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RANITIDINE EFFERVESCENT TABLETS 300MG

Active substance(s): RANITIDINE HYDROCHLORIDE

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TEVA UK Ref:

231-30-20108-E LEA RANITIDINE HCL A/S EFF TAB RAT
Version:

1

04 September 2014

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ranitidine 150 mg effervescent tablets
Ranitidine 300 mg effervescent tablets
(ranitidine)

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 Ranitidine effervescent tablets are and
what they are used for
2. What you need to know before you take
Ranitidine effervescent tablets
3. How to take Ranitidine effervescent tablets
4. Possible side effects
5. How to store Ranitidine effervescent tablets
6. Contents of pack and other information

1.

WHAT RANITIDINE
EFFERVESCENT TABLETS ARE
AND WHAT THEY ARE USED FOR

Ranitidine is a gastrointestinal drug. It belongs
to the group known as histamine H2 receptor
blockers, which reduce the secretion of stomach
acid.
For adults Ranitidine effervescent tablets are
used for the treatment of diseases of the
stomach and duodenum, in which a reduction of
stomach acid is required:
• Intestinal ulcers
• Benign stomach ulcers
• Prevention of the return of stomach ulcers in
patients with recurrent ulcers
• Inflammation of the gullet as a result of the
backflow of stomach contents (reflux
oesophagitis)
• Zollinger-Ellison Syndrome (a disease whereby
the stomach produces too much acid).
Ranitidine is not indicated for the treatment of
mild stomach/intestinal complaints, such as
nervous stomach.
For children (3 to 18 years) Ranitidine
effervescent tablets are used for:
• the short term treatment of stomach ulcers
(ulcers in the part of the gut that connects to
the duodenum)
• the treatment of inflammation of the gullet
(the tube between your mouth and stomach)
caused by too much stomach acid. This can
cause pain or discomfort sometimes known as
“indigestion”, “dyspepsia” or “heartburn”.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE RANITIDINE
EFFERVESCENT TABLETS
Do not take Ranitidine effervescent tablets:
• if you are allergic to ranitidine or any of the
other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ranitidine effervescent tablets.
• if you suffer from a reduced kidney function; a
lower dose may be needed (see section 3:
“How to take Ranitidine effervescent tablets”)
• if you have a history of porphyria (a severe
illness whose symptoms include severe
stomach pain, mental confusion and muscle
weakness)
• if you suffer from severe liver impairment; you
should use this medicine with caution
• if you are elderly, if you have a chronic lung
disease, diabetes or problems with your
immune system, you may have an increased
risk of developing community acquired
pneumonia
• if you have mild, short-lasting stomach or
intestinal complaints; ranitidine is indicated
for patients with severe complaints and
should not be used to treat mild complaints.
Stomach and duodenal ulcers can be caused by
a certain bacteria called Helicobacter pylori. Your
doctor may therefore prescribe other medicines
(antibiotics) that can kill these bacteria.
Before starting treatment with ranitidine, it is
important that your doctor has established that
your stomach/ duodenal ulcer is not malignant.
Ask your doctor if any of the above warnings
apply to you, or has ever applied to you in the
past.
Other medicines and Ranitidine effervescent
tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
An interaction may occur if you take these
effervescent tablets at the same time as:
• coumarin anticoagulants (e.g. warfarin, for
thinning your blood)
• procainamide and N-acetylprocainamide
(medicines for the treatment of cardiac
arrhythmias)

• triazolam, midazolam (mood-enhancing
drugs)
• glipizide (medicine for the treatment of
diabetes)
• ketoconazole (medicine for the treatment of
fungal infections)
• atazanavir, delaviridine (medicine for
treatment of HIV infection)
• gefitinib (medicine for treatment of lung
cancer).
You should always take medicines which reduce
stomach acid (e.g. antacids, sucralfate) 2 hours
after Ranitidine effervescent tablets, in order to
prevent a reduction in the efficacy of Ranitidine
effervescent tablets.
Ranitidine effervescent tablets with food, drink
and alcohol
This medicine can be used with or without a meal.
Ranitidine can increase the effect of alcohol.
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.
If you are pregnant, might become pregnant or
are breast-feeding, you should not take this
medicine unless your doctor advises it is
essential.
Ranitidine passes into breast milk.
Breast-feeding is therefore not recommended
whilst using Ranitidine.
Driving and using machines
No effects on the ability to drive or operate
machinery were reported when using Ranitidine
effervescent tablets only. Ranitidine effervescent
tablets can increase the effect of a small amount
of alcohol. If you have drunk alcohol, do not drive
and/or use machines that require you to be alert.
Ranitidine effervescent tablets contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars (e.g.
lactose), contact your doctor before taking this
medicine.
Ranitidine effervescent tablets contains sodium
Each Ranitidine 150 mg effervescent tablet
contains 120 mg of sodium, the 300 mg
effervescent tablet contains 240 mg of sodium.
You should bear this in mind if you are on a
low-sodium or sodium-free diet.

