PHINGROUM 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. PHINGROUM, 25 mg, film-coated tablets
3. PHINGROUM, 50 mg, film-coated tablets
4. PHINGROUM, 100 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
5. What is PHINGROUM and what is it used for
6. Important information before taking PHINGROUM
   1. When not to take PHINGROUM
   2. Warnings and precautions
   3. Children and adolescents
   4. PHINGROUM and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. PHINGROUM contains sodium
7. How to take PHINGROUM
   1. Overdose of PHINGROUM
   2. Missed dose of PHINGROUM
   3. Stopping PHINGROUM treatment
8. Possible side effects
   1. Reporting side effects
9. How to store PHINGROUM
10. Contents of the pack and other information
    1. What PHINGROUM contains
    2. What PHINGROUM looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Date of last revision of the leaflet: June 2024

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

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is PHINGROUM and what is it 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 is PHINGROUM and what is it 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 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 produced by the body.
Your doctor has prescribed this medicine to reduce high blood sugar levels caused by type 2 diabetes. The medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels, which may already be taken with meals and a program of physical exercise.
What is type 2 diabetes?
Type 2 diabetes is a disease in which the body does not produce enough insulin, and the insulin produced does not work as it should. 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 amputation of limbs.

2. Important information before taking PHINGROUM

When not to take PHINGROUM

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

Warnings and precautions

Patients taking PHINGROUM have reported cases of pancreatitis (see section 4).
If you experience blisters on the skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may advise you to stop taking PHINGROUM.
Tell your doctor if you have or have had:

• pancreatic disease (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high triglyceride levels in the blood. In such 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 disease that has occurred in the past or is currently present;
• 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 low blood sugar levels. However, if this medicine is taken with a sulfonylurea derivative or insulin, it may cause low blood sugar levels (hypoglycemia). Your 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 in children under 10 years of age.

PHINGROUM and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, tell your doctor if you are taking digoxin (a medicine used to treat heart rhythm disorders and other heart conditions). When taking PHINGROUM with digoxin, your doctor should monitor your digoxin blood levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 whether this medicine passes into breast milk. Do not take this medicine while breastfeeding or if you plan 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 operating machinery, consider that dizziness and drowsiness have been reported.
Taking this medicine with sulfonylurea derivatives or insulin may cause low blood sugar levels (hypoglycemia), which can affect your ability to drive or operate machinery or work without safe foot support.

PHINGROUM contains sodium

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

3. How to take PHINGROUM

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 film-coated tablet;
• once a day;
• taken orally.

If you have kidney problems, your doctor may prescribe a lower dose of PHINGROUM (e.g., 25 mg or 50 mg).
This medicine can be taken with or without food and drinks.
Your doctor may advise you to take only this medicine or this medicine and certain other medicines that lower blood sugar levels.
Diet and physical exercise help your body use the sugar in your blood better. When taking PHINGROUM, it is important to follow the diet and exercise plan recommended by your doctor.
The 50 mg and 100 mg tablets of [Brand Name] can be divided into two equal doses.
If your doctor has prescribed half a 50 mg or 100 mg tablet, follow the instructions below for dividing the tablets [Brand Name].
Tablet division instructions

• 1. Place the tablet on a flat, hard surface (e.g., a table, countertop), with the dividing line on the top surface.
• 2. Break the tablet in half along the vertical dividing line, pressing it against the surface with two index fingers, as shown in figures 1 and 2.

Figures 1 and 2: Dividing the [Brand Name] tablet into two equal doses.

Overdose of PHINGROUM

If you have taken more than the prescribed dose of this medicine, contact your doctor immediately.

Missed 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 your blood sugar levels, you should 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 taking this medicine, 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 PHINGROUM 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, with or without nausea and vomiting - these may be symptoms of pancreatitis.

If you experience a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, or peeling skin, and swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking the 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 who added sitagliptin to metformin, the following side effects were reported:
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, diarrhea, constipation, drowsiness.
Some patients experienced various gastrointestinal symptoms after starting treatment with sitagliptin in combination with metformin (common).
In some patients who took sitagliptin in combination with a sulfonylurea derivative and metformin, the following side effects were reported:
Very common (may affect more than 1 in 10 people): low blood sugar levels.
Common: constipation.
In some patients who took sitagliptin and pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet.
In some patients who took sitagliptin, pioglitazone, and metformin, the following side effects were reported:
Common: swelling of the hands or feet.
In some patients who took sitagliptin and insulin (with or without metformin), the following side effects were reported:
Common: flu.
Uncommon: dry mouth.
In some patients who took sitagliptin alone or with other anti-diabetic medicines in clinical trials or after the medicine was marketed, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, stuffy or runny nose and sore throat, bone and joint pain, arm or leg pain.
Uncommon: dizziness, constipation, itching.
Rare: decreased platelet count.
Frequency not known: kidney disease (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blisters on the skin).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store PHINGROUM

There are no special storage instructions for this medicine.
Keep this 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 month.
The inscription on the packaging after the abbreviation "EXP" means the expiry date, and after the abbreviation "Lot/LOT" means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What PHINGROUM contains

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg, 50 mg, or 100 mg of sitagliptin.
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium carboxymethyl cellulose (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

[Brand Name] 25 mg: light pink, round, biconvex film-coated tablet; tablet diameter 5.9-6.3 mm.
[Brand Name] 50 mg: light orange, round, biconvex film-coated tablet with a dividing line on one side and "50" embossed on the other side; tablet diameter 7.9-8.3 mm.
The tablet can be divided into two equal doses.
[Brand Name] 100 mg: light brown, round, biconvex film-coated tablet with a dividing line on one side and "100" embossed on the other side; tablet diameter 9.9-10.4 mm.
The tablet can be divided into two equal doses.
PVC/PVDC/Aluminum blisters, in a cardboard box. Packs of 14, 28, 30, 56, 84, 90, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone +48 22 364 61 01
Manufacturer
FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 i 15
08028 Barcelona, Spain

Date of last revision of the leaflet: June 2024