Tredaptive 1000 mg/20 mg modified-release tablets

The name of your medicine is Tredaptive. It contains two different active substances:

• nicotinic acid, a lipid modifying medicine, and
• laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.

The medicine comes as a modified-release tablet. This means one or more active substances are released slowly over a period of time.

Tredaptive is used in addition to diet

• to lower your ?bad? cholesterol level. It does this by lowering the levels of total cholesterol, LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood;
• to raise levels of ?good? cholesterol (HDL cholesterol) and apo A-I (a part of HDL).

What should I know about cholesterol?

Cholesterol is one of several fats found in your blood. Your total cholesterol is made up mainly of ?bad? (LDL) and ?good? (HDL) cholesterol.

LDL cholesterol is often called ?bad? cholesterol because it can build up in the walls of your arteries and form plaque. Over time, this plaque build-up can lead to a clogging of your arteries. This clogging can slow or block blood flow to vital organs such as the heart and brain. When the blood flow is blocked, the result can be a heart attack or stroke.

HDL cholesterol is often called ?good? cholesterol because it helps keep the ?bad? cholesterol from building up in the arteries and because it protects against heart disease.

Triglycerides are another fat in your blood. They may raise your risk of having heart problems.

In most people, at first there are no signs of cholesterol problems. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol and discuss your goals with your doctor.

Tredaptive is used if you need to improve cholesterol and fat levels in your blood (primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia):

• when you cannot control your cholesterol levels with a statin (class of cholesterol-lowering medicines working in the liver);
• when you cannot tolerate a statin or when a statin is not recommended for you.

Tredaptive can be used by itself or with other medicines to treat cholesterol problems. You should stay on a diet designed to lower cholesterol or other non-pharmacological treatments (e.g. exercise, weight reduction) while you take this medicine.

Do not take Tredaptive if

• you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Tredaptive (listed in section 6).
• you currently have liver problems.
• you have an ulcer in your stomach.
• you have arterial bleeding.

Do not take Tredaptive if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tredaptive.

Take special care with Tredaptive

Tell your doctor about all of your medical conditions. Check with your doctor or pharmacist before and while taking your medicine if:

• you have any allergies.
• you have ever had liver disease, jaundice (a liver disorder causing yellowing of the skin and whites of the eyes), or hepatobiliary (liver and bile duct) disease.
• you have kidney problems.
• you have thyroid problems.
• you drink large amounts of alcohol.
• you or close family members have a hereditary muscle disorder, or you have ever had muscle problems during treatment with cholesterol-lowering medicines called ?statins? or fibrates.
• you have unexplained muscle pain, muscle tenderness, or muscle weakness. If you have these symptoms talk to your doctor immediately.
• you have high blood sugar or diabetes.
• you have heart problems.
• you are going to have an operation.
• you have gout.
• you have low levels of phosphorus.
• you are over 70 years old.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tredaptive.

Blood tests and monitoring

• See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level.
• Your doctor should do a blood test before you start taking Tredaptive to check how well your liver is working.
• Your doctor may also want you to periodically have blood tests after you start taking Tredaptive, to check how well your liver is working and for other side effects.

Children and adolescents

Tredaptive has not been studied in children and adolescents who are under 18 years of age.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, vitamins, and herbal supplements.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• medicines used to lower blood pressure.
• medicines used to lower cholesterol called ?bile acid sequestrants?, such as colestyramine.
• zidovudine, a medicine used for HIV.
• midazolam, a medicine to make you sleepy before some medical procedures.
• vitamins or supplements that contain nicotinic acid.
• clopidogrel, a medicine to help prevent harmful blood clots.
• medicines used to lower cholesterol called ?statins?, a class of medicine that works in the liver.

Also tell your doctor if you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tredaptive.

Taking Tredaptive with food and drink

• Take Tredaptive with food.
• To lower your chance of flushing, avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive.
• It is important to follow the advice given in section 3 How to take Tredaptive.

Pregnancy and breast-feeding

Talk with your doctor before taking Tredaptive if:

• You are pregnant or plan to become pregnant. It is not known if Tredaptive will harm your unborn baby.
• You are breast-feeding or plan to breast-feed. It is not known if Tredaptive will pass into your breast milk. However, nicotinic acid a component of Tredaptive does pass into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will decide if Tredaptive is right for you.

Driving and using machines

The effects of Tredaptive on the ability to drive and use machines have not been studied. However, some people get dizzy after taking Tredaptive. If you get dizzy, you should avoid driving or operating machines after taking Tredaptive.

Important information about some of the ingredients of Tredaptive

Tredaptive contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Tredaptive exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take

• You should start by taking one tablet a day.
• After 4 weeks, your doctor may raise your dose to two tablets a day.

