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RABEPRAZOLE 10MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM

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Package leaflet: Information for the patient

Rabeprazole 10mg and 20mg
Gastro-resistant Tablets
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,
pharmacist or nurse.
•  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.
•  The full name of the product is Rabeprazole 10mg
and 20mg Gastro-resistant Tablets but within the
leaflet it will be referred to as Rabeprazole tablets.

Remember to also mention any other ill-effects like pain
in your joints.
If the above applies to you, consult your doctor before
taking Rabeprazole tablets.
Your doctor may perform or have performed an
additional investigation called an endoscopy in order
to diagnose your condition and/or exclude malignant
disease. The possibility of stomach and oesophageal
tumours should be excluded before the treatment is
started.
If you take Rabeprazole tablets on a long-term basis
(longer than 1 year) your doctor will probably monitor
you regularly. You should report any new or different
symptoms whenever you see your doctor.
Taking a proton pump inhibitor like Rabeprazole tablets,
especially over a period of more than one year, may
slightly increase your risk of fracture of 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)

What is in this leaflet:
1 What Rabeprazole tablets are and what
they are used for
2 What you need to know before you take
Rabeprazole tablets
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information
1

Talk to your doctor straight away if you experience
severe (watery or bloody) or persistent diarrhoea with
symptoms such as fever, abdominal pain or tenderness,
as rabeprazole has been associated with a small
increase in infectious diarrhoea.
Some abnormal blood values have been reported
during treatment with Rabeprazole tablets. Usually,
the values become normal when the treatment is
discontinued.

 hat Rabeprazole tablets are and what
W
they are used for

Rabeprazole tablets belong to a group of medicines
called Proton Pump Inhibitors (PPIs).
Rabeprazole tablets act by reducing the amount of acid
made by the stomach.
Rabeprazole tablets are used to treat:
• ulcer in the upper part of the intestine (duodenal ulcer)
and benign stomach ulcer.
• gastro-oesophageal reflux disease (GORD) with
or without ulcer. GORD is commonly referred to
as inflammation of the gullet caused by acid and
associated with heartburn. Heartburn is a burning
feeling rising from the stomach or lower chest up
towards the neck. Rabeprazole tablets may be used as
a long term treatment of GORD (GORD maintenance).
Rabeprazole tablets may also be used for the
symptomatic treatment of moderate to very severe
gastro-oesophageal reflux disease (symptomatic
GORD).
• Zollinger-Ellison Syndrome, which is a condition when
the stomach makes extremely high amounts of acid.

Children

Rabeprazole tablets are not recommended for use in
children.

Other medicines and Rabeprazole tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
is especially important in case you are taking any of the
following medicines:
•a
 tazanavir (used to treat HIV); it is not recommended
to take Rabeprazole tablets if you are taking atazanavir.
•k
 etaconazole or itraconazole (used to treat infections
caused by a fungus).

Pregnancy and breast-feeding

Rabeprazole tablets must not be used during
pregnancy and breast-feeding.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.

In combination with two antibiotics (clarithromycin
and amoxicillin) Rabeprazole tablets are used for the
eradication of H pylori infection in patients with peptic
ulcer disease. For further information on the antibiotics
used in the H pylori eradication therapy see the
individual patient information leaflets.
2

 hat you need to know before you take
W
Rabeprazole tablets
Do not take Rabeprazole tablets if you

Driving and using machines

It is unlikely that Rabeprazole tablets would affect your
ability to drive or operate machinery.
However, occasionally rabeprazole can cause sleepiness.
Therefore, driving and operating complex machinery
should be avoided if you are affected.
3

How to take

• are allergic to rabeprazole sodium or any of the other
ingredients of this medicine (listed in section 6).
• are pregnant or breast feeding.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The recommended dose
is:

Warnings and precautions

Adults and elderly

Talk to your doctor, pharmacist or nurse before
taking Rabeprazole tablets if you
• are allergic to other proton pump inhibitors.
• have or have had any liver problems.
• are taking a medicine called atazanavir (used to treat
HIV).
• if you have ever had a skin reaction after treatment
with a medicine similar to Rabeprazole 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 Rabeprazole.

