Consumer medicine information

Terry White Chemists Ranitidine Tablets



Brand name

Terry White Chemists Ranitidine

Active ingredient





Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Terry White Chemists Ranitidine Tablets.

What is in this leaflet

Read this leaflet carefully before taking your medicine.

This leaflet answers some common questions about ranitidine. 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 has weighed the risks of you using 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 your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is Terry White Chemists Ranitidine tablets. It contains the active ingredient ranitidine (as hydrochloride).

It is used to treat:

  • Duodenal ulcer
  • Gastric ulcer
  • Reflux oesophagitis
  • Scleroderma oesophagitis
  • Zollinger-Ellison syndrome

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

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

How it works

Ranitidine belongs to a group of medicines called H2 antagonists or H2 blockers.

Ranitidine works by decreasing the amount of acid made by the stomach. This helps reduce pain and also allows an ulcer and/or reflux disease to heal in most people.

There is no evidence that this medicine is addictive.

Use in children

Experience with ranitidine preparations in children is limited and such use has not been fully evaluated in clinical studies. It has, however, been used successfully in children aged 8 to 18 years in doses up to 150 mg twice daily.

Before you take this medicine

When you must not take it

Do not take this medicine if:

  • You are hypersensitive to, or have had an allergic reaction to, ranitidine or any of the ingredients listed at the end of this leaflet.
  • The expiry date (EXP) printed on the pack has passed.
  • The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

  • You are allergic to foods, dyes, preservatives or any other medicines
  • You have ever had an allergic reaction to ranitidine or any of the ingredients listed at the end of this leaflet
  • You are allergic to any medicine
  • You have had stomach ulcers before and you are taking non-steroidal anti-inflammatory (NSAID) medicines
  • You have kidney disease
  • You have liver disease
  • You have a disease known as porphyria (rare disease of blood pigments)
  • You have lung disease, cough or a chest infection
  • You are diabetic
  • You have problems with your immune system
  • You have stomach cancer
  • You are over 65 years of age.
  • You are pregnant, likely to get pregnant or are breastfeeding. Your doctor will tell you if you should take this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, have taken any recently or if you start any new ones. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop with or without a prescription.

Some medicines may interact with ranitidine. These include:

  • sucralfate, another medicine used to treat peptic ulcer
  • ketoconazole, a medicine used to treat fungal infection
  • heart medication e.g. procainamide
  • anticoagulant e.g. warfarin
  • benzodiazepines e.g. triazolam, midazolam
  • antiretrovirals e.g. atazanavir, delavirdine
  • antidiabetic e.g. glipizide
  • anticancer e.g. gefitinib
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), used to treat pain and inflammation.

If you are taking any of the above medicines, you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with ranitidine.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow each tablet whole with a glass of water.

When to take it

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

It does not matter if you take it before, with or after food.

If ranitidine is prescribed twice a day, the best time to take it is in the morning and at bedtime.

If ranitidine is prescribed once daily, the best time to take it is at bedtime.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses. This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:

  • you are about to be started on any new medicine
  • you are pregnant or are planning to become pregnant
  • you are breastfeeding or are planning to breastfeed
  • you are about to have any blood tests
  • you are going to have surgery or an anaesthetic or are going into hospital.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:

  • Give this medicine to anyone else, even if their symptoms seem similar to yours.
  • Take your medicine to treat any other condition unless your doctor tells you to.
  • Stop taking your medicine, or change the dosage, without first checking with your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.

Ranitidine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ranitidine may cause dizziness or light-headedness in some people.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are taking ranitidine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor if you notice any of the following:

  • headache
  • dizziness or light-headedness
  • uncontrolled movements. This effect is reversible and should get better once you stop taking this medicine
  • if you are a man, breast tenderness and/or breast enlargement; loss in sexual desire or performance. The interference with sexual function is normally reversible and should get better once you stop taking this medicine
  • inflammation of blood vessels (vasculitis)
  • abdominal discomfort or pain
  • constipation or diarrhoea (especially if antibiotics are also being taken)
  • sore joints and/or muscles
  • feeling of agitation or depression
  • hallucinations
  • loss of hair.

