Consumer medicine information

TAZAC

Nizatidine

BRAND INFORMATION

Brand name

Tazac Capsules

Active ingredient

Nizatidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using TAZAC.

What is in this leaflet

This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information that is known about Tazac.

It does not take the place of talking with your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tazac 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 this medicine.

You may need to read it again.

What TAZAC is used for

Tazac contains an active ingredient called nizatidine. It belongs to a class of medicines called H2-antagonists or H2-blockers.

Tazac is used to treat the following conditions:

Reflux oesophagitis
This can be caused by reflux or "washing back" of food and acid from the stomach into the food pipe. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn.

Ulcers
Depending on the position of the ulcer it is either called a gastric or duodenal ulcer.

A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. Tazac is also used to stop duodenal ulcers from coming back.

Tazac works by reducing the amount of acid in your stomach. This helps reduce the pain and allows the ulcer and reflux disease to heal in most people.

Ask your doctor or pharmacist if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Tazac if you have ever had an allergic reaction to:

  • nizatidine or other histamine H2-receptor antagonists (e.g. cimetidine, ranitidine, famotidine)
  • any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take Tazac after the expiry printed on the pack.

If you take this medicine after the expiry date has passed it may not work as well.

Do not take Tazac if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you:

  • are pregnant or intend to become pregnant
  • are breast feeding or plan to breast feed
  • have kidney or liver disease.

If you have not told your doctor about any of these things, tell them before you take Tazac.

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 may affect the way other medicines work. Medicines such as ketoconazole and itraconazole used to treat fungal infections may be affected by Tazac. Your doctor or pharmacist will be able to tell you what to do when taking Tazac with other medicines.

How to take it

How much to take

Depending on your condition, your doctor will tell you how much Tazac to take each day.

When to take it

The 150 mg capsule is usually taken in the morning and in the evening before you go to bed.

The 300 mg capsule is usually taken once daily, at bedtime.

How to take it

Swallow the capsule whole with a glass of water or another liquid.

How long do I take it

Do not stop taking the capsules just because you feel better.

Your doctor will tell you how long you should continue taking Tazac. If you stop taking your capsules too early then your condition may not have been properly treated.

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 Tazac 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 to make up for the dose that you missed.

If you take too much (overdose)

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

You may need urgent medical attention.

While you are taking it

Things you must do

Tell your doctor or pharmacist if you start any new medicine while you are taking Tazac.

If you are taking it for an ulcer, you should go to your doctor regularly for checkups to make sure that Tazac has healed your ulcer.

Tell your doctor immediately if you become pregnant while taking Tazac.

Things you must not do

Do not give this medicine to anyone else even if their symptoms seem similar to yours.

Your doctor has prescribed it for you and your condition.

Do not take Tazac to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Tazac affects you.

This medicine may cause dizziness or lightheadedness in some people. Make sure you know how you react to it before you drive a car or operate any machinery.

Your doctor may advise you to limit your alcohol intake while you are being treated for your condition.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tazac.

Tazac helps most people who take it but it may have unwanted side effects in some people. All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Tell your doctor if you notice any of the following common side effects and they worry you:

  • sweating
  • itchy skin or rash
  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale.

Incidences of abnormal liver function, accompanied by jaundice (yellow skin) have been rarely reported by patients taking this medicine. This side effect has been reversed when Tazac is stopped.

Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

After taking it

Storage

Keep your capsules in the blister pack until it is time to take them.

If you take your capsules out of the blister pack, they may not keep as well.

Keep your capsules in a cool dry place where the temperature stays below 25 degrees Celsius.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.

Disposal

Dispose of the medicine where children cannot reach it.

If your doctor tells you to stop taking Tazac or you find that the expiry date has passed, ask your pharmacist what to do with any capsules you have left over.

Product Description

What it looks like

150 mg: Light and dark yellow capsule printed with "N150". Packs of 60 capsules.

300 mg: Light yellow and brown capsule printed with "N300". Packs of 30 capsules.

Ingredients

Tazac capsules contain 150 mg or 300 mg of nizatidine as the active ingredient.

The 150 mg capsule also contains the following inactive ingredients:

  • starch-maize
  • starch-pregelatinised maize
  • dimeticone 350
  • magnesium stearate
  • iron oxide yellow
  • titanium dioxide
  • gelatin
  • colorcon black ink S-1-8100.

