Consumer medicine information

Nicotinic Acid

Nicotinic acid

BRAND INFORMATION

Brand name

Nicotinic Acid

Active ingredient

Nicotinic acid

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nicotinic Acid.

What is in this leaflet

This leaflet answers some common questions about Nicotinic acid.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Nicotinic Acid is used for

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.

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.

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.

It is available from your pharmacist without a doctor's prescription.

Before you take Nicotinic Acid

Do not take Nicotinic acid if you have an allergy to:

  • Any medicine containing Nicotinic acid
  • 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.

Do not take this medicine if you have or have had:

  • significant liver problems
  • bleeding of any artery (a blood vessel)
  • recent heart attack.

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.

Do not take this medicine if you are breast-feeding. This medicine passes into breast milk and may affect your baby.

Do not take this medicine after the expiry date printed on the pack 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.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had liver disease.

Your doctor will do a blood test to make sure you have no problems with your liver.

Tell your doctor or pharmacist if you 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.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and NICOTINIC ACID may interfere with each other. 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.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Nicotinic acid.

How to take 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.

Swallow the tablets whole with a glass of water. Do not chew the tablets.

Avoid alcohol and hot drinks when you take Nicotinic acid. Alcohol and hot drinks can increase side effects such as flushing and itching.

When to take it

Take Nicotinic acid after meals.

How long to take it

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 it

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 (overdose)

Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Nicotinic acid. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Too much Nicotinic acid may cause red or itchy skin, vomiting, diarrhoea, stomach discomfort or cramps, or fainting.

While you are using Nicotinic Acid

Things you must 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 become pregnant while taking this medicine, tell your doctor or pharmacist immediately.

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 must 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.

Side effects

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. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • skin flushing, which is a 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.

The above list includes the more common side effects of your medicine.

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, eg. painful swollen joints
  • difficulty seeing
  • fainting, dizziness when getting up from a sitting or lying position.

The above list includes serious side effects, which may require medical attention. Serious side effects are rare.

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 include swelling of the face, lips, mouth, throat or neck which may cause difficulty swallowing or breathing.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything 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 taking Nicotinic Acid

Storage

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.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Keep it 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 or pharmacist tells you to stop taking this medicine 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

NICOTINIC ACID tablets are white, flat tablets with a break bar on one side.

The tablets are available in bottles of 100's.

Ingredients

The tablets contain 250mg of Nicotinic acid as the active ingredient. They also contain:

  • Sugars (as lactose)
  • wheat starch
  • povidone
  • talc
  • magnesium stearate.

The medicine does not contain tartrazine or any other azo dyes.

Contains sugars (as lactose).

Supplier

Alphapharm Pty Limited
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian registration number:
AUST R 27193

This leaflet was prepared in October 2019.

Nicotinic Acid_cmi\1019/00

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Nicotinic Acid

Active ingredient

Nicotinic acid

Schedule

S3

 

1 Name of Medicine

Nicotinic acid BP 250 mg.

6.7 Physicochemical Properties

Molecular weight: 123.1.

Chemical structure.


CAS number.

CAS Registry no.: 59-67-6.

