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NICOTINIC ACID
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
The active ingredient in this medicine is Nicotinic Acid (also known as niacin/vitamin
B3). NICOTINIC ACID is used to treat high levels of cholesterol and triglycerides,
and pellagra, a nicotinic acid deficiency. For more information, see Section 1. Why am I taking NICOTINIC ACID? in the full CMI.
Do not take if you have ever had an allergic reaction to nicotinic acid or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take NICOTINIC ACID? in the full CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take NICOTINIC ACID? in the full CMI.
Some medicines may interfere with NICOTINIC ACID and affect how it works. A list of
these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
Your doctor or pharmacist will tell you how many tablets you will need to take each
day. This depends on your condition and whether or not you are taking any other medicines.
Swallow the tablets whole with a glass of water. Do not chew the tablets.
More instructions can be found in Section 4. How do I take NICOTINIC ACID? in the full CMI.
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking NICOTINIC ACID.
If you are about to have any blood or urine tests, tell your doctor that you are taking
this medicine.
Tell your doctor or pharmacist immediately if you are pregnant.
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Things you should not do
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Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take the medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not stop taking the medicine, or lower the dosage, without checking with your doctor
or pharmacist.
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Drinking alcohol
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Avoid alcohol and hot drinks when you take NICOTINIC ACID.
Alcohol and hot drinks can increase side effects such as flushing and itching.
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Looking after your medicine
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Keep the tablets in the bottle, in a cool, dry place below 30°C.
Keep your tablets where children cannot reach it.
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For more information, see Section 5. What should I know while taking NICOTINIC ACID? in the full CMI.
Tell your doctor or pharmacist if you notice any of the following: skin flushing (warmth, redness, itching or tingling that typically occurs on the
face, neck, chest and back), irregular or rapid heart beat, headache, dizziness ,
itch, rash, dry or scaly skin, boils, darkening or thickening of the skin, nausea
(feeling sick), vomiting, diarrhoea, heartburn or flatulence, nervousness. Tell your doctor as soon as possible if you notice any of the following: yellowing of the skin and/or eyes, shortness of breath, signs of gout, e.g. painful
swollen joints, difficulty seeing, fainting, dizziness when getting up from a sitting
or lying position. Tell your doctor immediately or go to Accident and Emergency at the nearest hospital
if you notice any of the following: signs of an allergic reaction including swelling of the face, lips, mouth, throat
or neck which may cause difficulty swallowing or breathing.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
NICOTINIC ACID
Active ingredient(s):
nicotinic acid
Consumer Medicine Information (CMI)
This leaflet provides important information about taking NICOTINIC ACID. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking NICOTINIC ACID.
Where to find information in this leaflet:
Nicotinic acid (also known as niacin) is vitamin B3, which occurs naturally in food.
Used as a medicine, it can improve levels of blood fats (lipids) such as cholesterol
and triglycerides.
Nicotinic acid works by reducing the amount of 'bad' cholesterol and triglycerides
made by the liver.
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.
NICOTINIC ACID is used to treat:
high levels of cholesterol and triglycerides which are fat-like substances in the
blood
pellagra, a nicotinic acid deficiency which is very rare in Australia. Symptoms of
pellagra include loss of appetite, lethargy, weakness, diarrhoea, dermatitis and mental
changes.
Cholesterol and triglycerides
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 to digest food) and some hormones.
Some people have a family history of high cholesterol.
However, having too much cholesterol in the blood can contribute to the development
of heart disease.
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.
There are different types of cholesterol, called LDL (low-density lipoprotein) and
HDL (high-density lipoprotein). LDL cholesterol is the 'bad' cholesterol that can
block your blood vessels. HDL cholesterol is the 'good' cholesterol that is thought
to remove the 'bad' cholesterol from the blood vessels.
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.
Having high levels of 'bad' cholesterol and triglycerides can be a problem. Over time,
this can form hard areas, called plaque, on the walls of your 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 or angina), and stroke.
Treating high cholesterol and triglycerides
High cholesterol and triglyceride levels can be treated in two main ways:
Lifestyle changes:
this includes a low-fat diet, increasing physical exercise, and weight management.
Medicines:
such as cholesterol-lowering agents.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Do not give NICOTINIC ACID to a child.
The safety and effectiveness of this medicine have not been established in this age
group.
NICOTINIC ACID is not addictive.
Do not take NICOTINIC ACID if:
you are allergic to nicotinic acid, or any of the ingredients listed at the end of
this leaflet. Some of the symptoms of an allergic reaction include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Always check the ingredients to make sure you can take this medicine.
you have or have had:
significant liver problems
bleeding of any artery (a blood vessel)
recent heart attack.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine talk to your doctor
or pharmacist.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
have or have had liver disease
Your doctor will do a blood test to make sure you have no problems with your liver.
have or have had any of the following medical conditions:
heart attack
heart, gallbladder, kidney or liver problems
bleeding problems
glaucoma (increased pressure in the eye)
stomach ulcer
diabetes
gout.
take any medicines for any other condition.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start taking this medicine.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Check with your doctor if you are pregnant or intend to become pregnant.
