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RABEPRAZOLE 10 MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM / RABEPRAZOLE SODIUM / RABEPRAZOLE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Rabeprazole 10 mg gastro-resistant tablets
Rabeprazole 20 mg gastro-resistant tablets
rabeprazole sodium

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.
In this leaflet:
1. What Rabeprazole is and what it is used for
2. Before you take Rabeprazole
3. How to take Rabeprazole
4. Possible side effects
5. How to store Rabeprazole
6. Further information

1.

WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR

Rabeprazole belongs to a group of medicines called Proton Pump Inhibitors (PPIs).
Rabeprazole acts by reducing the amount of acid made by the stomach.
Rabeprazole is 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 may also be used as a long
term treatment of GORD (GORD maintenance). Rabeprazole 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.

2.

BEFORE YOU TAKE RABEPRAZOLE

Do not take Rabeprazole
 if you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of Rabeprazole
gastro-resistant tablets (listed in Section 6).
 if you are pregnant or breast feeding
Take special care with Rabeprazole
 if you are allergic to other proton pump inhibitors
 if you have or have had any liver problems
 if you are taking a medicine called atazanavir (used to treat HIV)
If the above applies to you, consult your doctor before using Rabeprazole.

1

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 treatment is started.
If you take Rabeprazole 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.
Some abnormal blood values have been reported during treatment with Rabeprazole. Usually, the values
become normal when the treatment is discontinued.
Rabeprazole is not recommended for use in children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. This is especially important in case you are taking any of the
following medicines:
 atazanavir (used to treat HIV); it is not recommended to take Rabeprazole if you are taking atazanavir
 ketaconazole or itraconazole (used to treat infections caused by a fungus)
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Rabeprazole must not be used during pregnancy and breast-feeding.
Driving and using machines
It is unlikely that Rabeprazole 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 your are affected.

3.

HOW TO TAKE RABEPRAZOLE

Always take Rabeprazole exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is as follows:
Adults and elderly
Duodenal ulcer and benign gastric ulcer: 20 mg of Rabeprazole to be taken once daily in the morning. Most
patients with duodenal ulcer are treated for four weeks and most patients with benign gastric ulcer are treated
for six weeks. However a few patients may require additional treatment to achieve healing.
Gastro-Oesophageal Reflux Disease (GORD) with ulcer: 20 mg of Rabeprazole to be taken once daily for
four to eight weeks.
Long term treatment of GORD: 10 mg or 20 mg of Rabeprazole once daily depending upon response.
Symptomatic treatment of GORD: 10 mg of Rabeprazole once daily for 4 weeks. Once symptoms have
cleared your doctor may tell you to take 10 mg of Rabeprazole once daily when needed for subsequent
symptom control.
Zollinger-Ellison Syndrome: 60 mg of Rabeprazole 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.

Children
Rabeprazole is not recommended for use in children.
Instructions for use
2

The tablets must be swallowed whole with half a glass of water and may not be chewed or crushed.
When Rabeprazole is taken once daily, the tablets should be taken in the morning before breakfast.
If you take more Rabeprazole than you should
If you have taken more Rabeprazole than prescribed by your doctor, seek medical advice.
If you forget to take Rabeprazole
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. Do not take a double dose to make up for
a forgotten dose.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Rabeprazole can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Rabeprazole 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.
Reddening 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.
The frequency of possible side effects listed below is defined using the following convention:
Very common:
affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known:
frequency cannot be estimated from the available data
Common:
cough, sore throat (inflammation of the pharynx), running nose
nausea, vomiting, abdominal pain, diarrhoea, constipation, wind (flatulence)
back pain, non-specific pain
weakness or loss of strength, flu like symptoms
sleeplessness
headache, dizziness
infection
Uncommon:
nervousness
sleepiness
inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)
indigestion, dry mouth, belching
rash, skin redness (erythema)
muscle pains, joint pains, leg cramps
urinary tract infection
chest pain, chills, fever
increased liver enzymes, which is measured by blood tests
Rare:
blood problems such as reduced number of white cells or platelets. This can cause weakness, bruising
or make infections more likely.
3

-

increased number of white blood cells
allergic reactions including facial swelling, low blood pressure and breathing difficulties
loss of appetite
depression
visual 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
kidney inflammation (interstitial nephritis)
increased weight

Very rare:
sudden 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))
Not known
low levels of sodium in the blood
confusion
swelling of the feet and ankles
enlarged breasts in men
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.

