Consumer medicine information

Ranitidine Sandoz Tablets

Ranitidine

BRAND INFORMATION

Brand name

Ranitidine Sandoz

Active ingredient

Ranitidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ranitidine Sandoz Tablets.

What is in this leaflet

This leaflet answers some common questions about Ranitidine Sandoz.

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 risk of you taking 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 the medicine. You may need to read it again.

What Ranitidine Sandoz is used for

This medicine is used to treat:

  • Treat stomach and duodenal ulcer disease (also known as peptic ulcers). Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. These can be caused in part by too much acid being produced in the stomach. Ranitidine Sandoz is also used to help stop these ulcers from coming back.
  • Stop these ulcers from coming back
  • Treat reflux oesophagitis or reflux disease. This can be caused by "washing back" (reflux) of food and acid from the stomach into the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn
  • Treat Zollinger-Ellison syndrome, a rare condition where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.
  • Treat Scleroderma oesophagitis. Scleroderma is a rare condition, and in scleroderma oesophagitis the food pipe is abnormal and reflux occurs.

It contains the active ingredient ranitidine hydrochloride. Ranitidine hydrochloride 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 helps to reduce the pain and also allows the ulcer and/or reflux disease to heal in most people.

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

There is no evidence that Ranitidine Sandoz is addictive.

Before you take Ranitidine Sandoz

When you must not take it

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

  • ranitidine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product description
  • any other similar medicines.

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.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

  • acute porphyria, an inherited blood condition
  • stomach cancer
  • stomach ulcers before and you are taking NSAID medicines
  • kidney problems
  • liver problems
  • lung disease
  • diabetes
  • over 65 years of age
  • any condition where your immune system may be affected.

Tell your doctor if you have had to stop taking this or any other medicine for your ulcer or reflux.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking Ranitidine Sandoz.

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 Ranitidine Sandoz may interfere with each other. These include:

  • sucralfate, another medicine used to treat ulcers
  • warfarin, a medicine used to prevent blood clots
  • triazolam and midazolam, medicines used as sedatives
  • ketoconazole, an anti-fungal medicine
  • atazanavir and delavirdine, medicines used to treat HIV
  • glipizide, a medicine used for diabetics
  • gefitinib, a medicine used in the treatment of cancer
  • NSAID medicines, for pain and inflammation
  • Procainamide or n-acetylprocainamide, used to treat heart problems.

These medicines may be affected by Ranitidine Sandoz 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 and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Ranitidine Sandoz

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

The dosage of Ranitidine Sandoz depends on the condition it is being used to treat. The usual adult dosage range is 150mg to 300mg per day, taken as one 150mg tablet once or twice a day or one 300mg tablet at bed time. The treatment of Zollinger-Ellison syndrome may require higher doses.

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, Ranitidine Sandoz may not work as well and your problem may not improve.

How to take it

If you need to break Ranitidine Sandoz, hold the tablet with both hands and snap along the break line.

When to take Ranitidine Sandoz

It does not matter whether you take the tablets before or after food.

How long to take Ranitidine Sandoz

The duration of treatment with Ranitidine Sandoz depends on the condition it is being used to treat.

Your pain or other symptoms may take a few days to go away. Take all the tablets your doctor has prescribed for you, even if you feel better.

Your doctor may decide to continue your treatment with Ranitidine Sandoz, possibly at a different dosage range, in order to prevent the problem from coming back again.

Use in children

Ranitidine Sandoz has not been studied fully in children. However, it has been used successfully in children aged 8 to 18 years in doses up to 150mg twice daily. Your child's doctor will discuss the risks and benefits of your child taking Ranitidine Sandoz.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

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

If you have trouble remembering 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 Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Ranitidine Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking Ranitidine Sandoz

Things you must do

Always follow your doctor's instructions carefully.

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

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

Things you must not do

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Do not take Ranitidine Sandoz 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 Ranitidine Sandoz affects you. This medicine may cause dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine. If you drink, alcohol dizziness or light-headedness may be worse.

Side effects

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

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

These are the more common side effects of Ranitidine Sandoz. Mostly, these are mild and short-lived.