How to take

• Take Tredaptive once a day, in the evening or at bedtime.
• Take Tredaptive with food.
• Swallow each tablet whole. In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it.
• Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive. This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back).
• Taking aspirin before you take Tredaptive does not reduce your flushing more than taking Tredaptive alone. Therefore, taking aspirin to reduce flushing symptoms is not necessary. If you take aspirin for any other reason, continue to follow your doctor's advice.

If you take more Tredaptive than you should

• In the event of an overdose, the following adverse events were reported: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/discomfort, and back pain.
• If you take more than you should, talk to a doctor or pharmacist straight away.

If you forget to take Tredaptive

• If you miss a dose, do not take an extra dose. Continue with your usual dose the next evening or at bedtime. However, if you do not take Tredaptive for 7 or more days in a row, talk to your doctor before restarting Tredaptive.

If you stop taking Tredaptive

Do not stop taking Tredaptive without talking to your doctor. Your cholesterol problem may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Tredaptive can cause side effects, although not everybody gets them.

Side effects of Tredaptive are:

Very common (affects more than 1 in 10 patients)

• flushing (which usually includes redness of the skin, feeling warm, itching, or tingling, particularly in the head, neck, chest and upper back). If flushing occurs, symptoms are generally most noticeable at first and usually lessen over time.

Common (affects less than 1 in 10 patients)

• dizziness
• headache
• tingling or numbness of the hands or feet
• diarrhoea
• upset stomach or heartburn
• nausea (feeling sick)
• getting sick (vomiting)
• pruritus (itching)
• rash
• hives

Uncommon (affects less than 1 in 100 patients)

In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Tredaptive.

• swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away)
• fainting
• shortness of breath
• loss of control over urine and stool
• cold sweats
• shivering
• chills
• increased blood pressure
• swelling of the lips
• burning sensation
• whole body rash
• joint pain
• swelling of the legs
• rapid heart rate.

Additionally, during post-marketing experience with Tredaptive and/or other nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines), a sudden serious allergic reaction (anaphylactic shock) was reported. Symptoms included fainting, shortness of breath, wheezing or trouble breathing, swelling of the face, lips, tongue, itching or hives on the skin. This condition requires immediate medical attention. Blistering rash was also reported during post-marketing experience with Tredaptive and/or other nicotinic acid products.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Tredaptive after the expiry date (EXP) which is stated on the carton and the blister.

PVC/Aclar blisters: Store in the original packaging in order to protect from light and moisture.

Aluminium/Aluminium blisters: Do not store above 30°C. Store in the original packaging in order to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Tredaptive contains

• The active substances are nicotinic acid and laropiprant. Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
• The other ingredients are: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, and magnesium stearate.

What Tredaptive looks like and contents of the pack

Each modified-release tablet is a capsule-shaped, white to off-white tablet, with ?552? debossed on one side.

Opaque PVC/Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister.

Aluminium/Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Merck Sharp Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom Manufacturer Merck Sharp Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3 JU United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 38 693 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belge Tél 32 0 800 38 693 MSDBelgiuminfomerck.com

. 359 2 819 3737 info-msdbgmerck.com Magyarország MSD Magyarország Kft. Tel. 36 1 888 53 00 hungarymsdmerck.com

eská republika Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420 233 010 111 msdcrmerck.com Malta Merck Sharp Dohme Cyprus Limited Tel 357 22866700 maltainfomerck.com

Danmark Merck Sharp Dohme Tlf 45 43 28 77 66 Tredaptivemsd.dk Nederland Merck Sharp Dohme BV Tel 0800 99 99 000 medicalinfo.nlmerck.com

Deutschland MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS Tlf 47 32 20 73 00 msdnorgemsd.no

Eesti Merck Sharp Dohme OÜ Tel 372 613 9750 msdeestimerck.com Österreich Merck Sharp Dohme GmbH Tel 43 0 1 26 044 msd-medizinmerck.com

E BIANE . 3 0210 80091 11 Mailboxvianex.gr Polska MSD Polska Sp. z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com

España Merck Sharp Dohme de España, S.A. Tel 34 91 321 06 00 Tredaptivemsd.es Portugal Merck Sharp Dohme, Lda Tel 351 21 4465700 informacaodoentemerck.com

France Laboratoires Merck Sharp Dohme Chibret Tél 33 0 1 47 54 87 00 contactmsd-france.com România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

Slovenija Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com Ireland Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 2998700 medinfoirelandmerck.com

Ísland Icepharma hf. Sími 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com

talia MSD Italia S.r.l. Tel 39 06 361911 doccenmerck.com SuomiFinland MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi

Merck Sharp Dohme Cyprus Limited 80000 673 357 22866700 cyprusinfomerck.com Sverige Merck Sharp Dohme Sweden AB Tel 46 0 8 626 1400 medicinskinfomerck.com

Latvija SIA Merck Sharp Dohme Latvija Tel 371 67364 224 msdlvmerck.com United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medicalinformationukmerck.com

Lietuva
UAB ?Merck Sharp & Dohme?
Tel. +370 5 278 02 47msd_lietuva@merck.com

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