Inform your doctor immediately if you get any signs of liver problems which may cause one or more of the following:

  • generally feeling unwell
  • severe nausea (feeling sick)
  • loss of appetite
  • development of yellowish tinge to skin and/or eyes (jaundice)
  • fever
  • rash and/or itching
  • dark coloured urine
  • confusion
  • muscle tremor
  • vomiting (being sick)
  • severe stomach pain rarely caused by inflamed pancreas
  • blurred vision.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

  • unusual tiredness, shortness of breath or tendency to infections or bruising, which can be caused by upsets to "blood counts"
  • changes in the way the heart beats; either faster or slower
  • severe stomach pain or a change in the type of pain
  • symptoms of an allergic reaction including cough, shortness of breath, wheezing of difficulty breathing; swelling of the face, lips, tongue, throat; rash, itching or hives on the skin; fainting and/or hayfever-like symptoms.

Other problems are more likely to arise from the ulcer itself rather than the treatment. For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion occurring during treatment with ranitidine
  • you begin to vomit blood or food
  • your pass black (blood-stained) motions.

Other side effects not listed above may occur in some patients.

Storage and disposal


Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C. Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine 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.


If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What Terry White Chemists Ranitidine looks like

Terry White Chemists Ranitidine tablets are available in two different strengths:

  • Terry White Chemists Ranitidine 150 mg tablets: white to off-white, round, biconvex film coated tablets. Scored on one side and engraved "RAN" over "150" on the other side.
Available in blister packs of 60.
  • Terry White Chemists Ranitidine 300 mg tablets: white to off-white, capsule-shaped, biconvex film coated tablets. Scored on one side and engraved "RAN 300" on the other side
Available in blister packs of 30.

* Not all strengths, pack types and/or pack sizes may be available.


Each Terry White Chemists Ranitidine tablets contains 150 mg of ranitidine (as ranitidine hydrochloride) as the active ingredient.

Each Terry White Chemists Ranitidine tablets contains 300 mg of ranitidine as (as ranitidine hydrochloride) the active ingredient.

Terry White Chemists Ranitidine tablets also contains the following inactive ingredients:

  • Microcrystalline cellulose
  • magnesium stearate
  • colloidal anhydrous silica
  • hypromellose
  • polydextrose
  • titanium dioxide
  • vanillin
  • carnauba wax.

Terry White Chemists Ranitidine tablets are gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

Terry White Chemists Ranitidine 150 mg tablets blister pack: AUST R 121975.

Terry White Chemists Ranitidine 300 mg tablets blister pack: AUST R 121978.


Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

This leaflet was last updated in: March 2019.

Published by MIMS May 2019


Brand name

Terry White Chemists Ranitidine

Active ingredient





1 Name of Medicine

Ranitidine hydrochloride.

6.7 Physicochemical Properties

Ranitidine hydrochloride is a histamine H2-receptor antagonist. It is an aminoalkyl substituted furan and is structurally different from cimetidine, lacking the imidazole ring and the cyanoguanidine group.
Ranitidine hydrochloride is a white or pale yellow crystalline powder with a slightly bitter taste and sulfur-like odour. Ranitidine hydrochloride is freely soluble in water and methanol and sparingly soluble in ethanol (96%).
Chemical name: N-(2-(((5-[(dimethylamino) methyl]-2-furanyl) methyl)thio)ethyl) N'-methyl-2-nitro-1, 1-ethenediamine hydrochloride. Empirical Molecular Formula: C13H22N4O3S.HCl. Molecular Weight: 350.87.

Chemical structure.

CAS number.


2 Qualitative and Quantitative Composition

Each tablet contains ranitidine 150 mg or 300 mg.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ranitidine 150 mg tablets.

White to off-white, round, biconvex tablets. Scored on one side and engraved "RAN" over "150" on the other side.

Ranitidine 300 mg tablets.

