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RABEPRAZOLE SODIUM 10MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM / RABEPRAZOLE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rabeprazole Sodium 10mg Gastro-resistant tablets
and
Rabeprazole Sodium 20mg 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 or pharmacist. 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

1.

WHAT RABEPRAZOLE IS AND WHAT IT IS USED FOR

The name of your medicine is Rabeprazole Sodium 10mg Gastro-resistant tablets or
Rabeprazole Sodium 20mg Gastro-resistant tablets (called Rabeprazole throughout this
leaflet). This belongs to a group of medicines called ‘proton pump inhibitors’ (PPIs).
They work by lowering the amount of acid that your stomach produces.
Rabeprazole is 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)


Ulcers in your stomach or the upper part of your gut (intestine). If these are infected with
bacteria called ‘Helicobacter pylori’ (H. pylori), you will also be given antibiotics. Using
rabeprazole 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 RABEPRAZOLE

Do not take Rabeprazole
• if you are allergic to rabeprazole or any of the other ingredients of this medicine (listed in
section 6).
• if you are pregnant or think you are pregnant.



if you are breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazole:
• if you are allergic to other proton pump inhibitors or ‘substituted benzimidazoles’
• blood and liver problems have been seen in some patients but often get better when
rabeprazole is stopped
• if you have a stomach tumour
• if you have ever had liver problems
• if you are taking atazanavir for HIV infection
• if you have reduced body stores or risk factors for reduced vitamin B12 and receive long
term treatment with rabeprazole sodium. As with all acid reducing agents, rabeprazole
sodium 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
sodium that reduces stomach acid.
• if you are due to have a specific blood test (Chromogranin A).


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 sodium. Remember to
also mention any other ill-effects like pain in your joints.

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.
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 should not be given to children as there is no experience with Rabeprazole in
children.
Other medicines and Rabeprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

In particular, tell your doctor or pharmacist if you are taking one of the following medicines:
• Medicines to treat fungal infections (e.g. ketoconazole or itraconazole). Rabeprazole may
lower the amount of this type of medicine in your blood. Your doctor may need to adjust
your dose.
• Atazanavir for the treatment of 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) – 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
using Rabeprazole.
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.
There are no adequate data from the use of rabeprazole in pregnant women. Therefore you
must not take Rabeprazole if you are pregnant or think you might be pregnant.
It is not known whether the active substance passes into breast milk. Therefore you must not
take Rabeprazole if you are breastfeeding.
Driving and using machines
It is unlikely that Rabeprazole would affect your ability to drive and use machines.
However, occasionally Rabeprazole can cause drowsiness. Therefore, you should not drive or
use machines if you feel drowsy.

3.

HOW TO TAKE RABEPRAZOLE

Always take this medicine exactly as your doctor 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 glass 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 Older people
For ‘gastro-oesophageal reflux disease’ (GORD)
Treatment of moderate to severe symptoms (symptomatic GORD)
• The usual dose is one 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 usual dose is one 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 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 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 usual dose is one 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.
For ulcers caused by H. pylori infection and to stop them coming back
• The usual dose is one 20 mg tablet twice a day for 7 days.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.
The following combination is recommended:
Morning
20 mg rabeprazole sodium
500 mg clarithromycin
1000 mg amoxicillin

Evening
20 mg rabeprazole sodium
500 mg clarithromycin
1000 mg amoxicillin

For further information on the other medicines used to treat H. pylori, see the individual
product information leaflets.
Zollinger-Ellison Syndrome where excess acid is produced in the stomach
• The usual recommended starting dose is 60 mg (three 20 mg) tablets once a day.
• 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 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.
Use in children
The product should not be used in children.
If you take more Rabeprazole than you should
If you have taken more Rabeprazole than you should contact 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 (two doses at the same time) 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 product, 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 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 side effects – you may need urgent medical treatment:
• Serious allergic reactions (frequency rare: may affect up to 1 in 1,000 people): the signs
may include: sudden swelling of your face, difficulty breathing or low blood pressure
which may cause fainting or collapse.
• Other serious conditions (frequency rare: may affect up to 1 in 1,000 people): frequent
infections, such as sore throat or high temperature (fever), ulcers in your mouth and throat,
bruising or bleeding easily.

Serious skin conditions (frequency very rare : may affect up to 1 in 10,000 people):
severe skin blistering, or soreness or ulcers in your mouth and throat (erythema
multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome).

Other serious skin conditions (frequency not known: frequency cannot be estimated
from the available data); rash, possibly with pain in the joints (Sub-acute cutaneous
lupus erythematosus)
Other possible side effects
Common (may affect up to 1 in 10 people)
• Infections
• Difficulty sleeping
• Headache or feeling dizzy
• Cough, runny nose or sore throat, (pharyngitis)

Effect on your stomach or gut such as stomach pain, diarrhoea, feeling sick (nausea),
being sick (vomiting), constipation or wind (flatulence), benign polyps in the stomach
• Aches or back pain
• Weakness or flu-like symptoms.
Uncommon (may affect up to 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
Fractures of the hip, wrist and spine
Bladder infection (urinary tract infection)
Chest pain
Chills or fever
Changes in how your liver is working (shown in blood tests).

Rare (may affect up to 1 in 1000 people)
• Loss of appetite (anorexia)
• Depression
• Hypersensitivity (includes allergic reactions)
• Visual disturbances
• 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
Not known (frequency cannot be estimated from the available data)
• 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 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.
Reporting of side effects
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 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.
5.

HOW TO STORE RABEPRAZOLE

Keep this medicine out of the sight and reach of children.
Do not use Rabeprazole after the expiry date which is stated on the blister and outer carton
after “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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

What Rabeprazole contains:
The active substance is: rabeprazole sodium
Each Rabeprazole Sodium 10mg gastro-resistant tablet contains 10mg of rabeprazole sodium,
equivalent to 9.42mg rabeprazole
Each Rabeprazole Sodium 20mg gastro-resistant tablet contains 20mg of rabeprazole sodium,
equivalent to 18.85mg rabeprazole
The other ingredients are:
Tablet core:
Mannitol, magnesium oxide, sodium edetate, crospovidone type A, calcium stearate, povidone
Tablet coating:
triethyl citrate, methacrylic acid-ethyl acrylate copolymer (1:1), ethylcellulose, hypromellose,
sodium carbonate, anhydrous, titanium dioxide (E171), macrogol 400, yellow iron oxide
(E172).
Rabeprazole Sodium 10mg gastro-resistant tablets additionally contain red iron oxide (E172).
What Rabeprazole looks like and contents of the pack:
Rabeprazole 10 mg are pink, round, gastro-resistant tablets.
Rabeprazole 20 mg are yellow, round, gastro-resistant tablets.
They are supplied in blister packs of 5, 7, 14, 15, 25, 28, 30, 50, 56, 75, 98, 120 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
MANUFACTURER
Sofarimex – Ind. Quimica e Farmaceutica, S.A.
Av. Das Indústrias – Alto do Colaride
2735-213 Cacém
Portugal

Or
S.C. Zentiva S.A.
B-dul. Theodor Pallady nr.50
Sector 3, Bucuresti
Cod 032266
Romania

This leaflet was last revised inMarch 2017.

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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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