Product Information for the Patient

Jidinum 25 mg Film-Coated Tablets

Jidinum 50 mg Film-Coated Tablets

Jidinum 100 mg Film-Coated Tablets

sitagliptin

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

Jidinum contains the active ingredient sitagliptin, which belongs to a class of medications

known as DPP-4 inhibitors (dipeptidyl-peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.

This medication helps to increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.

Your doctor has prescribed this medication to help you reduce your blood sugar, which is too high due to your type 2 diabetes. This medication can be used alone or in combination with other medications (insulin, metformin, sulfonylureas, or thiazolidinediones) that reduce blood sugar, and that you may already be taking for your diabetes along with a diet and exercise program.

What is type 2 diabetes?

Type 2 diabetes is a disease that consists of your body not producing enough insulin, and the insulin it produces not working as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) accumulates in the blood. This can cause serious medical problems, such as heart disease, kidney disease, blindness, and amputation.

Do not takeJidinum

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

Warnings and precautions

Cases of pancreatitis have been reported in patients treated with sitagliptin (see section 4).

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

Inform your doctor if you have or have had:

- a pancreatic disease (such as pancreatitis)

- gallstones, alcohol addiction, or very high levels of triglycerides (a type of fat) in your 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 problems you currently have or have had in the past

- an allergic reaction to sitagliptin (see section 4)

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

Children and adolescents

Children and adolescents under 18 years old should not use this medication. It is not effective in children and adolescents aged 10 to 17 years. The safety and efficacy of this medication in children under 10 years old are unknown.

Other medications and Jidinum

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking digoxin (a medication used to treat irregular heartbeat and other heart problems). Your doctor may need to check your digoxin blood level if you are taking this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of this medication during pregnancy and lactation is unknown. Do not take this medication if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

The influence of this medication on your ability to drive or operate machinery is negligible. However, dizziness and somnolence have been reported, which may affect your ability to drive or operate machinery.

Additionally, taking this medication with medications called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and operate machinery or work safely without support.

Jidinum contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended usual dose is:

• one 100 mg film-coated tablet
• once a day
• by mouth

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

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

Your doctor may prescribe this medication alone or with other medications that also reduce blood sugar.

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 this medication.

If you take more Jidinum than you should

If you take more doses of this medication than prescribed, contact your doctor immediately.

If you forgot to take Jidinum

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

If you interrupt treatment with Jidinum

Continue taking this medication as long as your doctor prescribes it for you to continue helping to control your blood sugar. You should not stop taking this medication without first consulting your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

STOP taking sitagliptin and see your doctor immediately if you notice any of the following serious side effects:

• Intense and persistent abdominal pain (stomach area) that may reach the back with or without nausea and vomiting, as these may be signs of pancreatitis inflammation.

If you have a severe allergic reaction (unknown frequency), including skin rash, urticaria, skin blisters/detachment of the skin 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 the medicine for diabetes treatment.

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

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

Rare(may affect up to 1 in 100 people): stomach pain, diarrhea,

constipation, drowsiness.

Some patients presented the following side effects when they started the combination of sitagliptin and metformin together:

Frequent:different types of stomach discomfort

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

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

Frequent: constipation

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

Frequent:flatulence, swelling of hands or feet

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

Frequent:swelling of hands or feet

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

Frequent:flu

Rare:dry mouth

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

Frequent:low blood sugar, headache, upper respiratory tract infection, congestion or nasal mucosity and sore throat, arthritis, pain in the arm or leg

Rare: dizziness, constipation, itching

Unknown frequency:kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)

Reporting of side effects

If you experience any type of side effect, consult your doctor,pharmacistor nurse, even if it's about possible side effects that don't appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the medication that you no longer need at the Sigre point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Jidinum

• The active ingredient is sitagliptin. Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg, 50 mg, and 100 mg of sitagliptin.
• The other components are:
• core of the tablet: calcium phosphate anhydrous, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, stearic acid, and sodium.
• film-coated: Opadry II white 85F18422 (polyvinyl alcohol, titanium dioxide (E171), macrogol, talc), red iron oxide (E172) (for 50 mg and 100 mg), yellow iron oxide (E172) (for 25 mg and 100 mg).
  

Appearance of the product and contents of the package

Jidinum 25 mg film-coated tablets

Yellow, round, biconvex, film-coated tablets, with the inscription "25" on one face, with a diameter of approximately 6 mm. .

Jidinum 50 mg film-coated tablets

Round, biconvex, film-coated tablets, pale red in color, with the inscription "50" on one face, with a diameter of approximately 8 mm. .

Jidinum 100 mg film-coated tablets

Clear brown film-coated, round, biconvex tablets, with the logo "MC" engraved on one face, with a diameter of approximately 10 mm.

Aluminum/PVC/Aluminum blister packs containing 14, 28, 30, 56, 84, 90, 98 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Medochemie Ltd.

1-10 Constantinoupoleos Street,

3011 Limassol

Cyprus

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Local representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

Spain

Last review date of this leaflet: December 2021

The detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/