Suvacid Heartburn Relief

Pantoprazole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Suvacid Heartburn Relief. 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 or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

Take this medicine as directed and follow the advice given in this leaflet.

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 Suvacid Heartburn Relief is used for

Suvacid Heartburn Relief contains the active ingredient pantoprazole.

It is used for lasting symptomatic relief of frequent heartburn and stomach acid complaints due to gastro-oesophageal reflux.

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.

Frequent heartburn is when you have heartburn for two or more days a week. Heartburn that occurs frequently is a typical symptom of gastro-oesophageal reflux disease (GORD).

Suvacid Heartburn Relief is recommended for adults 18 years of age and over, suffering from heartburn at least 2 times a week.

It is not the right medicine for you if you suffer from heartburn only occasionally (one episode of heartburn a week or less), or if you want immediate relief of heartburn.

How Suvacid Heartburn Relief works

Pantoprazole belongs to a group of medicines called proton pump inhibitors (PPIs). It works by decreasing the amount of acid the stomach makes, to give relief from the symptoms.

It will start to suppress acid within a few hours, however it will not give instant symptom relief. You may need to take this medicine for a few days before experiencing the full effect.

This medicine is not addictive.

Before you take Suvacid Heartburn Relief

When you must not take it

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

• the active ingredient pantoprazole
• 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 Suvacid Heartburn Relief in combination with atazanavir (an anti-viral medication).

Do not take this medicine if you have cirrhosis or severe liver disease.

This medicine should not be given to children and adolescents under the age of 18 years. Safety and effectiveness in children and adolescents has not been established.

Do not take this medicine after the expiry date printed on the pack has passed If you take this medicine after the expiry date it may not work as well.

Do not take this medicine if the packaging is torn or shows signs of tampering. If it 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 or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if :

1. you have allergies to:

• pantoprazole
• any of the ingredients listed at the end of this leaflet
• any other medicines, foods, preservatives or dyes.

2. you are pregnant or plan to become pregnant or are breastfeeding
3. you have or have had any other medical conditions

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Suvacid Heartburn Relief.

Talk to your doctor first before taking this medicine if:

• you have previously taken heartburn / indigestion medications continuously for 4 or more weeks to control your heartburn
• you have jaundice, liver problems, anaemia, previous gastric ulcer or gastrointestinal surgery
• you have new or recently changed symptoms including persistent vomiting or vomiting of blood, blood in the stools or unexplained weight loss.

If you have experienced any of the above you should see your doctor immediately.

If you have suffered from frequent heartburn/indigestion symptoms for some time you should see your doctor.

You should also speak to your doctor before taking this medicine if you are due to have an endoscopy (a special test ordered by your doctor).

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Suvacid Heartburn Relief. These include:

• atazanavir (an anti-viral medication)
• medicines used to prevent blood clots (anticoagulants)
• medicines whose activity depends on the acidity of the stomach such as ketoconazole.

These medicines may be affected by Suvacid Heartburn Relief or may affect how well it works.

Speak with your doctor or pharmacist if you have any concerns about taking Suvacid Heartburn Relief with other medications. They have more information on medicines to be careful with or avoid while taking this medicine.

How to take Suvacid Heartburn Relief

How much to take

Take one tablet once a day (every 24 hours).

How to take it

Swallow the tablets whole with a full glass of water, with or without food.

Do not crush or chew the tablets. The tablets have a special coating to protect them from the acidic contents of your stomach. For the tablets to work effectively, this coating must not be broken.

When to take it

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take it

Take one tablet daily for at least 7 days, and up to 14 days. You should not take it for more than 14 days unless directed by a doctor.

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 continue to take it as you would normally.

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 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, New Zealand 0800  764  766) 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 Suvacid Heartburn Relief. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking Suvacid Heartburn Relief

Things you must do

Take this medicine exactly as your doctor or pharmacist has advised.

Tell your doctor if you become pregnant while taking Suvacid Heartburn Relief.

Tell all doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Tell your doctor or pharmacist if you do not feel better while taking this medicine.

If symptoms persist or recur within 2 weeks of completing the course, consult a doctor. Further examination may be recommended.

Things you must not do

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

Do not take Suvacid Heartburn Relief to treat any other complaints unless your doctor tells you to.

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.
• Aspirin and many other medicines used to treat arthritis/period pain/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.
• Eating habits eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.
• Smoking your doctor may advise you to stop smoking or at least cut down.
• Weight your doctor may suggest losing some weight to help your condition.

Side effects

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

Suvacid Heartburn Relief helps most people with reflux disease but it may have unwanted side effects in a few people.

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.

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:

• headache, dizziness
• nausea or vomiting
• diarrhoea, stomach pain, excessive gas in the stomach or bowel, constipation, indigestion
• dry mouth
• metallic taste
• weakness or tiredness
• increased sweating
• blurred vision
• skin problems such as itchiness and rash.

The above list includes the more common side effects of your medicine.

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

• unusual tiredness or weakness
• nausea or vomiting in combination with loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine

The above list includes serious side effects that may require urgent medical attention. 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.

Do not be alarmed by the lists of possible side effects. You may not experience any of them.

After taking Suvacid Heartburn Relief

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 Suvacid Heartburn Relief 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 you 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

Yellow and oval shaped enteric ( acid-resistant ) coated tablets, coded “20” in black ink on one side.

Available in blister packs of 7 and 14 enteric-coated tablets.

Ingredients

Suvacid Heartburn Relief contains 20 mg of pantopazole (as pantoprazole sodium sesquihydrate) as the active ingredient.

It also contains:

• sodium carbonate anhydrous
• microcrystalline cellulose
• crospovidone
• hydroxypropylcellulose
• colloidal anhydrous silica
• calcium stearate
• Opadry complete film coating system 03B22011

Yellow

• Eudragit L30D-55
• triethyl citrate
• 2212 Fine Black Ink.

This medicine does not contain gluten, lactose, sucrose, or tartrazine.

Supplier

Suvacid Heartburn Relief is supplied in Australia by:
Novartis Consumer Health Australasia Pty Ltd
ABN 46 004 535 513
329-333 Police Road
Mulgrave Vic 3170

NZ Office: Auckland, New Zealand
Toll-free phone
Australia: 1800 069 643
New Zealand: 0800 700 222

This leaflet was prepared in August 2009.

Australian Register Number AUST R XXXXX

Published by MIMS/myDr October 2010

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. UBM Medica Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of UBM Medica Australias knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. UBM Medica Australia, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.