Phingroum

Poland
Brand name Phingroum
Form tablets, film-coated
Active substance / Dosage
sitagliptin hydrochloride monohydrate · 108.96 mg
Prescription type Prescription only
ATC code
A10BH01
Registration number 100402681
Manufacturer Farmaprojects S.A.U.

Table of Contents

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 this medicine, as it contains
important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, please ask your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It 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.

Leaflet contents

  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 called
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,
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 glucose. When this happens, 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. Important information before taking PHINGROUM

When not to take 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 to take PHINGROUM, discuss this with your doctor or pharmacist.
Cases of pancreatitis have been reported in patients taking PHINGROUM (see section 4).
If the patient develops blisters on the skin, this may be a sign of a disease called bullous pemphigoid.
The doctor may advise the patient to stop taking PHINGROUM.
Inform the doctor if the patient has or has had:

  • pancreatic 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 complication of diabetes characterized by high blood sugar levels, rapid weight loss, nausea or vomiting);
  • any kidney disease in the past or currently;
  • an allergic reaction to PHINGROUM (see section 4).

Since this medicine does not work 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. The 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.

PHINGROUM with other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
In particular, inform the doctor if the patient is taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking PHINGROUM together with digoxin, the blood level of digoxin should be monitored.

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 taking this medicine.
This medicine should not be used during pregnancy.
It is not known whether this medicine passes into human breast milk. This medicine should not be used during breastfeeding or when breastfeeding is planned.

Driving and using machines
This medicine has no effect or a negligible effect on the ability to drive and use machines. However, when driving and using machines, it should be noted 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 use machines or to work without secure foot support.

PHINGROUM contains sodium
PHINGROUM contains less than 1 mmol of sodium (23 mg) per dose, i.e. the medicine is considered "sodium-free".

3. How to use PHINGROUM

This medicine should always be taken exactly as directed 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 or without food and drinks.
The doctor may recommend treatment with this medicine alone or in combination with other
medicines that lower 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 your doctor.
The 50 mg and 100 mg tablets of PHINGROUM may be divided into two equal doses.
If your 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 a tablet

  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 on it with two index fingers, as shown in Figures 1 and 2.
Two repeated patterns showing a close-up of the upper front teeth with a visible vertical gap between the two central incisors

Figures 1 and 2: Splitting a PHINGROUM tablet into two equal doses.
Taking more than the recommended dose of PHINGROUM
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 your 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 breathing or swallowing, treatment with the medicine must be stopped and immediate contact with a doctor is required. 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 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).

In some patients using sitagliptin in combination with a sulfonylurea and metformin, the following adverse reactions occurred:
Very common (may affect more than 1 in 10 people): low blood sugar levels.
Common: constipation.

In some patients using sitagliptin with pioglitazone, the following adverse reactions occurred:
Common: bloating, swelling of hands or feet.

In some patients taking sitagliptin in combination with pioglitazone and metformin, the following adverse reactions occurred:
Common: swelling of hands or feet.

In some patients taking sitagliptin in combination 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 during post-marketing use, the following adverse reactions occurred:
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 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 be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
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 the medicine.

5. How to store PHINGROUM

No special storage conditions apply.
Keep the 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 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 required. Proper disposal helps 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 division line on one side and "50" embossed on the other; 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 division line on one side and "100" embossed on the other; tablet diameter 9.9–10.4 mm.
The tablet can be divided into equal doses.
Packs of 14, 28, 30, 56, 84, 90, 98 film-coated tablets in PVC/PVDC/Aluminium blisters, contained 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 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, film-coated tablets