Skip to Content

UK Edition. Click here for US version.

PARIET 10MG TABLETS

Active substance(s): RABEPRAZOLE / RABEPRAZOLE / RABEPRAZOLE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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. See section 4.

The name of your medicine is Pariet 10mg Tablets but will
be referred to as Pariet throughout this leaflet. Please
note that this leaflet also contains information about
another strength Pariet 20mg Tablets.
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 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 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 illeffects 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 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.
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report any 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 above 25°C.
Do not refrigerate.
Do not take the tablet after the expiry date which is stated
on the carton and blister labels after ‘Exp’. The expiry date
refers to the last day of that month.

If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Contents of the pack and other information
What Pariet contains
Pariet contains 10mg of the active substance rabeprazole
sodium.
The other ingredients are: mannitol, magnesium
oxide, low substituted hyprolose, hyprolose,
magnesium stearate, ethyl cellulose, hypromellose
phthalate, mono diacetylated glycerides, talc,
titanium dioxide (E171), red iron oxide (E172),
carnauba wax and ink (white shellac, black iron oxide
(E172)), dehydrated ethyl alcohol and 1-butanol.
What Pariet looks like and contents of the pack
Pariet is small, pink round tablet marked with ‘E241’ 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: Janssen Pharmaceutica N.V.,
Turnhoutseweg 30, 2340 Beerse, Belgium.
OR
Eisai Manufacturing Ltd, Titan Court, 2 Bishop Square,
Hatfield, Hertfordshire, AL10 9NE, UK.

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 18799/0285
Leaflet date: 27.04.2017

POM

Pariet is a registered trademark of Eisai Ltd.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format
suitable for you.

Expand Transcript

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.

Hide