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RABEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM

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Package leaflet: Information for the patient

Rabeprazole Sodium 10 mg
Gastro-resistant Tablets
Rabeprazole Sodium 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Rabeprazole is and what it is used for
2. What you need to know before you take Rabeprazole
3. How to take Rabeprazole
4. Possible side effects
5. How to store Rabeprazole
6. Contents of the pack and other information
The name of your medicine is Rabeprazole Sodium 10 mg
or 20 mg Gastro-resistant Tablets (referred to as Rabeprazole
throughout this leaflet).

1. What Rabeprazole is and what it is used for

If you are taking this medicine for a long time, your doctor
will want to monitor you.
Taking a proton pump inhibitor like Rabeprazole, 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).

Children

Rabeprazole is not recommended in children because there
is no experience of its use in this group.

Other medicines and Rabeprazole

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
include 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. Rabeprazole 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. Rabeprazole 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 and inflammatory conditions) – if
you are taking a high dose of methotrexate, your doctor
may temporarily stop your Rabeprazole treatment.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Rabeprazole.

Pregnancy and breast-feeding

Rabeprazole contains rabeprazole which belongs to a
group of medicines called ‘Proton Pump Inhibitors’ (PPIs).
They work by lowering the amount of acid that your
stomach produces.

• Do not use Rabeprazole if you are pregnant or think you
may be pregnant
• Do not use Rabeprazole if you are breast-feeding or
planning to breast-feed

Rabeprazole tablets can be used to treat the following
conditions:

Driving and using machines

• Symptomatic treatment of erosive or ulcerative
‘Gastro-Oesophageal Reflux Disease’ (GORD) commonly
referred to as inflammation of the gullet caused by stomach
acid and associated with heartburn, or for long-term
treatment of GORD (GORD maintainance). GORD is caused
when acid and food from your stomach escapes into your
food pipe and can cause inflammation (oesophagus)
• The symptomatic treatment of moderate to very severe
gastro-oesophageal reflux disease (symptomatic GORD)
also associated with heartburn.
• Ulcers in your stomach or the upper part of your
gut (intestine)
• Zollinger-Ellison Syndrome where your stomach produces
too much acid

2. What you need to know before you
take Rabeprazole
Do not take Rabeprazole:

• if you are allergic to or any of the other ingredients of this
medicine (listed in section 6)
• if you are pregnant or think that you are pregnant
• if you are breast-feeding
If you are not sure, talk to your doctor or pharmacist before
using rabeprazole.
Also see Pregnancy and breast-feeding section.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rabeprazole:
• If you are allergic to other proton pump inhibitor
medicines or 'substituted benzimidazoles' (such as
lansoprazole, omeprazole, esomeprazole, pantoprazole)
• If you have a tumour in the stomach or food pipe. Your
doctor may carry out certain tests to rule out cancer
before starting treatment with rabeprazole.
• If you have severe liver problems.
• If you are taking atazanavir - for HIV infection (see section
2, Other medicines and Rabeprazole).
• If you are on long term treatment with rabeprazole and
are also taking medicines like digoxin (used to treat
heart problems) or water tablets such as furosemide,
spironolactone, hydrochlorothiazides (used to treat high
blood pressure or heart problems).
• If you have reduced body stores or risk factors for reduced
vitamin B12 and receive rabeprazole long-term treatment.
As with all acid reducing agents, rabeprazole may lead to
a reduced absorption of vitamin B12.
• If you have ever had a skin reaction after treatment with a
medicine similar to rabeprazole that reduces stomach acid.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking Rabeprazole.

During treatment

• Blood problems (such as reduction in blood cells which
may cause more frequent infections and fever or easy
bruising and bleeding) and liver problems (such as an
increase or decrease in liver enzymes which may be seen
in blood tests) have been seen in some patients but often
get better when Rabeprazole is stopped.
• If you experience severe (watery or bloody) diarrhoea with
symptoms such as fever, abdominal pain or tenderness,
stop taking Rabeprazole and see a doctor straight away.
• 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 rabeprazole. Remember
to also mention any other ill-effects like pain in your joints.

