Disit 50 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Disit 50 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 Disit is and what it is used for
- What you need to know before taking Disit
- How to take Disit
- Possible side effects
- How to store Disit
- Contents of the pack and other information
1. What Disit is and what it is used for
Disit 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 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 (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 starting to take Disit
Do not take Disit
- if you are allergic to sitagliptin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting this medicine.
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients treated with sitagliptin (see section 4).
If you develop blisters on the skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking this medicine.
Tell 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 or insulin medicine.
Children and adolescents
Children and adolescents under 18 years of age should not use this medicine. It is not known whether this medicine is safe and effective in children and adolescents under 18 years of age.
Other medicines and Disit
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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). It may be necessary to monitor the level of digoxin in your blood if you are taking sitagliptin.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
You should not take this medicine during pregnancy.
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 effect 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 a secure support point.
3. How to take Disit
Follow exactly the instructions for use of 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
- by oral administration
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 that you follow the diet and exercise regimen recommended by your doctor while taking sitagliptin.
If you take more Disit than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, or consult your doctor or pharmacist.
If you forget to take Disit
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, then skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop taking Disit
Keep taking this medicine for as long as your doctor prescribes it so that it can continue helping you 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 gets them.
STOP taking this medicine and contact your doctor immediately if you experience any of the following serious adverse effects:
- Severe and persistent pain in the abdomen (stomach area) that 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 your diabetes treatment to another medicine.
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 various types of stomach discomfort when starting sitagliptin and metformin together (classified as common frequency).
Some patients experienced the following adverse effects while taking sitagliptin in combination with a sulphonylurea 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
Uncommon: dry mouth
Some patients experienced the following adverse effects while taking sitagliptin alone during clinical trials, or during post-approval use 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, arm or leg pain
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 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Disit
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 packaging 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 collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Disit
The active substance is sitagliptin. Each film-coated tablet contains 56.685 mg of sitagliptin hydrochloride, equivalent to 50 mg of sitagliptin.
- The other components are: In the tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), sodium croscarmellose (E468), magnesium stearate (E470b) and stearoyl fumarate sodium. The tablet coating contains: polyvinyl alcohol, macrogol, talc (E553b), titanium dioxide (E171) and yellow iron oxide (E172).
Appearance of the product and contents of the pack
Film-coated tablet, round, biconvex, light yellow in colour.
PVC/PVDC-aluminum blisters.
Packs containing 28 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
Date of the most recent review of this leaflet: January 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.