Consumer medicine information

Ranital Tablets



Brand name

Ranital Tablets

Active ingredient



Unscheduled: 14's; S2: 28's


Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ranital Tablets.


This leaflet answers some common questions about Ranital®.

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

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.


This medicine is used to relieve the symptoms of gastro-oesophageal reflux such as heartburn and acid indigestion. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus.

Gastro-oesophageal reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn, as well as an unsettled stomach.

It contains the active ingredient ranitidine hydrochloride.

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

It works by decreasing the amount of acid made by the stomach. This acid usually helps with the digestion of food, but an excess of this acid can result in gastro-oesophageal reflux.

Unlike antacid medications that work by neutralising the acidic content in the stomach, and only work for a few hours, Ranital® reduces the pain and relieves the symptoms of heartburn and indigestion by reducing acid production for up to twelve hours. This means that Ranital® works by preventing the excess acid problem, and also provides long lasting relief.

There is no evidence that Ranital® is addictive.


When you must not take it

Do not take this medicine if you have an allergy to:

  • ranitidine, the active ingredient, or any of the inactive ingredients mentioned at the end of this leaflet under Product Description
  • any other similar medicines such as medicines for ulcer or reflux.

Some of the symptoms of an allergic reaction may 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 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 or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any of the following medical conditions:

  • kidney or liver problems
  • acute porphyria, an inherited blood condition
  • are over 40 years of age, and it is the first time you have experienced symptoms of reflux or indigestion, or that these symptoms have recently changed
  • peptic, duodenal, or stomach ulcer
  • symptoms like vomiting, diarrhoea, passage of blood, "coffee ground" like substance in vomit or faeces, or unintended weight loss
  • lung disease
  • diabetes
  • any condition where your immune system may be affected
  • other medical conditions.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breastfeeding.

It may affect your developing baby if you take it during pregnancy.

The active ingredient in Ranital® passes into breast milk and there is a possibility that your baby may be affected.

Your doctor can discuss with you the risks and benefits involved.

There is not enough information to recommend the use of this medicine for children under the age of twelve years.

Do not use this medicine without consulting your child's doctor first.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you start taking Ranital®.

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 Ranital® may interfere with each other. These include:

  • warfarin, a medicine used to prevent blood clots
  • triazolam and midazolam, medicines used as sedatives
  • ketoconazole, an anti-fungal
  • atazanavir and delaviridine, medicines used to treat HIV
  • glipizide, a medicine used for diabetes
  • gefitinib, a medicine used in the treatment of cancer
  • sucralfate, another medicine used to treat reflux and ulcers.

These medicines may be affected by Ranital®, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist have more information on medicines to be careful with or avoid while taking this medicine.


Follow all directions given to you by your doctor or pharmacist carefully.

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

Adults and children over the age of twelve years
The usual dosage is one tablet, to be taken when symptoms appear. If symptoms return or persist for more than one hour, take another tablet.

Do not take more than two tablets in a 24 hour period.

Children under of age of twelve years
Ranital® is not recommended for children under twelve years of age except under doctor's advice.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Ranital® may not work as well and your problem may not improve.

How to take it

Swallow the tablet whole with a full glass of liquid.

When to take Ranital®

Take your medicine with or without food.

How long to take Ranital®

Ranital® is for short-term use only. If symptoms persist or worsen, please see your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 131 126) or New Zealand 0800 POISON or 0800 764766) for advice or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else has taken too much Ranital®. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.


Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Ranital®.

If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

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

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

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

This medicine may cause dizziness or light-headedness in some people.

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol, dizziness or light-headedness may be worse.

Things that may help your condition

Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.

Alcohol -
your doctor or pharmacist may advise you to limit your alcohol intake.

Aspirin and similar medicines used to treat arthritis, period pain or headaches -
these medicines may irritate the stomach and may make your condition worse. Your doctor or pharmacist can suggest other medicines you can take.

Caffeine -
your doctor or pharmacist may suggest to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and cola drinks, because they contain ingredients that may irritate your stomach.

Eating habits -
eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.

Smoking -
your doctor or pharmacist may advise you to stop smoking or at least cut down.

Weight -
if you are overweight, your doctor or pharmacist may suggest losing some weight to help your condition.


