Patient leaflet - Sitagliptin/metformin Hydrochloride 50 mg / 850 mg film-coated tablets
1. What Sitagliptin/Metformin hydrochloride is and what it is used for
sitagliptin/metformin hydrochloride contains two different medicines called sitagliptin and metformin.
sitagliptin belongs to a class of medicines called DPP-4
inhibitors (dipeptidyl peptidase-4 inhibitors) • metformin belongs to a class of medicines called
biguanides.
short time if you have a condition that may be
associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking sitagliptin/metformin hydrochloride and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:
- vomiting
- stomach ache (abdominal pain)
- muscle cramps
- a general feeling of not being well with severe tiredness - difficulty in breathing
- reduced body temperature and heartbeat
Lactic acidosis is a medical emergency and must be treated in a hospital.
They work together to control blood sugar levels in adult
patients with a form of diabetes called ‘type 2 diabetes mellitus’. This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body.
Along with diet and exercise, this medicine helps lower your blood sugar. This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones).
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.
Talk to your doctor or pharmacist before taking
sitagliptin/metformin hydrochloride:
- if you have or have had a disease of the pancreas (such as pancreatitis)
- if you have or have had 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 type 1 diabetes. This is sometimes called insulin-dependent diabetes
- if you have or have had an allergic reaction to sitagliptin, metformin, or sitagliptin/metformin hydrochloride (see section 4)
- if you are taking a sulphonylurea or insulin, diabetes medicines, together with sitagliptin/metformin hydrochloride, as you may experience low blood sugar levels (hypoglycaemia). Your doctor may reduce the dose of your sulphonylurea or insulin
2. What you need to know before you take Sitagliptin/Metformin hydrochloride
Do not take sitagliptin/metformin hydrochloride:
if you are allergic to sitagliptin or metformin or any of the
other ingredients of this medicine (listed in section 6). - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe
hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
if you have a severe infection or are dehydrated - if you are going to have an X-ray where you will be
injected with a dye. You will need to stop taking sitagliptin/metformin hydrochloride at the time of the X-ray and for 2 or more days after as directed by your doctor, depending on how your kidneys are working - if you have recently had a heart attack or have severe
circulatory problems, such as ‘shock’ or breathing difficulties
- if you have liver problems
if you drink alcohol to excess (either every day or only
from time to time)
- if you are breast-feeding
Do not take sitagliptin/metformin hydrochloride if any of the above apply to you and talk with your doctor about other ways of managing your diabetes. If you are not sure, talk to your doctor, pharmacist or nurse before taking sitagliptin/metformin hydrochloride.
Warnings and precautions
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin/metformin hydrochloride (see section 4).
If you encounter blistering of the skin, it may be a sign for a condition called bullous pemphigoid. Your doctor may ask you to stop sitagliptin/metformin hydrochloride. Risk of lactic acidosis
sitagliptin/metformin hydrochloride may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Talk to your doctor promptly for further instructions if: • You are known to suffer from a genetically inherited
disease affecting mitochondria (the energy producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or Maternal Inherited Diabetes and Deafness (MIDD).
You have any of these symptoms after starting metformin:
seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine and deafness. Stop taking sitagliptin/metformin hydrochloride for a
If you need to have major surgery you must stop taking sitagliptin/metformin hydrochloride during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with
sitagliptin/metformin hydrochloride.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking sitagliptin/metformin hydrochloride.
During treatment with sitagliptin/metformin hydrochloride, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Children and adolescents
Children and adolescents below 18 years should not use this medicine. It is not effective in children and adolescents between the ages of 10 and 17 years. It is not known if this medicine is safe and effective when used in children younger than 10 years.
Other medicines and sitagliptin/metformin hydrochloride
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking sitagliptin/metformin hydrochloride before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with sitagliptin/metformin hydrochloride.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of sitagliptin/metformin hydrochloride. It is especially important to mention the following:
- medicines (taken by mouth, inhalation, or injection) used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
- medicines which increase urine production (diuretics) • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
specific medicines for the treatment of bronchial asthma
(β-sympathomimetics)
iodinated contrast agents or alcohol-containing
medicines
- certain medicines used to treat stomach problems such as cimetidine
- ranolazine, a medicine used to treat angina • dolutegravir, a medicine used to treat HIV infection • vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
- digoxin (to treat irregular heartbeat and other heart problems). The level of digoxin in your blood may need to be checked if taking with sitagliptin/metformin hydrochloride.
sitagliptin/metformin hydrochloride with alcohol
Avoid excessive alcohol intake while taking
sitagliptin/metformin hydrochloride since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
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. Do not take this medicine if you are breast-feeding. See section 2, Do not take sitagliptin/metformin hydrochloride. 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 with sitagliptin, 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.
sitagliptin/metformin hydrochloride contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Sitagliptin/Metformin hydrochloride
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take one tablet:
- twice daily by mouth
- with meals to lower your chance of an upset stomach. • Your doctor may need to increase your dose to control
your blood sugar.
If you have reduced kidney function, your doctor may
prescribe a lower dose.
You should continue the diet recommended by your doctor during treatment with this medicine and take care that your carbohydrate intake is equally distributed over the day. This medicine alone is unlikely to cause abnormally low blood sugar (hypoglycaemia). When this medicine is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.