White to off-white, capsule-shaped, biconvex tablets. Scored on one side and engraved "RAN 300" on the other side.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Animal experiments both in vitro and in vivo have established that ranitidine is a selective, competitive antagonist of histamine at H2-receptor sites. Ranitidine has no significant interaction at histamine H1-receptors, muscarinic receptors or β-adrenoceptors. Ranitidine is a potent inhibitor of gastric secretion in the rat and dog.
All the evidence from human studies is compatible with a selective, competitive antagonism of histamine H2-receptors by ranitidine in humans. Oral or intravenous administration of ranitidine inhibits both basal gastric secretions and gastric acid secretion induced by histamine, pentagastrin and other secretagogues. On a weight basis ranitidine is between 4 and 9 times more potent than cimetidine.
After oral administration of ranitidine, the plasma concentrations of ranitidine achieved are directly related to the dose administered. A plasma ranitidine concentration of 50-100 nanogram/mL has an inhibitory effect upon stimulated gastric acid secretion of approximately 50%.
Inhibition of pentagastrin induced gastric acid secretion increases with dose and is approximately 90% two hours after an oral 150 mg dose and a significant effect is still evident 12 hours after this dose. In 10 patients with duodenal ulcer, 150 mg given orally every 12 hours significantly reduced mean 24 hour hydrogen ion activity by 69% and nocturnal gastric acid output by 90%, whereas cimetidine (200 mg three times daily and 400 mg at night) reduced mean 24 hour hydrogen ion activity by 48% and nocturnal gastric acid output by 70%.
Pepsin secretion is also inhibited by ranitidine, but secretion of gastric mucus is not affected. Ranitidine does not alter the secretion of bicarbonate or enzymes from the pancreas in response to secretin and pancreozymin. Reduction in gastric acid secretion induced by ranitidine 150 mg twice daily for 7 days did not cause bacterial overgrowth in the stomach.
Pulse rate, blood pressure, electrocardiogram (ECG) and electroencephalogram (EEG) were not significantly affected in humans following recommended doses of ranitidine.
Chronic ranitidine therapy (300 mg/day for 28 days) had no effect on serum prolactin, gastrin, thyroid stimulating hormone, follicle stimulating hormone, luteinising hormone, gonadotrophins, testosterone, oestriol, progesterone or cortisol levels.
One study in 30 male duodenal ulcer patients showed a significant decrease in basal thyroxine levels after four weeks of treatment with 300 mg ranitidine daily, but no significant change in thyroid stimulating hormone was noted. Acute administration of 50 mg ranitidine intravenously had no effect on plasma aldosterone in healthy male volunteers whereas it caused a significant reduction in vasopressin. Cimetidine 200 mg intravenously had a similar effect on vasopressin.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties


Peak plasma levels occur about 2-3 hours after oral administration of ranitidine. Absorption is not significantly altered by food or concurrent antacid administration.
Following oral administration of 150 mg ranitidine, maximum plasma concentrations (300 to 580 nanogram/mL) occurred after 1 to 3 hours. Two distinct peaks or a plateau in the absorption phase suggest reabsorption of drug secreted into the intestine. Bioavailability of ranitidine is approximately 50%. Serum protein binding of ranitidine in man is in the range 10-19%. The elimination half-life is approximately 2 hours.


Ranitidine is not extensively bound to plasma proteins (15%), but exhibits a large volume of distribution ranging from 96 to 142 L.


The fraction of the dose recovered as metabolites is similar after both oral and intravenous dosing; and includes 6% of the dose in urine as the N-oxide, 2% as the S-oxide and small amounts of desmethylranitidine and the furoic acid analogue. The 24 hour urinary recovery of free ranitidine and its metabolites is about 40% after oral administration of the drug.


Plasma concentrations decline biexponentially, with a terminal half-life of 2 to 3 hours. The major route of elimination of unchanged ranitidine is renal. Renal clearance is approximately 500 mL/min, which exceeds glomerular filtration indicating net renal tubular secretion.

Patients over 50 years of age.

In patients over 50 years of age, half-life is prolonged (3 to 4 hours) and clearance is reduced, consistent with the age related decline of renal function. However, systemic exposure and accumulation are 50% higher. This difference exceeds the effect of declining renal function, and indicates increased bioavailability in older patients. Impairment of renal function requires a reduction in dosage (see Section 4.4 Special Warnings and Precautions for Use).
Impairment of hepatic function may increase the bioavailability of ranitidine but has no significant effect on the elimination half-life. However, in the presence of normal renal function, no dosage reduction for oral or intravenous ranitidine appears necessary in patients with hepatic impairment.

5.3 Preclinical Safety Data


No data available.


No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Duodenal ulcer.

Short-term treatment of proven duodenal ulcer.
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.

Gastric ulcer.

Short-term treatment of proven gastric ulcer.
Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer.

Reflux oesophagitis.

Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative antireflux measures and simple drug therapies such as antacids.
Maintenance treatment to reduce the risk of relapse of reflux oesophagitis.

Scleroderma oesophagitis.

Treatment of scleroderma oesophagitis.

Zollinger-Ellison syndrome.

Treatment of gastrinoma (Zollinger-Ellison syndrome).

4.3 Contraindications

Ranitidine tablets are contraindicated in patients with a known hypersensitivity to ranitidine hydrochloride or any components in this preparation.

4.4 Special Warnings and Precautions for Use


Bradycardia has been reported rarely in association with rapid administration of ranitidine injection, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.

