Sitagliptin phosphate monohydrate/simvastatin
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What JUVICOR is used for
JUVICOR contains 2 medicines. One is used to control blood sugar (glucose) in patients with type 2 diabetes mellitus and the
other helps to reduce cholesterol levels and the risk of heart disease. JUVICOR is used when diet and exercise are not enough
to control your blood glucose and is used in combination with other medicines for treating diabetes.
Type 2 diabetes mellitus
This type of diabetes is also known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity onset 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 glucose. When this happens, glucose builds up in the blood.
This can lead to serious medical problems.
Signs of high blood glucose may include:
lethargy or tiredness
passing large amounts of urine
The main goal of treating diabetes is to lower your blood glucose to a normal level. Lowering and controlling blood glucose
may help prevent or delay complications of diabetes, such as heart disease, kidney disease, blindness, and amputation. High
blood glucose levels can be lowered by diet and exercise, and by certain medicines.
JUVICOR also helps to reduce the health risks associated with coronary heart disease by reducing the amount of cholesterol
in the blood.
Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as making bile
acids (which help digest food) and some hormones.
Cholesterol is present in many foods and is also made in your body by the liver. If your body does not balance the amount
of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol becomes too high.
High cholesterol can contribute to heart disease by clogging the blood vessels that carry oxygen and nutrients to the heart.
Over time, this can form hard areas, called plaque, on the walls of blood vessels, making it more difficult for the blood
to flow. This blocking of your blood vessels can lead to heart disease (such as heart attack and angina), and stroke.
High cholesterol results from many factors, including eating foods high in saturated fats, certain diseases or genetic conditions,
and lack of exercise. Lowering high cholesterol can help reduce your chances of having heart disease.
LDL-cholesterol is called "bad" cholesterol because it is the cholesterol that clogs your arteries. HDL, on the other hand,
is thought to remove cholesterol from the blood vessels and is, therefore, considered to be "good" cholesterol. There is another
type of fat called triglyceride, which is a source of energy. High levels of triglyceride can be associated with a low level
of "good" cholesterol and may increase your risk of heart disease.
In most people, there are no symptoms of high cholesterol or triglycerides. Your doctor can measure your cholesterol and triglycerides
with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.
Heart disease can have many causes. Your chances of having heart disease may be increased by several factors, which include:
high blood pressure
family history of heart disease
You can help control the first five of these causes of heart disease.
If you have heart disease, diabetes, history of stroke, or other vessel disease (regardless of the amount of cholesterol in
your blood), one of the medications in JUVICOR:
can help prolong your life by reducing the risk of heart attack or stroke
reduce the need for surgery to increase blood flow to the legs and major organs such as the heart
reduce the need for hospitalisation for chest pain (called angina)
Your doctor may have prescribed JUVICOR for another reason. Ask your doctor if you have any questions about why JUVICOR has
been prescribed for you.
How JUVICOR works
JUVICOR contains two medicines, sitagliptin (as phosphate monohydrate) and simvastatin.
Sitagliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood
glucose levels in patients with type 2 diabetes mellitus. Simvastatin belongs to a group of medicines called hydroxymethylglutaryl-coenzyme
A (HMG-CoA) reductase inhibitors which reduces the amount of cholesterol made by the liver.
helps to improve the levels of insulin after a meal
decreases the amount of glucose made by the body
works when blood glucose is high, especially after a meal. This is when the body needs the greatest amount of help in lowering
blood glucose. JUVICOR also lowers blood glucose between meals.
by itself is unlikely to cause low blood glucose (hypoglycaemia) because it does not work when your blood glucose is low
reduces the level of LDL (bad) cholesterol and triglycerides (fatty substances) in your blood and raises HDL (good) cholesterol
JUVICOR does not reduce the cholesterol and triglycerides that come from fat in food. Therefore, when you are taking JUVICOR,
you also need to follow a low fat diet and other measures, such as exercise and weight control.
Ask your doctor or pharmacist to learn more about JUVICOR, diabetes, heart disease or high cholesterol.
This medicine is available only with a doctor's prescription.
Before you take JUVICOR
When you must not take it
Do not take JUVICOR if:
you are allergic to any of the ingredients in JUVICOR (listed at the end of this leaflet)
Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips, mouth,
tongue or throat or painful joints.
If you are not sure if you have an allergy to JUVICOR, check with your doctor.
you are diagnosed with active liver disease
you are pregnant or breast-feeding
Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.
you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides
Do not take if the expiry date on the pack has passed. Do not take if the packaging is torn or shows signs of tampering.
If you take this medicine after the expiry date has passed, it may not work. If it has expired or is damaged, return it to
your pharmacist for disposal.
Do not give JUVICOR to children under 18 years of age.
The safety and effectiveness of JUVICOR have not been established in children under 18 years of age.
