RANITIDINE 300MG TABLETS

Active substance: RANITIDINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Ranitil 150mg Tablets & Ranitil 300mg Tablets
(Ranitidine Hydrochloride)
Please read all of this leaflet carefully before you use this medicine
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed only for you. Do not pass it onto others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist

In this leaflet:
1
2
3

What Ranitil Tablets are and what they are used for
Before you take Ranitil Tablets
How to take Ranitil Tablets

1 What Ranitil Tablets are

and what they are used for

Ranitil belongs to a group of medicines called H2
antagonists, which reduce the amount of acid in your
stomach.
You may have been given ranitidine previously by
your doctor under a different brand name. However
the effect of the Ranitil will be the same.
This medicine is used to:
treat ulcers in the stomach (gastric ulcer) or upper
part of the intestine (duodenal ulcer), including
those associated with non−steroidal anti−
inflammatory medicines (NSAIDs), often used to
treat arthritis and as pain killers (see ’Taking other
medicines)
prevent ulcers which may be caused by non−
steroidal anti−inflammatory drugs (NSAIDs)
(see above and ’Taking other medicines)
treat ulcers in the upper part of the intestine
(duodenal ulcer) associated with the bacteria
Helicobacter pylori when used with antibiotics
treat ulcers which develop after an operation
treat a rare disorder which causes excessive
production of acid in the stomach due to increased
levels of the hormone gastrin (Zollinger−Ellison
syndrome)
treat inflammation of the food pipe (oesophagus),
caused by stomach acid which flows back into the
food pipe (oesophageal reflux disease). The most
common symptom is heartburn. Ranitil is also
used in the long term management of healed
inflammation of the food pipe (oesophagitis)
treat long lasting (chronic) episodes of indigestion,
which are related to meals or disturbs sleep but not
associated with the preceding conditions
prevent ulcers (known as stress ulcers) from
bleeding in seriously ill patients
prevent ulcers in the stomach and upper part of the
intestine (peptic ulcer) from bleeding again
prevent damage to the lungs caused by breathing
in stomach fluids (acid aspiration) whilst under
anaesthetic or in women during childbirth
Children aged 3 − 18 years
treat (short term) ulcers in the stomach and upper
part of the intestine (peptic ulcer)
treat stomach acid which flows back into the food
pipe (oesophagus) (gastro−oesophageal reflux
disease− GORD)

2 Before taking Ranitil Tablets

4
5
6

Possible side effects
How to store Ranitil Tablets
Further information

In particular tell your doctor or pharmacist if you are
taking the following:
Non−steroidal anti−inflammatories (NSAIDs), often
used to treat arthritis or as pain killers e.g.
indometacin, aspirin
Ranitil may interfere with the actions of other
medicines, in particular the following:
Medicines for thinning the blood (anticoagulants),
such as warfarin
Procainamide, used to control an irregular or rapid
heart rate
Ranitil may increase the absorption of the following:
Triazolam, used to treat difficulty in sleeping
Midazolam, usually used to sedate patients before
surgery
Glipizide, used for diabetes
Ranitil may decrease the absorption of the following:
Ketoconazole, used to treat skin and fungal
infections
Atazanavir and delaviridine, used to treat HIV
infection
Gefitnib (used as a cancer treatment)
Sucralfate used to treat ulcers of the esophagus,
stomach, or small intestine
Pregnancy and Breast−feeding
If you are pregnant, planning to become pregnant or
you are breast−feeding, talk to your doctor before
taking this medicine. Ranitil should only be used if
considered essential by your doctor.
Driving and using machines
There are no reports of Ranitil interfering with the
ability to drive or operate machinery.
Important information about some of the
ingredients of this medicine:
This medicine contains lactose: If you have been
told by your doctor that you have intolerance to some
sugars, contact your doctor before taking this
medicine.

3 How to take Ranitil Tablets
Take this medicine as your doctor or pharmacist has
told you. Look on the label and ask your doctor or
pharmacist if you are not sure. The doses stated
below are guidelines only.
Ranitil Tablets are to be taken orally with a glass of
water
Adults (including the elderly) and adolescents 12
years and over
The usual dosage is 150mg twice a day, taken in the
morning and evening.

Do not take if:
you are allergic to ranitidine or any of the other
ingredients (listed in Further Information on the
Ulcers in the stomach (gastric ulcer) or upper part
back page) An allergic reaction can include a rash, of the intestine (duodenal ulcer):
itching or shortness of breath
As an alternative to the usual dose, your doctor may
decide to give a single bedtime dose of 300mg
Take special care
In most cases gastric and duodenal ulcers will heal
Talk to your doctor before taking if:
within four weeks. If this is not the case your doctor
you are over 40 and recently had indigestion for
will most likely extend the course for a further four
the first time or your symptoms have changed
you have severe kidney problems. The dose of this weeks.
medicine will need to be adjusted (see section 3)
Post operative ulcers:
you have a history of short lived attacks of a rare
The usual dosage is 150mg twice a day. In most
illness called porphyria. Your doctor may advise
cases, post operative ulcers will heal within four weeks.
you not to take Ranitil
you are or think you may be pregnant
Ulcers associated with taking NSAID medicines:
you are breast feeding
The usual dosage is 150mg twice a day. Treatment
you are taking non−steroidal anti−inflammatory
may last eight weeks.
drugs (NSAIDs). You should see your doctor
regularly, in particular if elderly or you have a
To prevent NSAID associated ulcers:
history of ulcers
The usual dose is 150mg twice a day with NSAID
you are elderly, have long term lung disease,
therapy.
diabetes or have a weakened immune system
Ulcers in the upper part of the intestine (duodenal
caused by certain diseases or treatments. You
ulcer) associated with the bacteria Helicobacter
may have an increased risk of developing
pylori:
inflammation of the lungs (pneumonia) whilst
The usual dosage is 150mg twice a day or 300mg
taking Ranitil
at bedtime. This may be given with the antibiotics
amoxicillin 750mg (three times a day) and
Taking other medicines
metronidazole 500mg (three times a day) for a
Tell your doctor or pharmacist about any medicines
duration of two weeks. Treatment with Ranitil should
you are taking or have recently taken, even those
continue for a further two weeks.
bought without a prescription.
Continued....

