Ranitidine (as hydrochloride)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about ranitidine. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine.
You may want to read it again.
What this medicine is used for
The name of your medicine is APO-Ranitidine tablets. It contains the active ingredient
ranitidine (as hydrochloride).
It is used to treat:
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Ranitidine belongs to a group of medicines called H2 antagonists or H2 blockers.
Ranitidine works by decreasing the amount of acid made by the stomach. This helps
reduce pain and also allows an ulcer and/or reflux disease to heal in most people.
There is no evidence that this medicine is addictive.
Use in children
Experience with ranitidine preparations in children is limited and such use has not
been fully evaluated in clinical studies. It has, however, been used successfully
in children aged 8 to 18 years in doses up to 150 mg twice daily.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You are hypersensitive to, or have had an allergic reaction to, ranitidine or any
of the ingredients listed at the end of this leaflet.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
You are allergic to foods, dyes, preservatives or any other medicines
You have ever had an allergic reaction to ranitidine or any of the ingredients listed
at the end of this leaflet
You are allergic to any medicine
You have had stomach ulcers before and you are taking non-steroidal anti-inflammatory
You have kidney disease
You have liver disease
You have a disease known as porphyria (rare disease of blood pigments)
You have lung disease, cough or a chest infection
You are diabetic
You have problems with your immune system
You have stomach cancer
You are over 65 years of age.
You are pregnant, likely to get pregnant or are breastfeeding. Your doctor will tell
you if you should take this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, have taken any
recently or if you start any new ones. This includes vitamins and supplements that
are available from your pharmacy, supermarket or health food shop with or without
Some medicines may interact with ranitidine. These include:
sucralfate, another medicine used to treat peptic ulcer
ketoconazole, a medicine used to treat fungal infection
heart medication e.g. procainamide
anticoagulant e.g. warfarin
benzodiazepines e.g. triazolam, midazolam
antiretrovirals e.g. atazanavir, delavirdine
antidiabetic e.g. glipizide
anticancer e.g. gefitinib
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), used to treat pain and inflammation.
If you are taking any of the above medicines, you may need a different dose or you
may need to take different medicines.
Other medicines not listed above may also interact with ranitidine.
How to take this medicine
Follow carefully all directions given to you by your doctor. Their instructions may
be different to the information in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with
How to take it
Swallow each tablet whole with a glass of water.
When to take it
Take this medicine at the same time each day. Taking it at the same time each day
will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
If ranitidine is prescribed twice a day, the best time to take it is in the morning
and at bedtime.
If ranitidine is prescribed once daily, the best time to take it is at bedtime.
If you do not understand the instructions on the box, ask your doctor or pharmacist
How long to take it
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the missed dose and take your next
dose at the usual time. Otherwise, take it as soon as you remember and then go back
to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately
telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia)
for advice. Alternatively, go to the Accident and Emergency department at your nearest
Do this even if there are no signs of discomfort or poisoning. You may need urgent
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breastfeed
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor tells you to.
Stop taking your medicine, or change the dosage, without first checking with your
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
Ranitidine generally does not cause any problems with your ability to drive a car
or operate machinery. However, as with many other medicines, ranitidine may cause
dizziness or light-headedness in some people.
Tell your doctor as soon as possible if you do not feel well while you are taking
ranitidine or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any
of them. All medicines can have side effects. Sometimes they are serious but most
of the time they are not.
Tell your doctor if you notice any of the following:
dizziness or light-headedness
uncontrolled movements. This effect is reversible and should get better once you stop
taking this medicine
if you are a man, breast tenderness and/or breast enlargement; loss in sexual desire
or performance. The interference with sexual function is normally reversible and should
get better once you stop taking this medicine
inflammation of blood vessels (vasculitis)
abdominal discomfort or pain
constipation or diarrhoea (especially if antibiotics are also being taken)
sore joints and/or muscles
feeling of agitation or depression
loss of hair.
Inform your doctor immediately if you get any signs of liver problems which may cause
one or more of the following:
generally feeling unwell
severe nausea (feeling sick)
loss of appetite
development of yellowish tinge to skin and/or eyes (jaundice)
rash and/or itching
dark coloured urine
vomiting (being sick)
severe stomach pain rarely caused by inflamed pancreas
If you experience any of the following, stop taking your medicine and contact your
doctor immediately or go to the Accident and Emergency department at your nearest
unusual tiredness, shortness of breath or tendency to infections or bruising, which
can be caused by upsets to "blood counts"
changes in the way the heart beats; either faster or slower
severe stomach pain or a change in the type of pain
symptoms of an allergic reaction including cough, shortness of breath, wheezing of
difficulty breathing; swelling of the face, lips, tongue, throat; rash, itching or
hives on the skin; fainting and/or hayfever-like symptoms.
Other problems are more likely to arise from the ulcer itself rather than the treatment.
For this reason, contact your doctor immediately if you notice any of the following:
pain or indigestion occurring during treatment with ranitidine
you begin to vomit blood or food
your pass black (blood-stained) motions.
Other side effects not listed above may occur in some patients.
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave it on a window sill or in the car. Heat and dampness can destroy some
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or it has passed its expiry
date, your pharmacist can dispose of the remaining medicine safely.
What APO-Ranitidine looks like
APO-Ranitidine tablets are available in two different strengths:
APO-Ranitidine 150 mg tablets: white to off-white, round, biconvex film coated tablets.
Scored on one side and engraved "RAN" over "150" on the other side.
Available in blister packs of 60.
APO-Ranitidine 300 mg tablets: white to off-white, capsule-shaped, biconvex film coated
tablets. Scored on one side and engraved "RAN 300" on the other side
Available in blister packs of 30.
* Not all strengths, pack types and/or pack sizes may be available.
Each APO-Ranitidine tablets contains 150 mg of ranitidine (as ranitidine hydrochloride)
as the active ingredient.
Each APO-Ranitidine tablets contains 300 mg of ranitidine as (as ranitidine hydrochloride)
the active ingredient.
APO-Ranitidine tablets also contains the following inactive ingredients:
colloidal anhydrous silica
APO-Ranitidine tablets are gluten-free, lactose-free, sucrose-free, tartrazine-free
and free of other azo dyes.
Australian Registration Numbers
APO-Ranitidine 150 mg tablets: blister pack AUST R 122013.
APO-Ranitidine 300 mg tablets: blister pack AUST R 122014.
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was last updated in: