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PARIET 20MG GASTRO-RESISTANT TABLET

Active substance(s): RABEPRAZOLE SODIUM / RABEPRAZOLE SODIUM

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2002911
PACKAGE LEAFLET: INFORMATION FOR THE USER

10 mg and 20 mg gastro-resistant 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. See section 4.

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
• Ulcers in your stomach or the upper part of your
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)

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, breast-feeding and fertility
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 have reduced body stores or risk factors
for reduced vitamin B12 and receive long term
treatment with rabeprazole sodium. As with all
acid reducing agents, rabeprazole sodium may
lead to a reduced absorption of vitamin B12
• If you have ever had a skin reaction after
treatment with a medicine similar to Pariet that
reduces stomach acid.
• If you get a rash on your skin, especially in
areas exposed to the sun tell your doctor as
soon as you can, as you may need to stop
your treatment with Pariet. Remember to also
mention any other ill-effects like pain in your
joints.
• You are due to have a specific blood test
(Chromogranin A)
If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist before using Pariet.
Children
Pariet should not be used in children.

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).
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.
• Methotrexate (a chemotherapy medicine used
in high doses to treat cancer) – if you are taking
a high dose of methotrexate, your doctor may
temporarily stop your Pariet treatment.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using Pariet.
Pregnancy, 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 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
Adults and older people
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 20 mg 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.
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 less 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
• Benign polyps in the stomach.
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
• Fractures of the hip, wrist and spine
• 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)”
• Rash, possibly with pain in the joints
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 of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
(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
What Pariet contains
Each Pariet 10 mg tablet contains 10 mg of the
active substance rabeprazole sodium.
The other ingredients it contains:
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.
Each Pariet 20 mg tablet contains 20 mg of the
active substance rabeprazole sodium.
The other ingredients it contains:
mannitol, magnesium oxide, low-substituted
hyprolose, hyprolose, magnesium stearate,
ethylcellulose, hypromellose phthalate, diacetylated
monoglycerides, talc, titanium dioxide (E171),
yellow iron oxide (E172), Carnauba wax and ink
(white shellac, red iron oxide (E172)), glycerine
fatty acid ester, dehydrated ethyl alcohol,
1-butanol.

What Pariet looks like and contents of the pack
Pariet 10 mg gastro-resistant tablet is a pink,
film coated biconvex tablet with ‘E241’ printed
on one side.
Pariet 20 mg gastro-resistant tablet is a yellow,
film coated biconvex tablet with ‘E243’ printed
on one side.
The tablets are packed in blister strips and come in
pack sizes that contain: 1, 5, 7, 14, 15, 25, 28, 30,
50, 56, 75, 98, 112 or 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Eisai Limited, European Knowledge Centre,
Mosquito Way, Hatfield, Hertfordshire, AL10 9SN,
United Kingdom.
e-mail: EUmedinfo@eisai.net
Manufacturer:
Eisai Manufacturing Limited, European Knowledge
Centre, Mosquito Way, Hatfield, Hertfordshire,
AL10 9SN, United Kingdom.
This leaflet was last revised in 02/2017.

2002911

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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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