MIFOGLAME 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. MIFOGLAME, 50 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet
3. What is Mifoglame and what is it used for
4. Important information before taking Mifoglame
   1. When not to take Mifoglame
   2. Warnings and precautions
   3. Children and adolescents
   4. Mifoglame and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Mifoglame contains sodium
5. How to take Mifoglame
   1. Overdose of Mifoglame
   2. Missed dose of Mifoglame
   3. Stopping Mifoglame treatment
6. Possible side effects
   1. Reporting side effects
7. How to store Mifoglame
8. Contents of the pack and other information
   1. What Mifoglame contains
   2. What Mifoglame looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the package leaflet:

Package Leaflet: Information for the Patient

MIFOGLAME, 50 mg, coated tablets

Sitagliptin

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Mifoglame and what is it used for

Mifoglame contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps to increase the amount of insulin released after a meal and decrease the amount of sugar produced by the body.
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 reduce 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 condition where 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 health problems, such as heart disease, kidney disease, loss of vision, and limb amputation.

2. Important information before taking Mifoglame

When not to take Mifoglame

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

Warnings and precautions

Before taking Mifoglame, discuss this with your doctor or pharmacist.
There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).
If you experience blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may advise you to stop taking Mifoglame.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, the risk of pancreatitis (see section 4) may increase;
• type 1 diabetes;
• diabetic ketoacidosis (a complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney problems, past or present;
• an allergic reaction to Mifoglame (see section 4).

Because this medicine does not work when blood sugar levels are low, it is unlikely to cause low blood sugar levels (hypoglycemia). 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

Children and adolescents under 18 years of age should not take this medicine. 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 in children under 10 years of age.

Mifoglame and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking Mifoglame with digoxin, your doctor may need to check your digoxin blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy.
It is not known if this medicine passes into human breast milk. Do not take this medicine while breastfeeding or if breastfeeding is planned.

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 can affect your ability to drive and use machines or work without safe foot support.

Mifoglame contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Mifoglame

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:

• one 100 mg coated tablet;
• once a day;
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose of Mifoglame (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drink.
Your doctor may advise you to take this medicine alone or with other medicines that reduce blood sugar levels.
Diet and exercise help your body use blood sugar better. When taking Mifoglame, it is important to follow the diet and exercise plan recommended by your doctor.

Overdose of Mifoglame

If you have taken more than the prescribed dose, contact your doctor immediately.

Missed dose of Mifoglame

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 dosing schedule. Do not take a double dose.

Stopping Mifoglame treatment

To maintain control of your blood sugar levels, you should continue to take this medicine 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 medicine, 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 Mifoglame 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, as these may be signs of pancreatitis.

In case of 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 who added sitagliptin to metformin, the following side effects were reported:

Frequently (may affect up to 1 in 10 people): low blood sugar levels, nausea, bloating, vomiting
Less frequently (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients experienced various stomach problems when starting treatment with sitagliptin in combination with metformin (frequently).
In some patients who took sitagliptin in combination with a sulfonylurea and metformin, the following side effects were reported:

Very frequently (may affect more than 1 in 10 people): low blood sugar levels
Frequently: constipation
In some patients who took sitagliptin and pioglitazone, the following side effects were reported:

Frequently: bloating, swelling of the hands or feet
In some patients who took sitagliptin and pioglitazone and metformin, the following side effects were reported:

Frequently: swelling of the hands or feet
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects were reported:

Frequently: flu
Less frequently: dry mouth
In some patients who took sitagliptin alone or with other anti-diabetic medicines in clinical studies or after marketing authorization, the following side effects were reported:

Frequently: low blood sugar levels, headache, upper respiratory tract infections, stuffy nose or sinusitis, and sore throat, osteoarthritis, arm or leg pain
Less frequently: dizziness, constipation, itching
Rarely: reduced platelet count
Frequency not known: kidney problems (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, please inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 Mifoglame

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 Mifoglame contains

The active substance is sitagliptin. Each Mifoglame 50 mg coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.

• The other ingredients are: Tablet core:microcrystalline cellulose (PH 101, PH 102), calcium hydrogen phosphate, crospovidone type B, magnesium stearate, and sodium stearyl fumarate. Mifoglame 50 mg, coated tablets (Opadry II Beige- 85F270024): polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What Mifoglame looks like and contents of the pack

Mifoglame 50 mg, coated tablets are light beige, round, coated tablets, with the marking "50" on one side and no markings on the other side.
PVC/PE/PVDC/Aluminum blisters packaged in a cardboard box.
Packaging contains 28 coated tablets.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

Remedica Ltd.
Aharnon Street
Limassol Industrial Estate
3056 Limassol
Cyprus

Date of last revision of the package leaflet: