Phingroum

Package leaflet: Information for the patient

PHINGROUM, 25 mg, film-coated tablets
PHINGROUM, 50 mg, film-coated tablets
PHINGROUM, 100 mg, film-coated tablets
Sitagliptin
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What PHINGROUM is and what it is used for

PHINGROUM contains the active substance sitagliptin, which belongs to a class of medicines known as
DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), which reduce blood glucose levels in adults with
type 2 diabetes.
This medicine helps increase the amount of insulin released after meals and reduces the amount of
glucose produced by the body.
Your doctor has prescribed this medicine to help lower high blood glucose levels caused by type 2
diabetes. It may be used alone or in combination with other glucose-lowering medicines (such as
insulin, metformin, sulfonylurea derivatives or glitazones) that you may already be taking, along with
diet and exercise programme.
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 properly, or the body may also produce too much glucose. When this occurs, sugar
(glucose) accumulates in the blood. This may lead to serious health problems such as heart disease,
kidney disease, vision loss, and limb amputations.

2. Information before using PHINGROUM

When not to use PHINGROUM

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

Warnings and precautions
Before starting treatment with PHINGROUM, discuss this with your doctor or pharmacist.
Cases of pancreatitis (see section 4) have been reported in patients taking PHINGROUM.
If the patient develops blisters on the skin, this may be a sign of a disease known as bullous pemphigoid.
The doctor may advise the patient to stop taking PHINGROUM.
Inform the doctor if the patient has had or currently has:

• pancreatic disease (e.g. pancreatitis);
• gallstones, alcohol dependence, or very high blood triglyceride levels (a type of fat). 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 problems in the past or currently;
• allergic reaction to PHINGROUM (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 used together with a sulfonylurea derivative or insulin, low blood sugar (hypoglycaemia) may occur. The doctor may reduce the dose of the sulfonylurea derivative 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 for use in children under 10 years of age.
PHINGROUM with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). Blood digoxin levels should be monitored during concomitant use of PHINGROUM and digoxin.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human milk. This medicine should not be used during 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, when driving or operating machinery, consider that dizziness and drowsiness have been reported.
Taking this medicine together with medicines called sulfonylurea derivatives 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.
PHINGROUM contains sodium
PHINGROUM contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use PHINGROUM

This medicine should always be taken as prescribed by the doctor. In case of doubt, consult
your 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 doctor may prescribe a lower dose of
PHINGROUM (e.g. 25 mg or 50 mg).
This medicine may be taken with food and drinks or independently of food and drinks.
The doctor may recommend treatment with this medicine alone or this medicine 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 PHINGROUM, it is important to follow the diet and physical activity regimen recommended by the doctor.
The 50 mg and 100 mg tablets of PHINGROUM may be divided into two equal doses.
If the doctor has prescribed half a 50 mg tablet or half a 100 mg tablet, please follow the instructions below for splitting PHINGROUM tablets.
Instructions for splitting tablets

1. Place the tablet on a flat, hard surface (e.g. a table or countertop), with the score line facing upwards.
2. Break the tablet along the vertical line by pressing down with two index fingers, as shown in Figures 1 and 2.

Figures 1 and 2: Splitting a PHINGROUM tablet into two equal doses.
Taking more PHINGROUM than prescribed
If you take more than the prescribed dose of this medicine, contact your doctor immediately.
Missing a dose of PHINGROUM
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose.
Stopping PHINGROUM treatment
To maintain control of blood sugar levels, take this medicine for as long as your doctor recommends. Do not stop taking this medicine without consulting your doctor first.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should DISCONTINUE PHINGROUM and contact your doctor immediately 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 – 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 must be stopped immediately and you should contact your doctor without delay. Your doctor may prescribe another medicine to treat the allergic reaction and a different 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 with 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, stuffy or runny nose and sore throat, osteoarthritis, pain in arm or leg.
Uncommon: dizziness, constipation, itching.
Rare: decreased platelet count.
Frequency not known: kidney disorders (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 also be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products 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 provide more information on the safety of this medicine.

5. How to store PHINGROUM

There are no special storage instructions for this medicine.
The medicine should be stored in a place inaccessible and out of sight 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.
The marking on the packaging following the abbreviation "EXP" indicates the expiry date, and following the abbreviation "Lot" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What PHINGROUM contains

• The active substance is sitagliptin. Each coated tablet contains sitagliptin hydrochloride monohydrate, equivalent to 25 mg, 50 mg or 100 mg of sitagliptin, respectively.
• Other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl starch (type A), colloidal anhydrous silica, sodium stearyl fumarate. Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What PHINGROUM looks like and contents of the pack
PHINGROUM 25 mg: light pink, round, biconvex coated tablet; tablet diameter 5.9–6.3 mm.
PHINGROUM 50 mg: light orange, round, biconvex coated tablet with a score line on one side and engraved "50" on the other side; tablet diameter 7.9–8.3 mm.
The tablet can be divided into equal doses.
PHINGROUM 100 mg: light brown, round, biconvex coated tablet with a score line on one side and engraved "100" on the other side; tablet diameter 9.9–10.4 mm.
The tablet can be divided into equal doses.
Packs of 14, 28, 30, 56, 84, 90, 98 coated tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 and 15
08028 Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany - Sitagliptin 089PHARM 25 mg Filmtabletten
Sitagliptin 089PHARM 50 mg Filmtabletten
Sitagliptin 089PHARM 100 mg Filmtabletten
Poland - PHINGROUM, 25 mg, 50 mg, 100 mg, coated tablets