Juvicor (Sitagliptin phosphate monohydrate/simvastatin) Drug / Medicine Information

Sitagliptin phosphate monohydrate/simvastatin

Consumer Medicine Information

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

headache

thirst

passing large amounts of urine

blurred vision

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.

Cholesterol

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

Heart disease can have many causes. Your chances of having heart disease may be increased by several factors, which include:

high cholesterol

high blood pressure

cigarette smoking

diabetes

excess weight

family history of heart disease

male gender

post-menopause

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.

JUVICOR:

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:

1. 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

2. 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.

3. 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.

4. 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.

5. you are pregnant, suspect you are pregnant, or intend to become pregnant.

JUVICOR should not be used during pregnancy.

6. you are breastfeeding or plan to breastfeed.

JUVICOR should not be used while breastfeeding or if planning to breastfeed.

7. 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.

8. 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 tablets.

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 time.

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 them.

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:

uncontrolled diabetes

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 JUVICOR.

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.

Diet

Continue the low fat diet recommended by your doctor, dietician or pharmacist.

Weight

Your doctor may advise you to lose weight if you are overweight.

Exercise

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.

Smoking

Your doctor may advise you to stop smoking or at least cut down.

Side Effects

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:

1. stomach/bowel problems such as:

stomach upset or pain

feeling sick (nausea)

digestive disturbances (including indigestion, wind/gas in the stomach)

vomiting

constipation

diarrhoea

2. changes in the way your body feels such as:

weakness

headache

dizziness

sexual difficulties including erectile dysfunction

arm, leg, joint or back pain

3. difficulty thinking or working because of:

poor memory, memory loss, confusion

trouble sleeping

feelings of depression

4. 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

5. hair loss

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 JUVICOR)

brown/black coloured urine

On rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death.

This risk of muscle problems is greater for:

patients taking higher doses of JUVICOR

older patients (65 years of age and older)

female patients

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

Storage

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.

Disposal

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.

Product description

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.

Ingredients

Active ingredients:

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.

Inactive ingredients:

anhydrous calcium hydrogen phosphate

microcrystalline cellulose

croscarmellose sodium

sodium stearylfumarate

magnesium stearate

ascorbic acid

citric acid monohydrate

lactose

pregelatinised maize starch

butylated hydroxyanisole

Inactive ingredients of film-coating:

polyvinyl alcohol

macrogol 3350

purified talc

titanium dioxide

iron oxide red CI77491

iron oxide yellow CI77492

iron oxide black CI77499

JUVICOR does not contain gluten, sucrose, tartrazine or any other azo dyes.

Supplier

JUVICOR is supplied in

Australia by:

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

WPC-MK0431D-T-102012