your Doctor May Monitor Your Digoxin Blood Levels.

Lonamo with Food and Drink

You Can Take Lonamo with or Without Food and Drinks.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication.
Do Not Take this Medication During Pregnancy.
It is Not Known if this Medication Passes into Breast Milk. Do Not Take this Medication During Breastfeeding or if You Plan to Breastfeed.

Driving and Using Machines

This Medication is Unlikely to Affect Your Ability to Drive or Use Machines. However, When Driving or Using Machines, Consider that Dizziness and Drowsiness Have Been Reported.
Taking this Medication with Sulfonylurea Derivatives or Insulin May Cause Hypoglycemia, Which Can Affect Your Ability to Drive or Use Machines or Work Without Safe Foot Support.

Lonamo Contains Sodium

This Medication Contains Less Than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Essentially Sodium-Free.

3. How to Take Lonamo

Always Take this Medication Exactly as Your Doctor Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist.
The Usual 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 in a Lower Dose (25 mg) are Available on the Market.
This Medication Can be Taken with or Without Food and Drinks.
Your Doctor May Prescribe this Medication Alone or with Certain Other Medications that Lower Blood Sugar Levels.
Diet and Exercise Help Your Body Make Better Use of the Sugar in Your Blood. While 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 of this Medication 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 Possible. If it is Almost Time for Your Next Dose, Skip the Missed Dose and Continue with Your Regular Schedule.
Do Not Take a Double Dose of this Medication.

What to Do if You Stop Taking Lonamo

To Maintain Control of Your Blood Sugar Levels, Take this Medication for as Long as Your Doctor Recommends. Do Not Stop Taking this Medication Without Consulting Your Doctor First.
If You Have Any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, this Medication 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 - These May be Symptoms of Pancreatitis.

If You Experience a Severe Allergic Reaction (Frequency Not Known), Including Rash, Hives, Blisters on the Skin, or Peeling Skin, and Swelling of the Face, Lips, Tongue, and Throat, Which May Cause Difficulty Breathing or Swallowing, Stop Taking this Medication and Contact Your Doctor Immediately. Your Doctor May Prescribe a Medication to Treat the Allergic Reaction and Another Medication to Treat Diabetes.
In Some Patients Who Added Sitagliptin to Metformin, the Following Side Effects Were Reported:
Common (May Affect Up to 1 in 10 People): Low Blood Sugar, Nausea, Bloating, Vomiting.
Uncommon (May Affect Up to 1 in 100 People): Abdominal Pain, Diarrhea, Constipation, Drowsiness.
In Some Patients Who Took Sitagliptin in Combination with Metformin, Various Gastrointestinal Symptoms Were Reported (Common).
In Some Patients Who Took Sitagliptin in Combination with a Sulfonylurea Derivative and Metformin, the Following Side Effects Were Reported:
Very Common (May Affect More Than 1 in 10 People): Low Blood Sugar
Common: Constipation
In Some Patients Who Took Sitagliptin and Pioglitazone, the Following Side Effects Were Reported:
Common: Bloating, Swelling of the Hands or Feet
In Some Patients Who Took Sitagliptin in Combination with Pioglitazone and Metformin, the Following Side Effects Were Reported:
Common: Swelling of the Hands or Feet
In Some Patients Who Took Sitagliptin in Combination with Insulin (With or Without Metformin), the Following Side Effects Were Reported:
Common: Flu
Uncommon: Dry Mouth
In Clinical Trials, Some Patients Who Took Sitagliptin Alone or in Combination with Other Anti-Diabetic Medications Reported the Following Side Effects:
Common: Low Blood Sugar, Headache, Upper Respiratory Tract Infections, Nasal Congestion or Runny Nose, and Sore Throat, 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 Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. You Can Also Report Side Effects Directly to the Department of Medicinal Product Monitoring, 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Lonamo

Keep this Medication Out of the Sight and Reach of Children.
Do Not Use this Medication After the Expiry Date Stated on the Carton and Blister Pack After “EXP”. The Expiry Date Refers to the Last Day of the Month.
There are No Special Storage Conditions for this Medication.
Do Not Throw Away Any Medications via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Used. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Lonamo Contains

• The Active Substance is Sitagliptin.