Jidinum 25 mg film-coated tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Jidinum 25 mg film-coated tablets EFG
Jidinum 50 mg film-coated tablets EFG
Jidinum 100 mg film-coated tablets EFG
sitagliptin
Read the 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Jidinum is and what it is used for
- What you need to know before taking Jidinum
- How to take Jidinum
- Possible adverse effects
- How to store Jidinum
- Contents of the pack and other information
1. What Jidinum is and what it is used for
Jidinum contains the active substance sitagliptin, which belongs to a class of medicines known as DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that reduce blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps increase insulin levels produced after a meal and decreases the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar, which is too high due to your type 2 diabetes. This medicine may be used alone or in combination with other blood sugar-lowering medicines (such as insulin, metformin, sulfonylureas, or glitazones) 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 condition in which your body does not produce enough insulin, and the insulin your body does produce does not work as well as it should. Your body may also produce too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems, such as heart disease, kidney disease, blindness, and amputation.
2. What you need to know before taking Jidinum
Do not take Jidinum
- if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin (see section 4).
If you notice blisters on the skin, this may be a sign of a disease called bullous pemphigoid. Your doctor may ask you to stop taking this medicine.
Inform your doctor if you have or have had:
- a pancreatic disease (such as pancreatitis)
- gallstones, alcohol addiction, or very high blood levels of triglycerides (a type of fat). These medical conditions may increase your risk of developing pancreatitis (see section 4)
- type 1 diabetes
- diabetic ketoacidosis (a diabetes complication causing high blood sugar levels, rapid weight loss, nausea or vomiting)
- any kidney problems currently or 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 act when blood sugar levels are low. However, when this medicine is used in combination with a medicine containing a sulfonylurea or with insulin, low blood sugar (hypoglycemia) may occur. Your doctor may reduce the dose of your sulfonylurea-containing medicine or insulin.
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 unknown whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Jidinum
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
In particular, inform your doctor if you are taking digoxin (a medicine used to treat irregular heartbeat and other heart problems). Monitoring of digoxin levels in your blood may be needed if you are taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether this medicine passes into breast milk. You should not take this medicine if you are breastfeeding or plan to breastfeed.
Driving and using machines
The influence of this medicine on the ability to drive or use machines is none or negligible. However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.
Also, taking this medicine together with medicines called sulfonylureas or with insulin may cause hypoglycemia, which may affect your ability to drive and use machines or work without secure footing.
Jidinum contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Jidinum
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The usual recommended dose is:
- one 100 mg film-coated tablet
- once daily
- taken orally
If you have kidney problems, your doctor may prescribe you lower doses (such as 25 mg or 50 mg).
You may take this medicine with or without food and drinks.
Your doctor may prescribe this medicine alone or together with other medicines that also lower blood sugar.
Diet and exercise can help your body use sugar more effectively. It is important to follow the diet and exercise plan recommended by your doctor while taking this medicine.
If you take more Jidinum than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Jidinum
If you forget a dose, take it as soon as you remember. If you do not remember until it is 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 Jidinum
Keep taking this medicine for as long as your doctor continues to prescribe it, so that it can continue helping to control your blood sugar. You should not stop taking this medicine without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
STOP taking sitagliptin and contact your doctor immediately if you notice any of the following serious adverse effects:
- Severe and persistent pain in the abdomen (stomach area) which may extend to the back, with or without nausea and vomiting, as these may be signs of inflammation of the pancreas (pancreatitis).
If you have a severe allergic reaction (frequency not known), including skin rash, hives, blistering or peeling of the skin, and swelling of the face, lips, tongue, or 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 will switch you to a different medicine for the treatment of diabetes.
Some patients experienced the following adverse effects after adding sitagliptin to metformin treatment:
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, diarrhoea, constipation, drowsiness
Some patients experienced the following adverse effects when starting combination treatment with sitagliptin and metformin together:
Common: various types of stomach discomfort
Some patients experienced the following adverse 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 adverse effects while taking sitagliptin and pioglitazone:
Common: flatulence, swelling of hands or legs
Some patients experienced the following adverse effects while taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of hands or legs
Some patients experienced the following adverse effects while taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza-like illness
Uncommon: dry mouth
Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during use after approval, alone and/or in combination with other diabetes medicines:
Common: low blood sugar, headache, upper respiratory tract infection, nasal congestion or runny nose, sore throat, osteoarthritis, pain in arm or leg
Uncommon: dizziness, constipation, itching
Rare: reduction in platelet count
Frequency not known: kidney problems (which sometimes require dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of blistering skin condition)
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Jidinum Storage
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the carton after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Jidinum
- The active substance is sitagliptin. Each tablet contains sitagliptin hydrochloride monohydrate equivalent to 25 mg, 50 mg or 100 mg of sitagliptin.
- The other components are:
- tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, stearoyl fumarate and sodium.
- film coating: Opadry II white 85F18422 (polyvinyl alcohol, titanium dioxide (E171), macrogol, talc), iron oxide red (E172) (for 50 mg and 100 mg), iron oxide yellow (E172) (for 25 mg and 100 mg).
Appearance of the product and contents of the container
Jidinum 25 mg film-coated tablets
Yellow, round, biconvex, film-coated tablets, marked with "25" on one side, with a diameter of approximately 6 mm.
Jidinum 50 mg film-coated tablets
Round, biconvex, film-coated tablets, pale red in colour, marked with "50" on one side, with a diameter of approximately 8 mm.
Jidinum 100 mg film-coated tablets
Light brown, round, biconvex, film-coated tablets, with the logo "MC" engraved on one side, with a diameter of approximately 10 mm.
Blister packs made of Polyamide/Aluminium/PVC/Aluminium containing 14, 28, 30, 56, 84, 90, 98 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and 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 Authorisation Holder:
Local representative:
Medochemie Iberia S.A., Sucursal en España
Avenida de las Águilas, nº 2 B; 5th floor, office 6,
28044 Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
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Date of the most recent review of this leaflet: December 2021
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/