PARIET 10MG TABLETS

Active substance: RABEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PARIET® 10mg TABLETS
(rabeprazole sodium)
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.

The name of your medicine is Pariet 10mg Tablets
or Pariet 20mg Tablets but will be referred to as
Pariet throughout this leaflet.
What is in this leaflet:
1. What Pariet is and what it is used for
2. What you need to know before you take
Pariet
3. How to take Pariet
4. Possible side effects
5. How to store Pariet
6. Contents of the pack and other information

1. WHAT PARIET IS AND WHAT IT IS USED FOR
Pariet tablets contain 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. WHAT YOU NEED TO KNOW 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.
Warnings and precautions
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).

Children
Pariet 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
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.
Pregnancy and breast-feeding and fertility
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.
Driving and using machines
You may feel sleepy while taking Pariet. If this
happens, do not drive or use any tools or
machines.

3. HOW TO TAKE PARIET
Always take Pariet 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 10mg 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 10mg 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 10mg or 20mg
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 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 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 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
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.
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)

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.

Reporting side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide
more information on the safety of this medicine

5. HOW TO STORE PARIET
Keep out of the sight and reach of children.
Do not store this medicine above 25° C.
Do not refrigerate.
Do not use Pariet after the expiry date which is
stated on the carton and blister foil. The expiry
date refers to the last day of that month.

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
Each Pariet 10mg tablet contains 10mg of the
active substance rabeprazole sodium.
The other ingredients it contains are: mannitol,
magnesium oxide, low-substituted hyprolose,
ethylcellulose, talc, hypromellose phthalate,
diacetylated monoglycerides, red iron oxide
(E172), carnauba wax, black printing ink, soya
lecithin (E322), pharmaceutical glaze, black iron
oxide (E172), propylene glycol, medicinal
antifoam A and titanium dioxide (E171).
Each Pariet 20mg tablet contains 20mg of the
active substance rabeprazole sodium.
The other ingredients it contains are:mannitol,
magnesium oxide, low-substituted hydroxypropyl
cellulose, hydroxypropyl cellulose, magnesium
stearate, ethylcellulose, talc, hypromellose
phthalate, diacetylated monoglycerides, red iron
oxide (E172), carnauba wax, black printing ink,
soya lecithin (E322), pharmaceutical glaze, black
iron oxide (E172), propylene glycol, medicinal
antifoam A, yellow iron oxide (E172).

What Pariet looks like and contents of the pack
The 10mg are small, pink round tablets marked
with ‘E241’ on one side and plain on the reverse.
The 20mg are small, yellow, round tablets marked
with ‘E243’ on one side and plain on the reverse.
The tablets are packed in blister strips and come
in pack sizes that contain: 14 tablets.
Manufactured by:
Eisai Co. Ltd, (Misato Plant), 950 Oaza Hiroki,
Misato-cho, Kodama-gun, Saitama Prefecture
367-01, Japan.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare
Unit 4 Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
PARIET® 10mg TABLETS
PL No: 18799/0285

POM

Leaflet date: 10.10.2014
PARIET is a registered trademark of Eisai Ltd.

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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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