Ranitidine-PS Tablets

Ranitidine-PS Tablets is a brand of medicine containing the active ingredient ranitidine.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

RANITIDINE-PS

Ranitidine hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about RANITIDINE-PS.

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 RANITIDINE-PS 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 this medicine. You may need to read it again.

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What RANITIDINE-PS is used for

The name of your medicine is RANITIDINE-PS. It contains the active ingredient ranitidine hydrochloride.

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

RANITIDINE works by reducing the amount of acid produced by your stomach.

RANITIDINE is used for the following:

  • to treat and prevent peptic ulcers. Peptic ulcers are ulcers that occur in the stomach or duodenum.
  • treatment of reflux or heartburn
  • Zollinger-Ellison Syndrome
  • Scleroderma oesophagitis

By reducing the amount of acid produced by the stomach, RANITIDINE reduces the pain associated with the above conditions, helps ulcers to heal and helps heal oesphagitis.

Your doctor may have prescribed RANITIDINE-PS for another reason. Ask your doctor if you have any questions about why RANITIDINE-PS has been prescribed for you.

RANITIDINE-PS is available only with a doctor’s prescription.

RANITIDINE-PS is not addictive.

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Before you take RANITIDINE-PS

When you must not take it

Do not take RANITIDINE-PS if you have an allergy to ranitidine or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hives, itching or skin rash or fainting.

Do not take RANITIDINE-PS if you have or have had acute porphyria.

Do not take RANITIDINE-PS after the expiry date printed on the pack.

Do not take RANITIDINE-PS if the packaging is torn or shows signs of tampering or if the tablets do not look quite right.

If you are not sure whether you should start taking RANITIDINE-PS, talk to your doctor.

Use in children

Your child’s doctor will discuss the risks and benefits of your child using RANITIDINE-PS.

Before you start to take it

Tell your doctor if you have any 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.

RANITIDINE-PS may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of using RANITIDINE-PS if you are pregnant.

Tell your doctor if you are breast-feeding or planning to breast-feed. RANITIDINE-PS passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of using RANITIDINE-PS if you are breast-feeding.

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

  • kidney problems
  • liver problems
  • acute porphyria

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including any medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may interfere with RANITIDINE-PS. These include:

  • sucralfate, another medicine used to treat peptic ulcers

This medicine may be affected by RANITIDINE-PS 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 and pharmacist have more information on medicines to be careful with or avoid while taking RANITIDINE-PS.

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How to take RANITIDINE-PS

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

Your doctor will tell you how many tablets you will need to take each day. This depends on your condition and whether you are taking any other medicines.

How to take it

Swallow RANITIDINE-PS with a full glass of water.

When to take it

It does not matter if you take RANITIDINE-PS before or after food.

Take each dose of your RANITIDINE-PS at the same time each day. Taking each dose of RANITIDINE-PS 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

If you are taking RANITIDINE-PS to heal an ulcer you may need to take it for 4 to 8 weeks.

If you are taking RANITIDINE-PS to treat reflux disease you may need to take it for up to 3 months.

It is important that you take the full course of RANITIDINE-PS prescribed by your doctor so that your condition is properly treated.

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

Continue taking RANITIDINE-PS for as long as your doctor prescribes.

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 your tablets as you would normally.

Do not take a double dose to make up for the dose that you 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 RANITIDINE-PS .Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

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While you are taking RANITIDINE-PS

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking RANITIDINE-PS

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking RANITIDINE-PS.

Tell your doctor immediately if you become pregnant while taking RANITIDINE-PS.

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 RANITIDINE-PS to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how RANITIDINE-PS affects you. RANITIDINE-PS may cause dizziness, drowsiness or light-headedness in some people. Make sure you know how you react to RANITIDINE-PS before you drive a car, operate machinery or do anything else that could be dangerous if you are affected.

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Side effects

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

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, light-headedness or drowsiness
  • headache
  • muscle or joint pain
  • constipation or diarrhoea
  • feeling sick (nausea) or vomiting
  • sexual problems
  • difficulty sleeping
  • abdominal pain
  • blurred vision

These side effects are usually mild.

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

  • yellowing of the skin or eyes (jaundice)
  • depression, confusion or hallucinations
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen stop taking RANITIDINE-PS and tell your doctor immediately or go to Accident and Emergency at the nearest hospital:

  • any skin reaction, for example rash, itching, hives, flaking or peeling of the skin
  • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
  • asthma, wheezing, shortness of breath or difficulty breathing
  • chest pain, changes in heart rate (fast, slow or irregular)
  • severe upper stomach pain often with nausea and vomiting

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

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

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

Tell your doctor immediately if you develop any of the following, which may be complications of your condition rather than the treatment:

  • ongoing stomach pains
  • unexpected weight loss
  • passing black or bloody motions
  • vomiting blood

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After taking RANITIDINE-PS

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 will not keep well.

Keep your RANITIDINE-PS in a cool dry place where it stays below 25ºC.

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

Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines.

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.

Disposal

If your doctor tells you to stop taking RANITIDINE-PS or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

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Product description

What it looks like

  • RANITIDINE-PS 150 mg tablets are round creamish-yellow, biconvex, film-coated tablets printed with ‘RAN 150’ in black ink on one side.
  • RANITIDINE-PS 300 mg tablets are round creamish-yellow, biconvex, film-coated tablets printed with ‘RAN 300’ in black ink on one side.

RANITIDINE-PS 150 and 300mg tablets are available in packs of 60.

Ingredients

Active ingredient:

  • RANITIDINE-PS 150 mg:
    150 mg ranitidine (as ranitidine hydrochloride) per tablet.
  • RANITIDINE-PS 300 mg:
    300 mg ranitidine (as ranitidine hydrochloride) per tablet.

Inactive ingredients:
Each RANITIDINE-PS tablet also contains:

  • cellulose - microcrystalline
  • croscarmellose sodium
  • silica - colloidal anhydrous
  • talc - purified
  • magnesium stearate
  • hypromellose
  • castor oil
  • iron oxide yellow- CI 77492
  • titanium dioxide
  • opacode-S-1-27794 Black

Supplier

www.ascentpharma.com.au

Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne VIC 3205

Australian Registration Numbers:
RANITIDINE-PS 150 mg tablets, blisters: AUST R 148523
RANITIDINE-PS 300 mg tablets, blisters: AUST R 148526

This leaflet was prepared in February 2012.

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CMI provided by MIMS Australia, August 2015  

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