Mifoglame

Package leaflet: Information for the patient

MIFOGLAME, 50 mg, film-coated tablets
Sitagliptinum
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, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, 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.

Table of contents

1. What Mifoglame is and what it is 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 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), which reduce blood sugar levels in adults with type 2 diabetes.
This medicine helps increase the amount of insulin released after meals and reduces the amount of sugar
produced by the body.
Your doctor has prescribed this medicine to lower high blood sugar levels caused by type 2 diabetes.
Mifoglame 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, and the insulin produced does not work properly. The body may also produce too much sugar. When this happens, sugar (glucose) accumulates 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 disease called bullous pemphigoid. Your doctor may advise you to stop taking Mifoglame.
Tell your doctor if you have or have had:

• pancreas disease (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 characterized by high blood sugar levels, rapid weight loss, nausea, or vomiting);
• any kidney disease, either in the past or currently;
• 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. 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 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform 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, consult your doctor or pharmacist before using this medicine.
Do 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 breastfeeding is planned.

Driving and operating machinery
This medicine has no effect or a negligible effect on the ability to drive and operate machinery. 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 in turn may affect the ability to drive and operate machinery or work without secure foot support.

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

3. How to use Mifoglame

This medicine should always be taken 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 independently of meals and drinks.

The physician may recommend treatment with this medicine alone or in combination with certain 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 physical activity regimen recommended by the physician.

Taking more Mifoglame than recommended
If more than the recommended dose of this medicine is taken, 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 the 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 any medicine, 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 severe 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, urticaria, 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. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.

The following adverse reactions have been reported in some patients when sitagliptin was added to metformin:

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, diarrhoea, constipation, drowsiness

Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).

The following adverse reactions have been reported in some patients taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar levels
Common: constipation

The following adverse reactions have been reported in some patients taking sitagliptin and pioglitazone:

Common: bloating, swelling of hands or feet

The following adverse reactions have been reported in some patients taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet

The following adverse reactions have been reported in some patients taking sitagliptin with insulin (with or without metformin):

Common: influenza-like illness
Uncommon: dry mouth

The following adverse reactions have been reported in some patients taking sitagliptin alone and/or with other antidiabetic medicines in clinical trials or during post-marketing use:

Common: low blood sugar levels, 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 skin blistering).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 to provide more information on the safety of the 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 should 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 packaging and other information

What Mifoglame contains
The active substance is sitagliptin. Each Mifoglame 50 mg coated tablet contains
sitagliptin hydrochloride monohydrate equivalent to 50 mg of sitagliptin.

• Other components are: Tablet core: microcrystalline cellulose (PH 101, PH 102), calcium hydrogen phosphate, crospovidone type B, magnesium stearate, and sodium stearyl fumarate. Coating of Mifoglame 50 mg coated tablets (Opadry II Beige - 85F270024): 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 50 mg coated tablets are light beige, round, film-coated tablets, embossed with the marking "50" on one side and unmarked on the other side.
Blister packs made of PVC/PE/PVDC/Aluminium, packed in cardboard boxes.
Pack sizes contain 28 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