Pariet 20 mg
Pariet 10 mg
Please read this leaflet carefully before you start to use your medicine. It contains a summary of the information available on your medicine. If after reading this you do not understand or have any questions, ask your doctor or pharmacist (chemist).
Pharmaceutical companies are not allowed to answer questions from patients about their medicines.
Keep this leaflet. You may want to read it again.
About your medicine
Trade Name
The name of your medicine is
PARIET 20mg or
PARIET 10mg.
Composition
What is the active substance?
The active ingredient is rabeprazole sodium.
Each yellow PARIET tablet contains 20mg rabeprazole sodium; and each pink PARIET tablet contains 10mg of rabeprazole sodium.
The tablets also contain the following inactive ingredients: mannitol, magnesium oxide, low substituted hyprolose, hyprolose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (E171), yellow iron oxide (E172) (20mg only), red iron oxide (E172) (10mg only), carnauba wax and ink ((White shellac, red iron oxide (E172), Carnauba wax, Glycerine fatty acid ester, Dehydrated Ethyl Alcohol, 1-Butanol - 20mg tablets); and (White shellac, black iron oxide (E172), Dehydrated Ethyl Alcohol, 1-Butanol - 10mg tablets)).
Pharmaceutical form and treatment classification
What is PARIET (rabeprazole sodium)?
PARIET (rabeprazole sodium) belongs to a class of medicines called Proton Pump Inhibitors (PPIs).
PARIET is available as yellow or pink enteric-coated delayed-release (gastro-resistant) tablets.
The tablets come in aluminium foil blister strips of 1, 7, 10, 14 or 15 tablets per strip. Multiples of these blister strips are placed directly into a carton.
Marketing and manufacturing of PARIET
Who is the Marketing Authorisation Holder responsible for PARIET?
The name and address of the company holding the Product Licence for PARIET is:
Who is responsible for manufacturing PARIET?
PARIET bulk tablets are manufactured for Eisai Ltd. by:
Saitama Prefecture 367-0198
What your medicine is for
Why take PARIET tablets?
PARIET tablets are used to treat people diagnosed as having active duodenal ulcer, active benign gastric/stomach ulcer (peptic ulcers), symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD) commonly referred to as inflammation of the gullet caused by acid and associated with heartburn, or for long-term treatment of GORD (GORD maintenance). PARIET tablets are also used for the symptomatic treatment of moderate to very severe gastrooesophageal reflux disease (symptomatic GORD) also associated with heartburn.
PARIET tablets act by reducing the amount of acid made by the stomach. This allows ulcers to heal and symptoms of pain to improve. Pariet is also sometimes given to patients whose stomachs make extremely high amounts of acid, a condition called Zollinger-Ellison Syndrome. In combination with two antibiotics (clarithromycin and amoxycillin) PARIET tablets are used for the eradication of H pylori infection in patients with peptic ulcer disease. For further information on the antibiotic components of the H pylori eradication therapy see the individual product information leaflets.
PARIET is not recommended for use in children.
Before using PARIET tablets
Do not take this medicine without consulting your doctor.
Tell your doctor or pharmacist if:
- you are allergic to any of the ingredients listed above
- you are allergic to other proton pump inhibitors
- you have been told you have a stomach tumour
- you think you might be pregnant or are breast feeding
- you are under 12 years of age
- you have a history of liver disease
- you are taking either of these medicines, digoxin or ketoconazole
- you are taking any other medicines.
If you are in doubt, consult your doctor or pharmacist before using PARIET tablets.
It is unlikely that PARIET would affect your ability to drive or operate machinery.
However, occasionally rabeprazole sodium can induce drowsiness. Therefore, driving and operating complex machinery should be avoided if this effect occurs during treatment.
How to use PARIET tablets
How much PARIET should you take?
When and how often should you take it?
Always follow your doctor’s or pharmacist’s advice about how and when to take your medicine. Do not change the dose or length of the treatment yourself.