5.

HOW TO STORE RABEPRAZOLE

Keep out of the reach and sight of children.
Blister packs: Store below 25C. Store in the original package in order to protect from moisture.
Tablet containers: Store below 25C. Keep the container tightly closed in order to protect from moisture.
Do not use Rabeprazole after the expiry date which is stated on the carton and label/blister after Expiry
Date/Exp. 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 no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Rabeprazole gastro-resistant tablets contain
-

The active substance is rabeprazole sodium. Each tablet contains 10 mg or 20 mg 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 lauryl
sulphate, propylene glycol, talc, iron oxide red (E172) iron oxide yellow (E172) titanium dioxide
(E171)

What Rabeprazole gastro-resistant tablets look like and contents of the pack

4

Rabeprazole 10 mg gastro-resistant tablet: Pink, coated, elliptical, biconvex tablet. Rabeprazole
20 mg gastro-resistant tablet: Yellow, coated, elliptical, biconvex tablet.
Pack sizes:
Blister packs (aluminium/aluminium): 1, 5, 7, 14, 15, 20, 25, 28, 30, 50, 56, 60, 75, 98, 100 and 120 tablets
Plastic tablet containers with a desiccant: 30, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Aptil
Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing London
W5 5TL
Manufacturer:
Actavis hf
Reykjavikurvegi 78
P.O.Box 420
IS-220 Hafnarfjordur
Iceland

This leaflet was last updated in 10/2016.

1

PACKAGE LEAFLET: INFORMATION FOR THE USER
Rabeprazole 10 mg gastro-resistant tablets
Rabeprazole 20 mg gastro-resistant tablets
rabeprazole sodium

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.
In this leaflet:
7. What Rabeprazole is and what it is used for
8. Before you take Rabeprazole
9. How to take Rabeprazole
10. Possible side effects
11. How to store Rabeprazole
12. Further information

7.

WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR

Rabeprazole belongs to a group of medicines called Proton Pump Inhibitors (PPIs).
Rabeprazole acts by reducing the amount of acid made by the stomach.
Rabeprazole is 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 may also be used as a long
term treatment of GORD (GORD maintenance). Rabeprazole 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.

8.

BEFORE YOU TAKE RABEPRAZOLE

Do not take Rabeprazole
 if you are allergic (hypersensitive) to rabeprazole sodium or any of the other ingredients of Rabeprazole
gastro-resistant tablets (listed in Section 6).
 if you are pregnant or breast feeding
Take special care with Rabeprazole
 if you are allergic to other proton pump inhibitors
 if you have or have had any liver problems
 if you are taking a medicine called atazanavir (used to treat HIV)
If the above applies to you, consult your doctor before using Rabeprazole.
2

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 treatment is started.
If you take Rabeprazole 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.
Some abnormal blood values have been reported during treatment with Rabeprazole. Usually, the values
become normal when the treatment is discontinued.
Rabeprazole is not recommended for use in children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. This is especially important in case you are taking any of the
following medicines:
 atazanavir (used to treat HIV); it is not recommended to take Rabeprazole if you are taking atazanavir
 ketaconazole or itraconazole (used to treat infections caused by a fungus)
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Rabeprazole must not be used during pregnancy and breast-feeding.
Driving and using machines
It is unlikely that Rabeprazole 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 your are affected.

9.

