Sitagliptin Sun

Package leaflet: Information for the patient

Sitagliptin SUN 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

sitagliptin
Read this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Sitagliptin SUN is and what it is used for
2. What you need to know before taking Sitagliptin SUN
3. How to take Sitagliptin SUN
4. Possible side effects
5. How to store Sitagliptin SUN
6. Contents of the pack and other information

1. What is Sitagliptin SUN and what is it used for?

Sitagliptin SUN contains the active substance sitagliptin, which belongs to a class of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors that lower blood sugar levels in adult patients with type 2 diabetes mellitus.
This medicine helps increase the levels of insulin released after a meal and reduces the amount of sugar produced by the body.
Your doctor has prescribed this medicine to help you lower your blood sugar level, which is too high due to type 2 diabetes. This medicine can be used alone or in combination with other blood sugar-lowering medicines (insulin, metformin, sulfonylureas or glitazones) that you may already be taking to treat your diabetes, along with a diet and exercise programme.

What is type 2 diabetes?
Type 2 diabetes is a condition in which the body does not produce enough insulin, and the insulin the body produces does not work as well as it should. The 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 limb amputations.

2. What you need to know before taking Sitagliptin SUN

Do not take Sitagliptin SUN

• 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 observed in patients treated with Sitagliptin SUN (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 treatment with 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 diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting)
• any kidney problems, past or present
• an allergic reaction to sitagliptin (see section 4)

It is unlikely that this medicine will cause low blood sugar levels (hypoglycaemia) because it does not act when blood sugar is low. However, when this medicine is taken with a sulphonylurea or with insulin, a reduction in blood sugar levels (hypoglycaemia) may occur. Your doctor may reduce your dose of sulphonylurea or insulin.
Children and adolescents
Children and adolescents under 18 years of age must not take this medicine. It is not effective in children and adolescents aged between 10 and 17 years. It is not known whether this medicine is safe and effective when used in children under 10 years of age.
Other medicines and Sitagliptin SUN
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 heartbeats and other heart-related problems). It may be necessary to monitor digoxin levels in the blood if taken together with sitagliptin.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You must not use this medicine during pregnancy.
It is not known whether this medicine passes into breast milk. You must not take this medicine if you are breastfeeding or think you may need to breastfeed.
Driving and using machines
This medicine has no effect or negligible effect on the ability to drive and use machines. However, dizziness and drowsiness have been reported, which may affect your ability to drive and use machines.
Taking this medicine together with other medicines called sulphonylureas or with insulin may cause hypoglycaemia, which may affect your ability to drive, use machines, or work without protective barriers.
Sitagliptin SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
Sitagliptin SUN contains hydrogenated castor oil
It may cause stomach upset and diarrhoea.

3. How to take Sitagliptin SUN

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The usual recommended dose is:

• one 100 mg film-coated tablet
• once daily
• by mouth

If you have kidney problems, your doctor may prescribe a lower dose (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 lower blood sugar levels.
Diet and physical exercise can help your body use blood sugar more effectively.
While taking sitagliptin, it is important to continue the diet and exercise programme recommended by your doctor.
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 take your next dose at the regular time.
Do not take a double dose of this medicine.
If you stop taking Sitagliptin SUN
Continue taking this medicine for as long as your doctor prescribes it, so that you can keep controlling your blood sugar levels. Do not stop taking this medicine without first talking to your doctor.
If you have any doubts about how to use 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 your doctor immediately if you notice any of the following serious side 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 rash, hives, blistering of the skin or peeling skin, and swelling of the face, lips, tongue and throat, which may cause difficulty breathing or swallowing, stop treatment with this medicine and contact your doctor immediately. Your doctor may prescribe you a medicine to treat your allergic reaction and a different medicine for your diabetes.

Some patients experienced the following side effects when sitagliptin was added to metformin:
Common (may affect up to 1 in 10 people): low blood sugar level, 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 as part of combination therapy (frequency is common).

Some patients experienced the following side effects when taking sitagliptin in combination with a sulfonylurea and metformin:
Very common (may affect more than 1 in 10 people): low blood sugar level
Common: constipation

Some patients experienced the following side effects when taking sitagliptin and pioglitazone:
Common: flatulence, swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with pioglitazone and metformin:
Common: swelling of the hands or legs

Some patients experienced the following side effects when taking sitagliptin in combination with insulin (with or without metformin):
Common: influenza
Uncommon: dry mouth

Some patients experienced the following side effects when taking sitagliptin alone in clinical studies, or during post-marketing use alone and/or with other diabetes medicines:
Common: low blood sugar level, headache, upper respiratory tract infection, stuffy or runny nose and sore throat, osteoarthritis, pain in arms or legs
Uncommon: dizziness, constipation, itching
Rare: reduced 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 skin blister)

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V.* By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sitagliptin SUN contains

• The active substance is sitagliptin:
  o Each film-coated tablet of Sitagliptin SUN 25 mg contains sitagliptin fumarate, equivalent to 25 mg of sitagliptin.
  o Each film-coated tablet of Sitagliptin SUN 50 mg contains sitagliptin fumarate, equivalent to 50 mg of sitagliptin.
  o Each film-coated tablet of Sitagliptin SUN 100 mg 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, glyceryl dibehenate, magnesium stearate (E470B).
  o Tablet coating: hypromellose 2910/5 (E464), titanium dioxide (E171), macrogol 6000 (E1521), talc (E553B), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Sitagliptin SUN and contents of the pack

• Sitagliptin SUN 25 mg film-coated tablets: light pink, round, film-coated tablets, approximately 6 mm x 3 mm in size, marked with "F1" on one side and smooth on the other.
• Sitagliptin SUN 50 mg film-coated tablets: light beige, round, film-coated tablets, approximately 8 mm x 4 mm in size, marked with "F2" on one side and smooth on the other.
• Sitagliptin SUN 100 mg film-coated tablets: beige, round, film-coated tablets, approximately 10 mm x 4.5 mm in size, marked with "F3" on one side and smooth on the other.

Sitagliptin SUN film-coated tablets are packed in PA/Alu/PE blister packs + desiccant/HDPE/Alu. They are available in packs of 28, 56 or 98 film-coated tablets.
Sitagliptin SUN film-coated tablets are also available in packs containing an HDPE bottle with 90 film-coated tablets.
Not all 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 any information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder.

België/Belgique/Belgien/България/Česká republika/
Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/
Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/
Malta/Nederland/Norge/Österreich/Portugal/
Slovenija/Slovenská republika/Suomi/Finland/Sverige
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/
Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna
Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501

Germany
Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Tel. +49 (0) 214 40399 0

Spain
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
Spain
Tel. +34 93 342 78 90

France
Sun Pharma France
11-15, Quai de Dion Bouton
92800 Puteaux
France
Tel. +33 1 41 44 44 50

Italy
Sun Pharma Italia Srl
Viale Giulio Richard, 3
20143 Milan
Italy
Tel. +39 02 33 49 07 93

Poland
Ranbaxy (Poland) Sp. Z o.o.
ul. Kubickiego 11
02-954 Warsaw
Poland
Tel. +48 22 642 07 75

Romania
Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judeţul Cluj
Romania
Tel. +40 (264) 501 500

United Kingdom (Northern Ireland)
Sun Pharma UK Limited
6-9 The Square
Stockley Park
Uxbridge
UB11 1FW
United Kingdom
Tel. +44 (0) 208 848 8688

More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.