Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about pantoprazole. 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 using this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

Pantoprazole belongs to a group of medicines called proton pump inhibitors (PPIs). PPIs work by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place.

Ulcers
Pantoprazole is used to treat and help heal duodenal and gastric 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.

Pantoprazole may also be used to prevent ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). These are medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis (inflammation of the joints).

Reflux disease
Pantoprazole 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.

Pantoprazole is also used to prevent reflux oesophagitis from coming back.

Zollinger-Ellison syndrome
Pantoprazole is 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.

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

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

There is not enough information to recommend the use of this medicine in children.

Before you take this medicine

When you must not take it

Do not take this medicine if you are lactose-intolerant. These tablets contain lactose.

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

• pantoprazole
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue, throat or other parts of the body
• rash, itching or hives on the skin

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

Do not take this medicine in combination with antibiotics or any other medicine if:

• you are allergic to any of the antibiotics or medicines your doctor may prescribe with pantoprazole
• you have moderate to severe liver or kidney disease

Do not take this medicine in combination with atazanavir or nelfinavir (anti-viral medications).

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or 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.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any other medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you have any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• vomiting blood
• difficulty or pain when swallowing
• you look pale and feel weak
• you notice blood in your stools

Your doctor may need to perform some additional tests before you take this medicine.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

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 and pantoprazole may interfere with each other. These include:

• warfarin and phenprocoumon, used to prevent blood clots
• atazanavir and nelfinavir, used to treat viral infections such as HIV
• ketoconazole, itraconazole and posaconazole, used to treat fungal infection
• methotrexate, used to treat arthritis and some types of cancer
• erlotinib or related medicines, used to treat cancer
• tacrolimus and mycophenolate mofetil, used to suppress the immune system
• fluvoxamine, used to treat anxiety and depression.

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

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Other interactions not listed above may also occur.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ to the information contained in this leaflet.

If you do not understand any written instructions, ask your doctor or pharmacist for help.

How much to take

The usual dose is one tablet per day.

Your doctor will prescribe the dose that is right for you.

The dose and frequency of pantoprazole that your doctor prescribes for you depends on your medical condition. Your doctor may change the dose as your condition changes.

How to take it

Swallow your tablets whole with water with or without food.

Do not crush or chew the tablets. APO-Pantoprazole 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 your medicine at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you are taking this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

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 medicine 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 13 11 26) 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 pantoprazole. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking pantoprazole.

Tell any other doctors, dentists and pharmacists who treat you that you are taking pantoprazole.

If you are going to have surgery, tell the surgeon that you are taking this medicine.

Tell your doctor immediately if you become pregnant while you are taking pantoprazole.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests, and you may need to stop pantoprazole for a period of time before the test.

Do not stop pantoprazole until your doctor has discussed this with you.

Keep all of your doctor’s appointments so that your progress can be checked. If you take pantoprazole for a long period of time, e.g. over 1 year, you will need to see your doctor regularly so that they can monitor your condition.

Tell your doctor if you do not feel better while taking this medicine. Your doctor may recommend further examination.

Tell your doctor if your reflux symptoms return after you stop taking this medicine. The symptoms of reflux may return after stopping pantoprazole suddenly, especially if you have taken it for a while.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor tells you to.

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

Do not stop taking your medicine, or change the dosage, without checking with your doctor.

Things to be careful of

Be careful while driving or operating machinery until you know how pantoprazole affects you. This medicine may cause dizziness, in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Things that may help your condition

Some self-help measures suggested below may help your condition. Your doctor or pharmacist can give you more information about these measures.

• 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 pantoprazole.

This medicine helps most people, 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.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

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

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• unusual tiredness or weakness
• nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine
• blood in the urine
• increased or decreased need to urinate
• severe skin problems such as itchiness, redness, rash with swelling, blistering or peeling of the skin or rash when exposed to the sun, possibly with pain in the joints and general fever
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• frequent infections such as fever, severe chills, sore throat or mouth ulcers
• chest pain
• shortness of breath
• high blood pressure
• water retention, swelling
• bleeding or bruising more easily than normal
• depression, confusion or anxiety
• bone fracture of the hip, wrist or spine (mainly a risk in people who take high doses of PPIs or use them long term (a year or longer))
• symptoms such as seizures, abnormal or fast heartbeat or jerking/shaking movements. These can be a sign of low magnesium, calcium or potassium levels in your blood
• severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may occur in some people.

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.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take them. If you take the tablets out of their original packaging they may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C. Protect from light and moisture.

Do not store your medicine, 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 your doctor tells you to 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 APO-Pantoprazole looks like

The tablets are available as 20 mg and 40 mg strengths. The tablets have an acid-resistant coating called an enteric coating.

20 mg tablets
Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "20" on the other side. AUST R 156339.

Bottle of 30, 100 and 500 tablets.

40 mg tablets
Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "40" on the other side. AUST R 156341.

Bottle of 30, 100 and 500 tablets.

*Not all strengths and/or pack sizes may be available.

Ingredients

The active ingredient in the tablets is pantoprazole (as sodium sesquihydrate).

