GenRx Cimetidine Tablets 400mg (Pack of 60)

GenRx(R) CIMETIDINE

Cimetidine (sye-MET-i-deen)

Consumer Medicine Information

For a copy of a large print leaflet Ph: 1800 195 055

What is in this leaflet

This leaflet answers some common questions about GenRx Cimetidine.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking cimetidine 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 the medicine.

You may need to read it again.

What GenRx Cimetidine is used for

Ulcers:

Cimetidine is used to treat/help heal 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 made in the stomach.

Cimetidine is also used to help stop duodenal ulcers from coming back.

  • Reflux oesophagitis:

    Cimetidine is used to 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.

    For Zollinger-Ellison syndrome:

    Cimetidine is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.

    Your doctor, however, may have prescribed cimetidine for another reason. Ask your doctor if you have any questions about why cimetidine has been prescribed for you.

    How cimetidine works

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

    Cimetidine works by decreasing the amount of acid made by the stomach. This helps reduce the pain and also allows the ulcer and/or reflux disease to heal in most people.

  • Before you take GenRx Cimetidine

    When you must not take it

    Do not take cimetidine if you have had an allergic reaction to cimetidine or any of the other ingredients listed at the end of this leaflet.

    Some of the symptoms of an allergic reaction may include:

  • hives or severe skin reactions
  • difficulty in breathing
  • swelling of the limbs, face, mouth or throat.
  • If you have taken cimetidine before and became unwell, tell your doctor or pharmacist before taking the first dose.

    Do not take cimetidine if the expiry date printed on the pack has passed.

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

    Do not take cimetidine if the packaging is torn or shows signs of tampering.

    Cimetidine should not be given to children unless instructed by their doctor. There is only a small amount of information available about the use of cimetidine in children.

    If you are not sure whether you should start taking cimetidine, talk to your doctor.

    Before you start to take it

    You must tell your doctor or pharmacist if you are allergic to any other medicines, foods, dyes or preservatives.

    You must tell your doctor or pharmacist if you have or have ever had any other health problems or other medical conditions, including:

  • liver problems
  • kidney problems (the dose of cimetidine may need to be adjusted).
  • You must tell your doctor or pharmacist if you are pregnant or if you intend to become pregnant.

    Cimetidine may affect your developing baby if you take it during pregnancy. Your doctor or pharmacist will discuss with you the possible risks and benefits of taking cimetidine during pregnancy.

    You must tell your doctor or pharmacist if you are breast-feeding.

    Cimetidine passes into breast-milk and may affect your baby. Your doctor or pharmacist will discuss the possible risks and benefits of taking cimetidine whilst breast-feeding.

    If you have not told your doctor or pharmacist about any of the above, tell them before you take your cimetidine.

    Taking other medicines

    Tell your doctor if you are taking any other medicines or have taken other medicines recently. This includes those medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

    Some medicines may interfere with cimetidine. These include:

  • medicines for lowering blood pressure or treating heart conditions (eg. nifedipine)
  • medicines for convulsions (eg. phenytoin)
  • medicines for preventing blood clots (eg. warfarin)
  • medicines for treating breathing problems (eg. theophylline)
  • medicines for treating depression or anxiety
  • medicines that contain chlormethiazole (for alcohol withdrawal/anxiety)
  • medicines that contain metformin (for diabetes).
  • Antacids should be taken at least one hour before or after taking cimetidine. Some antacids may reduce the absorption of cimetidine.

    These medicines may be affected by cimetidine or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

    Your doctor or pharmacist may have more information on medicines to be careful with or avoid while you are taking cimetidine.

    How to take GenRx Cimetidine

    Your doctor will tell you how much to take and when to take it. Take cimetidine exactly as your doctor has prescribed.

    How much to take

    To treat an ulcer the usual dose of cimetidine is 800 mg each day. This can be taken once daily at bed-time or as 400 mg in the morning and 400 mg at bed-time.

    To prevent an ulcer from forming again the usual dose is 400 mg at bed-time.

    In reflux disease, the usual adult dose is 800 mg each day for up to 12 weeks. This can be taken once daily at bed-time or as 400 mg in the morning and 400 mg at bed-time.

    Cimetidine does not provide instant relief of symptoms.

    For other conditions the dose prescribed by your doctor may be different.

    If you do not understand the instructions on the packet, ask your doctor or pharmacist for help.

    How to take it

    Take cimetidine tablets with a full glass of water or another liquid.

    Cimetidine can be taken with or without food.

  • Take cimetidine at the same time each day. Taking your medicine at the same time each day will give the best effect. It will also help you to remember when to take your medicine.
  • How long to take it

  • If you are taking cimetidine to heal an ulcer you may need to take it for 4 to 8 weeks.
  • If you are taking cimetidine to treat reflux disease you may need to take it for up to 12 weeks.
  • If you are taking cimetidine to stop an ulcer coming back or for Zollinger-Ellison syndrome, your doctor will let you know how long you need to take the tablets. Your doctor will need to assess your condition regularly.
  • Keep taking cimetidine for as long as your doctor tells you to. Do not stop taking cimetidine just because you feel better.

    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 the dose as soon as you remember, and then go back to taking it as you would normally.
    Do not try to make up for missed doses by taking more than one dose at a time.

    Taking more than the prescribed dose can increase the chance of unwanted side effects.