Duodenal ulcer and benign gastric ulcer: 20mg
of Rabeprazole tablets to be taken once daily in the
morning. Most patients with duodenal ulcer are treated
for four weeks and most patients with benign stomach
ulcer are treated for six weeks. However a few patients
may require additional treatment to achieve healing.
Gastro-Oesophageal Reflux Disease (GORD) with
ulcer: 20mg of Rabeprazole tablets to be taken once
daily for four to eight weeks.
Long term treatment of GORD: 10mg or 20mg
of Rabeprazole tablets once daily depending upon
response.
Symptomatic treatment of GORD: 10mg of
Rabeprazole tablets once daily for 4 weeks.

Continued top of next column
AAAI6663

Continued over page

Rabeprazole 10mg & 20mg 28 Gastro-resistant Tablets PIL - UK
item no: AAAI6663

dimensions: 170 x 380

print proof no: 2

pharmacode:

origination date: 14.01.16

min pt size: 10

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 08.02.16

Technical Approval

revised by: S.Anson

date sent: 14.01.16

supplier: Actavis Iceland

technically app. date: 15.01.16

Non Printing Colours
1.
2.
3.

Once symptoms have cleared your doctor may tell you
to take 10mg of Rabeprazole tablets once daily when
needed for subsequent symptom control.
Zollinger-Ellison Syndrome: 60mg of Rabeprazole
tablets once a day to start with. The dose may then
be adjusted by your doctor depending on how you
respond to the treatment. Your doctor will tell you how
many tablets to take and when to take them.
Eradication of H. pylori: 20mg of Rabeprazole tablets
to be taken twice each day and normally for 7 days (in
combination with two antibiotics - clarithromycin and
amoxicillin).

failure (hepatic encephalopathy)
• itching, sweating, skin blisters
• k idney inflammation (interstitial nephritis)
• increased weight
Very rare side effects (may affect up to 1 in 10,000
people):
• s udden onset of severe rash or blistering or peeling
skin. This may be associated with a high fever and
joint pains (erythema multiforme, Stevens-Johnson
syndrome (SJS), toxic epidermal necrolysis (TEN))

If you have taken more Rabeprazole tablets than
prescribed by your doctor, seek medical advice.

Not known (frequency cannot be estimated from the
available data):
• low levels of sodium in the blood
• c onfusion
• s welling of the feet and ankles
• e nlarged breasts in men
• If you are on Rabeprazole tablets 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.
• r ash, possible with pain in the joints.

If you forget to take Rabeprazole tablets

Reporting of side effects

Use in children

Rabeprazole tablets is not recommended for use in
children.

Instructions for use

The tablets must be swallowed whole with half a
glass of water and may not be chewed or crushed.
When Rabeprazole tablets are taken once daily,
the tablets should be taken in the morning before
breakfast.

If you take more Rabeprazole tablets than you
should

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose, take it as soon as you
remember. If it is almost time to take the next dose, wait
until then.
4

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 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.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you notice any of the following serious side
effects, stop taking Rabeprazole tablets and contact
a doctor immediately:
• sudden wheezing, swelling of your lips, face or body,
rash, fainting or difficulties swallowing (severe allergic
reaction).
• yellow skin, dark urine and tiredness which can be
symptoms of liver problems.
• r eddening of the skin with blisters or peeling and
may be associated with a high fever and joint pains.
There may also be severe blisters and bleeding in the
lips, eyes, mouth, nose and genitals. This could be
erythema multiforme, Stevens-Johnson syndrome or
toxic epidermal necrolysis.

Common side effects (may affect up to 1 in10 people):
• c ough, sore throat (inflammation of the pharynx),
runny nose
•n
 ausea, vomiting, abdominal pain, diarrhoea,
constipation, wind (flatulence)
•b
 ack pain, non-specific pain
•w
 eakness or loss of strength, flu like symptoms
• s leeplessness
•h
 eadache, dizziness
• infection
Uncommon side effects (may affect up to 1 in 100
people):
•n
 ervousness
• s leepiness
• inflammation of the bronchial tubes (bronchitis),
inflammation of the sinuses (sinusitis)
• indigestion, dry mouth, belching
• r ash, skin redness (erythema)
•m
 uscle pains, joint pains, leg cramps
•u
 rinary tract infection
• c hest pain, chills, fever
• increased liver enzymes, which is measured by blood
tests
• fracture of the hip, wrist or spine
Rare side effects (may affect up to 1 in 1,000 people):
•b
 lood problems such as reduced number of white
cells or platelets. This can cause weakness, bruising or
make infections more likely
• increased number of white blood cells
• a llergic reactions including facial swelling, low blood
pressure and breathing difficulties
• loss of appetite
•d
 epression
• v isual disturbance
• inflammation of the stomach, inflammation of the
mouth, taste disturbance
• inflammation of the liver, jaundice (yellowing of the
skin or eyes), brain disturbance associated with liver

5

How to store

6

Contents of the pack and other information

Keep this medicine out of the sight and reach of
children.
Blister packs: Store below 25°C. Store in the original
package in order to protect from moisture.
Do not use this medicine after the expiry date which
is stated on the carton and blister after EXP. The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help to protect the environment.