If you are not sure whether you should start taking JUVICOR, talk to your doctor.
Before or while you take it
Tell your doctor if:
you have or have had an allergic reaction to sitagliptin, simvastatin, or JUVICOR; or any other medicines or substances such
as foods, preservatives or dyes
you have or have had type 1 diabetes or a condition called diabetic ketoacidosis (increased ketones in the blood or urine)
JUVICOR should not be used in these conditions.
you have or have had any kidney problems, or any past or present medical problems
JUVICOR should not be used in individuals with certain kidney problems.
you consume substantial quantities of alcohol or have a past history of liver disease.
JUVICOR should not be used in individuals with certain liver problems. Your doctor will do a blood test to make sure you have
no problems with your liver.
you are pregnant, suspect you are pregnant, or intend to become pregnant.
JUVICOR should not be used during pregnancy.
you are breastfeeding or plan to breastfeed.
JUVICOR should not be used while breastfeeding or if planning to breastfeed.
you have unexplained muscle pain, tenderness or weakness not caused by exercise. This is because on rare occasions, muscle
problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death.
Your doctor may do a blood test to check for certain muscle problems.
you are taking niacin or a niacin-containing product, particularly if you are Chinese.
If you have not told your doctor about any of the above, tell him/her before you take any JUVICOR.
Taking other medicines
Tell your doctor if you are taking any other medicines, including herbal supplements and medicines that you buy without a
prescription from your pharmacy, supermarket or health food shop.
Some medicines should not be taken with JUVICOR as they may increase the risk of muscle problems with JUVICOR (see Side Effects).
It is particularly important to tell your doctor if you are taking:
medicines used to treat certain fungal infections including ketoconazole, itraconazole, posaconazole, and voriconazole
erythromycin, clarithromycin, telithromycin, and fusidic acid - antibiotics used to treat infections
protease inhibitors used to treat HIV infection, including indinavir, nelfinavir, ritonavir, saquinavir
certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
nefazodone, used to treat depression
gemfibrozil, used to treat high cholesterol levels
cyclosporin, used to suppress the immune system
danazol, a hormone used to treat gynaecological problems
If you are taking any of the above, your doctor may suggest stopping JUVICOR temporarily or permanently.
It is important to tell your doctor if you are taking the following medicines as they may also interfere with JUVICOR and
increase the risk of muscle problems:
verapamil, diltiazem or amlodipine, used to treat high blood pressure, angina or other heart conditions
amiodarone, used to treat irregular heart beat
colchicine, used for gout
other medicines to lower cholesterol levels, for example, other fibrates
Some medicines, herbal products, or dietary supplements may be affected by JUVICOR, or may affect how well it works. You may
need different amounts of your medicine or you may need to take different medicines. Tell your doctor if you are taking digoxin
(used to treat heart failure or irregular heart beat), warfarin (an anticoagulant) or other medicines used to prevent blood
clots), fenofibrate, or nicotinic acid (also known as niacin, vitamin B3).
When JUVICOR is used in combination with a sulphonylurea (another glucose lowering) medicine, low blood glucose levels with
symptoms (hypoglycaemia) due to the sulphonylurea can occur.
Lower doses of the sulphonylurea medicine may be required.
Talk to your doctor if you are not sure whether you should be taking this medicine.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking JUVICOR.
How to take JUVICOR
Take JUVICOR only when prescribed by your doctor.
Your doctor will tell you how many JUVICOR tablets to take and how often you should take them.
Swallow JUVICOR with a glass of water.
If you are currently taking a medicine that contains sitagliptin and/or simvastatin which are contained in JUVICOR:
stop taking your current medicine(s) that contain sitagliptin and/or simvastatin as this may result in you taking more medicine
than you need
take the remaining medicine(s) to your pharmacist for safe disposal
Medicines containing sitagliptin include: JANUMET, JANUVIA.
Medicines containing simvastatin include: APO-SIMVASTATIN, AURO-SIMVASTATIN, CHEMMART SIMVASTATIN, LIPEX, MYVAST, PHARMACOR
SIMVASTATIN, RANSIM, SIMVAR, SIMVASTATIN-DP, SIMVASTATIN-GA, SIMVASTATIN-SPIRIT, SIMVASTATIN GENERICHEALTH, SIMVASTATIN PFIZER,
SIMVASTATIN SANDOZ, SIMVASTATIN TABLETS, SIMVASTATIN WINTHROP, SIMVASYN, SYNTHON SIMVASTATIN, TERRY WHITE CHEMISTS SIMVASTATIN,
VYTORIN, ZIMSTAT, ZOCOR.
Check with your doctor if you are not sure about the medicines you are taking.
Carefully follow all directions given to you by your doctor and pharmacist.