    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 Poisons Information Centre (telephone 13 11 26) for advice, or go to the Accident and Emergency Department at your nearest hospital if you think you or anyone else may have taken too much cimetidine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers for these places handy.

    If you take too much cimetidine you may feel:

  • tired
  • confused
  • unresponsive.
  • While you are taking GenRx Cimetidine

    Things you must do

    Take cimetidine exactly as your doctor has prescribed.

    Tell all doctors, pharmacist and dentists who are treating you that you are taking cimetidine.

    Tell your doctor immediately if you become pregnant while taking cimetidine.

    Tell your doctor immediately if you develop any of the following. These may be complications of your condition:

  • ongoing stomach pains
  • unexpected weight loss
  • passing black motions
  • vomiting blood.
  • Things you must not do

    Do not give cimetidine to anyone else, even if they have the same symptoms as you.

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

  • Do not take any other medicines, whether they are prescription or over-the-counter medicines, unless they have been approved or recommended by a doctor or pharmacist that knows you are taking cimetidine.

    Things to be careful of

    Be careful driving or operating machinery until you know how cimetidine affects you.

    Cimetidine does not generally cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, cimetidine may cause dizziness or lightheadedness in some people.

    Make sure you know how you react to cimetidine before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs, do not drive.

    If you drink alcohol, dizziness and/or drowsiness may be worse.

    Things that may help your condition:

    Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.

  • Alcohol
  • your doctor may advise you to limit your alcohol intake. Drinking alcohol may worsen your symptoms.
  • Smoking
  • your doctor may advise you to stop smoking or at least cut down. Smoking can affect ulcer healing.
  • Eating habits
  • eat smaller, more frequent meals. Eat slowly and chew your food carefully. Avoid food that causes you stomach pain and discomfort.
  • Weight
  • your doctor may suggest losing some weight to help your condition.
  • Aspirin and many other medicines used to treat arthritis, period pain or headaches
  • these medicines may irritate the stomach and may make your condition worse. Your doctor or pharmacist may suggest other medicines you can take.
  • Caffeine
  • your doctor may advise you to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and cola drinks, because they contain ingredients that may irritate your stomach.
  • Talk to your doctor or pharmacist about other measures that may help you.

    Side effects

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

    Cimetidine helps most people with peptic ulcers or reflux disease, but it may have unwanted side effects in a few people.

    All medicines 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 to answer any questions you may have.

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

  • headache, tiredness, dizziness or drowsiness
  • vomiting or feeling sick, flatulence (wind), diarrhoea or constipation
  • mild skin rash, muscle aches and pains, hair loss
  • in men: enlarged breasts and sexual problems (these have been reported rarely).
  • These side effects are usually mild.

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

  • depressed mood or confusion
  • fast heart beat, slow heart beat or irregular heart beat
  • unusual bleeding or bruising
  • yellowing of the skin and eyes, also called jaundice
  • fever.
  • Stop taking cimetidine and contact a doctor immediately or go to the Accident and Emergency Department of your nearest hospital if any of the following happens:

  • swelling of limbs, face, mouth or throat
  • shortness of breath or breathing difficulties
  • hives or severe skin reactions.
  • These indicate a severe allergic reaction to cimetidine. Allergy to cimetidine is rare.

    Other side effects not listed above may also occur in some patients.

    Tell your doctor or pharmacist if you notice anything making you feel unwell when you are taking, or soon after you have finished taking, cimetidine.

    Ask your doctor or pharmacist if you do not understand anything in this list.

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

    After taking GenRx Cimetidine

    Storage

    Cimetidine should be kept away from light.

    Keep your tablets in their packet until it is time to take them.

    If you take the tablets out of their packet they may not keep well.

    Keep cimetidine in a cool, dry place where it stays below 25 degrees C. Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills.

    Heat and dampness can destroy some medicines.

    Keep your tablets where young children cannot reach them.

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

    Disposal

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

    Product description

    What it looks like

    GenRx Cimetidine 400mg tablets are white, oval, biconvex, film-coated tablets. One side is engraved “APO-400”, the other side is plain. In blister packs of 60 tablets.

    (AUST R 78168)

    GenRx Cimetidine 800mg tablets are white, oval, biconvex, film-coated tablets. One side is engraved “APO-800”, the other side is plain. In blister packs of 30 tablets.

    (AUST R 78169)

    GenRx Cimetidine 400mg & 800mg tablets may develop a characteristic odour. The tablets can still be taken if this occurs.

    Ingredients

    GenRx Cimetidine tablets contain 400mg or 800mg of cimetidine as the active ingredient.

    The tablets also contain:

  • silica – colloidal anhydrous
  • croscarmellose sodium
  • magnesium stearate
  • cellulose – microcrystalline
  • hydroxypropylcellulose
  • hypromellose
  • macrogol 8000
  • Titanium dioxide.
  • GenRx Cimetidine tablets do not contain sucrose, gluten, tartrazine or any other azo dyes.

    Sponsor

  • GenRx Pty Ltd
  • ABN 52 096 916 148
  • Level 21, 390 St Kilda Road
  • Melbourne Victoria 3004
  • Australia
  • GenRx is a registered trade mark of GenRx Pty Ltd.
  • Date of leaflet preparation:
  • February 2004
  • ENQUIRE

    1800 200 736