The 300 mg capsule also contains the following inactive ingredients:

  • starch-maize
  • starch-pregelatinised maize
  • povidone
  • carmellose
  • dimeticone 350
  • talc-purified
  • iron oxide red
  • iron oxide yellow
  • titanium dioxide
  • gelatin
  • colorcon black ink S-1-8100.

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

Distributor

Arrow Pharma Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

Australian Registration Numbers:
TAZAC 150 mg - AUST R 49325
TAZAC 300 mg - AUST R 49326

This leaflet was prepared in June 2016.

BRAND INFORMATION

Brand name

Tazac Capsules

Active ingredient

Nizatidine

Schedule

S4

 

Name of the medicine

Nizatidine.

Excipients.

150 mg capsule.

Maize starch, pregelatinised maize starch, dimethicone 350, magnesium stearate, iron oxide yellow, titanium dioxide, gelatin and colorcon black ink S-1-8100.

300 mg capsule.

Maize starch, pregelatinised maize starch, povidone, carmellose, dimethicone 350, purified talc, iron oxide red, iron oxide yellow, titanium dioxide, gelatin and colorcon black ink S-1-8100.

Description

Chemical name: N-[2-[[[2-(dimethylamino) methyl]-4 -thiazolyl] -methyl]thio] -ethyl]-N'-methyl-2 -nitro-1,1 -ethenediamine (see structural formula below). Molecular formula: C12H21N5O2S2. MW: 331.46. CAS: 76963-41-2. Tazac is an off white to buff crystalline solid which is sparingly soluble in water.

Pharmacology

Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells.

Antisecretory activity.

Effects on acid secretion.

Nizatidine significantly inhibits basal and nocturnal gastric acid secretion for up to 12 hours. Nizatidine also significantly inhibits gastric acid secretion stimulated by food, caffeine, betazole and pentagastrin in a dose dependent manner. Rebound hypersecretion of gastric acid may occur after cessation of the drug.

Effects on other gastrointestinal secretions. Pepsin.

Oral administration of nizatidine 75 to 300 mg does not affect pepsin activity in gastric secretions. Total pepsin output is reduced in proportion to the reduced volume of gastric secretions.

Intrinsic factor.

Intrinsic factor is not decreased in subjects administered nizatidine.

Serum gastrin.

Nizatidine has no effect on basal serum gastrin. No rebound of gastrin secretion was observed when food was ingested 12 hours after administration of nizatidine.

Other pharmacologic actions.

Hormones.

Nizatidine was not shown to affect the serum concentrations of gonadotropins, growth hormone, antidiuretic hormone, cortisol, triiodothyronine, thyroxine, testosterone, 5-dihydrotestosterone, androstenedione or oestradiol. With acute nizatidine administration, transient increases in serum prolactin have been observed in male animals.
Nizatidine had no demonstrable antiandrogenic action.

Pharmacokinetics.

Onset of action: half an hour; duration of action: up to 12 hours. The absolute oral bioavailability of nizatidine exceeds 70%. Peak plasma concentrations (700 to 1,800 microgram/L for a 150 mg dose and 1,400 to 3,600 microgram/L for a 300 mg dose) occur from 0.5 to 3 hours following the dose. A concentration of 1,000 microgram/L is equivalent to 3 micromol/L; a dose of 300 mg is equivalent to 905 micromoles. Plasma concentrations 12 hours after administration are less than 10 microgram/L. The elimination half-life is 1 to 1.5 hours, plasma clearance is 40 to 60 L/hour, and the volume of distribution is 0.8 to 1.5 L/kg. Because of the short half-life and rapid clearance of nizatidine, accumulation of the drug would not be expected in individuals with normal renal function who take either 300 mg once daily in the evening or 150 mg twice daily. Nizatidine exhibits dose proportionality over the recommended dose range.
The oral bioavailability of nizatidine is unaffected by concomitant ingestion of propantheline. Antacids consisting of aluminium and magnesium hydroxides with simethicone decrease the absorption of nizatidine by about 10%. With food, the AUC and Cmax increase by approximately 10%.
Charcoal has also been shown to reduce oral bioavailability of nizatidine. This reduction is in the range of 20 to 25%.
Less than 7% of an oral dose is metabolised as N2-monodesmethyl-nizatidine, an H2-receptor antagonist, which is the principal metabolite excreted in the urine. Other likely metabolites are the N2-oxide (less than 5% of the dose) and the S-oxide (less than 6% of the dose).
More than 90% of an oral dose of nizatidine is excreted in the urine within 12 hours. About 60% of an oral dose is excreted as unchanged drug. Renal clearance is about 500 mL/minute, which indicates excretion by active tubular secretion. Less than 6% of an administered dose is eliminated in the faeces.
Moderate to severe renal impairment significantly prolongs the half-life and decreases the clearance of nizatidine. In individuals who are functionally anephric, the half-life is 3.5 to 11 hours, and the plasma clearance is 7 to 14 L/hour. To avoid accumulation of the drug in individuals with clinically significant renal impairment, the amount and/or frequency of doses of nizatidine should be reduced in proportion to the severity of dysfunction (see Dosage and Administration).
Approximately 35% of nizatidine is bound to plasma protein, mainly to α1-acid glycoprotein. Warfarin, diazepam, paracetamol, propantheline, phenobarbitone and propranolol did not affect plasma protein binding of nizatidine in vitro.

