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RABEPRAZOLE SODIUM 10 MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM / RABEPRAZOLE SODIUM / 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 or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.
What is in this leaflet
1. What Rabeprazole sodium is and what it is used for
2. What you need to know before you take Rabeprazole sodium
3. How to take Rabeprazole sodium
4. Possible side effects
5. How to store Rabeprazole sodium
6. Contents of the pack and other information

1. WHAT RABEPRAZOLE SODIUM IS AND WHAT IT IS USED FOR
Rabeprazole sodium tablets contain rabeprazole. It belongs to a class of medicines called proton pump
inhibitors. They act by reducing the amount of acid made by the stomach.
Rabeprazole sodium tablets are used for:
• Active duodenal ulcer or active benign gastric/stomach ulcer (peptic ulcers).
• Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD) commonly referred to as
inflammation of the gullet caused by acid and associated with heartburn, or for long-term treatment of GORD
(GORD maintenance).
• The symptomatic treatment of moderate to very severe gastrooesophageal reflux disease (symptomatic
GORD) also associated with heartburn.
• Zollinger-Ellison syndrome, a rare condition in patients whose stomachs make extremely high amounts of
acid.
• In combination with two antibiotics (clarithromycin and amoxycillin) Rabeprazole sodium tablets are used for
the eradication of H pylori infection in patients with peptic ulcer disease.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RABEPRAZOLE SODIUM
Do not take Rabeprazole sodium:
• if you are allergic to rabeprazole sodium or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant, you think you might be pregnant or if you are breast feeding (please see Pregnancy and
breast-feeding)
Warnings and precautions
Talk to your doctor or pharmacist before taking Rabeprazole sodium.
Tell your doctor or pharmacist:
• if you are allergic to other proton pump inhibitors
• if you have been told you have a stomach tumour
• if you have a history of liver disease
• if you are taking atazanavir (a drug used to treat HIV)
• 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 are taking this medicine for a long time, your doctor will want to monitor you.
Blood and liver problems have been seen in some patients but often get better when rabeprazole treatment is
stopped.
If you experience severe (watery or bloody) diarrhoea with symptoms such as fever, abdominal pain or
tenderness, stop taking Rabeprazole sodium and see a doctor straight away.
Taking a proton pump inhibitor like Rabeprazole sodium, 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 and adolescents
Rabeprazole sodium should not be used in children.
Other medicines and Rabeprazole sodium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist:
• if you are taking ketoconazole or itraconazole (drugs used to treat fungal infections). Rabeprazole sodium
may lower the amount of this type of medicine in your blood. Your doctor may need to adjust your dose.
• if you are taking atazanavir (a drug used to treat HIV). Rabeprazole sodium may lower the amount of this type
of medicine in your blood and they should not be used together.
• if you are taking 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 sodium treatment.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Rabeprazole
sodium.
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.
Do not take Rabeprazole sodium tablets if you are pregnant or think you may be pregnant.
Do not take Rabeprazole sodium tablets if you are breast-feeding or planning to breast-feed.
Driving and using machines
You may feel sleepy while taking Rabeprazole sodium. If this happens, do not drive or use any tools or
machines.

3. HOW TO TAKE RABEPRAZOLE SODIUM
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are
not sure.
YOU MUST SWALLOW THE RABEPRAZOLE SODIUM TABLET WHOLE.
DO NOT CRUSH OR CHEW IT.
The dosages below are those usually recommended for adults and the elderly. Do not change the dose or
length of the treatment yourself.
Use in children
Rabeprazole sodium should not be used in children.
Active duodenal ulcer and active benign gastric ulcer
The usual dose is one Rabeprazole sodium 20 mg tablet once a day.
If you have an active duodenal ulcer, your treatment is expected to continue for four weeks; but after that time
your doctor may decide to continue your treatment for a further four weeks.
If you have an active benign gastric ulcer, your treatment is expected to continue for six weeks; but after that
time your doctor may decide to continue your treatment for a further six weeks.
Erosive or ulcerative gastro-oesophageal reflux disease
The usual dose is one Rabeprazole sodium 20 mg once a day. Your treatment is expected to continue for four
weeks; but after that time your doctor may decide to continue your treatment for a further four weeks.
GORD maintenance
The usual dose is one Rabeprazole sodium 10 mg or 20 mg once a day. Your doctor will advise you on how
long to take your tablets. You need to see your doctor at regular intervals for review of your tablets and
symptoms.
Symptomatic GORD
The usual dose is one Rabeprazole sodium 10 mg once a day. Your once daily treatment is expected to
continue for up to four weeks. If your symptoms do not resolve within four weeks consult your doctor.
Following this initial four week treatment, if your symptoms return, your doctor may then tell you to take one
Rabeprazole sodium 10 mg tablet as and when you require it in order to control your symptoms.

