Patient Information Leaflet

MIFOGLAME, 100 mg, film-coated tablets
Sitagliptin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet Contents

What Mifoglame is and what it is used for
Important information before taking Mifoglame
How to take Mifoglame
Possible side effects
How to store Mifoglame
Contents of the pack and other information

1. What Mifoglame is and what it is used for
Mifoglame contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps increase the amount of insulin released after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help lower high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas or glitazones) that you may already be taking, along with diet and exercise.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, the insulin produced does not work as it should, or the body produces too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious health problems such as heart disease, kidney disease, vision loss and limb amputations.

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
Talk to your doctor or pharmacist before taking Mifoglame.
Cases of pancreatitis (inflammation of the pancreas) have been reported in patients taking sitagliptin (see section 4).
If you develop 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:

pancreas problems (e.g. pancreatitis);
gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In such cases, the risk of pancreatitis may be increased (see section 4);
type 1 diabetes;
diabetic ketoacidosis (a diabetes complication characterised by high blood sugar levels, rapid weight loss, nausea or vomiting);
any kidney problems, currently or in the past;
an allergic reaction to Mifoglame (see section 4).

Since this medicine does not act when blood sugar levels are low, it is unlikely to cause excessively low blood sugar levels. However, if this medicine is taken together with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) 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 whether this medicine is safe and effective in children under 10 years of age.

Mifoglame with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood levels of digoxin should be monitored when taking Mifoglame with digoxin.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.
You should not take this medicine during pregnancy.
It is not known whether this medicine passes into human milk. Do not take this medicine while breastfeeding or if you plan to breastfeed.

Driving and using machines
This medicine has no or negligible effect on the ability to drive and use machines. However, bear in mind that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylureas or with insulin may lead to hypoglycaemia, which may affect your ability to drive and use machines or work without secure foot support.

Mifoglame contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

3. How to use Mifoglame

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

The usual recommended dose is:

one 100 mg coated tablet;
once daily;
taken orally.

If the patient has impaired kidney function, the physician may recommend a lower dose of Mifoglame (e.g. 25 mg or 50 mg).

This medicine may be taken regardless of meals or drinks.

The physician may recommend treatment with this medicine alone or in combination with other medicines that reduce blood sugar levels.

Diet and physical exercise help the body to use blood sugar more effectively. While taking Mifoglame, it is important to follow the diet and perform the physical activities recommended by the physician.

Taking more Mifoglame than recommended
If more of this medicine is taken than recommended, contact a doctor immediately.

Missing a dose of Mifoglame
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose.

Stopping Mifoglame treatment
To maintain control of blood sugar levels, continue taking this medicine for as long as directed by the physician. Do not stop taking this medicine without first consulting the physician.

If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should DISCONTINUE Mifoglame and immediately contact your doctor if any of the following serious adverse reactions occur:

Severe and persistent abdominal pain (in the stomach area), possibly radiating to the back, with or without nausea and vomiting, as these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency unknown), including rash, hives, skin blisters or skin peeling, and swelling of the face, lips, tongue, or throat, which may cause difficulty in breathing or swallowing, treatment with the medicine should be stopped and immediate medical advice sought. The doctor may prescribe medication to treat the allergic reaction and another medicine to treat diabetes.
In some patients, the following adverse reactions occurred when sitagliptin was added to metformin:
Common (may occur in up to 1 in 10 people): low blood sugar, nausea, bloating, vomiting
Uncommon (may occur in up to 1 in 100 people): stomach pain, diarrhoea, constipation, drowsiness
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).
In some patients using sitagliptin in combination with a sulfonylurea and metformin, the following adverse reactions occurred:
Very common (may occur in more than 1 in 10 people): low blood sugar
Common: constipation
In some patients using sitagliptin and pioglitazone, the following adverse reactions occurred:
Common: bloating, swelling of hands or feet
In some patients using sitagliptin in combination with pioglitazone and metformin, the following adverse reactions occurred:
Common: swelling of hands or feet
In some patients using sitagliptin with insulin (with or without metformin), the following adverse reactions occurred:
Common: influenza-like illness
Uncommon: dry mouth
In some patients using sitagliptin alone and/or with other antidiabetic medicines in clinical trials or after marketing authorization, the following adverse reactions occurred:
Common: low blood sugar, headache, upper respiratory tract infections, nasal congestion or runny nose and sore throat, bone and joint inflammation, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare: decreased 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 of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Mifoglame

Keep this medicine out of 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 the stated month.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Mifoglame contains
The active substance is sitagliptin. Each Mifoglame 100 mg film-coated tablet contains
sitagliptin hydrochloride monohydrate equivalent to 100 mg of sitagliptin.

Other ingredients are: Tablet core: microcrystalline cellulose (PH 101, PH 102), calcium hydrogen phosphate, crospovidone type B, magnesium stearate, and sodium stearyl fumarate.

Coating of Mifoglame 100 mg film-coated tablets (Opadry II Orange - 85F230079): polyvinyl alcohol, polyethylene glycol 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 film-coated tablets are beige, round, film-coated tablets, embossed with the code "100" on one side and unmarked on the other side.
Blister packs made of PVC/PE/PVDC/Aluminium, packed in cardboard boxes.
Pack sizes: 28 film-coated tablets.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: + 48 17 865 51 00

Manufacturer
Remedica Ltd.
Aharnon Street
Limassol Industrial Estate
3056 Limassol
Cyprus