What Rabeprazole tablets contain

• The active substance is rabeprazole sodium. Each
tablet contains either 10mg or 20mg of rabeprazole
sodium.
• The other ingredients are: core: povidone, mannitol
(E421), light magnesium oxide, low substituted
hydroxypropyl cellulose, magnesium stearate; sealing:
ethyl cellulose, light magnesium oxide; gastro-resistant
coating: Methacrylic acid-ethyl acrylate copolymer,
polysorbate 80, sodium laurilsulfate, propylene glycol,
talc, iron oxide red (E172) iron oxide yellow (E172)
titanium dioxide (E171).
What Rabeprazole tablets look like and contents of
the pack
Rabeprazole 10mg gastro-resistant tablet: Pink, coated,
elliptical, biconvex tablet.
Rabeprazole 20mg gastro-resistant tablet: Yellow,
coated, elliptical, biconvex tablet.
Pack sizes:
28 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Actavis hf
Reykjavikurvegur 78
220 Hafnarfjordur
Iceland

This leaflet was last revised in January 2016

If you would like a leaflet with
larger text, please contact
01271 385257.

Continued top of next column
AAAI6663

Actavis, Barnstaple, EX32 8NS, UK

Rabeprazole 10mg & 20mg 28 Gastro-resistant Tablets PIL - UK
item no: AAAI6663

dimensions: 170 x 380

print proof no: 2

pharmacode:

origination date: 14.01.16

min pt size: 10

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 08.02.16

Technical Approval

revised by: S.Anson

date sent: 14.01.16

supplier: Actavis Iceland

technically app. date: 15.01.16

Non Printing Colours
1.
2.
3.

Package leaflet: Information for the patient

Rabeprazole 10mg and 20mg
Gastro-resistant Tablets
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,
pharmacist or nurse.
•  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.
•  The full name of the product is Rabeprazole 10mg
and 20mg Gastro-resistant Tablets but within the
leaflet it will be referred to as Rabeprazole tablets.

Remember to also mention any other ill-effects like pain in
your joints.
If the above applies to you, consult your doctor before
taking Rabeprazole tablets.
Your doctor may perform or have performed an additional
investigation called an endoscopy in order to diagnose
your condition and/or exclude malignant disease. The
possibility of stomach and oesophageal tumours should
be excluded before the treatment is started.
If you take Rabeprazole tablets on a long-term basis
(longer than 1 year) your doctor will probably monitor
you regularly. You should report any new or different
symptoms whenever you see your doctor.
Taking a proton pump inhibitor like Rabeprazole tablets,
especially over a period of more than one year, may
slightly increase your risk of fracture of 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)

What is in this leaflet:
1 What Rabeprazole tablets are and what they
are used for
2 What you need to know before you take
Rabeprazole tablets
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information
1

2

Talk to your doctor straight away if you experience
severe (watery or bloody) or persistent diarrhoea with
symptoms such as fever, abdominal pain or tenderness, as
rabeprazole has been associated with a small increase in
infectious diarrhoea.
Some abnormal blood values have been reported during
treatment with Rabeprazole tablets. Usually, the values
become normal when the treatment is discontinued.

 hat Rabeprazole tablets are and what they
W
are used for

Children

Rabeprazole tablets belong to a group of medicines called
Proton Pump Inhibitors (PPIs).
Rabeprazole tablets act by reducing the amount of acid
made by the stomach.
Rabeprazole tablets are used to treat:
• ulcer in the upper part of the intestine (duodenal ulcer)
and benign stomach ulcer.
• gastro-oesophageal reflux disease (GORD) with or
without ulcer. GORD is commonly referred to as
inflammation of the gullet caused by acid and associated
with heartburn. Heartburn is a burning feeling rising
from the stomach or lower chest up towards the
neck. Rabeprazole tablets may be used as a long term
treatment of GORD (GORD maintenance). Rabeprazole
tablets may also be used for the symptomatic treatment
of moderate to very severe gastro-oesophageal reflux
disease (symptomatic GORD).
• Zollinger-Ellison Syndrome, which is a condition when
the stomach makes extremely high amounts of acid.