Gastric ulcer.

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and therefore may delay diagnosis of the condition. Accordingly, where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with ranitidine syrup, tablets or injection is instituted.

Gastric pH and pneumonia.

Agents that elevate gastric pH may increase the already present risk of nosocomial pneumonia in intubated ICU patients receiving mechanical ventilation.
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 H2-histamine receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).

Use in hepatic impairment.

Studies in patients with hepatic dysfunction (compensated cirrhosis) indicate that there are minor, but clinically insignificant alterations in ranitidine half-life, distribution, clearance and bioavailability. Nevertheless, caution should be observed in patients with hepatic dysfunction since ranitidine is metabolised by the liver.

Higher doses.

The use of higher than recommended doses of intravenous H2-antagonists has been associated with rises in hepatic enzymes when treatment has been extended beyond five days.
ALT levels were increased to twice the pretreatment levels following prolonged IV administration of ranitidine (see Section 4.8 Adverse Effects (Undesirable Effects)). Therefore it may be prudent to monitor AST and ALT in patients receiving IV treatment for 5 days or longer and in those with pre-existing liver diseases.

Use in renal impairment.

Ranitidine is excreted via the kidneys. In the presence of severe renal impairment, plasma levels of ranitidine are increased and prolonged. Accordingly, in the presence of significant renal impairment, serum levels should be monitored and dosage adjustments made. The clearance of ranitidine is increased during haemodialysis.

Tobacco smoking.

Tobacco smoking appears to contribute to an increased risk of developing peptic ulcer disease and may also impair ulcer healing or increase the risk of ulcer recurrence (see Section 4.2 Dose and Method of Administration).

Long-term use.

The risk of ulcer recurrence is determined by many factors. In some cases, long periods of treatment may be necessary and/or repeated. Evidence from controlled clinical trials of up to 18 months continuous treatment with ranitidine did not reveal any undue untoward effects.


In patients with a history of acute porphyria, rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria.

Use in the elderly.

Since malignancy is more common in the elderly, particular consideration must be given to this before therapy with ranitidine is instituted.
Elderly patients receiving NSAIDs concomitantly with ranitidine should be closely supervised.
Sporadic cases of drug interactions have been reported in elderly patients involving both hypoglycaemic drugs and theophylline. The significance of these reports cannot be determined at present, as controlled clinical trials with theophylline and ranitidine have shown no interaction (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Elderly patients may be at risk for confusional states and depression (see Section 4.8 Adverse Effects (Undesirable Effects)).
Ranitidine is known to be substantially excreted by the kidney and the risk of toxic reactions to this medicine may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function (see Section 4.4 Special Warnings and Precautions for Use, Use in renal impairment).

Paediatric use.

Experience with ranitidine preparations in children is limited and such use has not been fully evaluated in clinical studies. It has, however, been used successfully in children aged 8 to 18 years in doses up to 150 mg twice daily.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Ranitidine has the potential to affect the absorption, metabolism, or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

Inhibition of CYP450 linked mixed function oxygenase system.

Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lignocaine, phenytoin, propranolol and theophylline. There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

Alteration of gastric pH.

The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delavirdine, gefitinib).
If high doses (2 g) of sucralfate are coadministered with ranitidine, the absorption of ranitidine may be reduced. This effect is not seen if sucralfate is taken after an interval of at least two hours.

Competition for renal tubular secretion.

Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effects of ranitidine on human fertility. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to ranitidine.
(Category B1)
The safety of ranitidine in pregnancy has not been established. Ranitidine crosses the placenta. Ranitidine should only be used during pregnancy if considered essential. If the administration of ranitidine is considered to be necessary, its use requires that the potential benefits be weighed against possible hazards to the patient and to the foetus.
Ranitidine is secreted in breast milk in lactating mothers but the clinical significance of this has not been fully evaluated. Ranitidine should only be used by breastfeeding mothers if considered essential.

4.8 Adverse Effects (Undesirable Effects)

The following have been reported as adverse events in clinical trials or in routine management of patients treated with ranitidine. The relationship to ranitidine therapy has not been clear in many cases. Headache, sometimes severe, has been reported in a very small proportion of patients.

Body as a whole.

Anaphylaxis, chest pain (as part of a hypersensitivity reaction), fever (as part of a hypersensitivity reaction), headache (sometimes severe), hypotension (as part of a hypersensitivity reaction), malaise.


