Zoton Consumer Medicine Information

Lansoprazole 15mg and 30mg Capsules and 30mg Granules for Suspension

What is in this leaflet

This leaflet answers some common questions about ZOTON. It does not contain all the available information.

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 ZOTON against the benefits this medicine is expected to have for you.

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 ZOTON is used for

The name of your medicine is ZOTON. It contains the active ingredient called lansoprazole.

Ulcers:
ZOTON 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.
ZOTON is also used to help stop duodenal ulcers from coming back.

Reflux oesophagitis:
ZOTON is used to treat reflux oesophagitis or reflux disease. This can be caused by backflow (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.

H. pylori:
ZOTON is used for getting rid of Helicobacter pylori from the upper stomach in patients with peptic ulcers or chronic gastritis, when used with appropriate antibiotics.

Heartburn and stomach pain associated with reflux or peptic ulcer:
ZOTON is used for the short-term treatment of heartburn and peptic ulcer symptoms.

How ZOTON works

Proton pump inhibitors:
ZOTON belongs to a group of medicines called proton pump inhibitors (PPIs). ZOTON works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. There is no experience with the use of ZOTON in children.

Non-approved use

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

There is no evidence that ZOTON is habit-forming. This medicine is available only with a doctor's prescription.

Before you use ZOTON

When you must not use it

Do not use ZOTON if:

  1. You have an allergy to ZOTON or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction include a skin rash, itching, shortness of breath and a swollen face.
  2. You have severe liver disease.
    Your doctor will not prescribe ZOTON if you have had severe liver disease, or a tumour of the stomach region.
  3. The packaging is torn or shows signs of tampering.
  4. The expiry date (EXP) printed on the pack has passed.
    If you take this medicine after the expiry date it may not work as well.
    5.

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

Before you start to take it

You must tell your doctor if:

  1. You are pregnant or breast-feeding or intend to become pregnant or breast- feed.
    ZOTON should not be used during pregnancy or while breast-feeding.
  2. You have or have had any other medical conditions, including:
    • severe liver disease, or a tumour of the stomach region
    3.

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

Taking other medicines

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

Some medicines may interfere with ZOTON. These include: -

  • theophylline used to treat asthma
  • oral contraceptives
  • warfarin used to thin the blood
  • carbamazepine and phenytoin used to treat seizures
  • ketoconazole used in oral anti-fungal medicines
  • digoxin used to treat heart complaints
  • sucralfate used to treat gastric ulcers
  • antacids
  • iron preparations
  • ampicillin esters used in some antibiotics

These medicines may be affected by ZOTON, 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 will advise you.

How to take ZOTON

How much to take

The following are the most often used doses, but your doctor may adjust them to suit your needs

For Ulcers: one capsule daily
For Reflux oesophagitis: one capsule daily
For H. pylori (in combination with antibiotics): One capsule twice daily
For Heartburn or stomach pain: one capsule daily

How to take it

Take ZOTON in the morning before food. Swallow ZOTON capsules whole with a glass of water.

To take ZOTON powder for suspension:

  • Add 30 mL of water to a glass
  • Empty the granules from a sachet into the glass
  • Stir well and drink immediately.

How long to take it

You may find that the pain and discomfort caused by your ulcer or heartburn will go away well before you finish taking all your ZOTON capsules.

You should still continue to take ZOTON as directed, unless your doctor gives you other instructions.
Your doctor may want you to keep taking ZOTON on a long-term basis to stop the condition from coming back.

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 it as you would normally.

Do not take a double dose to make up for the dose that you missed.
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 (Tel 13 11 26 Australia; 0800 POISON or 0800 764 766 in New Zealand) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much ZOTON. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers for these places handy.

While you are taking ZOTON

Things you must do

Use ZOTON exactly as your doctor has prescribed.

Tell your doctor if you become pregnant while you are taking ZOTON.