Rabeprazole tablets are not recommended for use in
children.

In combination with two antibiotics (clarithromycin
and amoxicillin) Rabeprazole tablets are used for the
eradication of H pylori infection in patients with peptic
ulcer disease. For further information on the antibiotics
used in the H pylori eradication therapy see the individual
patient information leaflets.

It is unlikely that Rabeprazole tablets would affect your
ability to drive or operate machinery.
However, occasionally rabeprazole can cause sleepiness.
Therefore, driving and operating complex machinery
should be avoided if you are affected.

 hat you need to know before you take
W
Rabeprazole tablets

Do not take Rabeprazole tablets if you

• are allergic to rabeprazole sodium or any of the other
ingredients of this medicine (listed in section 6).
• are pregnant or breast feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Rabeprazole tablets if you
• are allergic to other proton pump inhibitors.
• have or have had any liver problems.
• are taking a medicine called atazanavir (used to treat
HIV).
• if you have ever had a skin reaction after treatment with
a medicine similar to Rabeprazole 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 Rabeprazole.

Other medicines and Rabeprazole tablets

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
is especially important in case you are taking any of the
following medicines:
•a
 tazanavir (used to treat HIV); it is not recommended to
take Rabeprazole tablets if you are taking atazanavir.
•k
 etaconazole or itraconazole (used to treat infections
caused by a fungus).

Pregnancy and breast-feeding

Rabeprazole tablets must not be used during pregnancy
and breast-feeding.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

Driving and using machines

3

How to take

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. The recommended dose is:

Adults and elderly

Duodenal ulcer and benign gastric ulcer: 20mg of
Rabeprazole tablets to be taken once daily in the morning.
Most patients with duodenal ulcer are treated for four
weeks and most patients with benign stomach ulcer are
treated for six weeks. However a few patients may require
additional treatment to achieve healing.
Gastro-Oesophageal Reflux Disease (GORD) with
ulcer: 20mg of Rabeprazole tablets to be taken once daily
for four to eight weeks.
Long term treatment of GORD: 10mg or 20mg of
Rabeprazole tablets once daily depending upon response.
Symptomatic treatment of GORD: 10mg of Rabeprazole
tablets once daily for 4 weeks. Once symptoms have
cleared your doctor may tell you to take 10mg of
Rabeprazole tablets once daily when needed for
subsequent symptom control.

Continued top of next column
AAAI6662

Continued over page

Rabeprazole 10mg & 20mg 28 Gastro-resistant Tablets PIL - UK
item no: AAAI6662

dimensions: 190 x 380

print proof no: 2

pharmacode:

origination date: 14.01.16

min pt size: 10

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 01.02.16

Technical Approval

revised by: S.Anson

date sent: 14.01.16

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 15.01.16

Non Printing Colours
1.
2.
3.

Zollinger-Ellison Syndrome: 60mg of Rabeprazole
tablets once a day to start with. The dose may then be
adjusted by your doctor depending on how you respond
to the treatment. Your doctor will tell you how many
tablets to take and when to take them.
Eradication of H. pylori: 20mg of Rabeprazole tablets
to be taken twice each day and normally for 7 days (in
combination with two antibiotics - clarithromycin and
amoxicillin).

Very rare side effects (may affect up to 1 in 10,000
people):
• s udden onset of severe rash or blistering or peeling skin.
This may be associated with a high fever and joint pains
(erythema multiforme, Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN)).

If you have taken more Rabeprazole tablets than
prescribed by your doctor, seek medical advice.

Not known (frequency cannot be estimated from the
available data):
• low levels of sodium in the blood.
• c onfusion.
• s welling of the feet and ankles.
• e nlarged breasts in men.
• If you are on Rabeprazole tablets 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.
• r ash, possible with pain in the joints.

If you forget to take Rabeprazole tablets

Reporting of side effects

Use in children

Rabeprazole tablets is not recommended for use in
children.

Instructions for use

The tablets must be swallowed whole with half a glass
of water and may not be chewed or crushed. When
Rabeprazole tablets are taken once daily, the tablets
should be taken in the morning before breakfast.