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

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:

  • constipation, nausea (feeling sick), vomiting, and diarrhoea
  • abdominal pain or discomfort.

These are mild, more common side effects of this medicine, and are short-lived.

  • headache, sometimes severe
  • tiredness, insomnia (sleeplessness)
  • dizziness or drowsiness
  • muscle and joint pain
  • abnormal uncontrolled movements, muscle twitching or spasms
  • depression
  • breast tenderness and/or breast enlargement.

These are rare side effects of the medicine.

Tell your doctor or pharmacist as soon as possible if you notice any of the following:

  • yellowing of skin or eyes (jaundice)
  • confusion, depression and hallucination
  • blurred vision
  • skin troubles such as rash (red spots), itching, skin lumps or hives
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal.

The above list includes serious side effects that may require urgent medical attention. Serious side effects are rare.

If any of the following happen, stop taking Ranital® and tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the limbs, eyelids, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, itchy rash or hives. These are the symptoms of an allergic reaction
  • severe upper stomach pain together with nausea and vomiting
  • chest pain, unusual heart beat (fast, slow or irregular).

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

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people



Keep your medicine in the original container.

If you need to take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C. Protect from light.

Do not store Ranital® 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 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.


If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.


What it looks like

Ranital® 150mg: yellow, round, film-coated tablets, scored on one side.

Available in blisters of 14 or 28 tablets.


Active ingredient:

  • Ranital® 150mg - 150mg ranitidine as ranitidine hydrochloride.

Inactive ingredients:

  • microcrystalline cellulose
  • calcium hydrogen phosphate
  • maize starch
  • sodium starch glycollate
  • magnesium stearate
  • colloidal
  • anhydrous silica
  • lactose
  • hypromellose
  • titanium dioxide
  • macrogol 4000
  • iron oxide yellow CI77492.

This medicine does not contain gluten.


Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road,
Macquarie Park, NSW 2113
Tel: 1800 634 500

Novartis New Zealand Ltd
PO Box 99102
Auckland 1149
New Zealand
Tel: 0800 354 335

This leaflet was revised in April 2016.

Australian Register Number
Ranital® 150mg film-coated tablets: AUST R 75206


Brand name

Ranital Tablets

Active ingredient



Unscheduled: 14's; S2: 28's


Name of the medicine

Ranitidine hydrochloride.


Microcrystalline cellulose, calcium hydrogen phosphate, maize starch, sodium starch glycollate (Type A), magnesium stearate, colloidal anhydrous silica, lactose, hypromellose, titanium dioxide, macrogol 4000, iron oxide yellow CI77492.


Chemical name: N-(2-(((5-[(dimethylamino) methyl]-2-furanyl) methyl)thio) ethyl)-N'- methyl-2-nitro1,1- ethenediamine hydrochloride.
A white to pale or slightly yellow crystalline powder, freely soluble in water and in methanol, sparingly soluble in ethanol, very slightly soluble in methylene chloride. It exhibits polymorphism.
CAS: [66357-59-3]. Molecular formula: C13H23ClN4O3S. MW: 350.9.
Ranital 150 mg tablets contain the active ingredient ranitidine hydrochloride.
(167.5 mg equivalent to 150 mg of ranitidine).
Ranital tablets also contain the following inactive ingredients: microcrystalline cellulose, calcium hydrogen phosphate, maize starch, sodium starch glycollate (Type A), magnesium stearate, colloidal anhydrous silica, lactose, hypromellose, titanium dioxide, macrogol 4000, iron oxide yellow CI77492.


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 betaadrenoreceptors. 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 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 four and nine 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 to 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, being approximately 90% two hours after an oral 150 mg dose and a significant effect is still evident twelve hours after this dose. In ten patients with duodenal ulcer, ranitidine 150 mg given orally every twelve 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 seven days did not cause bacterial overgrowth in the stomach.
Pulse rate, blood pressure, ECG and 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 patients with duodenal ulcer showed a significant decrease in basal thyroxine levels after four weeks of treatment with ranitidine 300 mg daily, but no significant change in thyroid stimulating hormone was noted.