If you take more sitagliptin/metformin hydrochloride than you should
If you take more than the prescribed dose of this medicine, contact your doctor immediately. Go to the hospital if you have symptoms of lactic acidosis such as feeling cold or uncomfortable, severe nausea or vomiting, stomach ache, unexplained weight loss, muscular cramps, or rapid breathing (see section “Warnings and precautions”). If you forget to take sitagliptin/metformin hydrochloride
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 sitagliptin/metformin hydrochloride
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 stop taking
sitagliptin/metformin hydrochloride, your blood sugar may rise again.
If you have any further questions on the use of 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/metformin hydrochloride 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).
sitagliptin/metformin hydrochloride may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and
precautions”). If this happens, you must stop taking sitagliptin/metformin hydrochloride and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
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 taking metformin have experienced the following side effects after starting sitagliptin:
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 diarrhoea, nausea,
flatulence, constipation, stomach ache or vomiting when starting the combination of sitagliptin and metformin together (frequency is common).
Some patients have experienced the following side effects while taking this medicine with a sulphonylurea such as glimepiride:
Very common (may affect more than 1 in 10 people): low blood sugar
Common: constipation
Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone: Common: swelling of the hands or legs
Some patients have experienced the following side effects while taking this medicine in combination with insulin: Very common: low blood sugar
Uncommon: dry mouth, headache
Some patients have experienced the following side effects
during clinical studies while taking sitagliptin alone (one of the medicines in sitagliptin/metformin hydrochloride) or during post-approval use of sitagliptin/metformin hydrochloride or sitagliptin alone 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
Rare: reduced number of platelets
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, ba
ck
pain, interstitial lung disease, bullous pemphigoid (a typ
e of
skin blister)
Some patients have experienced the following side effe
cts
while taking metformin alone:
Very common: nausea, vomiting, diarrhoea, stomach a
che
and loss of appetite. These symptoms may happen wh
en
you start taking metformin and usually go away Common: a metallic taste, decreased or low vitamin B1
2
levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pi
ns
and needles (paraesthesia) or pale or yellow skin). You
r
doctor may arrange some tests to find out the cause of
your symptoms because some of these may also be caused
by
diabetes or due to other unrelated health problems.
Very rare: hepatitis (a problem with your liver), hives, redness of the skin (rash) or itching
Reporting of side effects
If you get any side effects, talk to your doctor, pharmaci
st or nurse. This includes any possible side effects not listed
in
this leaflet. You can also report side effects directly via t
he
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard o
r
search for MHRA Yellow Card in the Google Play or Ap
ple
App Store. By reporting side effects you can help provi
de
more information on the safety of this medicine.
5. How to store Sitagliptin/Metformin hydrochlo
ride
Keep this medicine out of the sight and reach of childre
n.
Do not use this medicine after the expiry date which is stated on the blister/bottle and the carton after ‘EXP’. T
he
expiry date refers to the last day of the month. After first opening of the HDPE bottle: 100 days. Keep t
he
bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw aw
ay
medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other informatio
n
What sitagliptin/metformin hydrochloride contains
The active substances are sitagliptin and metformin. • Each sitagliptin/metformin hydrochloride 50 mg/850
mg
film-coated tablet (tablet) contains sitagliptin phosph
ate
monohydrate equivalent to 50 mg of sitagliptin and 8
50
mg of metformin hydrochloride.
Each sitagliptin/metformin hydrochloride 50 mg/100
0 mg film-coated tablet (tablet) contains sitagliptin phosph
ate
monohydrate equivalent to 50 mg of sitagliptin and 1
000 mg of metformin hydrochloride.
- The other ingredients are:
Tablet core: Microcrystalline cellulose (CEOLUS UF
702),
Croscarmellose sodium, Povidone (K-30), Sodium Laurilsulfate (Kolliphorfine), Sodium stearyl fumarate
.
Film coating:, Opadry II complete FC SYS 85F5405
95
Pink, Opadry II complete FCSYS 85F565335 Brown
.
What sitagliptin/metformin hydrochloride looks like
contents of the pack
and
Sitagliptin/metformin hydrochloride 50 mg/850 mg
film-coated tablets are Pink, oval shaped (modified capsule) film coated tablets, debossed with ‘SM2’ on
side and plain on other side.
one
Sitagliptin/metformin hydrochloride 50 mg/1000 mg
film-coated tablets are Red, oval shaped (modified capsule) film coated tablets, debossed with ‘SM3’ on
side and plain on other side.
one
Sitagliptin/metformin hydrochloride 50 mg/850 mg Film-coated Tablet packed in HDPE bottle contain 60 a
nd
100 Tablets and sitagliptin/metformin hydrochloride 50 mg/1000 Tablet packed in HDPE bottle contain 60, 100
and
500 Tablets.
A PVC/PVDC clear film with plain Aluminium foil blisters
and
Aluminum blister pack placed into cardboard boxes containing 10, 14, 28, 56, 60, 112, 168, 180, 196 film-c
oated
Tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Novumgen Limited
20-22 Wenlock Road, London, N1 7GU, United Kingdom
Manufacturer:
SCIOM LIMITED
UNIT-4, Martinfield Business Centre, Martinfield, Welwyn Garden City, AL7 1HG, United Kingdom