Consumer medicine information

Rani 2

Ranitidine

BRAND INFORMATION

Brand name

Rani 2

Active ingredient

Ranitidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Rani 2.

What is in this leaflet

This leaflet answers some common questions about Rani 2.

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

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Rani 2 against the benefits they expect it will have for you.

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

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

What Rani 2 is used for

Rani 2 is used to:

  • treat stomach and duodenal ulcers (duodenal ulcers occur in the tube leading out of the stomach).
  • prevent stomach and duodenal ulcers from coming back.
  • treat and prevent reflux oesophagitis (also known as reflux), which is the washing back of food and acid from the stomach up into the food pipe. Reflux can cause heartburn, a painful burning sensation which occurs in the chest and rises up to the throat.
  • treat Zollinger-Ellison syndrome, a rare disorder where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.
  • treat scleroderma oesophagitis, a rare condition in which the food pipe becomes thick and hardened, allowing acid to reflux.

Rani 2 belongs to a group of medicines called histamine2 (H2) antagonists or histamine2 (H2) blockers. These medicines work by reducing the amount of acid produced by the stomach. This helps to heal the ulcer and/or reflux disease.

Ask your doctor if you have any questions about why Rani 2 has been prescribed for you. Your doctor may have prescribed Rani 2 for another reason.

Rani 2 is not recommended for use in children under the age of 8, as there have been limited studies of its effects in children of this age group.

There is no evidence that Rani 2 is addictive.

Before you take Rani 2

When you must not take it

Do not take Rani 2 if you are allergic to medicines containing ranitidine or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

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.

Before you start to take it

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

Tell your doctor if you are pregnant or plan to become pregnant. The safety of Rani 2 in pregnancy has not been established. Rani 2 is not recommended for use during pregnancy.

If there is a need to consider Rani 2 during your pregnancy, your doctor will discuss with you the risks and benefits of taking it.

Tell your doctor if you are breastfeeding or wish to breastfeed. Rani 2 passes into breast milk. Your doctor will discuss the risks and benefits of taking Rani 2 when breastfeeding.

Tell your doctor if you smoke. Smoking may worsen your condition. Your doctor may advise you to reduce or stop smoking.

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

  • kidney problems
  • acute porphyria (rare disease of blood pigments)
  • chronic lung disease
  • diabetes
  • a weakened immune system or lowered resistance to infection, sometimes caused by certain diseases or treatments.

Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you start taking Rani 2.

Taking other medicines

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

Some medicines and Rani 2 may interfere with each other. These include:

  • sucralfate, another medicine used to treat stomach and/or duodenal ulcers
  • warfarin, a medicine used to prevent blood clots
  • triazolam, midazolam, used as sedatives
  • ketoconazole, a medicine used to treat fungal infections
  • atazanavir and delaviridine, medicines used to treat HIV infection
  • glipizide, a medicine used to treat diabetes
  • gefitinib, a medicine used to treat cancer.

You may need different amounts of your medicine, or you may need to take different medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

How to take Rani 2

How much to take

The dose varies from person to person.

The usual dose is 150 mg to 300 mg per day, taken as one 150mg tablet once or twice a day, or one 300mg tablet at night. Your doctor may advise you to take a different dose. This depends on your condition.

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

How to take it

Swallow the tablets with a glass of water.

When to take it

Rani 2 can be taken with or without food.

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 the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

How long to take it

If you are taking Rani 2 to heal an ulcer, you will need to take it for 4 to 8 weeks.

If you are taking Rani 2 to treat reflux disease, you may need to take it for up to 12 weeks.

It is very important that you take the full course of Rani 2 prescribed by your doctor so that your condition is properly treated.

Even when you have completed your tablets, your doctor may decide to continue your treatment with Rani 2, possibly at a different dosage, in order to prevent the problem coming back again.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Rani 2. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking Rani 2

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Rani 2.

If you become pregnant while taking Rani 2, tell your doctor.

Visit your doctor regularly so they can check on your progress.

If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking Rani 2.

Things you must not do

Do not stop taking Rani 2, or lower the dose, without checking with your doctor.

Do not use Rani 2 to treat any other conditions unless your doctor tells you to.