Description Rabeprazole Sodium 10 mg,20 mg 28

You may feel sleepy while taking Rabeprazole. If this
happens, do not drive or use any tools or machines.

3. How to take Rabeprazole
Always take this medicine 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 or bottle 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

Adults and the Elderly
For ‘Gastro-Oesophageal Reflux Disease’ (GORD)’
Treatment of moderate to severe symptoms
(symptomatic GORD)
• The recommended dose is one Rabeprazole 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 Rabeprazole 10 mg tablet
as and when you require it.
Treatment of more severe symptoms (erosive or
ulcerative GORD)
• The recommended dose is one Rabeprazole 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 recommended dose is one Rabeprazole 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 recommended dose is one Rabeprazole 20 mg tablet
once a day for 6 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take Rabeprazole for another
6 weeks if your condition does not improve.
For ulcers of the intestine (duodenal ulcers)
• The recommended dose is one Rabeprazole 20 mg tablet
once a day for 4 weeks
• Take the tablet in the morning before eating
• Your doctor may tell you to take Rabeprazole for another
4 weeks if your condition does not improve.
Zollinger-Ellison Syndrome where excess acid is produced
in the stomach
• The recommended dose is three Rabeprazole 20 mg
tablets once a day to start with. The dose may be
increased to three Rabeprazole 20 mg tablets twice daily.
Single daily doses up to 100 mg (five Rabeprazole 20 mg
tablets) per day may be given.
• 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.

Use in children

The medicine should not to be used in children because
there is no experience of its use in this group.

Date: 25 Sep 2015

Component Type Leaflet

Pharma Code NA

No. of colours

Affiliate Item Code 709466

SAP No. NA

Colours

Superceded Affiliate Item Code 681733
TrackWise PR No. 709466
MA No.

PL 04569/0927,
PL04569/0928

Vendor Job No. 263340
Trackwise Proof No. 3
Glams Proof No. NA

Packing Site/Printer NA

Client Market UK

Supplier Code NA

Keyline/Drawing No. NA
Barcode Info NA

1

Time: 16:38
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 180 x 400 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Patients with liver problems

You should consult your doctor who will take special care
when beginning treatment with Rabeprazole and while you
continue to be treated with Rabeprazole.

If you take more Rabeprazole than you should

If you take more Rabeprazole 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 Rabeprazole

• 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 to make up for a forgotten dose.

If you stop taking Rabeprazole

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
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The side effects are usually mild or moderate and improve
without you having to stop taking this medicine.

Stop taking Rabeprazole and see a doctor straight
away if you notice any of the following serious side
effects – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people):
• Fracture of the hip, wrist or spine
Rare (may affect up to 1 in 1,000 people).
• 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. This may be due to decrease in certain
type of white blood cells.
• Liver problems including inflammation of the liver
(hepatitis), yellowing of your skin and whites of your
eyes (jaundice), patients who have previously had liver
problems may get hepatic encephalopathy (brain damage
due to liver disease)
Very rare (may affect up to 1 in 10,000 people)
• Blistering of the skin, and/or mucous membranes
of the lips, eyes, mouth, nasal passages or genitals
(Steven-Johnson syndrome) or peeling off the skin (toxic
epidermal necrolysis).
Not known (frequency cannot be estimated from the
available data):
• Rash, possibly with pain in the joints.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Infections
• Difficulty sleeping
• Headache or feeling dizzy
• Cough, sore throat (pharyngitis), runny nose
• 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, flu-like symptoms
Uncommon (may affect up to 1 in 100 people)
• Feeling nervous, drowsy
• Chest infection (bronchitis)
• Painful and blocked sinuses (sinusitis)
• Dry mouth
• Indigestion, belching
• Skin rash or redness
• Muscle, leg pain or cramps, or joint pain
• Bladder infection (urinary tract infection)
• Chest pain
• Chills, fever
• Changes in how your liver is working (shown in blood tests)
Rare (may affect up to 1 in 1,000 people)
• Loss of appetite (Anorexia)
• Depression
• Visual disturbance
• Sore mouth (stomatitis) or taste disturbance
• Upset stomach or stomach pain
• Itchy rash
• Sweating
• Kidney problems
• Weight gain
• Increase in certain type of white blood cells (leucocytosis)
• Reduction in blood platelets resulting in bleeding or
bruising more easily than normal.

