Consumer medicine information

AUSRAN

Ranitidine

BRAND INFORMATION

Brand name

Ausran Tablets

Active ingredient

Ranitidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using AUSRAN.

What is in this leaflet

This leaflet answers some common questions about AUSRAN.

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 taking AUSRAN against the benefits they expect it will have for you.

Talk to your doctor or pharmacist if you have any concerns about taking this medicine.

Keep this leaflet with this medicine.

You may need to read it again.

What is AUSRAN used for

The name of your medicine is AUSRAN. It contains the active ingredient called ranitidine hydrochloride.

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

This medicine is used to help reduce the amount of acid produced by your stomach in people who have:

  • Peptic ulcers, also called gastric ulcers if it occurs in the stomach or duodenal ulcers if they occur in the duodenum (the tube that leads out of the stomach)
    Peptic ulcers cause pain and discomfort (indigestion) which is felt between the naval and the breast bone.

AUSRAN can also be used to stop these ulcers from coming back.

  • Reflux oesphagitis
    This condition is caused by the washing back, or reflux, of food and acid from the stomach into the food pipe. It causes a burning sensation in the chest rising up to the throat and is also known as heartburn. It usually occurs after eating or at night and gets worse when you bend over.
  • Zollinger-Ellison disease
    This is a rare condition where the stomach produces too much acid.
  • Scleroderma oesphagitis
    By reducing the amount of acid produced by the stomach, AUSRAN reduces the pain associated with the above conditions, helps ulcers to heal and helps heal oesphagitis.

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

AUSRAN is not addictive. AUSRAN is only available with a doctor’s prescription.

Before you take AUSRAN

When you must not take it

Do not take AUSRAN if you have or have had acute porphyria

Do not take it if you are allergic to ranitidine or any of the inactive ingredients listed at the end of this leaflet.

Do not take AUSRAN after the expiry date printed on the pack.

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

Do not take AUSRAN if the packaging is torn or shows signs of tampering, or if the tablets do not look quite right.

Talk to your doctor if you are not sure whether you should be taking AUSRAN.

Before you start to take it

Tell your doctor if you have allergies to:

  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant.

Like many other medicines, the use of AUSRAN is not recommended during pregnancy. Your doctor will discuss the risks and benefits of using AUSRAN if you are pregnant.

Tell your doctor if you are breast-feeding or planning to breast-feed.

Your baby may absorb this medicine from breast milk and therefore there is the possibility of harm to the baby. Your doctor will discuss the risks and benefits of using AUSRAN if you are breast-feeding

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

  • kidney or liver problems
  • chronic lung disease
  • diabetes
  • immunocompromised
  • acute porphyria

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you use AUSRAN.

Taking other medicines

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

Some medicines may interfere with the absorption of AUSRAN. These include:

  • sucralfate (Carafate®), another medicine used to treat peptic ulcers

These medicines may be affected by AUSRAN or may affect how well it works. You may need to use different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.

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

How to take AUSRAN

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 on the box, ask your doctor or pharmacist for help.

How much to take

The dose of AUSRAN will vary depending on what condition you are being treated for. The following information includes the average doses of AUSRAN.

The usual adult dose is 150 to 300 mg per day, taken as one 150 mg tablet once or twice a day, or one 300 mg tablet at bedtime.

How to take it

Swallow the tablet with a full glass of water.

When to take it

It does not matter if you take AUSRAN before or after food.

Take your medicine at about the same time each day.

Taking your tablets at the same time each day will have the best effect. It will also help you to remember when to take the tablets.

How long to take it

AUSRAN helps control your condition, but does not cure it. Therefore you must take it every day.

Your pain or other symptoms may take a few days to go away.

Continue taking AUSRAN even if you feel better.

Even when you finish your tablets, your doctor may want you to continue taking AUSRAN, possibly at a different dose, to help stop the problem coming back again.

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 it as you would normally.

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

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

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

If you take too much (Overdose)

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

You may need urgent medical attention.

While you are taking AUSRAN

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking AUSRAN.

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking AUSRAN.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking AUSRAN.

Tell your doctor if you become pregnant while taking this medicine.

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

Things you must not do

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

Do not use AUSRAN to treat any other complaints unless your doctor tells you to.

Do not stop taking it, or change the dose, without first checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Side effects

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

AUSRAN helps most people reduce the amount of acid in the stomach, but may have unwanted side effects in a few people.

All medicines can 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 any questions you may have.

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

  • dizziness or light-headedness
  • headache
  • muscle or joint pain
  • depression
  • constipation

These are the more common side effects of AUSRAN. These side effects are usually mild.