Do not give Rani 2 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 Rani 2 affects you. Rani 2 generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Rani 2 may cause dizziness or light-headedness in some people.

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 may advise you to limit your alcohol intake.
  • Aspirin and many other medicines used to treat arthritis, period pain and headaches - these medicines may irritate the stomach and may make your condition worse. Your doctor or pharmacist may suggest other medicines you can take.
  • Caffeine - your doctor may advise you 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 may advise you to stop smoking or at least cut down.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Rani 2.

Like all other medicines, Rani 2 may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age, you may have an increased chance of getting side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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

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

  • headache
  • tiredness or weakness
  • sleeping problems
  • dizziness
  • decreased sex drive, impotence
  • constipation, diarrhoea
  • nausea, vomiting
  • stomach cramps or pain
  • muscle or joint pain
  • hair loss
  • blurred vision
  • abnormal uncontrolled movements, muscle twitching or spasms.

Tell your doctor immediately if you notice any of the following:

  • skin rash, redness, itching
  • fast, slow or irregular heart beat
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • yellow colouring of the skin or eyes
  • general illness associated with weight loss
  • depression, confusion, hallucinations.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • severe stomach pain or discomfort
  • severe skin reactions
  • swelling of the eyelids, face, throat or tongue causing difficulty breathing or swallowing
  • severe chest pain or tightness.

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

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

Some health problems may arise from the condition being treated itself, rather than the treatment. For this reason, contact your doctor immediately if you notice any of the following:

  • pain or indigestion which occurs during treatment with Rani 2
  • passing black or blood stained motions.

After taking Rani 2

Storage

Keep Rani 2 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.

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack, they will not keep well.

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

Do not store Rani 2 or any other medicine in the bathroom or near a sink. Do not leave Rani 2 in the car or on windowsills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Rani 2, or your tablets have passed its expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Rani 2 comes in 2 strengths of tablets:

  • Rani 2 150 mg - creamish yellow, biconvex, round, film-coated tablets marked "G" on one side and "00" over "30" on the other. Each blister pack contains 60 tablets.
  • Rani 2 300 mg- creamish yellow, biconvex, capsule-shaped, film-coated tablets marked "G" on one side and "0031" on the reverse. Each blister pack contains 30 tablets.

Ingredients

The active ingredient in Rani 2 is ranitidine (as ranitidine hydrochloride).

Each tablet contains 150 mg or 300 mg of ranitidine.

Rani 2 tablets contain the following inactive ingredients:

  • microcrystalline cellulose
  • magnesium stearate
  • hypromellose
  • castor oil
  • ferric oxide yellow
  • titanium dioxide
  • purified talc

The 300 mg tablets also contain croscarmellose sodium.

The tablets are gluten free.

Supplier

Rani 2 is supplied in Australia by:

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

Australian registration numbers:

Rani 2 150mg - AUST R 285696

Rani 2 300mg - AUST R 285693

This leaflet was prepared on 23 March 2020.

Rani 2_cmi\Mar20/00

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Rani 2

Active ingredient

Ranitidine

Schedule

S4

 

1 Name of Medicine

Ranitidine hydrochloride.

6.7 Physicochemical Properties

Ranitidine hydrochloride is a white or pale yellow, crystalline powder, freely soluble in water and in methanol, sparingly soluble in ethanol, very slightly soluble in methylene chloride.
Ranitidine is an aminoalkyl-substituted furan and is structurally different from cimetidine lacking the imidazole ring and the cyanoguanidine group.

Chemical structure.


Chemical name: N-(2-(((5-((dimethylamino) methyl)-2-furan-yl) methyl)thio)ethyl)-N'- methyl -2-nitro-1,1-ethenediamine hydrochloride.
Molecular formula: C13H22N4O3S.HCl.
Molecular weight: 350.9.

CAS number.

66357-59-3.

2 Qualitative and Quantitative Composition

Each Rani 2 tablet contains ranitidine hydrochloride as the active ingredient equivalent to 150 mg or 300 mg of ranitidine. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Rani 2 150 mg.

Creamish yellow, biconvex, round, film-coated tablets with "G" on one side and "00" over "30" on the reverse.

Rani 2 300 mg.