Zollinger-Ellison syndrome
The usual recommended dose is three Rabeprazole sodium 20 mg 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. You need to see your doctor at regular intervals for review
of your tablets and symptoms.
Eradication of H. pylori
The usual recommended dose is Rabeprazole sodium 20 mg to be taken (in combination with two antibiotics clarithromycin 500 mg and amoxycillin 1 g) twice each day and normally for 7 days. Relief of symptoms will
normally occur before the ulcer has completely healed. Therefore it is important that you do not stop taking
the tablets until told to do so by your doctor. For further information on the other components of the H. pylori
eradication therapy see the individual product information leaflets.
If you take more Rabeprazole sodium than you should
Do not take more tablets each day than you are prescribed. If you accidentally take more tablets than the
prescribed dose, please consult your doctor or go to the hospital straight away. Always take the tablets and
the carton with you to the hospital so that the doctor knows what has been taken.
If you forget to take Rabeprazole sodium
If you forget to take a dose, just take it immediately when you remember, and then continue as usual. If you
forget to take your medicine for more than 5 days, call 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 sodium
Do not change the dosage or stop the medication without discussing it with your doctor first.
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 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 sodium and see a doctor straight away if you notice any of the following side
effects - you may need urgent medical treatment:
• 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
• Bruising or bleeding easily
These side effects are rare (may affect up to 1 in 1,000 people).
• Severe skin blistering, or soreness or ulcers in your mouth and throat
These side effects are very rare (may affect up to 1 in 10,000 people).
Other possible side effects:
Common (may affect up to 1 in 10 people):
• Infection
• Insomnia (difficult sleeping)
• Headaches, dizziness
• Cough, pharyngitis (sore throat), rhinitis (runny nose)
• Diarrhoea, vomiting, nausea, abdominal pain, constipation (costiveness), flatulence (wind)
• Pain without any known cause, back pain
• Asthenia (weakness), flu like syndrome
Uncommon (may affect up to 1 in 100 people):
• Nervousness or drowsiness
• Bronchitis, sinusitis
• Dyspepsia (indigestion), dry mouth, eructation (belching)
• Skin rash, redness of the skin
• Muscle or joint pain, leg cramps, fracture of the hip, wrist or spine
• Urinary tract infection
• Chest pain
• Chills, fever
• Changes in liver function test values
Rare (may affect up to 1 in 1,000 people):
• Anorexia (loss of appetite)
• Depression
• Hypersensitivity (including allergic reactions)
• Vision disturbances
• Gastritis (upset stomach or stomach pain), stomatitis (sore mouth), taste disturbances
• Liver problems such as hepatitis (inflammation of the liver) and jaundice (yellowing of your skin and whites
of your eyes), hepatic encephalopathy (brain damage due to liver disease)
• Itching, sweating, skin blisters (these reactions have usually resolved after discontinuation of therapy)
• Sweating
• Kidney problems such as interstitial nephritis (disorders of the connective tissue within the kidney)
• Weight gain
• Changes in white blood cells (shown in blood tests) which may result in frequent infection
• Thrombocytopenia (decrease of blood platelets) - reduction in blood platelets resulting in bleeding or
bruising more easily than normal
Frequency not known (frequency cannot be estimated from available data):
• Confusion
• Swelling of the feet or ankles
• Breast swelling in men
• Hyponatremia (low levels of sodium in the blood) – the symptoms are feeling sick and unwell with weak
muscles or confused
• Rash, possibly with pain in the joints
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: Yellow Card Scheme Website: 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 SODIUM
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 packaging. The expiry date refers to the
last day of that month.
Store in the original package in order to protect from moisture and light.
Do not store above 30°C.
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 sodium contains
• The active substance is rabeprazole sodium.
Rabeprazole sodium 10 mg gastro-resistant tablets
Each gastro-resistant tablet contains 10 mg rabeprazole sodium equivalent to 9.42 mg rabeprazole.
Rabeprazole sodium 20 mg gastro-resistant tablets
Each gastro-resistant tablet contains 20 mg rabeprazole sodium equivalent to 18.85 mg rabeprazole.
• The other ingredients are mannitol (E421), light magnesium oxide (E530), hydroxypropylcellulose (E463),
low-substituted hydroxypropylcellulose (E463) and magnesium stearate (E572) in the tablet core, and
ethylcellulose (E462), light magnesium oxide (E530), hypromellose phthalate, diacetylated monoglycerides
(E472a), talc (E553b), titanium dioxide (E171), red iron oxide (E172) (10 mg only) and yellow iron oxide
(E172) (20 mg only) in the coating.
What Rabeprazole sodium looks like and contents of the pack
10 mg gastro-resistant tablets are orange-pink, biconvex, round tablets with bevelled edges, tablet diameter
approximately 5.7 mm.
20 mg gastro-resistant tablets are slightly brownish yellow, biconvex, round, tablet diameter approximately
7.2 mm.
For both strengths, boxes of 7, 10, 14, 15, 28, 30, 56, 60, 90, 98 and 100 gastro-resistant tablets in blisters
are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Distributed by:
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in 10/2016.

P0560

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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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