Pariet

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Rabeprazole sodium

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about PARIET tablets. 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 taking PARIET against the benefits this medicine is expected to have for you.

If you have any concerns about using PARIET ask your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What PARIET is used for

The name of your medicine is PARIET. It contains the active ingredient rabeprazole sodium.

PARIET belongs to a group of medicines called proton pump inhibitors (PPIs). PARIET works by decreasing the amount of acid the stomach makes, to give relief from the symptoms and allow healing to take place. Your food will still be digested in the same way.

Gastro-oesophageal reflux disease:

PARIET is used to treat gastro-oesophageal reflux disease (GORD), commonly known as 'reflux'. This can be caused by food and acid from the stomach flowing the wrong way (reflux) back up 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. PARIET is also used to help stop gastro-oesophageal reflux disease from coming back or relapsing.

Peptic Ulcers:

PARIET is used to treat 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 ulcers can be caused by too much acid being made in the stomach.

Most people who have a peptic ulcer also have bacteria called Helicobacter pylori in their stomach. Your doctor may also prescribe a course of antibiotics (clarithromycin and amoxycillin) for you. When PARIET is taken with antibiotics, the combination therapy will kill the Helicobacter pylori and let your ulcer heal.

Chronic Gastritis:

The presence of the bacteria Helicobacter pylori may cause the stomach to become inflamed, resulting in pain, nausea and vomiting; all of which are signs of chronic gastritis.

When PARIET tablets are taken with antibiotics, they will help kill Helicobacter pylori and allow the stomach to heal.

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

PARIET is only available with a doctor's prescription.

Before you take PARIET

When you must not take it:

Do not take PARIET if you have an allergy (hypersensitivity) to:

rabeprazole sodium

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

other proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole).

Symptoms of an allergic (hypersensitive) reaction may include:

rash, itching or hives on the skin

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

Do not take PARIET if:

the packaging is torn or shows signs of tampering.

the expiry date (month and year) printed on the pack has passed. If you take PARIET after the expiry date it may not work.

PARIET should not be given to children under 18 years of age. Safety and effectiveness of PARIET in children has not been established.

Before you start to take it:

You must tell your doctor if:

you are pregnant or intend to become pregnant.

you are breast-feeding or intend to breast-feed. It is not known if PARIET passes into breast milk.

you have now, or have had in the past, liver problems.

Taking other medicines:

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

Do not take PARIET and tell your doctor or pharmacist if you are taking any of the following:

atazanavir, a medicine used (with other antiretrovirals) to treat HIV-1 infection.

clopidogrel, an antiplatelet medicine.

You should not take PARIET while taking these medicines.

Also tell your doctor or pharmacist if you are taking any of the following:

cyclosporin, a medicine used to treat several conditions including prevention of graft rejection following kidney, liver or heart transplantation; severe, active rheumatoid arthritis; severe skin diseases; kidney disease where other treatments have failed.

methotrexate, a medicine used to treat some kinds of cancer. It is also used to treat psoriasis (skin disease) and rheumatoid arthritis.

digoxin, a medicine used to treat heart problems.

ketoconazole, a medicine used to treat fungal infections.

mycophenolate mofetil, a medicine used to prevent organ rejection following kidney, liver or heart transplants.

clarithromycin, a medicine used to treat infections.

These medicines may be affected by PARIET or may affect how well PARIET works. Your doctor or pharmacist can tell you what to do if you are taking any other medicines.

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

Your doctor will advise you whether or not to take PARIET or if you need to have your dose adjusted.

How to take PARIET

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

How much to take:

Adults

The usual dose is one tablet, to be taken once daily, at the same time each day.

The dose of PARIET tablets is usually 20 mg, but may vary from 10 mg to 40 mg per day depending on what condition you are being treated for and how severe it is.

For treating Helicobacter pylori infections in combination with antibiotics (clarithromycin and amoxycillin), the usual dose is one 20mg tablet twice daily, morning and evening, for 7 days.

Children

PARIET should not be given to children under 18 years of age. Safety and effectiveness of PARIET in children has not been established.

How to take it:

PARIET should be swallowed whole, with a glass of water or other liquid.

Do NOT crush or chew the tablets. They have a special coating, which protects them from the acid in your stomach. If the coating is broken by chewing, the tablets may not work.

It does not matter if you take PARIET with food or on an empty stomach.

