Sitagliptin Sun 100 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sitagliptina SUN 25 mg film-coated tablets
Sitagliptina SUN 50 mg film-coated tablets
Sitagliptina SUN 100 mg film-coated tablets
sitagliptin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, including any side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Sitagliptina SUN is and what it is used for
- What you need to know before taking Sitagliptina SUN
- How to take Sitagliptina SUN
- Possible side effects
- How to store Sitagliptina SUN
- Contents of the pack and other information
1. What Sitagliptina SUN is and what it is used for
Sitagliptina SUN contains the active substance sitagliptin, which belongs to a class of medicines called 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 Sitagliptina SUN
Do not take Sitagliptina SUN
- if you are allergic to sitagliptin or 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 develop blisters on your skin, this may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Sitagliptina SUN.
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-containing medicine or insulin.
Children and adolescents
Children and adolescents under 18 years of age must 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.
Taking Sitagliptina SUN with other medicines
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. This medicine should not be taken 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 negligible or none. However, dizziness and drowsiness have been reported and may affect your ability to drive or use machines.
In addition, 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 support.
Sitagliptina SUN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, essentially "sodium-free".
Sitagliptina SUN contains hydrogenated castor oil
It may cause stomach discomfort and diarrhea.
3. How to take Sitagliptin SUN
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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.
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 plan recommended by your doctor while taking sitagliptin.
If you take more Sitagliptin SUN than you should
If you take more of this medicine than prescribed, contact your doctor immediately.
If you forget to take Sitagliptin SUN
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 schedule. Do not take a double dose of this medicine.
If you stop taking Sitagliptin SUN
Keep taking this medicine for as long as your doctor continues to prescribe it, so 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 will experience 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 experience 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 which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately. Your doctor will prescribe a treatment for the allergic reaction and switch you to another medicine for the treatment of diabetes.
Some patients experienced the following adverse effects when sitagliptin was added to 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, drowsiness
Some patients experienced various types of stomach discomfort when starting treatment with sitagliptin and metformin together (frequency classified as common).
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 (flu)
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 (sometimes requiring 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 effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Sitagliptin SUN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Sitagliptina SUN
-
The active substance is sitagliptin:
o Each Sitagliptina SUN 25 mg film-coated tablet contains sitagliptin fumarate equivalent to 25 mg of sitagliptin.
o Each Sitagliptina SUN 50 mg film-coated tablet contains sitagliptin fumarate equivalent to 50 mg of sitagliptin.
o Each Sitagliptina SUN 100 mg film-coated tablet contains sitagliptin fumarate equivalent to 100 mg of sitagliptin.
-
The other components are:
o Tablet core: calcium hydrogen phosphate (E341), crospovidone type A (E1202), hydrogenated castor oil, glycerol dibehenate, magnesium stearate (E470b).
o Film coating: hypromellose 2910/5 (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553b), red iron oxide (E172) and yellow iron oxide (E172).
Appearance of the product and contents of the pack
-
Sitagliptina SUN 25 mg film-coated tablets are round, light pink in colour, approximately 6 mm x 3 mm in size, marked with "F1" on one side and smooth on the other.
-
Sitagliptina SUN 50 mg film-coated tablets are round, light beige in colour, approximately 8 mm x 4 mm in size, marked with "F2" on one side and smooth on the other.
-
Sitagliptina SUN 100 mg film-coated tablets are round, beige in colour, approximately 10 mm x 4.5 mm in size, marked with "F3" on one side and smooth on the other.
Sitagliptina SUN film-coated tablets are packaged in blisters made of PA/Alu/PE + desiccant/HDPE/Alu or PA/Alu/PE + desiccant/Alu.
They are available in packs containing 28, 56 or 98 film-coated tablets.
Sitagliptina SUN film-coated tablets are also available in packs containing an HDPE bottle with 90 film-coated tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii nr. 124
Cluj-Napoca, 400632
Romania
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Deutschland
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Tel. +49 214 403 990
España
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
Spain
Tel. +34 93 342 78 90
France
Sun Pharma France
31 rue des Poissonniers
92200 Neuilly-sur-Seine
France
Tel. +33 1 41 44 44 50
Italia
Sun Pharma Italia Srl
Viale Giulio Richard, 1
20143 Milano
Italy
Tel. +39 02 33 49 07 93
Polska
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Poland
Tel. +48 22 642 07 75
România
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judetul Cluj
Romania
Tel. +40 (264) 501 500
Date of the most recent revision of this leaflet:
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.