PARIET PHARMACY 10MG GASTRO-RESISTANT TABLETS

Active substance: RABEPRAZOLE SODIUM

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MOCK-UP
ARF209

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pariet®Pharmacy

10 mg
gastro-resistant tablets

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.
• You must contact a doctor if your symptoms
worsen or do not improve after 2 weeks.
• 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:

Rabeprazole sodium

1. What Pariet Pharmacy is and what it is used for
2. Before you take Pariet Pharmacy
3. How to take Pariet Pharmacy
4. Possible side effects
5. How to store Pariet Pharmacy
6. Further information

1. What Pariet Pharmacy is and
what it is used for
Pariet Pharmacy 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 Pharmacy tablets give relief of
heartburn and acid reflux (when acid and food
from your stomach escapes into your food
pipe).

2. Before you take Pariet Pharmacy

• Atazanavir – for HIV infection. Pariet
Pharmacy may lower this type of medication
in your blood and they should not be used
together.
You should not take other medicines to
control stomach acid (e.g. other PPIs or tablets
called H2 blockers) at the same time as this
medicine.
Tell your doctor about any treatments you are
taking for heartburn or indigestion if you are
going to have a test called an endoscopy (a
test that looks inside the foodpipe).
Avoid using Pariet Pharmacy if you are going
to have a urea breath test.

Do not take Pariet Pharmacy if:
• You are allergic (hypersensitive) to
rabeprazole sodium, or any of the other
ingredients of Pariet Pharmacy (listed in
Section 6 below).
• You are pregnant or think that you are
pregnant.
• You are breast-feeding.
Pariet Pharmacy should not be taken to
prevent stomach problems.
Do not use Pariet Pharmacy if any of the above
applies to you.
If you are not sure, talk to your pharmacist
before using Pariet.
Ask your doctor before you take this
medicine if:
• You have unintentionally lost weight,
anaemia, bleeding of the stomach, difficulty
or pain on swallowing, persistent vomiting or
vomiting blood, a lump in your stomach
area, jaundice or have previously had a
gastric ulcer or stomach surgery.
• You are 55 years or older with symptoms
that are new or recently changed or if you
need to take treatment for your symptoms
on a daily basis.
Children
Pariet Pharmacy should not be used in
children or teenagers under the age of 18
years.
Take special care with Pariet Pharmacy
Check with your pharmacist before taking
Pariet Pharmacy if:
• You are allergic to other proton pump
inhibitor medicines.
• You have a stomach tumour.
• You have ever had liver problems.
• If you are taking atazanavir – for HIV
infection.
If you experience severe (watery or bloody)
diarrhoea with symptoms such as fever,
abdominal pain or tenderness, stop taking
Pariet Pharmacy and see a doctor straight
away.
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist
before using Pariet Pharmacy.

Pregnancy and breast-feeding
• Do not use if you are pregnant or think you
may be pregnant
• Do not use if you are breast-feeding or
planning to breast feed
Ask your pharmacist for advice before taking
any medicine during pregnancy or while
breast-feeding.
Taking Pariet Pharmacy with food and drink
Having your tablets with or after food does not
affect how Pariet Pharmacy works.
Driving and using machines
You may feel sleepy while taking Pariet
Pharmacy. If this happens, do not drive or use
any tools or machines.
Special advice for people taking medicines
for indigestion or heartburn without a
prescription
You should talk to your pharmacist or doctor if:
• You need to take medicines for heartburn or
indigestion for 4 weeks or more to control
your symptoms.
• You have lost weight without trying to; you
have been told you are are anaemic or you
have had bleeding from your stomach or
have black stools.
• You have difficulty swallowing or it is painful
to swallow.
• You are being sick a lot or there is blood in
your sick.
• You have noticed a lump in your stomach.
• You have had stomach ulcers in the past or
surgery for ulcers.
• You have yellowing of the skin (jaundice) or
any other serious illness.

Using other medicines
Please tell your 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 pharmacist if you are
taking any of the
following medicines:
• Ketoconazole or itraconazole – used to treat
infections caused by a fungus. Pariet
Pharmacy may lower the amount of this type
of medicine in your blood. Your doctor may
need to adjust your dose.

3. How to take Pariet Pharmacy
Always take Pariet Pharmacy exactly as this
leaflet tells 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.
• Take one Pariet Pharmacy 10 mg tablet once
a day for up to 2 weeks until your symptoms
are completely gone. If you still have
symptoms after taking Pariet Pharmacy every
day for 4 weeks you should talk to your
doctor.
• You may not get relief of your symptoms
with the first dose of Pariet Pharmacy.

If you take more Pariet Pharmacy than you
should
If you take more Pariet Pharmacy 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 Pharmacy
• 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.
• Do not take a double dose (two doses at the
same time) to make up for a forgotten dose.
If you have any further questions on the use of
this product, ask your pharmacist.

4. Possible side effects
Like all medicines, Pariet Pharmacy may
sometimes 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 Pharmacy 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).
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.
• Non-specific pain 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)
• Anorexia.
• Depression.
• Hypersensitivity.
• Visual disturbance.
• Sore mouth (stomatitis) or taste disturbance.
• Upset stomach.
• 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).
• Reduction in platelets.
Very rare (affect less than 1 in 10,000 people)
• Severe skin blistering, or soreness or ulcers in
your mouth and throat.
Other possible side effects (unknown
frequency)
• Breast swelling.
• Fluid retention.
• Changes in sodium levels (measured in
blood tests).
• Confusion.
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 Pharmacy
Keep out of the reach and sight of children.
Do not store this medicine above 25⁰C.
Do not refrigerate.
Do not use Pariet Pharmacy 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. Further Information

Marketing Authorisation Holder and
Manufacturer

What Pariet Pharmacy contains
Each Pariet Pharmacy 10 mg tablet contains
10 mg of the active substance rabeprazole
sodium.

Marketing Authorisation Holder:
Eisai Ltd., European Knowledge Centre
Mosquito Way,
Hatfield,
Herts,
AL10 9SN
UK

The other ingredients it contains are:
mannitol, magnesium oxide, low-substituted
hyprolose, hyprolose, magnesium stearate,
ethylcellulose, hypromellose phthalate,
diacetylated monoglycerides, talc, titanium
dioxide (E171), red iron oxide (E172), Carnauba
wax and ink (white shellac, black iron oxide
(E172)), dehydrated ethyl alcohol, 1-butanol.
What Pariet Pharmacy looks like and
contents of the pack
Pariet Pharmacy 10 mg gastro-resistant tablet
is a pink, film coated biconvex tablet with
‘E241’ printed on one side.
The tablets are packed in blister strips and
come in pack sizes that contain: 14 tablets.

Manufacturer:
Eisai Manufacturing Ltd, European Knowledge,
Centre, Mosquito Way, Hatfield, Hertfordshire,
AL10 9SN United Kingdom.
Pariet Pharmacy bulk tablets are manufactured
for Eisai Ltd. by: Eisai Co. Ltd., (Misato Plant),
950 Oaza Hiroki, Misato-cho, Kodama-gun,
Saitama Prefecture 367-0198, Japan.

This leaflet was last approved in 01/2012

Eisai Ltd.
MOCK-UP
ARF209

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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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