PARIET 20MG GASTRO-RESISTANT TABLET

Active substance: RABEPRAZOLE SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Interim Version - not for marketing

2001122
ARF 636

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.
• f you get any side effects, talk to your doctor
I
or pharmacist. This includes any possible side
effects not listed in this leaflet.

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

315mm

osteoporosis or if you are taking corticosteroids
(which can increase the risk of osteoporosis).
Children
Pariet should not be used in children.
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.
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Pariet.
Pregnancy and 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

PHARMA CODE
READ DIRECTION

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.
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 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.
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

PHARMA CODE
READ DIRECTION

Always take Pariet exactly as your doctor or
pharmacist has told you. 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 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.
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

70mm

PHARMA CODE
READ DIRECTION

315mm

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
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.
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)
• 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).
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 you get any side
effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet.

70mm

70mm

3. HOW TO TAKE PARIET

5. HOW TO STORE PARIET
Keep out of the reach and sight 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.  ONTENTS OF THE PACK
C
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
Marketing Authorisation Holder: Eisai Ltd,
European Knowledge Centre, Mosquito Way,
Hatfield, Hertfordshire, AL10 9SN, United Kingdom.
Manufacturer:
Eisai Manufacturing Ltd, European Knowledge
Centre, Mosquito Way, Hatfield, Hertfordshire,
AL10 9SN, United Kingdom.
Pariet 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 August 2012

2001122
ARF 636

Expand view ⇕

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
(web1)