Clinical Trials

Active duodenal ulcer.

In multicentre, double blind, placebo controlled studies, endoscopically diagnosed duodenal ulcers healed more rapidly following administration of nizatidine (300 mg at bedtime or 150 mg twice daily) than with placebo. Lower doses such as 100 mg at bedtime had slightly lower effectiveness.

Maintenance of healed duodenal ulcer.

In multicentre, double blind, comparator controlled studies, the healing rates following the administration of nizatidine (n = 388) were 81% within four weeks and 92% within eight weeks.
Treatment with a reduced dose of nizatidine has been shown to be effective as maintenance therapy following healing of active duodenal ulcers. In multicentre, double blind, placebo controlled studies, nizatidine 150 mg taken in the evening resulted in a significantly lower incidence of duodenal ulcer recurrence in patients treated for up to one year.

Benign gastric ulcer.

In multicentre, double blind, comparator controlled studies, patients received nizatidine 150 mg B.D. or 300 mg nocte. Healing rates in both dosage groups (66.2 and 65.2%, respectively) were not statistically different. Analysis of symptomatic responses showed that 68 to 76% of patients were symptom free after 4 weeks therapy.

Gastroesophageal reflux disease (reflux oesophagitis).

In multicentre, double blind, placebo controlled clinical trials, nizatidine was more effective than placebo in improving endoscopically diagnosed oesophagitis and in healing erosive and ulcerative oesophagitis.
In a study in patients with erosive or ulcerative oesophagitis, nizatidine 150 mg b.i.d., compared with placebo, yielded a higher healing rate at 3 weeks (16% versus 7%) and at 6 weeks (32% versus 16%, p < 0.05). In another study, nizatidine 150 mg twice daily compared to placebo treatment, showed a higher healing rate at 6 weeks (21 versus 11%, p < 0.05) and at 12 weeks (29 versus 13%, p < 0.01).
In addition, relief of associated heartburn was greater in patients treated with nizatidine. Patients treated with nizatidine consumed fewer antacids than did patients treated with placebo.

Indications

Tazac is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within four weeks.
Tazac is also indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied.
Tazac is indicated for up to 8 weeks for the treatment of benign gastric ulcer.
Tazac is indicated for up to 12 weeks for the treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux.

Contraindications

Known hypersensitivity to the drug. Because cross sensitivity in this class of compounds has been observed, nizatidine should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

Precautions

General.

Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.
Because nizatidine is excreted primarily by the kidney, dosage should be reduced in patients with moderate to severe renal insufficiency (see Dosage and Administration).
Pharmacokinetic studies in patients with hepatorenal syndrome have not been done. Part of the dose of nizatidine is metabolised in the liver. Nizatidine cannot be recommended in patients with hepatic failure. In patients with normal renal function and uncomplicated hepatic dysfunction, the disposition of nizatidine is similar to that in normal subjects.
There is a possibility of nosocomial pulmonary infections associated with bacterial colonisation of the stomach in patients in intensive care units receiving drugs which suppress acid secretion.

Effects on fertility.

In a 2 generation perinatal and postnatal fertility study in rats, doses of nizatidine up to 650 mg/kg/day produced no adverse effects on the reproductive performance of parental animals or their progeny.

Use in pregnancy.