Do not take this medicine if you are breast-feeding.
This medicine passes into breast milk and may affect your baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with NICOTINIC ACID and affect how it works. These include:
certain medicines used to lower high blood pressure
insulin or other medicines used to treat diabetes
aspirin
'statins', medicines used to lower cholesterol, e.g. pravastatin, simvastatin
colestipol, a medicine used to lower cholesterol
nicotine patches
isoniazid, a medicine used for tuberculosis
clonidine, a medicine used for high blood pressure and migraine.
These medicines may be affected by NICOTINIC ACID, or may affect how well it works.
You may need different amounts of your medicine, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NICOTINIC ACID.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking NICOTINIC ACID.
Carefully follow all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
In adults:
Pellagra:
One tablet twice a day.
High cholesterol and triglyceride levels:
Initially one tablet three times a day; increased by one tablet every four days to
a maximum daily dose of 12-18 tablets or as directed by your doctor.
Your doctor or pharmacist will tell you how many tablets you will need to take each
day. This depends on your condition and whether or not you are taking any other medicines.
How to take NICOTINIC ACID
Swallow the tablets whole with a glass of water. Do not chew the tablets.
How long to take NICOTINIC ACID
Continue taking your medicine for as long as your doctor or pharmacist tells you.
NICOTINIC ACID helps lower your cholesterol and triglyceride. It does not cure your
condition. Therefore, you must continue to take it as directed by your doctor or pharmacist
to keep your cholesterol and triglyceride levels controlled. If you stop taking it,
your cholesterol and triglyceride levels may become out of control.
If you forget to take NICOTINIC ACID
NICOTINIC ACID should be used regularly at the same time each day.
If you miss your dose at the usual time,
take the dose as soon as you remember, and then go back to taking your medicine as
directed.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much NICOTINIC ACID
If you think that you or anyone else may have taken too much NICOTINIC ACID, urgent
medical attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Too much NICOTINIC ACID may cause red or itchy skin, vomiting, diarrhoea, stomach
discomfort or cramps, or fainting.
Things you should do
If you are about to be started on any new medicine, tell your doctor or pharmacist
that you are taking NICOTINIC ACID.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking this medicine.
If you are about to have any blood or urine tests, tell your doctor that you are taking
this medicine.
NICOTINIC ACID may affect the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may recommend that you have regular blood tests while taking NICOTINIC
ACID to monitor the effect on your blood cholesterol and triglyceride levels.
If you are taking this medicine to lower your blood cholesterol and triglyceride levels,
maintain a low fat diet and exercise program to control your weight.
When you are taking this medicine, it will be easier to control your cholesterol and
triglyceride levels if you also exercise and follow a low fat diet, including plenty
of fruit and vegetables.
Things you should not do
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take the medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not stop taking the medicine, or lower the dosage, without checking with your doctor
or pharmacist.
Drinking alcohol
Avoid alcohol and hot drinks when you take NICOTINIC ACID.
Alcohol and hot drinks can increase side effects such as flushing and itching.
Looking after your medicine
Store below 30°C
Keep your tablets in the bottle until it is time to take them. If you take the tablets
out of the bottle they may not keep as well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking NICOTINIC ACID.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Do not be alarmed by the following lists of side effects.
You may not experience any of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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skin flushing (warmth, redness, itching or tingling that typically occurs on the face,
neck, chest and back).
Flushing is the most common side effect of nicotinic acid products. For most patients,
the flushing episodes will become less frequent and milder within a few weeks after
starting therapy, or may stop altogether.
irregular or rapid heart beat
headache
dizziness
itch, rash
dry or scaly skin, boils
darkening or thickening of the skin
nausea (feeling sick), vomiting
diarrhoea
heartburn or flatulence
nervousness
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Speak to your doctor or pharmacist if you have any of these less serious side effects
and they worry you.
This list includes the more common side effects of your medicine.
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Serious side effects
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Serious side effects
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What to do
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yellowing of the skin and/or eyes
shortness of breath
signs of gout, e.g. painful swollen joints
difficulty seeing
fainting, dizziness when getting up from a sitting or lying position.
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Tell your doctor as soon as possible if you notice any of the following serious side
effects:
This list includes serious side effects, which may require medical attention. Serious
side effects are rare.
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Very serious side effects
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Very serious side effects
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What to do
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signs of an allergic reaction include swelling of the face, lips, mouth, throat or
neck which may cause difficulty swallowing or breathing.
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Tell your doctor immediately or go to Accident and Emergency at the nearest hospital
if you notice any of the following:
This list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are very rare.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may 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.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
This medicine is available from your pharmacist without a doctor's prescription.
What NICOTINIC ACID contains
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Active ingredient
(main ingredient)
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Nicotinic acid 250 mg
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Other ingredients
(inactive ingredients)
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lactose monohydrate
wheat starch
povidone
purified talc
magnesium stearate
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Potential allergens
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Gluten and sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What NICOTINIC ACID looks like
NICOTINIC ACID tablets are white, bevelled edge tablets with a breakline on one side
(AUST R 27193).
NICOTINIC ACID is available in bottles of 100 tablets.
