Pelzont
laropiprant, nicotinic acid
nicotinic acid/laropiprant
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist. This includes any possible side
effects not listed in this leaflet.
What Pelzont is and what it is used for
What you need to know before you take Pelzont
How to take Pelzont
Possible side effects
How to store Pelzont
Contents of the pack and other information
The name of your medicine is Pelzont. It contains two different active substances:
nicotinic acid, a lipid modifying medicine, and
Medicinal product no longer authorised
laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.
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).
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.
when you cannot control your cholesterol levels with a statin alone (class of cholesterol-lowering medicines working in the liver);
when you cannot tolerate a statin or when a statin is not recommended for you.
Patients with combined mixed dyslipidaemia have high blood levels of ‘bad’ LDL cholesterol and triglycerides (a type of fat), and low levels of ‘good’ HDL cholesterol. Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high. Primary means that the hypercholesterolaemia does not have any identifiable cause.
you are allergic to nicotinic acid, to laropiprant, or to any of the other ingredients of this medicine (listed in section 6).
you currently have liver problems.
you have an ulcer in your stomach.
you have arterial bleeding.
Do not take Pelzont if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Pelzont.
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.
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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.
you are taking simvastatin (a statin) or a medicine containing simvastatin and are Chinese.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Pelzont.
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 Pelzont to check how well your liver is working.
Your doctor may also want you to periodically have blood tests after you start taking Pelzont, to check how well your liver is working and for other side effects.
Pelzont has not been studied in children and adolescents who are under 18 years of age. Therefore,
Pelzont should not be used in children and adolescents under 18 years of age.
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 and acetylsalicylic acid (ASA), medicines to help prevent harmful blood clots.
medicines used to lower cholesterol called ‘statins’.
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 Pelzont.
To lower your chance of flushing, avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Pelzont.
It is important to follow the advice given in section 3 How to take Pelzont.
Pelzont is not recommended in pregnancy unless clearly necessary.
Talk with your doctor before taking Pelzont if:
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You are pregnant or plan to become pregnant. It is not known if Pelzont will harm your unborn baby.
You are breast-feeding or plan to breast-feed. It is not known if Pelzont will pass into your breast milk. However, nicotinic acid a component of Pelzont does pass into breast milk.
Ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if Pelzont is right for you.
Some people get dizzy after taking Pelzont. If you get dizzy, you should avoid driving or operating
machines after taking Pelzont.
Pelzont 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 this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should start by taking one tablet a day.
After 4 weeks, your doctor may raise your dose to two tablets a day.
If you are switching from a medicine containing 2,000 mg or more of a prolonged-release nicotinic acid, your doctor can start you with two tablets of Pelzont a day. If you are switching from a medicine with less than 2,000 mg of prolonged-nicotinic acid, you should start by taking one tablet of Pelzont a day. After 4 weeks, your doctor may raise your dose of Pelzont to two
tablets a day.
Take Pelzont once a day, in the evening or at bedtime.
Take Pelzont 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 Pelzont. 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 Pelzont does not reduce your flushing more than taking Pelzont 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.
In the event of an overdose, the following side effects 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 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 Pelzont for 7 or more days in a row, talk to your doctor before restarting Pelzont.
Medicinal product no longer authorised
Do not stop taking Pelzont 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, this medicine can cause side effects, although not everybody gets them.
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.
headache
tingling or numbness of the hands or feet
abdominal pain
diarrhoea
upset stomach or heartburn
nausea (feeling sick)
getting sick (vomiting)
pruritus (itching)
rash
hives
gout
sleeplessness
dizziness
palpitation (feeling your heartbeat)
low blood pressure
shortness of breath
dry skin
rash with flat, red spots
muscle pain or tenderness
chills
pain
swelling of the fingers, toes or ankles
In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Pelzont.
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
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joint pain
swelling of the legs
rapid heart rate.
runny nose
decreased glucose (sugar) tolerance
anxiety
migraine
fainting
rapid or irregular heartbeat
dizziness upon standing
belching
stomach ulcer
skin disorder with dark velvety plaques called acanthosis nigricans
patches of darkened skin
sweating
muscle weakness
weakness
generalised swelling
Additionally, the following were reported during post-marketing experience with Pelzont and/or other
nicotinic acid products (alone and/or with certain other cholesterol-lowering medicines).
a sudden serious allergic reaction (anaphylactic shock). 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.
eye disorders called toxic amblyopia and cystoid macular oedema which may lead to blurred, decreased, or lost vision
yellowing of the skin and/or eyes (jaundice)
blistering rash.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 and the blister after EXP. Do not store above 30°C. Store in the original packaging in order to protect from light and moisture. Do not throw away any 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.
The active substances are nicotinic acid and laropiprant. Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
Medicinal product no longer authorised
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.
The medicine comes as a modified-release tablet. This means one or more active substances are released slowly over a period of time.
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.
Merck Sharp & Dohme Ltd. Merck Sharp & Dohme Ltd.
Hertford Road, Hoddesdon Shotton Lane, Cramlington
Hertfordshire EN11 9BU Northumberland NE23 3 JU
United Kingdom United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
MSD Belgium BVBA/SPRL
Tél/Tel: 0800 38 693 (+32 (0)27766211)
MSD Belgium BVBA/SPRL
Tél/Tel: 0800 38 693 (+32 (0)27766211)
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
MSD Pharma Hungary Kft.
Tel.: +36 1 888 53 00
Merck Sharp & Dohme s.r.o.
Tel.: +420 233 010 111
Merck Sharp & Dohme Cyprus Limited
Tel: +8007 4433 (+356 99917558)
MSD Danmark ApS
Tlf: +45 4482 4000
Merck Sharp & Dohme BV
Tel: 0800 99 99 000 (+31 23 5153153)
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673; (+49 (0) 89 4561 2612)
MSD (Norge) AS
Tlf: +47 32 20 73 00
Merck Sharp & Dohme OÜ
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Tel: +372 6144 200
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
MSD. A. Φ B.E.E.
Τηλ: +3 0210 98 97 300
MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
Merck Sharp & Dohme, Lda
Tel: +351 21 4465808
MSD France
Tél: + 33 (0) 1 80 46 40 40
Merck Sharp & Dohme Romania S.R.L.
Tel: +4021 529 29 00
Merck Sharp and Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
Vistor hf.
Sími: +354 535 7000
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010
Addenda Pharma S.r.l.
Tel: +39 06 91393303
MSD Finland Oy
Puh/Tel: +358 (0) 9 804650
Merck Sharp & Dohme Cyprus Limited
Τηλ: 80000 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija
Tel: +371 67364 224
Merck Sharp and Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com
UAB Merck Sharp & Dohme
Tel. +370 5 278 02 47
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