PARIET 10MG GASTRO-RESISTANT TABLETS

Active substance: RABEPRAZOLE SODIUM

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Pariet® 10mg and 20mg Gastro-resistant Tablets
Rabeprazole 10mg and 20mg Gastro-resistant Tablets
(rabeprazole sodium)
Your medicine is known by the above name, but will be referred to as Pariet
throughout this:
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 get 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

1) What Pariet is and what it is used for

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 apply to you, talk to your doctor or
pharmacist before using Pariet.
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 breastfeed.
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

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.

3) How to take Pariet

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.

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.

2) Before you take Pariet

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.

Do not take Pariet if:
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 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
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).
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.
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.

Always take Pariet exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.

Adults and the Elderly

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.

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.
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.
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 (affects 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 (affects 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 (affects 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
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 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)”.
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
Keep all medicines out of the sight and reach of children.
 Do not store above 25°C. Do not refrigerate
 If the blister strips are presented in an outer pouch, the strips should be
kept in the pouch and any remaining tablets discarded 3 months after
first opening the pouch.
 DO NOT use Pariet Tablets after 3 months of opening the aluminium
pouch, and in any case DO NOT use Pariet Tablets after the expiry
date which is printed on the label.
 If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
 Medicines should not be disposed of via waste water or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) Further information
What Pariet contains
The active ingredient is rabeprazole sodium.
Each Pariet 10mg gastro-resistant tablet contains 10mg of the active
ingredient rabeprazole sodium.
Each Pariet 20mg gastro-resistant tablet contains 20mg of the active
ingredient rabeprazole sodium.
Pariet Tablets also contain the following inactive ingredients:
Mannitol, magnesium oxide, low substituted hydroxyl propyl cellulose,
hydroxypropyl cellulose, magnesium stearate, ethylcellulose, hypromellose
phthalate, diacetylated monoglyceride, talc, titanium dioxide (E171), yellow
iron oxide (E172) (20mg only), red iron oxide (E172) (10mg only), carnauba
wax and ink (shellac food grade (E904), red iron oxide (E172), soya lecithin
(E322), antifoam DC151O – 20mg tablets); and (pharmaceutical glaze,
black iron oxide (E172), propylene glycol, medicinal antifoam A – 10 mg
Tablets.
What Pariet looks like and contents of the pack
Pariet 10mg gastro-resistant tablets are small pink round tablets marked
‘E241’ in a black printing ink on one side.
Pariet 20mg gastro-resistant tablets are small yellow round tablets marked
‘E243’ in a red printing ink on one side.
The tablets come in single-dose aluminium foil blister strips of 14 tablets per
strip.
PL 10383/1558
PL 10383/1559

Pariet® 10mg Gastro-resistant Tablets/
Rabeprazole 10mg Gastro-resistant Tablets
Pariet® 20mg Gastro-resistant Tablets/
Rabeprazole 20mg Gastro-resistant Tablets

POM

Who makes and repackages your medicine?
Your medicine is 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 Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet date: 03.08.2012
Pariet® is a registered trademark of Eisai Co. Ltd, Tokyo, Japan.

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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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