HOW TO TAKE RABEPRAZOLE

Always take Rabeprazole exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. The usual dose is as follows:
Adults and elderly
Duodenal ulcer and benign gastric ulcer: 20 mg of Rabeprazole to be taken once daily in the morning. Most
patients with duodenal ulcer are treated for four weeks and most patients with benign gastric ulcer are treated
for six weeks. However a few patients may require additional treatment to achieve healing.
Gastro-Oesophageal Reflux Disease (GORD) with ulcer: 20 mg of Rabeprazole to be taken once daily for
four to eight weeks.
Long term treatment of GORD: 10 mg or 20 mg of Rabeprazole once daily depending upon response.
Symptomatic treatment of GORD: 10 mg of Rabeprazole once daily for 4 weeks. Once symptoms have
cleared your doctor may tell you to take 10 mg of Rabeprazole once daily when needed for subsequent
symptom control.
Zollinger-Ellison Syndrome: 60 mg of Rabeprazole 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.

Children
Rabeprazole is not recommended for use in children.
Instructions for use
3

The tablets must be swallowed whole with half a glass of water and may not be chewed or crushed.
When Rabeprazole is taken once daily, the tablets should be taken in the morning before breakfast.
If you take more Rabeprazole than you should
If you have taken more Rabeprazole than prescribed by your doctor, seek medical advice.
If you forget to take Rabeprazole
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. Do not take a double dose to make up for
a forgotten dose.

10.

POSSIBLE SIDE EFFECTS

Like all medicines, Rabeprazole can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Rabeprazole 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.
Reddening 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.
The frequency of possible side effects listed below is defined using the following convention:
Very common:
affects more than 1 user in 10
Common:
affects 1 to 10 users in 100
Uncommon:
affects 1 to 10 users in 1,000
Rare:
affects 1 to 10 users in 10,000
Very rare:
affects less than 1 user in 10,000
Not known:
frequency cannot be estimated from the available data
Common:
cough, sore throat (inflammation of the pharynx), running nose
nausea, vomiting, abdominal pain, diarrhoea, constipation, wind (flatulence)
back pain, non-specific pain
weakness or loss of strength, flu like symptoms
sleeplessness
headache, dizziness
infection
Uncommon:
nervousness
sleepiness
inflammation of the bronchial tubes (bronchitis), inflammation of the sinuses (sinusitis)
indigestion, dry mouth, belching
rash, skin redness (erythema)
muscle pains, joint pains, leg cramps
urinary tract infection
chest pain, chills, fever
increased liver enzymes, which is measured by blood tests
Rare:
blood problems such as reduced number of white cells or platelets. This can cause weakness, bruising
or make infections more likely.
4

-

increased number of white blood cells
allergic reactions including facial swelling, low blood pressure and breathing difficulties
loss of appetite
depression
visual 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
kidney inflammation (interstitial nephritis)
increased weight

Very rare:
sudden 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))
Not known
low levels of sodium in the blood
confusion
swelling of the feet and ankles
enlarged breasts in men
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.

11.

HOW TO STORE RABEPRAZOLE

Keep out of the reach and sight of children.
Blister packs: Store below 25C. Store in the original package in order to protect from moisture.
Tablet containers: Store below 25C. Keep the container tightly closed in order to protect from moisture.
Do not use Rabeprazole after the expiry date which is stated on the carton and label/blister after Expiry
Date/Exp. 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 no longer required. These measures will help to protect the environment.

12.

FURTHER INFORMATION

What Rabeprazole gastro-resistant tablets contain
-

The active substance is rabeprazole sodium. Each tablet contains 10 mg or 20 mg 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 lauryl
sulphate, propylene glycol, talc, iron oxide red (E172) iron oxide yellow (E172) titanium dioxide
(E171)

What Rabeprazole gastro-resistant tablets look like and contents of the pack

5

Rabeprazole 10 mg gastro-resistant tablet: Pink, coated, elliptical, biconvex tablet.
Rabeprazole 20 mg gastro-resistant tablet: Yellow, coated, elliptical, biconvex tablet.
Pack sizes:
Blister packs (aluminium/aluminium): 1, 5, 7, 14, 15, 20, 25, 28, 30, 50, 56, 60, 75, 98, 100 and 120 tablets
Plastic tablet containers with a desiccant: 30, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturers:
Actavis hf
Reykjavikurvegi 78
P.O.Box 420
IS-220 Hafnarfjordur
Iceland
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This leaflet was last updated in 10/2016.

6

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.

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