(Category B3)
Oral reproduction studies in rats at doses up to 1,500 mg/kg, and in Dutch Belted rabbits at doses up to 275 mg/kg, revealed no evidence of impaired fertility or teratogenic effect. At doses above 275 mg/kg, treated rabbits had abortions, decreased number of live foetuses and depressed foetal weights. On intravenous administration to pregnant New Zealand White rabbits, nizatidine at 20 mg/kg produced cardiac enlargement, coarctation of the aortic arch and cutaneous oedema in one fetus; at 50 mg/kg it produced ventricular anomaly, distended abdomen, spina bifida, hydrocephaly and enlarged heart in one foetus.
There are, however, no adequate and well controlled studies in pregnant women. It is also not known whether nizatidine can cause foetal harm when administered to pregnant women, or whether it can affect reproduction capacity.
Nizatidine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Use in lactation.

Studies conducted in lactating women have shown that 0.1% of the administered oral dose of nizatidine is secreted in human milk in proportion to plasma concentrations. Because of the growth depression in pups reared by lactating rats treated with nizatidine, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Paediatric use.

Safety and effectiveness in children have not been established.

Use in the elderly.

Ulcer healing rates in elderly patients are similar to those in younger age groups. The incidence rates of adverse events and laboratory test abnormalities are also similar to those seen in other age groups. Age alone may not be an important factor in the disposition of nizatidine. Elderly patients may have reduced renal function (see Dosage and Administration).
In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of histamine H2-receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CL, 1.07 to 2.48).

Genotoxicity.

Nizatidine was not mutagenic in a battery of tests performed to evaluate its potential genetic toxicity, including bacterial mutation tests, unscheduled DNA synthesis, sister chromatid exchange, mouse lymphoma assay, chromosome aberration tests and a micronucleus test.

Carcinogenicity.

A two year oral carcinogenicity study in rats with doses as high as 500 mg/kg/day showed no evidence of a carcinogenic effect. There was a dose related increase in the density of enterochromaffin-like (ECL) cells in the gastric oxyntic mucosa. In a two year study in mice, there was no evidence of a carcinogenic effect in male mice, although hyperplastic nodules of the liver were increased in the high dose males as compared to placebo. Female mice given the high dose of nizatidine (2,000 mg/kg/day) showed marginally statistically significant increases in hepatic carcinoma and hepatic nodular hyperplasia with no numerical increase seen in any of the other dose groups. The rate of hepatic carcinoma in the high dose animals was within the historical control limits seen for the strain of mice used. The female mice were given a dose larger than the maximum tolerated dose, as indicated by excessive (30%) weight decrement as compared with concurrent controls and evidence of mild liver injury (transaminase elevations). The occurrence of a marginal finding at high dose only in animals given an excessive and somewhat hepatotoxic dose, with no evidence of a carcinogenic effect in rats, male mice, and female mice (given up to 360 mg/kg/day), and a negative mutagenicity battery, are not considered evidence of a carcinogenic potential for nizatidine.

Effect on laboratory tests.

False positive tests for urobilinogen with Multistix may occur during therapy with nizatidine.

Interactions

No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lignocaine, phenytoin, warfarin, aminophylline, diazepam and metoprolol. Nizatidine does not inhibit the cytochrome P450 linked drug metabolising enzyme system; therefore, drug interactions mediated by inhibition of hepatic metabolism are not expected to occur. However, nizatidine and other histamine H2-receptor antagonists can reduce the gastric absorption of drugs whose absorption is dependent on an acidic gastric pH. In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d. was administered concurrently.

Adverse Effects

Nizatidine has been shown to be generally well tolerated. The safety profile is at least as good, if not better, than other H2-receptor antagonists. Worldwide, controlled clinical trials of nizatidine included over 6,000 patients given nizatidine in studies of varying durations. Placebo controlled trials included over 2,600 patients given nizatidine and over 1,700 given placebo. Among the adverse events in these placebo controlled trials, anaemia (0.2% versus 0%) and urticaria (0.5% versus 0.1%) were significantly more common in the nizatidine group.

Hepatic.

