Skip to Content

UK Edition. Click here for US version.

RABEPRAZOLE SODIUM 10MG GASTRO-RESISTANT TABLETS

Active substance(s): RABEPRAZOLE SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
P15xxxx

Review - 4

Rabeprazole sodium

TEMP

P15xxxx

Rabeprazole sodium

60 mm

TEMP

Pharmacode position can change as per
Supplier’s m/c requirement & additional small
pharma code may appear on the front/back panel

Rabeprazole - UK - Leaflet

may lower the amount of this type of medicine in your blood and
they should not be used together.
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
- Do not use Rabeprazole sodium if you are pregnant or think
you may be pregnant
- Do not use Rabeprazole sodium if you are breast-feeding or
planning to breast-feed

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

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.

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.

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.

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

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 drink 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.

1. WHAT RABEPRAZOLE SODIUM IS AND WHAT IT IS USED
FOR

Adults and the Elderly

Rabeprazole sodium tablets contain the active ingredient rabeprazole
sodium. This belongs to a group of medicines called ‘Proton Pump
Inhibitors’ (PPIs). They work by lowering the amount of acid that your
stomach produces.

For ‘gastro-oesophageal reflux disease’ (GORD)
Treatment of moderate to severe symptoms (symptomatic
GORD)
- The usual dose is one Rabeprazole sodium 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 sodium 10 mg tablet as
and when you require it.

Rabeprazole sodium tablets are 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 ulcers are infected with bacteria called ‘Helicobacter
pylori’ (H. Pylori), you will also be given antibiotics. Using
Rabeprazole sodium 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.

Treatment of more severe symptoms (erosive or ulcerative
GORD)
- The usual dose is one Rabeprazole sodium 20 mg tablet once
a day for 4 to 8 weeks.
- Take the tablet in the morning before eating.

For ulcers of the stomach (peptic ulcers)
- The usual dose is one Rabeprazole sodium 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 sodium for
another 6 weeks if your condition does not improve.

Do not use Rabeprazole sodium if any of the above applies to you.
If you are not sure, talk to your doctor or pharmacist before using
Rabeprazole sodium.
Also see Pregnancy and breast-feeding section.

For ulcers of the intestine (duodenal ulcers)
- The usual dose is one Rabeprazole sodium 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 sodium for
another 4 weeks if your condition does not improve.

Children
Rabeprazole sodium should not be used in children.
Warnings and precautions
Check with your doctor or pharmacist before taking Rabeprazole
sodium if:
- You are allergic to other proton pump inhibitor medicines or
‘substituted benzimidazoles’.
- You have a stomach tumour.
- You have ever had liver problems.
- If you are taking atazanavir- for HIV infection.

For ulcers caused by H. Pylori infection and to stop them
coming back
- The usual dose is one Rabeprazole sodium 20 mg tablet twice
a day for seven days.
- Your doctor will also tell you to take antibiotics called amoxicillin
and clarithromycin.
For further information on the other medicines used for the H. Pylori
treatment, see the individual product information leaflets.

Blood and liver problems have been seen in some patients but often
get better when Rabeprazole sodium is stopped.
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before using Rabeprazole sodium.

Zollinger-Ellison Syndrome where excess acid is produced in
the stomach
- The usual 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.
If you are on long-term treatment you will need to see your doctor at
regular intervals for review of your tablets and symptoms.

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.
Other medicines and Rabeprazole sodium
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:
- Ketoconazole or itraconazole – used to treat infections caused
by a fungus. Rabeprazole sodium may lower the amount of this
type of medicine in your blood. Your doctor may need to adjust
your dose.
- Atazanavir– used to treat HIV-infection. Rabeprazole sodium

Children. The product should not to be used in children.
Patients with liver problems. You should consult your doctor who
will take special care when beginning treatment with Rabeprazole
sodium and while you continue to be treated with Rabeprazole
sodium.

5 mm

Outer line not to be printed.
5 mm

10 mm

Black

Size: 210 x 420 mm

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 below)
- You are pregnant or think that you are pregnant
- You are breast-feeding.

Font type: Helvetica (TT)
Font size: 9 pt.

Long-term treatment of symptoms (GORD maintenance)
- The usual dose is one Rabeprazole sodium 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RABEPRAZOLE SODIUM

Rabeprazole - UK - Leaflet

Review - 4

60 mm

If you take more Rabeprazole sodium than you should
If you take more Rabeprazole sodium than you should, talk to a
doctor or go to a hospital straight away. Take the medicine pack
with you.

- 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 sodium 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.

If you forget to take Rabeprazole sodium
- 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 sodium
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.

Do not be concerned by this list of side effects. You may not get any
of them. If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

5. HOW TO STORE RABEPRAZOLE SODIUM
Keep this medicine out of the sight and reach of children.

4. POSSIBLE SIDE EFFECTS

Store below 25°C.

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.

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.

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 (affects 1 to 10 users in 10,000).
- Severe skin blistering, or soreness or ulcers in your mouth and
throat.
These side effects are very rare (affects less than 1 user in 10,000).

Do not throw away any medicine 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.
Each gastro-resistant tablet contains 10 mg rabeprazole sodium,
equivalent to 9.42 mg rabeprazole.
Each gastro-resistant tablet contains 20 mg rabeprazole sodium,
equivalent to 18.85 mg rabeprazole.
The other ingredients are:
Tablet core: Mannitol, Magnesium oxide, hydroxy propylcellulose,
crospovidone, low-substituted hydroxy propylcellulose, Magnesium
stearate.
Under coating: Ethyl cellulose, magnesium oxide.
Enteric
coating:
Hypromellose
phthalate,
diacetylated
monoglycerides, talc, titanium dioxide (E171), yellow iron oxide
(E172) - 20mg only.

Other possible side effects:
Common (affects 1 to 10 users in 100)
- Infections
- Difficulty sleeping
- Headache or feeling dizzy
- Cough, runny nose or sore throat (pharyngitis)
- Effects on your stomach or gut such as stomach pain, diarrhoea,
wind (flatulence), feeling sick (nausea), being sick (vomiting) or
constipation
- Aches or back pain
- Weakness or flu-like symptoms.

What Rabeprazole sodium looks like and contents of the pack
Gastro-resistant tablet
Rabeprazole sodium 10 mg gastro-resistant tablet is round (diameter
5.72 mm), white, biconvex, enteric coated tablets.

Uncommon (affects 1 to 10 users in 1,000)
- 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
- Bladder infection (urinary tract infection)
- Chest pain
- Chills or fever
- Changes in how your liver is working (shown in blood tests)
- 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).

Rabeprazole sodium 20 mg gastro-resistant tablet is round (diameter
7.17 mm), yellow, biconvex, enteric coated tablets.
Rabeprazole sodium gastro-resistant tablets are available in
Polyamide/Aluminium/ PVC/Aluminium foil blister pack.
Blister pack: 14, 28, 30, 56 and 98 tablets.
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta

Rare (affects 1 to 10 users in 10,000)
- Loss of appetite (Anorexia)
- Depression
- Hypersensitivity (includes allergic reactions)
- Visual disturbance
- 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.

P15xxxx

5 mm

5 mm

10 mm

Black

Size: 210 x 420 mm

This leaflet was last revised in 06/2014

Other possible side effects (Not known – frequency cannot be
estimated from the available data)
- Breast swelling in men
- Fluid retention

Outer line not to be printed.

Font type: Helvetica (TT)
Font size: 9 pt.

Not all pack sizes may be marketed.

Expand view ⇕

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.

Hide