3. HOW TO TAKE RANITIDINE
EFFERVESCENT TABLETS
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Dissolve the effervescent tablets without
breaking them in a full glass of water. Wait until
the tablets have dissolved and then drink the
solution. You may take the tablets with or
without a meal.
Unless otherwise prescribed by your doctor, the
recommended dose is:
Dosage
Adults and adolescents (12 years and over) with
normal kidney function:
Intestinal or benign stomach ulcer
2 x 150 mg effervescent tablets or 1 x 300 mg
effervescent tablet a day, in a single dose after
an evening meal or in the evening before
bedtime; alternatively, in two doses, i.e. 150 mg
at breakfast and 150 mg in the evening before
bedtime. Treatment lasts for 4 weeks, but can be
extended to 8 weeks.
Prevention of stomach ulcer relapse (150 mg
strength only)
1 x 150 mg effervescent tablet per day, in the
evening before bedtime. Treatment lasts for 12
months or less, depending on the instructions of
the doctor.
Inflammation of the gullet due to backflow of
stomach acid
2 x 150 mg effervescent tablets or 1 x 300 mg
effervescent tablet a day, in a single dose after
an evening meal or in the evening before
bedtime. Alternatively, these tablets may be
taken in two doses, i.e. 150 mg at breakfast and
150 mg in the evening before bedtime. If
necessary, dosage can be increased to 4 x 150 mg
effervescent tablets or 2 x 300 mg effervescent
tablets a day. Treatment lasts for 8 weeks, but
can be extended to 12 weeks.

TEVA UK Ref:

231-30-20108-E LEA RANITIDINE HCL A/S EFF TAB RAT
Patients with severe stomach acid secretion (e.g.
caused by Zollinger-Ellison Syndrome)
Starting dose: 1 x 150 mg effervescent tablet
three times a day. If necessary, dosage can be
increased to 600 - 900 mg (4-6 x 150 mg
effervescent tablets or 2-3 x 300 mg effervescent
tablets) a day. Length of treatment: according to
your doctor’s instructions.
Patients with reduced kidney function
Your dosage will be lowered by your doctor,
depending on the extent to which your kidney
function is impaired.
Patients with reduced liver function
Such patients can be treated at the usual dosage
schedules.
Children over 30 kg of weight and from 3 to 11
years
Your doctor will work out the right dose for you
based on your child’s weight.
Treatment of stomach or duodenal (small
intestine) ulcers
The usual dose is 2 mg for each kg of body
weight, twice a day for four weeks. This dose
may be increased to 4 mg for each kg, twice a
day. Take each dose about 12 hours apart. The
duration of treatment may be increased to 8
weeks.
Treatment of heartburn due to too much acid
The usual dose is 2.5 mg for each kg of body
weight, twice a day for two weeks. The dose may
be increased to 5 mg for each kg, twice a day.
Take each dose about 12 hours apart.
If you take more Ranitidine effervescent tablets
than you should
If you have taken more than the prescribed dose,
you must contact your doctor or pharmacist
immediately.
If you forget to take Ranitidine effervescent
tablets
If you have forgotten a dose, take it as soon as
you remember. If it is nearly time for your next
dose, skip the forgotten dose and carry on as
normal. Do not take a double dose to make up
for the forgotten dose. You should check with
your doctor or pharmacist if you are not sure.
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 medicine can cause side
effects, although not everybody gets them.
Serious side effects
A few people can be allergic to some medicines.
These reactions can occur following
administration of a single dose. If any of the
following side effects come on soon after taking
these tablets, stop the tablets and tell your
doctor immediately or go to the casually
department at your nearest hospital:
• hives, swelling of tongue, lips, face and throat
(angioedema), fever, constriction of the
airways, drop in blood pressure, inadequate
blood flow through the body (circulatory
shock), chest pain.
These side effects occur rarely (less than 1 in
1,000 persons treated).
Other possible side effects
Uncommon (may affect up to 1 in 100 people)
• tiredness
• abdominal pain, diarrhoea, constipation,
feeling sick (these symptoms mostly improved
during continued treatment).
Rare (may affect up to 1 in 1,000 people)
• a slight rise in one laboratory value (serum
creatinine) (usually slight; normalised during
continued treatment)
• hypersensitivity reactions e.g. urticaria
(reddening of the skin with itching),
angioneurotic oedema (serious allergic
reaction which causes swelling of the face or
throat), fever, bronchospasm (difficulty in
breathing or wheezing), low blood pressure
and chest pain
• transient and reversible changes in liver
function tests
• skin rash, itching.
Very rare (may affect up to 1 in 10,000 people)
• there can be changes in the level of certain
substances in your blood (leucopenia,
thrombocytopenia, agranulocytosis,
pancytopenia). This can lead to you feeling
unusually tired or short of breath and being
more likely to bruise or get an infection.
• anaphylactic shock (serious allergic reaction
which causes difficulty in breathing or
dizziness). These events have been reported
after a single dose).
• reversible mental confusion, depression and
hallucinations. These have been reported
predominantly in severely ill and elderly
patients.
• headache (sometimes severe), dizziness and
reversible involuntary movement disorders.
• reversible blurred vision. There have been
reports of blurred vision, which is suggestive
of a change in accommodation.
• as with other H2 receptor antagonists
bradycardia (slower heart beat) and AV block
(disturbances in the conduction [flow] of
electrical impulses passing from the upper to
the lower chambers of the heart)
• vasculitis (your small blood vessels can
become swollen, often with skin rash)