Ask your doctor or pharmacist for help if you do not understand the instructions provided with this medicine.

If you forget to take it:

If you forget to take your tablet, take it as soon as you remember and then continue to take it as you would normally.

However, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you have taken too much (overdose):

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

While you are using PARIET

Things you must do:

Use PARIET exactly as your doctor has prescribed.

Always swallow PARIET tablets whole.

Tell your doctor if you become pregnant while you are taking PARIET

Tell your doctor or pharmacist that you are taking PARIET if you are about to start taking a new medicine.

Things you must not do:

Do not use PARIET to treat any other complaint unless your doctor says to.

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

Do not crush or chew the tablets.

Do not give PARIET to children.

Tell your doctor if you need to have a specific blood test (Chromogranin A) while you are taking PARIET.

It may affect the results of this test.

Side Effects

PARIET is usually well tolerated but tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PARIET.

PARIET helps most people with peptic ulcers or 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 treatment if you get some side effects.

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

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

dizziness

diarrhoea

nausea

stomach pain

wind

vomiting

constipation

runny or blocked nose

sore throat and discomfort when swallowing

cough

pain (including back, chest or join pain)

muscle weakness, physical weakness or lack of energy

rash or itchy rash accompanied by skin eruptions or blisters

flu-like symptoms

sleeplessness (insomnia)

indigestion

belching

dry mouth

leg cramps

swelling of the arms or legs

nervousness

sleepiness (somnolence)

loss of appetite for food (anorexia)

weight gain

sweating

These side effects are usually mild.

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

painful and/or frequent urination (common symptoms of a urinary tract infection)

vision or taste disturbance

depression

feeling dizzy, faint, lightheaded or weak (hypotension)

shortness of breath

signs of frequent infections such as fever, chills, sore throat or mouth ulcers.

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

Tell your doctor immediately and do not take your next dose of PARIET if you:

experience signs of allergy such as skin rash, reddening, blisters or itching, swelling of the face, lips or other parts of the body, shortness of breath or wheezing.

pass black (blood-stained) stools

If you experience symptoms such as severe (watery or bloody) diarrhoea, fever, abdominal pain or tenderness, you may have Clostridium difficile colitis (bowel inflammation).

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

you begin to vomit blood or food

you pass black (blood-stained) motions.

Under rare circumstances supervised by the doctor, proton pump inhibitors (PPIs) might be used for long periods of time.

Low magnesium can occur in some people who take a proton pump inhibitor. Symptoms of low magnesium can include: seizures, dizziness, spasms, cramps or muscle weakness.

Low magnesium can lead to low calcium and/or low potassium levels in blood.

Withdrawal of long-term PPI therapy may lead to worsening of acid-related symptoms.

People who take proton pump inhibitor medicines at high doses for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

Proton pump inhibitors may reduce the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor or pharmacist about the possibility of vitamin B-12 deficiency if you have been taking a proton pump inhibitor for a long time (i.e. more than 3 years).

Other side effects not listed above may also occur in some people. Tell your doctor if you notice anything making you feel unwell when you are taking, or soon after you have finished taking PARIET.

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

After using PARIET

Storage

PARIET tablets are packaged in a double-sided aluminium blister strip.

Do not take PARIET tablets out of the blister pack until it is time to take them. If you take them out of the blister they may not keep well.

Keep PARIET tablets in a cool dry place where the temperature is below 25°C. Do not keep PARIET in the refrigerator or freezer.

Do not store PARIET, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.

Disposal

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

Product Description

What PARIET tablets look like:

PARIET 10 mg tablets are pink and have "E241" in black ink on one side.

PARIET 20 mg tablets are pale yellow, and have "E243" in red ink on one side.

PARIET 10 mg tablets are supplied in blister packs of 7, 28 and 30 tablets.

PARIET 20 mg tablets are supplied in blister packs of 7, 28 and 30 tablets

Ingredients

Each PARIET tablet contains 10 mg or 20 mg of rabeprazole sodium as the active ingredient.

Each tablet also contains the following other ingredients:

mannitol, magnesium oxide, hyprolose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, purified talc, titanium dioxide and carnauba wax.

the 20 mg tablets also contain iron oxide yellow and are printed with red ink (Edible Ink Red A1).

the 10 mg tablets contain iron oxide red and are printed with gray ink (Edible Ink Gray F6).

The tablets do not contain lactose or gluten.