As with other H2-receptor antagonists, rare reports of AV block, asystole, bradycardia, tachycardia and premature ventricular beats.


Controlled studies in animals and humans have shown no stimulation of any pituitary hormone by ranitidine, no antiandrogenic activity, and cimetidine induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine was substituted. However, occasional cases of gynecomastia and galactorrhoea, impotence and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population.


Abdominal discomfort/ pain, constipation, diarrhoea, nausea/vomiting.


Rare reports of agranulocytosis or pancytopaenia, sometimes with marrow hypoplasia or aplasia have been reported. Blood count changes (leukopaenia, thrombocytopaenia) have occurred in a few patients. These are usually reversible.

Hepatic (see Section 4.4 Special Warnings and Precautions for Use).

Transient and reversible changes in liver function tests can occur. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg intravenously four times daily for 7 days, and in 4 of 24 subjects receiving 50 mg intravenously four times daily for 5 days. There have been occasional reports of hepatitis, hepatocellular or hepatocanalicular or mixed, with or without jaundice. These were usually reversible.


Very rare cases of acute interstitial nephritis have been reported.


Rare reports of arthralgia and myalgia.

Central nervous system.

The following were reported rarely.
Malaise, dizziness, somnolence, insomnia and vertigo.
Rarely, cases of reversible mental confusion, agitation, depression and hallucinations have been reported, predominantly in severely ill and elderly patients. In addition, reversible involuntary movement disorders have been reported rarely.
There have been a few reports of reversible blurred vision suggestive of a change in accommodation.
Reversible impotence has been reported rarely.


Rash including rare cases of mild erythema multiforme. Rare cases of vasculitis and alopecia have been reported.


The following cases were reported rarely: hypersensitivity reactions (e.g. fever, bronchospasm, anaphylactic shock, urticaria, vasculitis, angioneurotic oedema, hypotension, chest pain, rash, eosinophilia), small increases in serum creatinine, acute pancreatitis.

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 and contact Apotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.2 Dose and Method of Administration

Terry White Chemists Ranitidine tablets are intended for oral administration.


It is not necessary to time the ranitidine dose in relation to meals.

Acute duodenal ulceration.

Acute treatment.

300 mg taken orally as a single dose at bedtime, or 150 mg taken orally twice a day, in the morning and at bedtime. In most cases healing will occur in four weeks although a small number of patients may require an additional two to four weeks of therapy.

Maintenance treatment.

150 mg taken at night.
As smoking is associated with a higher rate of relapse of duodenal ulcer, patients should be advised to stop smoking. In patients unable to stop smoking, a dose of 300 mg at night provides additional therapeutic benefit.

Gastric ulcer.

Acute treatment.

300 mg taken orally as a single dose at bedtime, or 150 mg taken orally twice a day, in the morning and at bedtime. In most cases healing will occur in four weeks although a small number of patients may require an additional two to four weeks of therapy.

Maintenance treatment.

150 mg taken orally at night for a period of one year.

Gastrinoma (Zollinger-Ellison syndrome).

150 mg taken orally three times daily initially and increased, as necessary, to 600 to 900 mg/day.

Reflux oesophagitis.

Acute treatment.

300 mg taken orally as a single dose at bedtime or 150 mg taken orally twice daily, in the morning and at bedtime.
In severe reflux oesophagitis the efficacy of 300 mg, taken orally as a single dose at bedtime, has been established for up to three months.

Maintenance treatment.

150 mg taken twice daily, in the morning and at bedtime.

Renal impairment.

In patients with renal impairment or renal failure, dosage should be reduced as accumulation of ranitidine can occur. Dosage adjustments may be necessary in some older individuals based on renal function.

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


There has been virtually no experience of overdosage with ranitidine injection and limited experience with oral doses of ranitidine. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see Section 4.8 Adverse Effects (Undesirable Effects)).
Rapid bolus injection of 300 mg intravenously (six times the recommended dose which should be given slowly) caused dizziness and peripheral vasodilatation.


Symptomatic and supportive therapy should be given as appropriate.
If need be, the drug may be removed from the plasma by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)


6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, hypromellose, polydextrose, titanium dioxide, vanillin and carnauba wax.

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 25°C.

6.5 Nature and Contents of Container

Terry White Chemists Ranitidine.
150 mg tablets: Blister packs of 60. AUST R 121975.
300 mg tablets: Blister packs of 30. AUST R 121978.
Not all pack sizes or strengths may be available.

6.6 Special Precautions for Disposal

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

Summary Table of Changes