SUPROVIA 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Suprovia, 50 mg, Film-Coated Tablets
3. Suprovia, 100 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
4. What is Suprovia and what is it used for
5. Important information before taking Suprovia
   1. When not to take Suprovia
   2. Warnings and precautions
   3. Children and adolescents
   4. Suprovia and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Suprovia contains sodium
6. How to take Suprovia
   1. If you take more Suprovia than you should
   2. If you forget to take Suprovia
   3. If you stop taking Suprovia
7. Possible side effects
   1. Reporting of side effects
8. How to store Suprovia
9. Contents of the pack and other information What Suprovia contains
   1. What Suprovia looks like and contents of the pack
   2. Marketing authorization holder
   3. Manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. Suprovia: Spain, Malta, Poland, Romania
   6. Date of last revision of the package leaflet: 17.01.2023

Package Leaflet: Information for the Patient

Suprovia, 50 mg, Film-Coated Tablets

Suprovia, 100 mg, Film-Coated Tablets

Sitagliptin

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Suprovia and what is it 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 is Suprovia and what is it 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 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. This medicine can be used alone or in combination with other medicines (insulin, metformin, sulfonylureas, or glitazones) that lower blood sugar levels, which you may already be taking for diabetes, along with diet and exercise.
What is type 2 diabetes?
Type 2 diabetes is a condition where 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 limb amputation.

2. Important information before taking Suprovia

When not to take Suprovia

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

Warnings and precautions

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

• pancreatitis (e.g., pancreatitis);
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. In these situations, 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 problems, past or present;
• an allergic reaction to Suprovia (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 or insulin, it may cause low blood sugar levels (hypoglycemia). Your doctor may reduce the dose of the sulfonylurea or insulin.

Children and adolescents

Do not give this medicine to 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 if this medicine is safe and effective when used in children under 10 years of age.

Suprovia and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might 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 Suprovia with digoxin, your doctor may need to check the level of digoxin in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 if 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, dizziness and drowsiness have been reported, which may affect the ability to drive and use machines.
Taking this medicine with sulfonylureas or insulin may cause low blood sugar levels (hypoglycemia), which can affect the ability to drive and use machines or work without safe foot support.

Suprovia contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Suprovia

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 by mouth.

If you have kidney problems, your 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 drink.
Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar levels.
Diet and exercise help your body use the sugar in your blood. While taking Suprovia, it is important to follow the diet and exercise plan recommended by your doctor.

If you take more Suprovia than you should

If you take more Suprovia than you should, contact your doctor immediately.

If you forget to take Suprovia

If you forget to take a dose, take it as soon as you remember. 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.

If you stop taking Suprovia

To maintain control of your blood sugar levels, you should continue taking this medicine for as long as your doctor recommends. Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this product, 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 Suprovia and contact your doctor immediately if you experience any of the following serious side effects:

• Severe and persistent stomach pain (in the abdomen), which may radiate to the back, with or without nausea and vomiting - these may be symptoms of pancreatitis.

In case of a severe allergic reaction (frequency not known), including rash, hives, blisters on the skin, and peeling of the skin, as well as swelling of the face, lips, tongue, and throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor may prescribe a medicine to treat the allergic reaction and another medicine to treat diabetes.
In some patients, when sitagliptin was added 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
In some patients, when sitagliptin was taken in combination with metformin, the following side effects were reported (common): gastrointestinal symptoms.
In some patients, when sitagliptin was taken in combination with a sulfonylurea 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, when sitagliptin was taken with pioglitazone, the following side effects were reported:
Common: bloating, swelling of the hands or feet
In some patients, when sitagliptin was taken with pioglitazone and metformin, the following side effects were reported:
Common: swelling of the hands or feet
In some patients, when sitagliptin was taken with insulin (with or without metformin), the following side effects were reported:
Common: flu
Uncommon: dry mouth
In clinical studies, when sitagliptin was used as monotherapy or in combination with other anti-diabetic medicines, the following side effects were reported:
Common: low blood sugar levels, headache, upper respiratory tract infections, sore throat, and back pain
Uncommon: dizziness, constipation, itching
Rare: reduced number of platelets
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Medicines Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Suprovia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after 'EXP'. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information What Suprovia contains

Suprovia, 50 mg

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type 102) (E 460), sodium carmellose (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), yellow iron oxide (E 172), and red iron oxide (E 172).

Suprovia, 100 mg

• The active substance is sitagliptin. Each film-coated tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
• The other ingredients are: Tablet core: calcium hydrogen phosphate, microcrystalline cellulose (type 102) (E 460), sodium carmellose (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), yellow iron oxide (E 172), and red iron oxide (E 172).

What Suprovia looks like and contents of the pack

Suprovia 50 mg: round, light beige film-coated tablet, 8 mm in diameter, with 'S' engraved on one side.
Suprovia 100 mg: round, beige film-coated tablet, approximately 10 mm in diameter.
The pack contains 30 film-coated tablets in PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sp. z o.o.
Jerozolimskie Avenue 142B
02-305 Warsaw
tel. + 48 22 53 59 700

Manufacturer

SAG MANUFACTURING, S.L.U.
N-I Road, Km 36, San Agustín de Guadalix
28750 Madrid
Spain
GALENICUM HEALTH, S.L.
Cornella Avenue 144, 7º 1ª
08950 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Suprovia: Spain, Malta, Poland, Romania

Date of last revision of the package leaflet: 17.01.2023