2 Qualitative and Quantitative Composition

Nicotinic acid is a water soluble B complex vitamin which is able to reduce serum lipids.
Each tablet contains 250 mg of nicotinic acid as the active ingredient.
Nicotinic Acid also contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Nicotinic Acid tablets are white, with a single score on one side.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Nicotinic Acid lowers serum cholesterol and triglyceride concentrations by inhibiting the synthesis of very low density lipoproteins (VLDL) which are the precursors to the formation of low density lipoproteins, the principal carrier of blood cholesterol. Several possible modes of action have been proposed, including inhibition of hepatic synthesis of lipoproteins containing apolipoprotein B-100, promotion of lipoprotein lipase activity, and reduction of free fatty acid mobilisation from adipose tissue with an increase in faecal output of sterols. Oral therapy produces reduced triglyceride concentrations within several hours and reduced cholesterol concentrations within several days.
Nicotinic acid also has a vasodilation effect when administered in large doses, identified by flushing of the skin while plasma nicotinic acid levels are rising. This process is believed to be mediated by prostacyclin. Vasodilation occurs within 20 minutes of an oral dose and persists for about 20-60 minutes.
Nicotinic acid has been reported to stimulate histamine release resulting in increased gastric motility and acid production which may activate peptic ulcer. Reports have also indicated that large doses of nicotinic acid may decrease uric acid excretion and impair glucose tolerance. These effects may result in precipitation of an episode of gout in susceptible patients and may necessitate adjustment of diet and antihyperglycaemic therapy in diabetic patients.
The normal physiological role of nicotinic acid is as a component of the coenzymes NAD and NADP which are essential for oxidation/ reduction reactions in tissue respiration. Nicotinamide, a metabolite of nicotinic acid, possesses similar function as a vitamin but has no pharmacological value in reducing lipids.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Nicotinic acid is readily absorbed from the gastrointestinal tract following oral administration and is widely distributed in the body tissues.

Metabolism and excretion.

It is metabolised in the liver to nicotinamide when taken in physiological doses but when therapeutic doses are taken only a portion is converted to nicotinamide with the remainder eventually being excreted unchanged in the urine. Nicotinamide is widely distributed in the body and is further metabolised in the liver to N-methylnicotinamide and the 2-pyridone and 4-pyridone derivatives with some nicotinuric acid also being formed before being excreted in the urine. The elimination half-life is approximately 45 minutes, and time to peak serum concentration after oral administration is also 45 minutes.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

1. The treatment of hyperlipidaemia, hypertriglyceridaemia and Frederickson-Lees Levy hyperlipoproteinaemia type II, IIB, III, IV and V (as adjunctive therapy in addition to diet and other measures); and
2. Pellagra (note: pellagra in Australia is limited to special situations not typical of the general lifestyle. A variety of other non-nutritional factors may also lead to the development of the disease.)

4.3 Contraindications

Nicotinic acid may exacerbate hepatic dysfunction and large doses may exacerbate peptic ulcer, overt diabetes mellitus, gout or hyperuricaemia.
Large doses of nicotinic acid should not be used by persons with heart or gall bladder disease, arterial bleeding or glaucoma.
Contraindicated in cases of recent myocardial infarction.
Nicotinic acid is contraindicated in patients with severe idiosyncratic reactions to it or those who exhibit a sudden fall in peripheral vascular resistance.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Antihypertensive drugs.

Patients taking antihypertensive drugs should consult a physician before taking nicotinic acid. Antihypertensive drugs may have an additive vasodilating effect and produce postural hypotension.

Liver function.

Frequent monitoring of liver function should be performed during therapy to ascertain that the drug has no adverse effects.

Glucose tolerance.

As decreased glucose tolerance may occur, glucose tolerance tests should be performed regularly. Adjustment of diet and/or hypoglycaemic therapy may be necessary.

Serum uric acid levels.

Frequent monitoring of serum uric acid levels is advised as elevated uric acid levels may occur during long-term therapy.

Gastrointestinal irritation or peptic ulcer history.

Nicotinic acid causes release of histamine from the mast cells to stimulate gastric secretion of hydrochloric acid. Therefore, patients prone to gastrointestinal irritation or with a history of peptic ulcer should be closely supervised.

Myocardial infarction.

Nicotinic acid therapy should be withdrawn if the patient has a myocardial infarction.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Nicotinic acid may cause false elevation in fluorometric determinations of urinary catecholamines and false positive tests for urinary glucose when Benedict's reagent is used. Nicotinic acid has also been reported to give false positive results for blood bilirubin tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Adrenergic blocking agents.