Peak plasma levels occur about two to three hours after oral administration of ranitidine. Absorption is not significantly altered by food or concurrent antacid administration. Bioavailability of ranitidine is approximately 50%. Serum protein binding of ranitidine in humans is in the range of 10 to 19%. The elimination half-life is approximately two hours.
Ranitidine is excreted via the kidneys mainly as unchanged drug and in minor amounts as the N-oxide, S-oxide and desmethyl metabolites. The 24 hour urinary recovery of free ranitidine and its metabolites is about 40% after oral administration of the drug.
Impairment of renal function requires a reduction in dosage (see Precautions). 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 ranitidine appears necessary in patients with hepatic impairment.


For the relief of symptoms of gastro-oesophageal reflux.


Known hypersensitivity to ranitidine.
Known hypersensitivity to any of the inactive ingredients.


Use with caution in the following circumstances.

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 Ranital tablets is instituted.


Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranital should therefore be avoided in patients with a history of acute porphyria.

Gastric pH.

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

Impaired renal function.

Ranitidine is excreted via the kidneys and 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.

Use in pregnancy.

(Category B1)
The safety of ranitidine in pregnancy has not been established. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to ranitidine. Ranitidine crosses the placenta. 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.

Use in lactation.

Ranitidine is secreted in breast milk in lactating mothers but the clinical significance of this has not been fully evaluated. Ranital should only be used by nursing mothers if considered essential.

Use in children.

Experience with ranitidine tablets in children is limited and such use has not been fully evaluated in clinical studies. Ranital tablets are not recommended for children under 12 years of age except on medical advice.


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.
Interactions occur by several mechanisms including:

1) Inhibition of cytochrome P450-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, lidocaine, 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.

2) 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 (e.g. 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.

3) 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. ketaconazole, atazanavir, delaviridine, gefitnib).
Although ranitidine has been reported to bind weakly to cytochrome P450 in vitro, recommended doses of the drug do not inhibit the action of the cytochrome P450 linked oxygenase in the liver.
There are conflicting reports in the literature about possible interactions between ranitidine and several drugs; the clinical significance of these reports has not been substantiated.
If high doses (2 g) of sucralfate are coadministered with ranitidine, the absorption of the latter may be reduced. This effect is not seen if sucralfate is taken after an interval of two hours.

Adverse Effects

The following have been reported as events in clinical trials or in the 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.

Central nervous system.

Rarely, malaise, dizziness, somnolence, insomnia and vertigo. Rare cases of reversible mental confusion, 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.


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


Constipation, diarrhoea, nausea/vomiting, abdominal discomfort/pain.


Rare reports of arthralgias and myalgia.


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


Controlled studies in animals and humans have shown no stimulation of any pituitary hormone by ranitidine, no antiandrogenic activity, and cimetidine induced gynaecomastia and impotence in hypersecretory patients have resolved when ranitidine was substituted. However, occasional cases of gynaecomastia 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.


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


Very rare cases of acute interstitial nephritis have been reported.


Transient and reversible changes in liver-function tests can occur. There have been occasional reports of hepatitis, hepatocellular or hepatocanalicular or mixed, with or without jaundice. These were usually reversible.


Rare cases of hypersensitivity reactions (e.g. fever, bronchospasm, anaphylactic shock, urticaria, angioneurotic oedema, hypotension, chest pain, rash, eosinophilia), small increases in serum creatinine. Acute pancreatitis has been reported rarely.

Dosage and Administration

Ranital is an oral tablet.

Adults and children over 12 years.

Relief of symptoms of gastro-oesophageal reflux.

One tablet should be taken as soon as symptoms appear, at any time, day or night. If the symptoms return or persist for more than one hour, a second tablet can be taken. Not more than two tablets should be taken within a 24 hour period.
The tablet should be swallowed whole with liquid.
Not recommended for children under 12 years of age except under medical advice.


Contact Poisons Information Centre on 131 126 for advice on management of overdose.


There has been limited experience of overdosage 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 Adverse Effects).


Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.


Ranital 150 mg tablets.

Yellow, round, film-coated tablets, scored on one side. Available in aluminium blisters in packs of 14 or 28 tablets.


Store below 25°C. Protect from light.

Poison Schedule

14's: unscheduled; 28's: S2.