Suprovia

Package leaflet: Information for the user

Suprovia, 50 mg, film-coated tablets
Suprovia, 100 mg, film-coated tablets
Sitagliptin
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents

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

1. What Suprovia is and what it is used for

Suprovia 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 lower high blood glucose levels caused by type 2 diabetes.
This medicine may be used alone or in combination with other glucose-lowering medicines (insulin, metformin, sulfonylureas, or glitazones) that you may already be taking for diabetes, along with diet and an exercise program.

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 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. Important information before using Suprovia

When not to use Suprovia

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

Warnings and precautions
Cases of pancreatitis have been reported in patients taking Suprovia (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 Suprovia.
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 Suprovia (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 used 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
This medicine should not be used in children and adolescents under 18 years of age. 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.
Suprovia with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or 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 levels of digoxin should be monitored when Suprovia is taken together with 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 a 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, dizziness and somnolence have been reported, which may affect the ability to drive and operate machinery.
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.
Suprovia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Suprovia

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual recommended dose is:

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

If the patient has kidney function impairment, the doctor may prescribe a lower dose of sitagliptin (e.g. 25 mg or 50 mg).

This medicine can be taken with or without food and drinks.

Your doctor may recommend taking only this medicine or this medicine together with other medicines that lower blood sugar levels.

Diet and physical exercise help the body to use more effectively the sugar present in the blood. While taking Suprovia, it is important to follow the diet and physical activity regimen recommended by your doctor.

Taking more Suprovia than prescribed
If you take more of this medicine than prescribed, contact your doctor immediately.

Missing a dose of Suprovia
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 of this medicine.

Stopping Suprovia
To maintain control of your blood sugar levels, take this medicine for as long as your doctor recommends. Do not stop taking this medicine without first consulting your doctor.

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 experiences them.
You should DISCONTINUE Suprovia 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 medical advice must be sought immediately. The 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, flatulence, 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: flatulence, 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 in combination with insulin (with or without metformin):

Common: influenza-like illness
Uncommon: dry mouth

In clinical trials and post-marketing experience, when sitagliptin was used as monotherapy or in combination with other antidiabetic medicines, the following adverse reactions have been reported:

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 of Adverse Drug Reactions at the Office for Registration 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Suprovia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after:
"EXP". The expiry date refers to the last day of the stated month. There are no special storage
instructions for this medicine.
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 packaging and other information What does Suprovia contain?

Suprovia, 50 mg

• The active substance is sitagliptin. Each coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 50 mg of sitagliptin.
• Other ingredients are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type 102) (E 460), sodium croscarmellose (E 468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E 470b).
  Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), iron oxide yellow (E 172), and iron oxide red (E 172).

Suprovia, 100 mg

• The active substance is sitagliptin. Each coated tablet (tablet) contains sitagliptin hydrochloride monohydrate, equivalent to 100 mg of sitagliptin.
• Other ingredients are:
  Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type 102) (E 460), sodium croscarmellose (E 468), colloidal anhydrous silica, sodium stearyl fumarate, magnesium stearate (E 470b).
  Tablet coating: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), iron oxide yellow (E 172), and iron oxide red (E 172).

What Suprovia looks like and contents of the pack
Suprovia 50 mg: round, light beige, film-coated tablet with a diameter of 8 mm ± 0.5 mm, marked with "S" on one side.
Suprovia 100 mg: round, beige, film-coated tablet with a diameter of approximately 10 mm.
Pack contains 30 film-coated tablets in PVC/PE/PVDC/Aluminium blisters, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw
Tel. +48 22 53 59 700

Manufacturer
SAG MANUFACTURING, S.L.U.
Crta. N-I, Km 36, San Agustín de Guadalix
28750 Madrid
Spain

GALENICUM HEALTH, S.L.
Avinguda Cornella 144, 7º 1ª
08950 Barcelona
Spain

This medicinal product is authorised in the European Economic Area under the following names:
Suprovia: Spain, Malta, Poland, Romania