This may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
When to take it
Take JUVICOR once a day in the evening.
The liver produces its greatest amount of cholesterol when the body is at rest and when there is no dietary intake. For most
people this is at night when asleep. Therefore, JUVICOR is more effective when taken in the evening. A good time would be
after your evening meal. However, it does not matter whether you take it before or after food, although you should not take
it with a high-fat meal.
Take JUVICOR at about the same time each evening.
Taking your tablets at the same time each evening will have the best effect. It will also help you remember when to take the
How long to take it
Continue to take JUVICOR as long as your doctor prescribes it so you can continue to help control your blood glucose and cholesterol
levels. Make sure you keep enough JUVICOR to last over weekends and holidays.
JUVICOR will help control your diabetes and cholesterol but will not cure it. Therefore, you may have to take it for a long
Diet and exercise can help your body use its blood glucose better and better manage its cholesterol. It is important to stay
on your doctor's recommended diet, exercise and weight loss program while taking JUVICOR.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise,
take it as soon as you remember, and then go back to taking your tablets as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose of JUVICOR to make up for the dose that you missed.
If you have trouble remembering to take your tablet, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (in Australia, telephone 131 126; in New Zealand, telephone
0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital, if you think that you or anyone else
may have taken too much JUVICOR.
Do this even if there are no signs of discomfort or poisoning.
While you are using JUVICOR
Things you must do
If you become pregnant while taking JUVICOR, stop taking it and contact your doctor immediately.
Have your blood cholesterol and fats checked when your doctor says, to make sure JUVICOR is working.
Discuss your cholesterol levels and management plan with your doctor.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking JUVICOR.
Tell all doctors, dentists and pharmacists who are treating you that you are taking JUVICOR.
You may be asked to stop the tablets a few days before a surgery or procedure.
Make sure you, your friends, family and work colleagues can recognise the symptoms of high blood glucose and know how to treat
If you experience any of the signs of high blood glucose, contact your doctor immediately.
The risk of high blood glucose is increased in the following situations:
illness, infection or stress
not enough other diabetic medicines
certain other medicines
eating more carbohydrate or sugars than normal
If you become ill or experience extra stress, injury, fever, infection or need surgery, tell your doctor.
Your blood glucose may become difficult to control at these times. Your doctor may decide to change your treatment.
Make sure you check your blood glucose levels regularly.
This is the best way to tell if your diabetes is being controlled properly. Your doctor, diabetes educator or pharmacist
will show you how and when to do this.
Visit your doctor for regular checks of your eyes, feet, kidneys, heart, circulation/blood, and blood pressure.
Tell your doctor immediately if you notice the return of any symptoms of high blood glucose you had before starting.
Things you must not do
Do not give JUVICOR to anyone else, even if they have the same condition as you.
Things to be careful of
Avoid drinking large quantities of alcohol.
Limit your alcohol consumption to 2 standard drinks on any day for both men and women. You should try to have at least 2
alcohol free days a week.
Drinking large quantities of alcohol may increase the chance of your medicine causing liver disease.
Grapefruit juice should be avoided while taking JUVICOR.
The way JUVICOR works is affected by drinking grapefruit juice. It increases the chance of you getting side effects from
Talk to your doctor or pharmacist if you have any concerns.
Be careful driving or operating machinery until you know how JUVICOR affects you.
There have been side effects reported with the medicines in JUVICOR that may affect your ability to drive or operate machinery.
Individual responses to JUVICOR may vary. Ask your doctor or pharmacist for more information.
Changes to lifestyle that may help reduce the chance of coronary heart disease
Lowering high cholesterol can help reduce your chances of having heart disease. However, your chances of having heart disease
may be increased by several other factors including cigarette smoking and excess weight. Some self help measures suggested
below may help your condition and help reduce your chances of having heart disease. Talk to your doctor, pharmacist, or dietician
about these measures and for more information.
Continue the low fat diet recommended by your doctor, dietician or pharmacist.
Your doctor may advise you to lose weight if you are overweight.
May raise your levels of "good" cholesterol and reduce your chances of having heart disease. Make exercise a part of your
routine - walking is good. Ask your doctor for advice before starting exercise.
Your doctor may advise you to stop smoking or at least cut down.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking JUVICOR.
