MIFOGLAME 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. MIFOGLAME, 100 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. 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 with other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Mifoglame contains sodium
5. How to take Mifoglame
   1. Taking too much Mifoglame
   2. Forgetting to take 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 leaflet:

Package Leaflet: Information for the Patient

MIFOGLAME, 100 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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 made by the body.
Your doctor has prescribed this medicine to lower your high blood sugar levels, which are 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 you may already be taking for your diabetes, together 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 that it does produce does not work properly. 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 foot 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, talk to your doctor or pharmacist.
There have been reports of pancreatitis (inflammation of the pancreas) in patients taking sitagliptin (see section 4).
If you get blisters on your skin, it may be a sign of a condition called bullous pemphigoid. Your doctor may tell you to stop taking Mifoglame.
Tell your doctor if you have or have had:

• pancreatitis (inflammation of the pancreas);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these cases, 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, now or in the past;
• an allergic reaction to Mifoglame (see section 4).

Because this medicine does not work when your blood sugar levels are low, it is unlikely to cause low blood sugar (hypoglycemia). However, if you take this medicine with a sulfonylurea or insulin, you may get low blood sugar (hypoglycemia). 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 with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeats and other heart conditions). When taking Mifoglame with digoxin, your doctor may check your digoxin 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 breast milk. Do not take this medicine while breastfeeding or if you are planning to breastfeed.

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 (hypoglycemia), which may affect your ability to drive or use machines or work without safe support for your feet.

Mifoglame contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which 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 prescribe this medicine alone or with other medicines that lower blood sugar levels.
Diet and exercise help your body use sugar from your blood. While taking Mifoglame, it is important to follow the diet and exercise plan recommended by your doctor.

Taking too much Mifoglame

If you take more Mifoglame than you should, contact your doctor immediately.

Forgetting to take Mifoglame

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.

Stopping Mifoglame treatment

To keep your blood sugar levels under control, you should keep taking this medicine for as long as your doctor tells you to. Do not stop taking this medicine without talking to 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 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 and may be accompanied by nausea and vomiting, as these may be symptoms of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters, or peeling 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 your 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, nausea, bloating, vomiting
Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, drowsiness
Some patients experienced various stomach problems when they started taking sitagliptin with metformin (commonly).
In some patients, when sitagliptin was taken with a sulfonylurea 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, when sitagliptin was taken with pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin was taken with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was taken with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In some patients, when sitagliptin was taken alone or with other diabetes medicines in clinical studies or after marketing authorization, the following side effects were reported:
Common: low blood sugar, headache, upper respiratory tract infections, stuffy or runny nose, and sore throat, osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Rare: 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
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 which is 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Mifoglame contains

The active substance is sitagliptin. Each Mifoglame 100 mg coated tablet contains sitagliptin phosphate monohydrate, which is equivalent to 100 mg of 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 100 mg, coated tablets (Opadry II Orange- 85F230079): 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 100 mg, coated tablets are beige, round, coated tablets, with the marking “100” on one side and no markings on the other side.
PVC/PE/PVDC/Aluminum blisters packaged in a cardboard box.
Packs contain 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 leaflet: