Pariet 20mg Tablets
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PATIENT INFORMATION LEAFLET PARIET® 20mg TABLETS (rabeprazole sodium)
Please note that the leaflet also contains information about other strengths (Pariet 10mg T ablets).
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Pariet® 20mg Tablets is and what it is used for
2. What you need to know before you take Pariet® 20mg Tablets
3. How to take Pariet® 20mg Tablets
4. Possible side effects
5. How to store Pariet® 20mg Tablets
6. Contents of the pack and other information
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Pariet® 20mg Tablets contain the active ingredient rabeprazole sodium. medicines called 'Proton Pump Inhibitors' (PPIs). They work by lowering stomach produces.
This belongs to a the amount of acid
group of that your
Pariet® 20mg Tablets are used to treat the following conditions:
• 'Gastro-oesophageal reflux disease' (GORD), which can include heartburn. GORD is caused when acid and food from your stomach escapes into your food pipe (oesophagus)
• Ulcers in your stomach or the upper part of your gut (intestine). If these ulcers are infected with bacteria called 'Helicobacter pylori' (H. Pylori), you will also be given antibiotics. Using Pariet® 20mg Tablets and antibiotics together gets rid of the infection and makes the ulcer heal. It also stops the infection and ulcer from coming back
• Zollinger-Ellison Syndrome where your stomach produces too much acid.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARIET® 20mg TABLETS
Do not take Pariet® 20mg Tablets if:
• You are allergic (hypersensitive) to rabeprazole sodium, or any of the other ingredients of Pariet® 20mg Tablets (listed in Section 6 below)
• You are pregnant or think that you are pregnant
• You are breast-feeding.
Do not use Pariet® 20mg Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Pariet® 20mg Tablets.
Also see Pregnancy and breast-feeding section.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking Pariet® 20mg Tablets if:
• You are allergic to other proton pump inhibitor medicines or 'substituted benzimidazoles'.
• Blood and liver problems have been seen in some patients but often get better when Pariet® 20mg Tablets is stopped
• You have a stomach tumour
• You have ever had liver problems.
• If you are taking atazanavir - for HIV infection
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Pariet® 20mg Tablets. If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop taking Pariet® 20mg Tablets and see a doctor straight away.
Taking a proton pump inhibitor like Pariet® 20mg Tablets, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Children
Pariet® 20mg Tablets should not be used in children.
Other medicines and Pariet
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Ketoconazole or itraconazole - used to treat infections caused by a fungus. Pariet® 20mg Tablets may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.
• Atazanavir- used to treat HIV-infection. Pariet® 20mg Tablets may lower the amount of this type of medicine in your blood and they should not be used together.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Pariet® 20mg Tablets.
Pregnancy and breast-feeding and fertility
• Do not use Pariet® 20mg T ablets if you are pregnant or think you may be pregnant
• Do not use Pariet® 20mg Tablets if you are breast-feeding or planning to breast-feed.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
You may feel sleepy while taking Pariet® 20mg Tablets. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE _ PARIET® 20mg TABLETS
Always take Pariet® 20mg Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Only remove a tablet from the blister strip when it is time to take your medicine
• Swallow your tablets whole with a drink of water. Do not chew or crush the tablets
• Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition
• If you are taking this medicine for a long time, your doctor will want to monitor you.
Adults and the Elderly
For ‘gastro-oesophageal reflux disease' (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)
• The usual dose is one Pariet 10 mg tablet once a day for up to 4 weeks
• Take the tablet in the morning before eating
• If your condition returns after 4 weeks treatment, your doctor may tell you to take one Pariet 10 mg tablet as and when you require it.
Treatment of more severe symptoms (erosive or ulcerative GORD)
• The usual dose is one Pariet 20mg tablet once a day for 4 to 8 weeks
• Take the tablet in the morning before eating
Long-term treatment of symptoms (GORD maintenance)
• The usual dose is one Pariet 10 mg or 20 mg tablet once a day for as long as your doctor has told you
• Take the tablet in the morning before eating
• Your doctor will want to see you at regular intervals to check your symptoms and dosage.
For ulcers of the stomach (peptic ulcers)
• The usual dose is one Pariet® 20mg Tablet once a day for 6 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take Pariet® 20mg Tablets for another 6 weeks if your condition does not improve.
For ulcers of the intestine (duodenal ulcers)
• The usual dose is one Pariet® 20mg Tablet once a day for 4 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take Pariet® 20mg Tablets for another 4 weeks if your condition does not improve.
For ulcers caused by H. Pylori infection and to stop them coming back
• The usual dose is one Pariet® 20mg Tablet twice a day for seven days
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin
For further information on the other medicines used for the H. Pylori treatment, see the individual product information leaflets.