Tell your doctor or pharmacist that you are taking ZOTON if you are about to be started on any new medicines

Things you must not do

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

Do not use ZOTON 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 ZOTON affects you.
ZOTON generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, ZOTON may cause dizziness or light-headedness in some people. Make sure you know how you react to ZOTON before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
If you drink alcohol, dizziness or light-headedness 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.
  • 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. Eat your meals well before bedtime.
  • 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

Check with your doctor as soon as possible if you have any problems while taking ZOTON, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
ZOTON helps most people with peptic ulcers, reflux disease, or heartburn, but it may have unwanted side effects in a few people. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist any questions you may have.

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

  • headache
  • diarrhoea or constipation
  • stomach pain
  • nausea
  • indigestion
  • vomiting
  • dizziness
  • flatulence (wind)
  • skin rashes
  • joint aches or pains
  • upper respiratory infections (coughs, colds, sore throats or sinuses)
  • urinary tract infections
  • hives and itching
  • hair thinning
  • photosensitivity
  • tingling or numbness of hands and feet

These side effects are usually mild.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • red, itchy blistering spots
  • yellowing of the skin or eyes
  • liver disease with nausea, vomiting, loss of appetite, fever itching and dark coloured urine
  • kidney disease
  • sudden signs of allergy such as swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
  • bruising
  • bleeding under the skin
  • blood disease, with a lack of white blood cells and low platelet count
  • red or purple flat pinhead spots under the skin
  • depression
  • swelling of hands, ankles or feet
  • blurred vision
  • confusion
  • hallucinations
  • breast enlargement and impotence in men with long term use

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

As natural acid in the stomach helps to kill bacteria, the lowering of acid by acid-reducing drugs such as ZOTON may make some people have certain stomach infections. If you suffer from severe persistent diarrhoea and/or vomiting when taking ZOTON, tell your doctor.

Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything making you feel unwell when you are taking, or soon after you have finished taking, ZOTON.
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 ZOTON
  • you begin to vomit blood or food
  • you pass black (blood-stained) motions

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 ZOTON

Storage

Keep your capsules in their blister pack or the powder for suspension in the unopened sachet until it is time to take them.
If you take the capsule out of the box or the blister pack they may not keep well. Once the sachet of ZOTON powder is opened, it should be resuspended in water and taken immediately.

Keep ZOTON in a cool dry place where the temperature stays below 25°C. Do not store ZOTON or any other medicines 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 ZOTON where young 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 ZOTON or the capsules or sachets have passed their expiry date, ask your pharmacist what to do with any capsules or sachets that are left over.

Product description

What it looks like

ZOTON is available in a blister pack of 30 capsules.
The 30mg capsules are lavender and amethyst coloured and marked "Lederle" and "30 mg"
The 15mg capsules are yellow and marked "ZOTON" and "15 mg"

ZOTON is also available as granules for suspension, 30mg in laminated foil sachets in cartons of 28 sachets.
The granules are enteric coated pink granules for oral suspension. When made up in water, the granules give a pink liquid with a strawberry flavour.

Ingredients

Each ZOTON capsule contains either 15 mg or 30 mg of Lansoprazole as the active ingredient and the following additives:
Magnesium carbonate, sucrose, maize starch, hydroxypropylcellulose, methacrylic acid copolymer, talc, macrogol 8000, titanium dioxide, polysorbate 80, colloidal anhydrous silica, erythrosine (30mg capsule), indigo carmine (30mg capsule), iron oxide yellow (15 mg capsule) iron oxide black, gelatin.
ZOTON does not contain gluten, lactose, tartrazine or any other azo dyes.

Each sachet of ZOTON granules for suspension contains 30mg of Lansoprazole as the active ingredient and the following additives:
Magnesium carbonate, sucrose, maize starch, hydroxypropylcellulose, methacrylic acid copolymer, talc, macrogol 6000, titanium dioxide, polysorbate 80, colloidal anhydrous silica, mannitol, docusate sodium, crospovidone, xanthan gum, strawberry flavour (J2161), citric acid monohydrate, iron oxide red, magnesium stearate.

® Manufactured by and licensed from Takeda Chemical Industries Limited, Osaka Japan. Proprietor of the trade mark ZOTON®

Last Revised: 28 June 2002