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RABEPRAZOLE SODIUM 20MG GASTRO RESISTANT TABLETS

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Pariet® 10mg Gastro-Resistant Tablets /
Rabeprazole Sodium 10mg Gastro-Resistant Tablets
Pariet® 20mg Gastro-Resistant Tablets /
Rabeprazole Sodium 20mg Gastro-Resistant Tablets

Pregnancy and breast-feeding
• Do not use Pariet if you are pregnant or think you may be pregnant
• Do not use Pariet 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.

(rabeprazole sodium)

Driving and using machines
You may feel sleepy while taking Pariet. If this happens, do not drive or use
any tools or machines.

Your medicine is available as any of the above names, but will be referred to
as Pariet throughout this leaflet.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Pariet is and what it is used for
2. Before you take Pariet
3. How to take Pariet
4. Possible side effects
5. How to store Pariet
6. Further information

3. HOW TO TAKE PARIET
Always take Pariet exactly as your doctor has told you. You should 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.
The following is a translation of the days of the week which appear on the
blister strips:
MON
TUE
WED
THUR
FRI
SAT
SUN
Mo
Di
Mi
Do
Fr
Sa
So
Adults and the Elderly
For ‘gastro-oesophageal reflux disease’ (GORD)

1. WHAT PARIET IS AND WHAT IT IS USED FOR
Pariet tablet contains the active ingredient rabeprazole sodium. This belongs
to a group of medicines called ‘Proton Pump Inhibitors’ (PPIs). They work by
lowering the amount of acid that your stomach produces.
Pariet 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 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. BEFORE YOU TAKE PARIET
Do not take Pariet if:
• You are allergic (hypersensitive) to rabeprazole sodium, or any of the other
ingredients of Pariet (listed in Section 6 below)
• You are pregnant or think that you are pregnant
• You are breast-feeding.
Do not use Pariet if any of the above applies to you. If you are not sure, talk
to your doctor or pharmacist before using Pariet.
Also see Pregnancy and breast-feeding section.
Children
Pariet should not be used in children.
Take special care with Pariet
Check with your doctor or pharmacist before taking Pariet 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 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. If you experience severe (watery or bloody)
diarrhoea with symptoms such as fever, abdominal pain or tenderness, stop
taking Pariet and see a doctor straight away.
Taking a proton pump inhibitor like Pariet, 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).
Using other medicines
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 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 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.

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 20 mg tablet once a day for 6 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take Pariet for another 6 weeks if your
condition does not improve.
For ulcers of the intestine (duodenal ulcers)
• The usual dose is one Pariet 20 mg tablet once a day for 4 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take Pariet 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 20 mg 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 20 mg tablets 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 to be used in children.
Patients with liver problems. You should consult your doctor who will take
special care when beginning treatment with Pariet and while you continue to
be treated with Pariet.
If you take more Pariet than you should
If you take more Pariet 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
• 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
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

6. FURTHER INFORMATION

Like all medicines, Pariet 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.

What Pariet contains
The name of your medicine is Pariet. Each tablet contains either 20mg or
10mg of the active ingredient rabeprazole sodium. Your 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) and carnauba wax.

Stop taking Pariet 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)
• Musculoskeletal disorders.
• Fracture of the hip, wrist or spine.
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
• Changes 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 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 any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE PARIET
Do not store this medicine above 25°C.
DO NOT PUT THE TABLETS IN THE REFRIGERATOR.
As with all medicines, Pariet 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 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.
If you notice that your tablets have become discoloured or show any other
signs of deterioration, consult your pharmacist.

Pariet 10mg tablets also contain red iron oxide (E172) and black printing ink.
Pariet 20mg tablets also contain yellow iron oxide (E172) and red printing ink.
Pariet belong to a class of medicines called Proton Pump Inhibitors (PPIs).
What Pariet look like and contents of the pack
Pariet 20mg tablets are available as yellow, film-coated, biconvex, gastroresistant tablets, with ‘E243’ printed in red ink on one side.
Pariet 10mg tablets are available as pink, film-coated, biconvex, gastroresistant tablets, with ‘E241’ printed in black ink on one side.
The tablets come in calendar blister packs of 14, 28, 56 or 98 tablets.
Pariet tablets are manufactured by either Eisai Ltd., Hammersmith International
Centre, 3 Shortlands, London W6 8EE or Eisai Manufacturing Limited, European
Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United
Kingdom. Procured from within the EU by the Product Licence holder: Caseview
(PL) Ltd., 20 Alliance Court, Alliance Road, London W3 0RB. Repackaged by
OPD Laboratories Ltd, Colonial Way, Watford, Herts WD24 4PR.
PL 13826/1667 Pariet 10mg Gastro-Resistant Tablets
PL 13826/1668 Pariet 20mg Gastro-Resistant Tablets

POM

Leaflet revision date (ref) 16/10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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