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RABEPRAZOLE 10 MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM

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Package leaflet: Information for the patient
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 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.
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
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.

What you need to know before you take Rabeprazole

Do not take Rabeprazole
• if you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (listed in section
6).
• if you are pregnant or breast feeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking 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 taking Rabeprazole.

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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.
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).
Some abnormal blood values have been reported during treatment with Rabeprazole. Usually, the values
become normal when the treatment is discontinued.
Children
Rabeprazole is not recommended for use in children.
Other medicines and Rabeprazole
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:
• 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
Rabeprazole 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
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 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: 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.
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Use in children
Rabeprazole 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 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.
4.

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 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
fracture of the hip, wrist or spine
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Rare:
blood 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
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 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, disorentation, 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, pharmacist or nurse. This includes any side effects not listed
in this leaflet.

5.

How to store Rabeprazole

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.
Tablet containers: Store below 25°C. Keep the container tightly closed in order to protect from moisture.
Do not use this medicine 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.
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 protect the environment.

6.

Contents of the pack and other information

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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
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:
Caduceus Pharma Ltd.
6th Floor, 94 Wigmore Street
London W1U 3RF
United kingdom
Manufacturer:
Actavis hf
Reykjavikurvegi 78
P.O.Box 420
IS-220 Hafnarfjordur
Iceland

This leaflet was last revised in 04/2012.

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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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