If you take more Rabeprazole tablets than you
should

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose, take it as soon as you
remember. If it is almost time to take the next dose, wait
until then.
4

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 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.

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you notice any of the following serious side effects,
stop taking Rabeprazole tablets and contact a doctor
immediately:
• sudden wheezing, swelling of your lips, face or body,
rash, fainting or difficulties swallowing (severe allergic
reaction).
• yellow skin, dark urine and tiredness which can be
symptoms of liver problems.
• r eddening of the skin with blisters or peeling and may
be associated with a high fever and joint pains. There
may also be severe blisters and bleeding in the lips,
eyes, mouth, nose and genitals. This could be erythema
multiforme, Stevens-Johnson syndrome or toxic
epidermal necrolysis.
Common side effects (may affect up to 1 in10 people):
• c ough, sore throat (inflammation of the pharynx), runny
nose.
•n
 ausea, vomiting, abdominal pain, diarrhoea,
constipation, wind (flatulence).
•b
 ack pain, non-specific pain.
•w
 eakness or loss of strength, flu like symptoms.
• s leeplessness.
•h
 eadache, dizziness.
• infection.
Uncommon side effects (may affect up to 1 in 100
people):
•n
 ervousness.
• s leepiness.
• inflammation of the bronchial tubes (bronchitis),
inflammation of the sinuses (sinusitis).
• indigestion, dry mouth, belching.
• r ash, skin redness (erythema).
•m
 uscle pains, joint pains, leg cramps.
•u
 rinary tract infection.
• c hest pain, chills, fever.
• increased liver enzymes, which is measured by blood
tests.
• f racture of the hip, wrist or spine.
Rare side effects (may affect up to 1 in 1,000 people):
•b
 lood problems such as reduced number of white cells
or platelets. This can cause weakness, bruising or make
infections more likely.
• increased number of white blood cells.
• a llergic reactions including facial swelling, low blood
pressure and breathing difficulties.
• loss of appetite.
•d
 epression.
• v isual disturbance.
• inflammation of the stomach, inflammation of the
mouth, taste disturbance.
• inflammation of the liver, jaundice (yellowing of the skin
or eyes), brain disturbance associated with liver failure
(hepatic encephalopathy).
• itching, sweating, skin blisters.
• k idney inflammation (interstitial nephritis).
• increased weight.

5

6

How to store

Keep this medicine out of the sight and reach of children.
Blister packs: Store below 25°C. Store in the original
package in order to protect from moisture.
Do not use this medicine after the expiry date which is
stated on the carton and blister after EXP. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

Contents of the pack and other information

What Rabeprazole tablets contain

• The active substance is rabeprazole sodium. Each tablet
contains either 10mg or 20mg of rabeprazole sodium.
• The other ingredients are: core: povidone, mannitol
(E421), light magnesium oxide, low substituted
hydroxypropyl cellulose, magnesium stearate; sealing:
ethyl cellulose, light magnesium oxide; gastro-resistant
coating: Methacrylic acid-ethyl acrylate copolymer,
polysorbate 80, sodium laurilsulfate, propylene glycol,
talc, iron oxide red (E172) iron oxide yellow (E172)
titanium dioxide (E171).
What Rabeprazole tablets look like and contents of
the pack
Rabeprazole 10mg gastro-resistant tablet: Pink, coated,
elliptical, biconvex tablet.
Rabeprazole 20mg gastro-resistant tablet: Yellow, coated,
elliptical, biconvex tablet.
Pack sizes:
28 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland
Manufacturers
Actavis hf
Reykjavikurvegur 78
220 Hafnarfjordur
Iceland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This leaflet was last revised in January 2016

If you would like a leaflet with
larger text, please contact
01271 385257.

Continued top of next column
AAAI6662

Actavis, Barnstaple, EX32 8NS, UK

Rabeprazole 10mg & 20mg 28 Gastro-resistant Tablets PIL - UK
item no: AAAI6662

dimensions: 190 x 380

print proof no: 2

pharmacode:

origination date: 14.01.16

min pt size: 10

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 01.02.16

Technical Approval

revised by: S.Anson

date sent: 14.01.16

supplier: Actavis Bulgaria Dupnitsa

technically app. date: 15.01.16

Non Printing Colours
1.
2.
3.

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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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