Version:

1

04 September 2014

• acute pancreatitis (inflammation of the
pancreas, which causes severe pain in the
abdomen and back)
• an inflammation of the liver due to a virus or
other insult to the liver (hepatitis) with or
without jaundice, these were usually
reversible
• a particular form of skin rash (Erythema
multiforme)
• hair loss
• your joints or muscles are painful or swollen
or you cannot control their movement
(arthralgia and myalgia)
• inflammation of the kidneys (acute interstitial
nephritis)
• reversible impotence, breast symptoms and
breast conditions (such as gynaecomastia and
galactorrhoea).
Not known (cannot be estimated from the
available data)
• pneumonia (inflammation of the lung, see
section 2. “Warnings and precautions”).
Paediatric population
The safety of ranitidine has been assessed in
children aged 0 to 16 years with acid-related
disease and was generally well tolerated with an
adverse event profile resembling that in adults.
There are limited long term safety data available,
in particular regarding growth and development.
Reporting of side effects
If you get 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 RANITIDINE
EFFERVESCENT TABLETS
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 after EXP. The
expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the tube tightly closed in order to protect
from moisture.
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 Ranitidine effervescent tablets contains:
The active substance is ranitidine.
Each 150 mg effervescent tablet contains 168 mg
of ranitidine hydrochloride, equivalent to 150 mg
ranitidine.
Each 300 mg effervescent tablet contains 336 mg
of ranitidine hydrochloride, equivalent to 300 mg
ranitidine.
The other ingredients are Tartaric acid, sodium
hydrogen carbonate, lactose monohydrate,
povidone, riboflavin sodium phosphate (E101),
simethicone emulsion, sodium cyclamate,
saccharine sodium, lemon aroma (contains citral,
citronella oil, coriander oil, lime and arabic gum),
macrogol 6000 and sodium hydroxide.
What Ranitidine effervescent tablets look like
and contents of the pack
Yellow-white to light-yellow cylindrical
effervescent tablets with bevelled edges.
Ranitidine 150 mg effervescent tablets
Pack sizes: 10, 20, 30, 50, 60, 90 or 100
effervescent tablets.
Ranitidine 300 mg effervescent tablets
Pack sizes: 10, 20, 30, 50, or 100 effervescent
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Str. 3, D-89079
Ulm, Germany.
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143
Blaubeuren, Germany.
For any information about this medical product,
please contact the local representative of the
Marketing Authorisation Holder: ratiopharm UK
Ltd, Cosham, Portsmouth, PO6 1UP.
This leaflet was last revised in January 2014
20108-E

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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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