Like all medicines, JUVICOR may have unwanted side effects in some people. All medicines can have side effects. Sometimes
they are serious, most of the time they are not. JUVICOR is generally well tolerated. For the most part side effects have
been mild and short-lived. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if
Tell your doctor or pharmacist if you notice or have any of the following and they worry you:
stomach/bowel problems such as:
stomach upset or pain
feeling sick (nausea)
digestive disturbances (including indigestion, wind/gas in the stomach)
changes in the way your body feels such as:
sexual difficulties including erectile dysfunction
arm, leg, joint or back pain
difficulty thinking or working because of:
poor memory, memory loss, confusion
feelings of depression
signs of an infection of the breathing passages, including stuffy or runny nose, sore throat, cough, fever, and soreness in
the back of the nose and throat and discomfort when swallowing
Additional side effects have been reported in general use with the sitagliptin component of JUVICOR, when used with other
diabetes medicines. These include:
low blood glucose (hypoglycaemia) with and without symptoms
You may need lower doses of your other diabetes medicines so ask your doctor for advice.
Tell your doctor as soon as possible if
Tell your doctor as soon as possible if you notice any of the following:
aching muscle, muscle tenderness or weakness not caused by exercise (in very rare cases this may not go away after stopping
brown/black coloured urine
On rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to
This risk of muscle problems is greater for:
patients taking higher doses of JUVICOR
older patients (65 years of age and older)
patients with abnormal kidney function
patients with thyroid problems
Tell your doctor as soon as possible if you notice any of the following:
tingling in the hands or feet
signs of anaemia, such as tiredness, being short of breath, and looking pale
bruising more easily than normal
larger breasts than normal in men
Tell your doctor immediately or go to hospital if
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
allergic reactions, which may be serious, including rash, itchiness, hives, and swelling of the face, lips, mouth, tongue,
and throat that may cause difficulty in breathing or swallowing; joint pain, fever and shortness of breath. If you have an
allergic reaction, stop taking JUVICOR and call your doctor right away. Your doctor may prescribe a medication to treat your
allergic reaction and a different medication for your diabetes.
passing little or no urine (this may be a symptom of kidney problems)
problems breathing including persistent cough, shortness of breath or fever
severe and persistent stomach pain, often with nausea and vomiting. These may be symptoms of problems with your pancreas
which can be a serious, potentially life-threatening medical condition. Stop taking JUVICOR and call your doctor right away
if you experience these symptoms.
Liver problems can also occur and may be serious. Your doctor will do blood tests to check your liver.
Tell your doctor immediately if you have the following symptoms of liver problems:
fever, feel tired or weak, generally unwell
nausea, vomiting, loss of appetite
upper belly pain
dark coloured urine
yellowing of your skin and/or the whites of your eyes (also called jaundice)
light coloured bowel motions
Other side effects
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Some side effects can only be found when your doctor does blood, urine or other tests from time to time to check your progress.
After using JUVICOR
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep JUVICOR in a cool dry place where the temperature stays below 30°C. Store in original container.
Do not store JUVICOR or any other medicine in the bathroom or near a sink. Do not leave your JUVICOR tablets in the car or
on window sills.
Heat and dampness can destroy some medicines.
Keep your JUVICOR tablets where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking JUVICOR or the tablets have passed their expiry date, ask your pharmacist what to
do with any that are left over.
What it looks like
JUVICOR comes in three strengths of tablets:
100 mg/10 mg tablet - A pink-beige, round, bi-convex, film coated tablet, marked with MSD logo and "753" on one side, and
plain on the other side.
100 mg/20 mg tablet - A pink-beige, bi-convex, modified capsule shaped, film coated tablet, marked with MSD logo and "757"
on one side, and plain on the other side.
100 mg/40 mg tablet - An orange-beige, bi-convex, modified capsule shaped, film coated tablet, marked with MSD logo and "773"
on one side, and plain on the other side.
A box of JUVICOR contains 28 tablets. JUVICOR is also available in starter packs of 7 tablets.
Each JUVICOR tablet contains sitagliptin phosphate monohydrate 128.5 mg (=100 mg sitagliptin); and simvastatin 10 mg, 20 mg
or 40 mg.
It also contains the following inactive ingredients.
anhydrous calcium hydrogen phosphate
citric acid monohydrate
pregelatinised maize starch
Inactive ingredients of film-coating:
iron oxide red CI77491
iron oxide yellow CI77492
iron oxide black CI77499
JUVICOR does not contain gluten, sucrose, tartrazine or any other azo dyes.
JUVICOR is supplied in
Merck Sharp & Dohme
(Australia) Pty Limited
54-68 Ferndell Street
South Granville NSW 2142
JUVICOR is supplied in
New Zealand by:
Merck Sharp & Dohme
(New Zealand) Limited
P O Box 99851
Newmarket Auckland 1149
Tel: 0800 500 673
Date of Preparation
This leaflet was last revised on April 2013.
Australian Register Numbers:
100 mg/10 mg - AUST R 191482
100 mg/20 mg - AUST R 191478
100 mg/40 mg - AUST R 191481
This CMI leaflet was current at the time of printing. To check if it has been updated, please view our website www.msd-australia.com.au
or ask your pharmacist.
JUVICOR Tablet CMI A130412 v2.0