Creamish yellow, biconvex, capsule shaped, film-coated tablets with "G" on one side and "0031" on the reverse.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ranitidine hydrochloride is a histamine H2-receptor antagonist.
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 beta adrenoceptors. Ranitidine is a potent inhibitor of gastric secretion in the rat and dog.

Clinical trials.

All the evidence from human studies is compatible with a selective, competitive antagonism of histamine H2-receptors by ranitidine in man. 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 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 12 hours after this dose. In 10 patients with duodenal ulcer, 150 mg ranitidine 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 seven days did not cause bacterial overgrowth in the stomach.
Pulse rate, blood pressure, electrocardiogram and electroencephalogram were not significantly affected in man 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, estriol, progesterone or cortisol levels.
One study in 30 male duodenal ulcer patients showed a significant decrease in basal thyroxine levels after 4 weeks 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.

5.2 Pharmacokinetic Properties

Absorption.

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.
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. The absolute bioavailability of ranitidine is 50 to 60%, and plasma concentrations increase proportionally with increasing dose up to 200 mg. Bioavailability of ranitidine is approximately 50%. Serum protein binding of ranitidine in man is in the range 10% to 19%. The elimination half-life is approximately two hours.

Distribution.

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

Metabolism.

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.

Excretion.

Plasma concentrations decline bi-exponentially, 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 liver 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.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Short-term treatment of proven duodenal ulcer and gastric ulcer.
Maintenance treatment to reduce the risk of relapse in duodenal ulcer.
Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer.
Treatment of gastrinoma (Zollinger-Ellison syndrome).
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.
Treatment of scleroderma oesophagitis.

4.3 Contraindications

Patients with known hypersensitivity to ranitidine hydrochloride or any components of Rani 2 tablets.

4.4 Special Warnings and Precautions for Use

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 is instituted.

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 has not revealed any undue untoward effects.

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.

Gastric pH.

Agents that elevate gastric pH may increase the already present risk of nosocomial pneumonia in intubated intensive care patients receiving mechanical ventilation.

Pneumonia.

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 that had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).

Use in renal impairment.

Ranitidine is excreted via the kidneys and in the presence of 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 the elderly.

No data available.

Paediatric use.

Experience with ranitidine tablets 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.
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. ketoconazole, atazanavir, delavirdine, gefitinib).
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.

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 and 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 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.

Cardiovascular.

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

Gastrointestinal.

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

Musculoskeletal.

Rare reports of arthralgias and myalgia.

Haematologic.

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.

Endocrine.

Controlled studies in animals and man 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 breast conditions such as 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.

Integumental.

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

Hepatic.

Transient and reversible changes in the 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.

Renal.

Very rare cases of acute interstitial nephritis have been reported.

Other.

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

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

Acute duodenal or gastric ulceration.

Acute treatment.

300 mg taken as a single dose at bedtime, or 150 mg taken twice daily, in the morning and at bedtime.
It is not necessary to time the dose in relation to meals. In most cases healing will occur in four weeks although a small number of patients may require an additional two to four weeks therapy.

Maintenance treatment of duodenal ulcer.

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

Maintenance treatment of gastric ulcer.

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

Gastrinoma (Zollinger-Ellison syndrome).

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

Reflux oesophagitis.

Symptomatic treatment of reflux oesophagitis.

300 mg taken as a single dose at bedtime or 150 mg taken twice daily in the morning and at bedtime. It is not necessary to time the dose in relation to meals.
In severe reflux oesophagitis the efficacy of 300 mg, taken as a single dose at bedtime, has been established for up to three months.

Maintenance treatment of reflux oesophagitis.

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

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.

There has been 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)).

Treatment.

Clinical monitoring, symptomatic and supportive therapy should be employed.
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 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets contain the following inactive excipients: microcrystalline cellulose, magnesium stearate, hypromellose, castor oil, iron oxide yellow, titanium dioxide and purified talc.
The 300 mg tablets also contain croscarmellose sodium.

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

Bottles (HDPE).

Store below 25°C.

Blister packs (Al/Al).

Store below 30°C.

6.5 Nature and Contents of Container

Rani 2 150 mg.

Ranitidine hydrochloride 150 mg, bottles and blister packs of 60 tablets.

Rani 2 300 mg.

Ranitidine hydrochloride 300 mg bottles and blister packs of 30 tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

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