SITAGLIPTIN ASHCURE 50 mg FILM-COATED TABLETS

2. What you need to know before you take Sitagliptin AshCure

Do not take Sitagliptin AshCure

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

Warnings and precautions

There have been reports of pancreatitis (inflammation of the pancreas) in patients treated with sitagliptin (see section 4).

If you notice blisters on your skin, it may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking sitagliptin.

Tell your doctor if you have or have had:

• a disease of the pancreas (such as pancreatitis)
• gallstones, alcohol dependence, or very high levels of triglycerides (a type of fat) in the blood. These medical conditions may increase your risk of developing pancreatitis (see section 4)
• type 1 diabetes
• diabetic ketoacidosis (a complication of diabetes that causes high blood sugar levels, rapid weight loss, nausea, or vomiting)
• any kidney problem you have now or have had in the past
• an allergic reaction to sitagliptin (see section 4)

It is unlikely that this medicine will cause low blood sugar because it does not work when your blood sugar levels are low. However, when this medicine is used in combination with a medicine that contains a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea or insulin medicine.

Children and adolescents

Children and adolescents under 18 years of age should not use this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known if this medicine is safe and effective when used in children under 10 years of age.

Other medicines and Sitagliptin AshCure

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin levels if you are taking sitagliptin.

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.

This medicine should not be taken during pregnancy.

It is not known if this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

The effect of this medicine on your ability to drive or use machines is negligible or minimal. However, dizziness and somnolence have been reported, which may affect your ability to drive or use machines.

Also, taking this medicine with sulfonylurea or insulin medicines may cause low blood sugar (hypoglycemia), which may affect your ability to drive or use machines or work without a secure support.

Sitagliptin AshCure contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Sitagliptin AshCure

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
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose (such as 25 mg or 50 mg).

You can take this medicine with or without food and drinks.

Your doctor may prescribe this medicine alone or with other medicines that also reduce blood sugar levels.

Diet and exercise can help your body use sugar better. It is important that you follow the diet and exercise recommended by your doctor while taking sitagliptin.

If you take more Sitagliptin AshCure than you should

If you take more of this medicine than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sitagliptin AshCure

If you forget a dose, take it as soon as you remember. If you do not remember until the time of your next dose, then skip the missed dose and continue with your regular schedule. Do not take a double dose of this medicine.

If you stop taking Sitagliptin AshCure

Continue taking this medicine while your doctor prescribes it for you to help control your blood sugar levels. You should not stop taking this medicine without first consulting your doctor.

If you have any further questions on the use of 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 sitagliptin and contact a doctor immediatelyif you notice any of the following serious side effects:

Severe and persistent abdominal pain (in the stomach area) that may radiate to the back

• with or without nausea and vomiting, as these may be signs of pancreatitis.

If you have a severe allergic reaction (frequency not known), including skin rash, hives, blisters on the skin/exfoliative skin conditions, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, stop taking this medicine and consult your doctor immediately. Your doctor will prescribe a medicine to treat the allergic reaction and change your medicine for diabetes treatment.

Some patients experienced the following side effects after adding sitagliptin to their treatment with metformin:

Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting.

Uncommon (may affect up to 1 in 100 people): stomach pain, diarrhea, constipation, somnolence.

Some patients experienced different types of stomach upset when starting the combination of sitagliptin and metformin together (frequency classified as common).

Some patients experienced the following side effects while taking sitagliptin in combination with a sulfonylurea and metformin:

Very common (may affect more than 1 in 10 people): low blood sugar

Common: constipation.

Some patients experienced the following side effects while taking sitagliptin and pioglitazone:

Common: flatulence, swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:

Common: swelling of hands or feet.

Some patients experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):

Common: flu.

Uncommon: dry mouth.

Some patients experienced the following side effects while taking sitagliptin alone during clinical trials or after approval, alone and/or with other diabetes medicines:

Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, and sore throat, arthrosis, pain in the arm or leg

Uncommon: dizziness, constipation, itching.

Rare: reduced platelet count.

Frequency not known: kidney problems (which may require 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sitagliptin AshCure

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 label, blister, and carton after "EXP". The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. 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

Composition of Sitagliptin AshCure

The active substance is sitagliptin:

• Each 25 mg film-coated tablet of Sitagliptin AshCure contains sitagliptin hydrochloride, equivalent to 25 mg of sitagliptin.

• Each 50 mg film-coated tablet of Sitagliptin AshCure contains sitagliptin hydrochloride, equivalent to 50 mg of sitagliptin.

• Each 100 mg film-coated tablet of Sitagliptin AshCure contains sitagliptin hydrochloride, equivalent to 100 mg of sitagliptin.

The other ingredients (excipients) are:

• Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, and sodium stearyl fumarate.

• Coating material: poly(vinyl alcohol) (E1203), macrogol 3350 (E1521), talc, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).

Appearance and packaging

The 25 mg film-coated tablets of Sitagliptin AshCure are round, pink, with the inscription "SH1" engraved on one side and no inscription on the other.

The 50 mg film-coated tablets of Sitagliptin AshCure are round, light beige, with the inscription "SH2" engraved on one side and no inscription on the other.

The 100 mg film-coated tablets of Sitagliptin AshCure are round, beige, with the inscription "SH3" engraved on one side and no inscription on the other.

Sitagliptin AshCure 25 mg, 50 mg, and 100 mg film-coated tablets are available in:

• PVC/PVDC aluminum blister packs of 10, 28, 30, 50, 56, 84, 90, and 98 film-coated tablets.
• HDPE bottles of 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

AshCure Pharma B.V.

Aristotelesstraat 18,

1064 LD, Amsterdam,

Netherlands.

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

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

Germany: Sitagliptin AshCure 25 mg film-coated tablets

Sitagliptin AshCure 50 mg film-coated tablets

Sitagliptin AshCure 100 mg film-coated tablets

Spain: Sitagliptina AshCure 25 mg film-coated tablets EFG

Sitagliptina AshCure 50 mg film-coated tablets EFG

Sitagliptina AshCure 100 mg film-coated tablets EFG

Netherlands: Sitagliptine AshCure 25 mg filmomhulde tabletten

Sitagliptine AshCure 50 mg filmomhulde tabletten

Sitagliptine AshCure 100 mg filmomhulde tabletten

Poland: Sitagliptin AshCure 25 mg, tabletki powlekane

Sitagliptin AshCure 50 mg, tabletki powlekane

Sitagliptin AshCure 100 mg, tabletki powlekane

Czech Republic: Sitagliptin AshCure 25 mg potahované tablety

Sitagliptin AshCure 50 mg potahované tablety

Sitagliptin AshCure 100 mg potahované tablety

Portugal: Sitagliptina AshCure 25 mg comprimidos revestidos por película

Sitagliptina AshCure 50 mg comprimidos revestidos por película

Sitagliptina AshCure 100 mg comprimidos revestidos por película

Date of last revision of this leaflet:November 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/