The tablets also contain the following as inactive ingredients:

• lactose
• crospovidone
• microcrystalline cellulose
• magnesium stearate
• hypromellose
• macrogol 8000
• sodium carbonate
• methacrylic acid copolymer
• triethyl citrate
• purified talc
• titanium dioxide
• iron oxide yellow.

This medicine contains sugars (as lactose).

This medicine is gluten-free, sucrose-free, tartrazine-free and other azo dyes-free.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was last updated in November 2023.

Published by MIMS January 2024

1 Name of Medicine

Pantoprazole (as sodium sesquihydrate).

2 Qualitative and Quantitative Composition

Each enteric coated tablet contains 20 mg or 40 mg pantoprazole (as sodium sesquihydrate) as the active ingredient.
Excipients with known effect. Lactose.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

20 mg tablets. Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "20" on the other side.
40 mg tablets. Yellow, oval, biconvex, enteric-coated tablets engraved "APO" on one side, "40" on the other side.

4 Clinical Particulars

4.9 Overdose

Symptoms. There are no known symptoms of overdosage in humans. In individual cases 240 mg was administered IV or orally and was well tolerated. As pantoprazole is extensively protein bound, it is not readily dialyzable. As in any case of overdosage, treatment should be symptomatic and supportive measures should be utilised.
Treatment. Standard detoxification procedures apply.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. A number of in vitro and in vivo genotoxicity assays covering mutagenicity, clastogenicity and DNA damage endpoints were conducted on pantoprazole and the results were generally negative. Exposures achieved in the in vivo tests in mice and rats were well in excess of exposures expected clinically. However, pantoprazole was clearly positive in carefully conducted cytogenetic assays in human lymphocytes in vitro, both in the presence and absence of metabolic activation. Omeprazole was also positive in a comparable test conducted in the same laboratory, suggesting a possible class effect. A minute amount of radioactivity was bound to rat hepatic DNA after treatment with pantoprazole 200 mg/kg/day for 14 days. This is an estimated exposure 24-fold the clinical exposure from the 40 mg tablet. No distinct DNA adduct was detected.
Pantoprazole was found to be negative in the following studies: in vivo chromosome aberration assay in rat and bone marrow (126E/95), mouse lymphoma test (222E/95) and a gene mutation test in Chinese hamster ovary cells (in vitro) (188E/95). In addition, toxicokinetic studies were conducted in rats at the doses used in the bone marrow assay (50-1,200 mg/kg) (56E/96) and in mice at the high dose from the earlier micronucleus test (710 mg/kg) (89E/96). Pantoprazole exposure was high with the respective rat and mouse plasma AUCs being 7-100 and 9 to 12-fold the clinical exposure from a 40 mg tablet.
Carcinogenicity. A two year oral carcinogenicity study in Sprague-Dawley rats at doses up to 200 mg/kg/day showed gastric carcinoids were found after pantoprazole treatment at doses greater than 0.5 mg/kg/day in females and greater than 5 mg/kg/day in males, with none observed in controls. The estimated exposure (based on AUC) from these doses are at, or below, clinical exposure from a 40 mg tablet. The development of gastric tumours is attributed to chronic elevation of serum gastrin levels with associated histopathological changes in the gastrointestinal system.
In both male and female rats the development of hepatocellular adenomas was increased at doses greater than 5 mg/kg/day and the development of hepatocellular carcinomas was increased at doses greater than 50 mg/kg/day, with respective estimated exposures of 1 and 9-fold the AUC of the 40 mg clinical dose. Hepatocellular tumours, which were also observed in female mice at oral doses greater than 25 mg/kg/day (exposure similar to clinical exposure), may be associated with pantoprazole induced increases in hepatic enzyme activity.
Treatment with pantoprazole at doses greater than 50 mg/kg/day (exposure approximately 9-fold clinical exposure) also increased the development of thyroid follicular cell adenomas in male and female rats. Several studies in rats were conducted to investigate the effect of pantoprazole on the thyroid, the results of which suggested that the effect may be secondary to the induction of enzymes in the liver.
In a more recent carcinogenicity study, Fischer rats were studied using lower oral doses (5, 15 and 50 mg/kg/day, 0.5-, 2- and 7-fold the clinical AUC, respectively). Gastric carcinoids were detected at all doses in females and at the 15 and 50 mg/kg doses in males, while none were detected in controls. No metastases of these carcinoids were detected. There was no increase in the incidence of liver tumours. The dose of 15 mg/kg is seen to be the no effect level for liver tumours in rodents.
Consideration of the possible mechanisms involved in the development of the above drug related tumour types suggests that it is unlikely that there is any carcinogenic risk in humans at therapeutic dose levels of pantoprazole for short-term treatment.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Pantoprazole sodium sesquihydrate is a white to off white crystalline powder. Solubility is low at neutral pH and increases with increasing pH.
Chemical structure. Chemical name: sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl] benzimidazol-1-ide sesquihydrate.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPASOSE.gif Molecular formula: C₁₆H₁₄F₂N₃NaO₄S.1½ H₂O.
Molecular weight: 432.4.
CAS number. 164579-32-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOPANST.gif