Hepatocellular injury, evidenced by elevated liver enzyme tests (SGOT [AST], SGPT [ALT], or alkaline phosphatase), occurred in some patients and was possibly or probably related to nizatidine. In some cases there was marked elevation of SGOT, SGPT enzymes (greater than 500 IU/L), and in a single instance SGPT was greater than 2,000 IU/L. The overall rate of occurrences of elevated liver enzymes and elevations to three times the upper limit of normal, however, did not significantly differ from the rate of liver enzyme abnormalities in placebo treated patients. All abnormalities were reversible after discontinuation of nizatidine.
Rare cases of hepatitis and jaundice and cholestatic or mixed hepatocellular and cholestatic injury with jaundice have been reported, with reversal of the abnormalities after discontinuation of nizatidine.

Cardiovascular.

In clinical pharmacology studies, short episodes of asymptomatic ventricular tachycardia occurred in two individuals administered nizatidine and in three untreated subjects.

CNS.

Rare cases of reversible mental confusion have been reported.

Endocrine.

Clinical pharmacology studies and controlled clinical trials showed no evidence of antiandrogenic activity due to nizatidine. Impotence and decreased libido were reported with equal frequency by patients who received nizatidine and by those given placebo. Rare reports of gynaecomastia occurred.

Haematologic.

Anaemia was reported significantly more frequently in nizatidine (0.2%) than in placebo (0%) treated patients. Fatal thrombocytopenia was reported in a patient who was treated with nizatidine and another H2-receptor antagonist. On previous occasions, this patient had experienced thrombocytopenia while taking other drugs. Rare cases of thrombocytopenic purpura have been reported.

Integumental.

Sweating and urticaria were reported significantly more frequently in nizatidine than in placebo patients. Rash, exfoliative dermatitis and pruritus were also reported.

Hypersensitivity.

As with other H2-receptor antagonists, rare cases of anaphylaxis following administration of nizatidine have been reported. Rare episodes of hypersensitivity reactions (e.g. bronchospasm, laryngeal oedema, rash and eosinophilia) have been reported.

Body as a whole.

Serum sickness reactions have occurred rarely (in less than 1/1,000 patients) in conjunction with nizatidine use.

Genitourinary.

Reports of impotence have occurred.

Other.

Hyperuricaemia unassociated with gout or nephrolithiasis has been reported. Eosinophilia, fever and nausea related to nizatidine administration have been reported.

Dosage and Administration

Active duodenal ulcer.

The recommended oral dosage for adults is 150 mg twice daily or 300 mg once daily in the evening.

Benign gastric ulcer.

The recommended daily dose is 150 mg twice daily or 300 mg once daily in the evening. Prior to treatment with nizatidine, care should be taken to exclude the possibility of gastric cancer.

Maintenance therapy.

The recommended oral dosage for adults with duodenal ulcer is 150 mg once daily in the evening for a period not exceeding 12 months.

Gastroesophageal reflux disease.

The recommended oral dosage in adults for the treatment of erosions, ulcerations and associated heartburn is 150 mg twice daily.

Dosage adjustment for patients with moderate to severe renal insufficiency.

The dose for patients with renal dysfunction should be reduced as follows. If creatinine clearance is between 20 and 50 mL/minute, the dose should be 150 mg/day. If creatinine clearance is less than 20 mL/minute, the dose should be 150 mg every 2 days.

Maintenance therapy (duodenal ulcer).

If creatinine clearance is between 20 and 50 mL/minute, the dose should be 150 mg every 2 days. If creatinine clearance is less than 20 mL/minute, the dose should be 150 mg every 3 days.
Some elderly patients may have creatinine clearances of less than 50 mL/minute, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

Overdosage

Overdoses of nizatidine have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered.

Signs and symptoms.

There is little clinical experience with overdosage of nizatidine in humans. Test animals which received large doses of nizatidine have exhibited cholinergic type effects, including lacrimation, salivation, emesis, miosis and diarrhoea. Single oral doses of 800 mg/kg in dogs and of 1,200 mg/kg in monkeys were not lethal. Intravenous median lethal doses in the rat and mouse were 301 and 232 mg/kg, respectively.

Treatment.

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in the patient.
If overdosage occurs, use of activated charcoal should be considered along with clinical monitoring and supportive therapy. Renal dialysis for 4 to 6 hours has increased plasma clearance.
Contact the Poisons Information Centre on 131 126 for management of overdose.

Presentation

Capsules, 150 mg (size 2 capsule, dark yellow/ pale yellow, marked N150): 60's; 300 mg (size 1 capsule, brown/ pale yellow, marked N300): 30's (blister pack).

Storage

Store below 25°C.

Poison Schedule

S4.