Due to an additive vasodilating effect, postural hypotension may occur when nicotinic acid is added to the regimen of patients taking adrenergic blocking agents.

Antihyperglycaemic therapy.

Because nicotinic acid can cause hyperglycaemia, dosage adjustment of insulin or oral antihyperglycaemic therapy may be required in diabetic patients.

Aspirin.

Concurrent use of aspirin and nicotinic acid may result in a reduction of the warmth and flushing associated with nicotinic acid use. Also, concurrent use of aspirin may result in an increased and prolonged nicotinic acid concentration, and so the potential for nicotinic acid toxicity may exist.

Clonidine.

Concomitant nicotinic acid and clonidine has been reported to result in reduction in flushing of skin secondary to nicotinic acid.

Colestipol.

Nicotinic acid absorption may be affected by administration with colestipol. Combined use of these two drugs resulted in lower plasma cholesterol concentrations than were achieved with colestipol alone.

Glipizide.

Concomitant administration of glipizide and nicotinic acid may result in loss of blood glucose control since nicotinic acid can cause hyperglycaemia.

Isoniazid.

Concomitant administration of isoniazid and nicotinic acid may cause nicotinic acid requirements to be increased, but pellagra is rare, only occurring in patients with an underlying nicotinic acid deficiency.

Lovastatin/ pravastatin/ simvastatin.

The concurrent use of lovastatin, pravastatin or simvastatin and nicotinic acid may be associated with myopathy and an increased risk of rhabdomyolysis, and acute renal failure. Symptoms of myopathy and rhabdomyolysis should be monitored.

Nicotine.

If nicotinic acid and transdermal nicotine are used concurrently, flushing and dizziness after each nicotinic acid dose may occur.

Alcohol.

In one case report concomitant alcohol and nicotinic acid therapy resulted in delirium (paranoid ideation and asterixis) and lactic acidosis.

4.6 Fertility, Pregnancy and Lactation

(Category B2)
Category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Contraindicated.
Contraindicated.

4.8 Adverse Effects (Undesirable Effects)

Cardiovascular.

Acute flush, pounding in the head, sensation of heat, headache, hypotension. Atrial fibrillation and other arrhythmias in patients with CHD.

Dermatological.

Pruritus, dryness with mild epidermal exfoliation, brown pigmentation, hyperkeratosis, urticaria, furunculosis, rash. All these adverse reactions are reversible on cessation of drug therapy.

Endocrine.

Increased insulin requirements in diabetic patients, hypothyroidism.

Gastrointestinal.

Nausea, vomiting, diarrhoea, heartburn, flatulence, activation of peptic ulcer.

Hepatic.

Cholestatic jaundice, elevated liver function tests, ascites, hepatomegaly, patchy fibrosis, areas of necrosis, cholestasis and lymphocyte infiltration around the bile ducts.

Nervous system.

Nervousness.

Others.

Hyperuricaemia, toxic amblyopia.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

In adults.

Pellagra.

250 mg (one tablet) twice a day.

Hypercholesterolaemia, hypertriglyceridaemia.

250 mg three times daily increased by 250 mg increments every fourth day until a final daily dose of 3 to 4.5 g is reached.
Individual dosage is recommended because lipid reduction is dose related. Initially, plasma cholesterol and triglyceride levels should be monitored.
Tablets should be taken orally after meals.
Following oral administration, nicotinic acid induced vasodilation occurs within 20 minutes and persists for about 20 to 60 minutes.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Symptoms.

Cutaneous flush, pruritus, vomiting, diarrhoea, dyspepsia, syncope, severe abdominal cramps.

Treatment.

Discontinue drug and institute general supportive measures.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S3.

6 Pharmaceutical Particulars

6.1 List of Excipients

Inactive ingredients: lactose, starch-wheat, povidone, talc and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Container type.

Round amber glass bottle.

Pack sizes.

Available in bottles of 100's or 200's*.
* Not marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

Summary Table of Changes