The usual recommended dose you will be prescribed by your doctor for the acute indications - active duodenal ulcer, active benign gastric/stomach ulcer (peptic ulcers), symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD) is 20mg; 10mg for the symptomatic treatment of moderate to very severe GORD (symptomatic GORD) and for GORD maintenance 20mg or 10mg to be taken by mouth with a drink of water once each day before eating in the morning.
To treat a condition where your stomach makes extremely high amounts of acid, called Zollinger-Ellison Syndrome, the usual recommended dose you will be prescribed by your doctor is three 20mg tablets once a day to start with. The dose may then be adjusted by your doctor depending on how you respond to the treatment. Your doctor will tell you how many tablets to take and when to take them.
The usual recommended dose you will be prescribed by your doctor for the eradication of H pylori infection is 20mg to be taken (in combination with two antibiotics - clarithromycin 500mg and amoxycillin 1g) twice each day and normally for 7 days.
YOU MUST SWALLOW THE PARIET TABLET WHOLE.
DO NOT CRUSH OR CHEW IT.
For further information on the other components of the H pylori eradication therapy see the individual product information leaflets.
For how long should you take PARIET?
If you have an active duodenal ulcer, your treatment with PARIET is expected to continue for four weeks; but after that time your doctor may decide to continue your treatment for a further four weeks.
If you have an active benign gastric ulcer, your treatment with PARIET is expected to continue for six weeks; but after that time your doctor may decide to continue your treatment for a further six weeks.
If you have erosive or ulcerative gastro-oesophageal reflux disease (GORD), you will be instructed by your doctor or pharmacist to take your PARIET tablet for four to eight weeks. For long-term maintenance treatment of GORD your doctor or pharmacist will advise you on how long to take your tablets.
If you are on long-term treatment you need to see your doctor at regular intervals for review of your tablets and symptoms.
If you have moderate to very severe symptomatic gastro-oesophageal reflux disease (symptomatic GORD), your once daily treatment with PARIET is expected to continue for up to 4 weeks. If your symptoms do not resolve within 4 weeks consult your doctor. Following this initial 4 week treatment, if your symptoms return, your doctor may then tell you to take one PARIET 10mg tablet as and when you require it in order to control your symptoms.
If you have a condition where your stomach makes extremely high amounts of acid, called Zollinger-Ellison Syndrome, your doctor or pharmacist will advise you on how long to take your tablets. If you are on long-term treatment you need to see your doctor at regular intervals for review of your tablets and symptoms.
Your treatment with PARIET (in combination with two antibiotics) for the eradication of H pylori infection will last for 7 days. Relief of symptoms will normally occur before the ulcer has completely healed. Therefore it is important that you do not stop taking the tablets until told to do so by your doctor.
What if you take too many tablets?
Do not take more tablets each day than you are prescribed. If you accidentally take more tablets than the prescribed dose, consult your doctor or the Accident and Emergency Department of your local hospital. Always take the tablets and the carton with you to the hospital so that the doctor knows what has been taken.
What if you miss taking your tablets?
If you forget to take a dose, just take it immediately when you remember, and then continue as usual. If you forget to take your medicine for more than 5 days, call your doctor before taking any more medicine.
How quickly will the treatment start to work?
The clinical trials suggest that pain will start to get better within the first few days after you start taking PARIET. However the time to pain relief may vary from patient to patient.
After using PARIET tablets
What side effects could PARIET cause?
All medicines have some side effects. There have been reports of headaches, diarrhoea, abdominal pain, asthenia (weakness), flatulence (wind), and dry mouth linked with the use of PARIET tablets.
Other effects reported during treatment with PARIET were: rhinitis, pharyngitis, nausea, vomiting, non-specific pain/back/muscle/chest and joint pain, dizziness, flu like syndrome, infection, cough, constipation and insomnia. Further less frequent effects were dyspepsia (indigestion), nervousness, drowsiness, bronchitis, sinusitis, chills, eructation (belching), leg cramps, urinary tract infection, fever, breast swelling, fluid retention and in very isolated cases, anorexia, gastritis, weight gain, kidney problems, depression, itching, vision or taste disturbances, stomatitis (sore mouth), sweating and leucocytosis (increase in white blood cells). In most cases, these have been mild, lasting a short time and resolving without having to stop treatment.