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

  • skin rash, hives, itching
  • swelling of the eyelids, face or mouth
  • wheezing, chest pain, or a change in the type of pain
  • yellow colouring of the skin or eyes (jaundice)
  • confusion/hallucinations
  • fever
  • hypotension

These side effects are uncommon but may be serious and need urgent medical attention.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

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

After taking it

Storage

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

If you take the tablets out of the box or the blister pack they may not keep well.

Keep your AUSRAN in a cool dry place where it stays below 25°C.

Do not store it, or any other medicine, in the bathroom or near a sink.

Do not leave it in the car on hot days.

Heat and dampness can destroy some medicines.

Keep this medicine where young children cannot reach it.

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

Disposal

If your doctor tells you to stop taking AUSRAN or you find that they have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What it looks like

AUSRAN 150 mg tablets are available in packs of 60. Tablets are white, round, biconvex, film-coated, embossed with ‘150’ on one side and plain on the other.

AUSRAN 300 mg tablets are available in packs of 30. Tablets are white, oblong, biconvex, film-coated, embossed with ‘300’ on one side and plain on the other.

Ingredients

Active ingredient:

AUSRAN 150 mg

  • 150 mg ranitidine per tablet.

AUSRAN 300 mg

  • 300 mg ranitidine per tablet

Inactive ingredients

  • cellulose – microcrystalline
  • croscarmellose sodium
  • magnesium stearate
  • OPADRY Complete film coating YS-22-18096 White (USA).

BRAND INFORMATION

Brand name

Ausran Tablets

Active ingredient

Ranitidine

Schedule

S4

 

1 Name of Medicine

Ranitidine hydrochloride.

6.7 Physicochemical Properties

Ranitidine hydrochloride is an aminoalkyl substituted furan and is structurally different from cimetidine, lacking the imidazole ring and the cyanoguanidine group.
Chemical name: N-[2-[[[5-[(dimethylamino)methyl]-2- furanyl]methyl]thio]ethyl]-N'-methyl- 2-nitro-1, 1-ethenediamine hydrochloride. Empirical formula: C13H22N4O3S.HCl. MW: 350.9.
Ausran tablets contain ranitidine hydrochloride.

Chemical structure.

Its chemical structure is represented below:

CAS number.

CAS No.: 66357-59-3.

2 Qualitative and Quantitative Composition

Ausran is available in 150 mg and 300 mg tablets. Each tablet contains ranitidine hydrochloride equivalent to 150 mg or 300 mg of ranitidine respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ausran 150 mg tablets.

Each tablet is white, round, biconvex, film coated, embossed with '150' on one side and plain on the other, and contains ranitidine hydrochloride equivalent to 150 mg of ranitidine.

Ausran 300 mg tablets.

Each tablet is white, oblong, biconvex, film coated, embossed with '300' on one side and plain on the other, and contains ranitidine hydrochloride equivalent to 300 mg of ranitidine.
*Not currently marketed in Australia.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ausran 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.
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 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, electrocardiogram and electroencephalogram 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. Acute administration of ranitidine 50 mg 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

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.

Distribution and metabolism.

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.

Excretion.

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 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

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

Known hypersensitivity to ranitidine hydrochloride or any of the excipients listed (see Section 6.1 List of Excipients).

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 tablets 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 of 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 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).

Use in renal impairment.

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 the elderly.

No data available.

Paediatric use.

Experience with ranitidine preparations in children is limited and such use has not been fully evaluated in clinical studies. Ranitidine 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

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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There is 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 fetus due to ranitidine.
(Category B1)
The safety of ranitidine in pregnancy has not been established. Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to ranitidine. Ranitidine crosses the placenta. Ausran 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 fetus.
Ranitidine is secreted in breast milk in lactating mothers, but the clinical significance of this has not been fully evaluated. Ausran should only be used by nursing 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.

Hepatic.

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.

Renal.

Very rare cases of acute interstitial nephritis have been reported.

Musculoskeletal.

Rare reports of arthralgias and myalgia.

Haematological.

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 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 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.

Dermatological.

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

Other.

Rare cases of hypersensitivity reactions (e.g. fever, bronchospasm, anaphylactic shock, rash, eosinophilia, urticaria, angioneurotic oedema, hypotension, chest pain, rash, eosinophilia), 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

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 of therapy.

Maintenance treatment.

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.

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.

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 treatment periods of up to three months.

Maintenance treatment.

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

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 Section 4.8 Adverse Effects (Undesirable Effects)).

Treatment.

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 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet also contains the following excipients: cellulose - microcrystalline, croscarmellose sodium, magnesium stearate, Opadry II complete film coating system YS-22-18096 White (USA).

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. Protect from light.

6.5 Nature and Contents of Container

150 mg.

The tablets are supplied in a blister pack of 60 tablets, or as a bottle of 60 tablets* or 180 tablets*.

300 mg.

The tablets are supplied in a blister pack of 30 tablets, or as a bottle of 30 tablets* or 90 tablets*.
*Not currently marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes