Consumer medicine information

RANOXYL Tablets

Ranitidine (as hydrochloride)


Consumer Medicine Information

About your Ranoxyl Tablets

Read all of this leaflet carefully before you take your medicine.

This leaflet does not have the complete information available about your medicine. If you have any questions about your medicine, you should ask your doctor or pharmacist (also known as chemist).

All medicines have some risks. Sometimes new risks are found even when a medicine has been used for many years.

If there is anything you do not understand, ask your doctor or pharmacist. If you want more information, ask your doctor or pharmacist.

What is the name of my medicine?

The name of your medicine is Ranoxyl.

What is in my Ranoxyl?

The medicine in your Ranoxyl tablets is called ranitidine (as hydrochloride). This belongs to a group of medicines called H2-antagonists.

Each tablet contains either 150 or 300 milligrams of ranitidine. Your tablets also contain the following inactive ingredients.

  • Cellulose (460), magnesium stearate (572), titanium dioxide (171), hypromellose (464) and Glycerol triacetate. The 300 mg tablets also contain croscarmellose sodium.
  • Each Ranoxyl 300 mg tablet contain 0.8 mg of sodium
  • Ranoxyl tablets are free from gluten and lactose.
  • Pack sizes available: 150 mg – 60 tablets; 300 mg – 30 tablets.

What does my Ranoxyl do?

Ranoxyl is mostly used to:

  • treat stomach and duodenal ulcer disease (also known as peptic ulcer),
  • stop these ulcers from coming back,
  • treat reflux oesophagitis (also known as reflux).

These problems are caused, in part, by too much acid in the stomach. This can lead to pain such as heartburn. Ranoxyl works by reducing the amount of acid in the stomach. This reduces the pain and also allows the ulcer and reflux to heal.

Ranoxyl is also used to treat:

  • Zollinger-Ellison disease,
  • scleroderma oesophagitis.

Is there anything I should tell my doctor before starting my Ranoxyl?

Tell your doctor:

  • the name of all medicines you are already taking including those you have bought from a supermarket or a pharmacy, such as:
    – warfarin, used to prevent blood clots
    – triazolam and midazolam, used as sedatives
    – ketoconazole, an anti-fungal
    – atazanavir and delaviridine, used to treat HIV
    – glipizide, used for diabetics.
    – gefitinib, used in the treatment of cancer.
  • if you have to stop taking this or any other medicine for your ulcer or reflux,
  • if you have kidney disease,
  • if you are allergic to any medicine,
  • if you have a disease known as acute porphyria.

What if I am pregnant or breast feeding?

Tell your doctor if you are pregnant, likely to get pregnant or are breast feeding. Your doctor will tell you if you should take this medicine.

How do I take my Ranoxyl?

  • The dosage depends on the disease that you are suffering from. Your doctor or pharmacist will usually tell you how many Ranoxyl tablets to take and how often to take them. You will also find this information on the label of your medicine.
  • The normal adult dosage 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. Your doctor may prescribe a different dosage.
  • Do not take extra tablets. Do not take the tablets more often than you have been told.
  • It does not matter whether you take the tablets before or after food.
  • Ranoxyl tablets should be swallowed whole with a glass of water.
  • 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.
  • Even when you have completed your tablets, your doctor may decide to continue your treatment with Ranoxyl, possibly at a different dosage, in order to prevent the problem coming back again.

Use in Children:

Ranoxyl has not been studied fully in children. However, Ranoxyl has been used with good results in children aged 8 to 18 years in doses up to 150 mg twice daily.

What should I do if I miss my dose?

If you forget to take your Ranoxyl, take another as soon as possible unless it is nearly time for your next dose. Do not take a double dose to make up for the missed one.

Are there any side-effects with my Ranoxyl, and what should I do if I get any side-effects?

Like other medicines, Ranoxyl may cause some side-effects. Most of the side-effects will be minor and temporary, but some may be serious. Your doctor will be able to answer any questions you may have.

Tell your doctor straight away and do not take any more Ranoxyl if you get:

  • skin troubles such as rash (red spots), itching, skin lumps or hives,
  • swelling of the eyelids, face or lips,
  • wheezing, chest pain or tightness,
  • severe stomach pain or a change in the type of pain,
  • yellow colouring of the skin or eyes (jaundice),
  • confusion,
  • general illness associated with weight loss,
  • fever.

If you get any of the following side-effects after taking Ranoxyl tell your doctor, but there is no immediate reason to stop taking the tablets unless you are concerned:

  • headache,
  • joint or muscle pains,
  • dizziness,
  • depression,
  • constipation
  • breast tenderness and/or breast enlargement
  • breast discharge.

If you notice any symptoms that concern you or if the tablets cause any other side-effects, tell your doctor or pharmacist.

If you have taken all the tablets and still do not feel better tell your doctor as soon as possible.

What do I do in case of an overdose?

In the event of an overdose you should contact your nearest Poisons Information Centre, doctor or hospital emergency department.

How do I store my Ranoxyl?

  • Keep your Ranoxyl tablets away from heat (store below 30° C). For example, you should not leave them in the car on hot days.
  • Please keep your Ranoxyl tablets in a place where children cannot reach them.
  • You will find an “expiry” (or use by) date printed on the manufacturer’s label of the pack. Do not use the tablets after this date. Do not use the tablets if they are discoloured.
  • Keep your Ranoxyl tablets away from moisture. Leave the tablets in the pack until you are ready to use them.

Can I let someone else use my Ranoxyl?

Never give this medicine to someone else. The medicine is only for you. It may harm other people even if they seem to have the same symptoms that you have.

Product description

What Ranoxyl tablets look like.

Ranoxyl tablets come in two strengths:

  • Ranoxyl 150 mg tablets are white, film-coated tablets engraved “GX EC2” on one face and plain on the other.
  • Ranoxyl 300 mg tablets are white capsule-shaped, film-coated tablets engraved “GX EC3” on one face and plain on the other.

Who supplies my Ranoxyl?

www.ascentpharma.com.au

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

For further information call 1800 554 414.

Do not throw this leaflet away. You may need to read it again.

Date of Preparation: July 2012

  • Ranoxyl Tablets 150 mg AUST R 199391
  • Ranoxyl Tablets 300 mg AUST R 199392

Version 2.0

Published by MIMS March 2013