  • breast tenderness and/or breast enlargement
  • breast discharge
  • headache, sometimes severe
  • hair loss
  • sexual problems
  • tiredness or difficulty sleeping
  • dizziness or drowsiness
  • muscle and joint pain
  • abnormal uncontrolled movements, muscle twitching or spasms.

These are rare side effects of Ranitidine Sandoz.

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

  • yellowing of the skin or eyes (jaundice)
  • confusion, depression and hallucination
  • general illness associated with weight loss
  • blurred vision
  • skin rash
  • 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 medical attention. Serious side effects are rare.

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

  • swelling of the limbs, 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 or a change in the type of pain wheezing, chest pain or tightness, 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.

After taking Ranitidine Sandoz

Storage

Keep your medicine in the original container.

If you 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.

Do not store Ranitidine Sandoz 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.

Disposal

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.

Product description

What it looks like

Ranitidine Sandoz 150mg - yellow, round, film-coated tablets, scored on one side. Available in blisters of 60 tablets.

Ranitidine Sandoz 300mg - yellow, oblong, film-coated tablets, scored on one side. Available in blisters of 30 tablets.

Ingredients

Active ingredient:

  • Ranitidine Sandoz 150mg - 150mg ranitidine as ranitidine hydrochloride
  • Ranitidine Sandoz 300mg - 300mg ranitidine as ranitidine hydrochloride

Inactive ingredients:

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

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

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

This leaflet was revised in December 2018

Australian Register Numbers

150mg film-coated tablets: AUST R 70325
300mg film-coated tablets: AUST R 70356

Published by MIMS March 2019

BRAND INFORMATION

Brand name

Ranitidine Sandoz

Active ingredient

Ranitidine

Schedule

S4

 

1 Name of Medicine

Ranitidine hydrochloride.

6.7 Physicochemical Properties

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.
The chemical name of ranitidine hydrochloride is N-(2-(((5-[(dimethylamino)methyl]-2-furanyl) methyl)thio)ethyl)-N'-methyl-2-nitro-1,1-ethenediamine hydrochloride (C13H23ClN4O3S, MW: 350.9).

Chemical structure.

Its chemical structure is:

CAS number.

66357-59-3.

2 Qualitative and Quantitative Composition

Each Ranitidine Sandoz 150 mg tablets contains 150 mg ranitidine hydrochloride.
Each Ranitidine Sandoz 300 mg tablets contains 300 mg ranitidine hydrochloride.
List of excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ranitidine Sandoz 150 mg tablets.

Yellow, round, film-coated tablets, scored on one side.

Ranitidine Sandoz 300 mg tablets.

Yellow, oblong, film-coated tablets, scored on one 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 beta-adrenoreceptors. 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.

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.

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.

Metabolism.

The fraction of the dose recovered as metabolites after oral dosing 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.

In patient 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 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 anti-reflux 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 or to any component of the preparation.

4.4 Special Warnings and Precautions for Use

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 increase 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).

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.

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

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, delaviridine, 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 fetus due to ranitidine.
(Category B1)
Australian Pregnancy Category B1: Drugs, which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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 fetus.
 Ranitidine should only be used by nursing mothers if considered essential. Ranitidine is secreted in breast milk in lactating mothers but the clinical significance of this has not been fully evaluated.

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.

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.

Renal.

Very rare cases of acute interstitial nephritis have been reported.

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.

Other.

Rare cases of hypersensitivity reactions (e.g. fever, bronchospasm, anaphylactic shock, rash or uticaria, angioneurotic oedema, hypotension, chest pain, 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 http://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dosage.

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.

Method of administration.

Ranitidine Sandoz is an oral tablet.

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 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 Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ranitidine Sandoz tablets also contain the inactive ingredients: microcrystalline cellulose, calcium hydrogen phosphate, maize starch, sodium starch glycollate type A, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, iron oxide yellow.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5.

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

Ranitidine Sandoz 150 mg tablets.

Available in Al/Al blisters in packs of 60 tablets.

Ranitidine Sandoz 300 mg tablets.

Available in Al/Al blisters in packs of 30 tablets.
Not all presentations may be 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