PARIET 20MG TABLETS

Active substance: RABEPRAZOLE SODIUM

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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. 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 overleaf)
• You are pregnant or think that you are pregnant
• You are breast-feeding.
Do not use Pariet if any of the above apply to you. If you are not sure talk to your doctor or pharmacist
before using Pariet.
Also see Pregnancy and breast-feeding section

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

DATE:

CUSTOMER
APPROVED:

Children
Pariet should not be used in children.

If you experience severe (water or bloody) diarrhoea with symptoms such as fever, abdominal pain or
tenderness, stop taking Pariet and see a doctor straight away.

DATE:
30/04/12
DATE OF PROOF:

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

INC SAFETY WARNING

6464/2369B
CODE:

UK PIL DATED NOVEMBER 2010

Pariet 20mg tabs

DT

04-1957
Waymade

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.

PRODUCT:

PRE-PRESS NO.:

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

CUSTOMER:

ARTWORKER:

Q.A.
APPROVED:

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).

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
• Your doctor will tell you how many tablets to take and how long to take them for. This will depend
on your condition
• 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
• 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 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.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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

PROOF HISTORY:
v.1 - waymade - 30/04/12

Leaflet Flat Size = 148 x 432

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is known as the above name but will be referred to as Pariet throughout this leaflet.

WARNING!

27mm

PARIET® 20mg TABLETS
(rabeprazole sodium)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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.
Leaflet Flat Size = 148 x 432

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.

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.

DATE:
30/04/12
DATE OF PROOF:

INC SAFETY WARNING

UK PIL DATED NOVEMBER 2010

6464/2369B
CODE:

Q.A.
APPROVED:
DT
Pariet 20mg tabs

04-1957
Waymade

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 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
• 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.

PRODUCT:

ARTWORKER:

DATE:

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.

CUSTOMER:

PRE-PRESS NO.:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 30/04/12

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 (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
Keep out of the reach and sight of children.
Do not store this medicine above 25° C.
Store in the original container.
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. Further information
What Pariet contains
Each Pariet 20 mg tablet contains 20 mg of the active substance rabeprazole sodium.
The other ingredients it contains are:
Magnesium oxide, mannitol, hypromellose phthalate, low substituted hydroxypropyl cellulose, hydroxypropyl
cellulose, magnesium stearate, ethyl cellulose, diacetylated monoglycerides, talc, carnauba wax, yellow iron
oxide (E172), titanium dioxide (E171) and red printing ink.
What Pariet looks like and contents of the pack
Pariet 20 mg is a yellow round tablet marked ‘‫ ’ع342ع‬in red ink on one side and plain on the reverse.
The tablets are packed in blister strips and come in pack sizes of 28 and 56 tablets.
POM

PL No: 6464/2369

This product is manufactured by Janssen Pharmaceutica N.V.,Turnhoutseweg 20, 2340 Beerse, Belgium
and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 20.4.2012
Pariet® is a registered trademark of R & D Management Co. Ltd.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

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.

WARNING!

Children. This product should not be used in children.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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.

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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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