Zollinger-Ellison Syndrome where excess acid is produced in the stomach
• The usual dose is three Pariet® 20mg T ablets once a day to start with
• The dose may then be adjusted by your doctor depending on how you respond to the treatment.
If you are on long-term treatment you will need to see your doctor at regular intervals for review of your tablets and symptoms.
Children. The product should not be used in children.
Patients with liver problems. You should consult your doctor who will take special care when beginning treatment with Pariet® 20mg Tablets and while you continue to be treated with Pariet® 20mg Tablets
If you take more Pariet® 20mg Tablets than you should
If you take more Pariet® 20mg Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Pariet® 20mg Tablets
• If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual
• If you forget to take your medicine for more than 5 days, talk to your doctor before taking any more medicine
• Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Pariet® 20mg Tablets
Relief of symptoms will normally occur before the ulcer has completely healed. It is important that you do not stop taking the tablets until told to do so by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pariet® 20mg Tablets can cause side effects, although not everybody gets them. The side effects are usually mild and improve without you having to stop taking this medicine.
Stop taking Pariet® 20mg Tablets and see a doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
• Allergic reactions - the signs may include: sudden swelling of your face, difficulty breathing or low blood pressure which may cause fainting or collapse
• Frequent infections, such as a sore throat or high temperature (fever), or ulcers in your mouth or throat
• Bruising or bleeding easily.
These side effects are rare (affect less than 1 in 1,000 people).
• Severe skin blistering, or soreness or ulcers in your mouth and throat.
These side effects are very rare (affect fewer than 1 in 10,000 people).
Other possible side effects:
Common (affect less than 1 in 10 people)
• Infections
• Difficulty sleeping
• Headache or feeling dizzy
• Cough, runny nose or sore throat (pharyngitis)
• Effects on your stomach or gut such as stomach pain, diarrhoea, wind (flatulence), feeling sick (nausea), being sick (vomiting) or constipation
• Aches or back pain
• Weakness or flu-like symptoms.
Uncommon (affect less than 1 in 100 people)
• Feeling nervous or drowsy
• Chest infection (bronchitis)
• Painful and blocked sinuses (sinusitis)
• Dry mouth
• Indigestion or belching
• Skin rash or redness
• Muscle, leg or joint pain
• Bladder infection (urinary tract infection)
• Chest pain
• Chills or fever
• Changes in how your liver is working (shown in blood tests)
Rare (affect less than 1 in 1,000 people)
• Loss of appetite (Anorexia)
• Depression
• Hypersensitivity (includes allergic reactions)
• Visual disturbance
• Sore mouth (stomatitis) or taste disturbance
• Upset stomach or stomach pain
• Liver problems including yellowing of your skin and whites of your eyes (jaundice)
• Itchy rash or blistering skin
• Sweating
• Kidney problems
• Weight gain
• Change in white blood cells (shown in blood tests) which may result in frequent infection.
• Reduction in blood platelets resulting in bleeding or bruising more easily than normal.
Other possible side effects (unknown frequency)
• breast swelling in men
• fluid retention
• Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma.
• Patients who have previously had liver problems may very rarely get encephalopathy (a brain disease).
If you are on Pariet® 20mg Tablets for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Do not be concerned by this list of side effects. You may not get any of them. If you get any the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
|5. HOW TO STORE PARIET® 20mg TABLETS|
• Do not store above 25°C. Do not refrigerate.
• As with all medicines, Pariet® 20mg Tablets should be kept in a safe place where children cannot see or reach them.
• Do not use after the expiry date printed on the carton or blister labels.
• If your doctor tells you to stop taking this medicine, return any unused tablets to your doctor or pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The active ingredient is rabeprazole sodium. Each tablet contains 20mg rabeprazole sodium. The tablets are yellow and round marked ‘C243\
The tablets also contain the following inactive ingredients: mannitol, magnesium oxide, hydroxypropylcellulose, magnesium stearate, ethylcellulose, hypromellose phthalate, diacetylated monoglycerides, talc, titanium dioxide (El71), yellow iron oxide (El72), red iron oxide (E172), carnauba wax, shellac food grade, soya lecithin, antifoam and ink.
Pariet® 20mg Tablets is available as yellow enteric-coated delayed-release tablets.
The tablets are available as blister strips of 14 or 28 tablets.
PL No: 15814/0356 |POM|
This product is manufactured by Eisai Co. Ltd., (Misato Plant), 950 Oaza Hiroki, Misato-cho, Kodama-gun Saitama Prefecture 367-01, Japan and procured from within the EU and repackaged by the Product Licence holder: OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref) 23.05.2013
Pariet is a registered Trade Mark of Eisai Kabushiki Kasha, Japan.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.