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SITAPREN 50MG FILM-COATED TABLET

Active substance(s): SITAGLIPTIN MALATE / SITAGLIPTIN MALATE

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Sitapren 50 mg
film-coated tablets

Package leaflet: Information for the patient

Sitapren 50 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 further questions, ask your doctor,
pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor,
pharmacist, or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Sitapren is and what it is used for
2. What you need to know before you take Sitapren
3. How to take Sitapren
4. Possible side effects
5. How to store Sitapren
6. Contents of the pack and other information
1. What Sitapren is and what it is used for
Sitapren contains the active substance sitagliptin which
is a member of a class of medicines called DPP-4
inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers
blood sugar levels in adult patients with type 2 diabetes
mellitus.
This medicine helps to increase the levels of insulin
produced after a meal and decreases the amount of sugar
made by the body.
Your doctor has prescribed this medicine to help lower
your blood sugar, which is too high because of your type
2 diabetes. This medicine can be used alone or in
combination with certain other medicines (insulin,
metformin, sulphonylureas, or glitazones) that lower
blood sugar, which you may already be taking for your
diabetes together with a food and exercise plan.

MA-PRO-157 (310 x 170 mm)
Times New Roman 9 pt.

- type 1 diabetes
- diabetic ketoacidosis (a complication of diabetes with
high blood sugar, rapid weight loss, nausea or vomiting)
- any past or present kidney problems.
- an allergic reaction to Sitapren (see section 4).
This medicine is unlikely to cause low blood sugar
because it does not work when your blood sugar is low.
However, when this medicine is used in combination with
a sulphonylurea medicine or with insulin, low blood sugar
(hypoglycaemia) can occur. Your doctor may reduce the
dose of your sulphonylurea or insulin medicine.
Children and adolescents
Children and adolescents below 18 years should not use
this medicine. It is not known if this medicine is safe and
effective when used in children and adolescents under 18
years of age.
Other medicines and Sitapren
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 heart beat and other heart
problems). The level of digoxin in your blood may need
to be checked if taking with Sitapren.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You should not take this medicine during pregnancy.
It is not known if this medicine passes into breast milk.
You should not take this medicine if you are
breast-feeding or plan to breast-feed.
Driving and using machines
This medicine has no or negligible influence on the
ability to drive and use machines. However, dizziness
and drowsiness have been reported, which may affect
your ability to drive or use machines.
Taking this medicine in combination with medicines
called sulphonylureas or with insulin can cause
hypoglycaemia, which may affect your ability to drive
and use machines or work without safe foothold.
3. How to take Sitapren

What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does
not make enough insulin, and the insulin that your body
produces does not work as well as it should. Your body
can also make too much sugar. When this happens, sugar
(glucose) builds up in the blood. This can lead to serious
medical problems like heart disease, kidney disease,
blindness, and amputation.

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose is:
- one 100 mg film-coated tablet
- once a day
- by mouth

2. What you need to know before you take Sitapren
Do not take Sitapren
- 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 receiving Sitapren (see
section 4).
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 form of fat) in your blood. These
medical conditions can increase your chance of getting
pancreatitis (see section 4).

If you have kidney problems, your doctor may prescribe
lower doses (such as 25 mg or 50 mg).
You can take this medicine with or without food and
drink.
Your doctor may prescribe this medicine alone or with
certain other medicines that lower blood sugar.
Diet and exercise can help your body use its blood sugar
better. It is important to stay on the diet and exercise
recommended by your doctor while taking Sitapren.
If you take more Sitapren than you should
If you take more than the prescribed dosage of this
medicine, contact your doctor immediately.

If you forget to take Sitapren
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,
skip the missed dose and go back to your regular
schedule. Do not take a double dose of this medicine.
If you stop taking Sitapren
Continue to take this medicine as long as your doctor
prescribes it so you can continue to help control your
blood sugar. You should not stop taking this medicine
without talking to your doctor first.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

back pain, interstitial lung disease
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5. How to store Sitapren
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 carton after ‘EXP’. The expiry date refers to
the last day of that month.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
STOP taking Sitapren and contact a doctor
immediately if you notice any of the following serious
side effects:
• Severe and persistent pain in the abdomen (stomach
area) which might reach through to your back with or
without nausea and vomiting, as these could be signs
of an inflamed pancreas (pancreatitis).
If you have a serious allergic reaction (frequency not
known), including rash, hives, blisters on the skin/peeling
skin and swelling of the face, lips, tongue, and throat that
may cause difficulty in breathing or swallowing, stop
taking this medicine and call your doctor right away. Your
doctor may prescribe a medicine to treat your allergic
reaction and a different medicine for your diabetes.
Some patients have experienced the following side
effects after adding sitagliptin to 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
ache, diarrhoea, constipation, drowsiness
Some patients have experienced different types of stomach
discomfort when starting the combination of sitagliptin
and metformin together (frequency is common).

This medicine does not require any special storage
conditions.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
What Sitapren contains
- The active substance is sitagliptin. Each film-coated
tablet (tablet) contains sitagliptin malate, equivalent to
50 mg sitagliptin.
- The other ingredients are: microcrystalline cellulose
(E460), calcium hydrogen phosphate, anhydrous
(E341), croscarmellose sodium (E468), magnesium
stearate (E470b), and sodium stearyl fumarate. The
tablet film coating contains: Opadry II Beige 85F270026
(polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b), yellow iron oxide
(E172) and red iron oxide (E-172)).
What Sitapren looks like and contents of the pack
Beige round, biconvex coated tablets, embossed with
“E111” on one side.

Some patients have experienced the following side
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

Blister (PVC-PVDC/Aluminium). Packs of 14, 28, 30,
50, 56, 84, 90 and 98 film-coated tablets.

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

Marketing Authorisation Holder
PTR Pharma Consulting, Lda.
Rua Brito Pais, 8C Miraflores
1495-028 Algés
Portugal

Some patients have experienced the following side
effects while taking sitagliptin in combination with
pioglitazone and metformin:
Common: swelling of the hands or legs
Some patients have experienced the following side
effects while taking sitagliptin in combination with
insulin (with or without metformin):
Common: flu
Uncommon: dry mouth
Some patients have experienced the following side
effects while taking sitagliptin alone in clinical studies,
or during post-approval use alone and/or with other
diabetes medicines:
Common: low blood sugar, headache, upper respiratory
infection, stuffy or runny nose and sore throat,
osteoarthritis, arm or leg pain
Uncommon: dizziness, constipation, itching
Frequency not known: kidney problems (sometimes
requiring dialysis), vomiting, joint pain, muscle pain,

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Manufacturer
Laboratorios Dr. Esteve. S.A.
Sant Martí, s/n. Pol. Industrial La Roca
08107 - Martorelles (Barcelona) – Spain
This leaflet was last revised in June 2017.

MU3964-16-1

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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