• Low blood levels of sodium, which can cause tiredness
and confusion, muscle twitching, fits and coma
• If you are on Rabeprazole 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.
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 MHRA.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Rabeprazole
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the blister strips, bottle label or carton after EXP.
The expiry date refers to the last day of that month.
Your medicine should be used within 60 days after the
bottle is first opened. Therefore, you must throw away the
bottle 60 days after you first opened it, even if some tablets
are left. To help you remember, write down the date that
you opened it in the space on the bottle label.
Do not store above 25 ˚C. Store in the original container in
order to protect from moisture.
Do not use this medicine if you notice a change in colour of
the tablet during its use.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information
What Rabeprazole contains

Each Rabeprazole Sodium 10 mg Gastro-resistant Tablet
contains 9.42 mg rabeprazole.
Each Rabeprazole Sodium 20 mg Gastro-resistant Tablet
contains 18.85 mg rabeprazole.
The other ingredients are:
Core: Mannitol, magnesium oxide, heavy, hydroxypropyl
cellulose, low substituted hydroxypropyl cellulose,
magnesium stearate, ethylcellulose, iron oxide red
(E 172), iron oxide yellow (E 172), hypromellose
phthalate, acetylated mono and diglycerides, talc,
titanium dioxide (E 171).
Film-coating – 10 mg tablets: HPMC 2910/Hypromellose
6cP, titanium dioxide (E171),
acetylated monoglycerides
and iron oxide red (E172).
Film-coating – 20 mg tablets: HPMC 2910/Hypromellose
6cP, titanium dioxide (E171),
acetylated monoglycerides
and iron oxide yellow (E172).
Printing ink: Shellac~45% (20% Esterified), iron oxide black
(E172), propylene glycol and ammonium
hydroxide (28%).

What Rabeprazole looks like and contents of the pack

Rabeprazole Sodium 10 mg Gastro-resistant Tablet is a pink,
film-coated, round, biconvex tablet imprinted with ‘R3’ in black
ink on one side of the tablet and blank on the other side.
Rabeprazole Sodium 20 mg Gastro-resistant Tablet is a
yellow, film-coated, round, biconvex tablet imprinted with
‘R4’ in black ink on one side of the tablet and blank on the
other side.
The tablets are packed in blister strips or bottles and come
in pack sizes containing:
Blisters: 7, 14, 28, 30, 50, 56, 98, 100 tablets
Bottles: 30, 100 tablets
Perforated unit dose blister strips: 14 x 1, 28 x 1 and 50 x
1 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan,
Potters Bar
Hertfordshire, EN6 1TL
United Kingdom.

Manufacturer

Mylan Hungary Kft.
H-2900 Komárom, Mylan utca 1,
Hungary.
This leaflet was last revised in [08/2015].

Very rare (may affect up to 1 in 10,000 people)
• A rash with measle-like round patches (erythema multiforme).
Not known (frequency cannot be estimated from the
available data)
• Confusion
• Breast swelling in men
• Fluid retention which may cause swelling of the hands
and legs

Description Rabeprazole Sodium 10 mg,20 mg 28

Code No.: MH/DRUGS/25/NKD/89
709466

Date: 25 Sep 2015

Component Type Leaflet

Pharma Code NA

No. of colours

Affiliate Item Code 709466

SAP No. NA

Colours

Superceded Affiliate Item Code 681733
TrackWise PR No. 709466
MA No.

PL 04569/0927,
PL04569/0928

Vendor Job No. 263340
Trackwise Proof No. 3
Glams Proof No. NA

Packing Site/Printer NA

Client Market UK

Supplier Code NA

Keyline/Drawing No. NA
Barcode Info NA

1

Time: 16:38
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 180 x 400 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.

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