During treatment with PARIET skin rash, redness of the skin, itching and rarely skin blisters, liver problems and acute generalised reactions for example facial swelling, low blood pressure and shortness of breath have been reported which resolve after stopping the treatment.
Rarely, a decrease of white blood cells and/or blood platelets may occur. You should see your doctor immediately if you have any unexplained bruising.
Tell your doctor if you have any of these effects and if they are too uncomfortable for you. Also tell your doctor if any other effects occur while you are taking PARIET tablets.
For further information on the other components of the H pylori eradication therapy see the individual product information leaflets.
How to look after your medicine (PARIET tablets)
How should PARIET tablets be stored?
Do not store this medicine above 25°C.
DO NOT PUT THE TABLETS IN THE REFRIGERATOR.
As with all medicines, PARIET tablets should be kept in a safe place where children cannot see or reach them. This medicine is for you. Only a doctor can prescribe it for you. Do not share it with anyone else. It may harm them, even if they have the same symptoms as you.
DO NOT use PARIET tablets after the expiry date which is shown on the package and blister. Leave your tablets in the blister strip. Only remove one when it is time to take your medicine. If your doctor tells you to stop taking your medicine, you should return any you have not used to your pharmacist who will get rid of them safely.
More information
What can you do to help yourself?
- Peptic ulcer (Duodenal and Gastric ulcers)
- Do’s
- - Do take regular relaxed meals
- - Avoid foods that make you feel bad (or make the symptoms worse).
- Don’ts
- - Don’t take too much alcohol
- - Don’t smoke.
- Gastro-oesophageal reflux disease (Oesophagitis)
- Do’s
- - Do squat to pick up objects
- - Do raise the head of your bed on about 20cm blocks
- - Do try to reduce your weight if you are overweight. Avoid foods that make you feel bad (or make the symptoms worse).
- Don’ts
- - Don’t bend over from the waist
- - Don’t sleep lying flat
- - Don’t smoke or wear tight clothing.
The problem of too much acid!
Your doctor has prescribed PARIET tablets in order to treat you for either duodenal ulcer or gastric/stomach ulcer (together called peptic ulcers) or gastro-oesophageal reflux disease commonly referred to as acid inflammation of the gullet or heartburn.
What is a peptic ulcer?
A peptic ulcer is a small area in the stomach or the first part of the small bowel (the duodenum), where the protective lining has been worn away. Peptic ulcers have similarities with other ulcers. Ulcers quite often cause pain.
What causes peptic ulcers?
The stomach joins directly into the duodenum. An ulcer starts when acid normally present in the stomach attacks a small part of the wall of the stomach or duodenum. The stomach is normally covered by a protective coating but ulcers start where this coating is damaged; or, when too much acid from the stomach moves into the duodenum, which has no protective coating. Such ulcers cannot readily heal themselves, where there is continued flow of stomach acid.
What is gastro-oesophageal reflux disease (oesophagitis/GORD)?
Gastro-oesophageal reflux disease (oesophagitis or GORD) is where the oesophagus or gullet becomes inflamed, swollen and ulcerated because of repeated exposure to acid from the stomach.
What causes gastro-oesophageal reflux disease (oesophagitis/GORD)?
The stomach is usually protected from the acid it produces by the protective coating.
But, like the duodenum, the oesophagus has no protective coating. The oesophagus or gullet joins directly to the stomach. When acid from the stomach returns into the gullet, it may become inflamed, swollen and ulcerated. Healing of the inflammation and relief from pain or heartburn can be achieved by reducing the amount of stomach acid.
If you want to know more about your medicine, ask your doctor or pharmacist.
They have more information.
Date PARIET Leaflet (United Kingdom)
last revised: - June 2007
© Copyright Eisai Ltd.
Ref: PA023.1/ZES
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