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Inflammation of the food pipe (oesophagus),
caused by stomach acid flowing back into the
food pipe (oesophageal reflux disease):
The usual dose is 150mg twice a day or 300mg at
bedtime for up to eight weeks or, if required 12 weeks.

inflammation of the pancreas, which can cause
severe pain in the abdomen and back
headache (sometimes severe)
dizziness
slower heart beat
inflammation of blood vessels, often with skin rash
feeling sick or loss of appetite, with or without
jaundice (yellowing colour of skin and white of eyes).
This may be due to hepatitis
blistering of the skin
loss of hair
joint or muscle pain
kidney problems (symptoms may include a change
in the amount of urine passed and its colour,
nausea, vomiting, confusion, fever and rash)
in men, breast tenderness or enlargement or
sexual impotence
abnormal production of breast milk(in men and
women)

For more severe inflammation of the oesophagus
your doctor may increase the dose up to 150mg four
times a day for up to twelve weeks.
For healed oesophagitis, the usual dose is 150mg
twice a day.
Excessive production of acid in the stomach due
to increased levels of gastrin (Zollinger−Ellison
syndrome):
The usual starting dose is 150mg three times a day.
Depending on how you respond your doctor may
increase this up to 6g a day.
Chronic indigestion:
The usual dose is 150mg twice a day for up to six
weeks.
To prevent stress ulcers from bleeding (in
seriously ill patients) or ulcers in the stomach
and upper part of the intestine (peptic ulcer) from
bleeding again:
The usual dose is 150mg twice a day.
To prevent breathing in stomach fluids (acid
aspiration) under anaesthetic:
150mg may be given two hours before the induction
of a general an anaesthetic and also 150mg the
previous night.
To prevent breathing in stomach fluids (acid
aspiration) at the start of labour:
150mg may be given followed a further 150mg at 6−
hourly intervals.
Patients with severe kidney problems:
Your doctor will reduce your dose if you suffer from
severe kidney problems. The usual dose is 150mg
tablet given at bedtime for 4−8 weeks.

The following very rare side effects usually stop once
you stop taking this medicine
feeling confused, depressed or seeing or hearing
things that are not real (mostly in severely ill and
elderly patients)
blurred vision (reversible)
uncontrolled movements
If any of the side effects gets serious, or if you notice
any side effects not mentioned in this leaflet, please
tell your doctor or pharmacist.
If you have taken all the medicine and still feel unwell,
or if you have not taken all the medicine but feel
worse, tell your doctor.
Children aged 0 − 16 years
Assessment of the safety of Ranitidine in children
aged 0 − 16 years with acid−related disease, showed
that it is generally well tolerated. Any side effects
were similar to those for adults.
However, there is only limited long term safety data
available, in particular regarding growth and
development.

Duration of treatment:
Even if you feel better, your doctor may decide to
continue your treatment with Ranitidine Tablets in
5 How to store Ranitil Tablets
order to prevent the pain and discomfort returning. It
is important that you keep taking your medicine for as Looking after your medicine
long as you are told to. Do not stop taking the tablets,
Keep out of the reach and sight of children.
continue with the full course of treatment that has
Do not store above 25°C.
been prescribed for you.
Store in the original container.
Do not use after the expiry date (month, year) on
Children (3 to 11 years):
the label and carton. The expiry date refers to the
Ulcers in the stomach and upper part of the
last day of that month.
intestine (peptic ulcers)
If it is out of date or you no longer want it, take it
Short term treatment − the usual dose is
back to the pharmacy.
4mg/kg to 8mg/kg twice a day, up to a maximum of
Do not use Ranitil Tablets if you notice anything
300mg Ranitil daily, for 4 weeks.
wrong with the medicine. Talk to your pharmacist.
For patients with complete healing, another 4 weeks
Medicines should not be disposed of via
or treatment may be required.
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
Stomach acid which flows back into the food pipe
required. These measures will help to protect the
(gastro−oesophageal reflux disease − GORD)
environment.
the usual dose is 5mg/kg to 10mg/kg twice a day, up
to a maximum of 600mg)
If you take more Ranitil than you should (overdose): 6 Further information
Taking more than it says on the label is unlikely to be
dangerous, unless a lot of tablets are taken at once.
What Ranitil Tablets contains
In that case, phone your doctor or go to your nearest The active substance is Ranitidine Hydrochloride.
accident and emergency department straight away.
Ranitil 150mg Tablets contain 150mg ranitidine and
Ranitil 300mg Tablets contain 300mg ranitidine
If you forget to take this medicine:
Take another dose as soon as you remember. Then
go on as before. Do not take a double dose to make
up for a forgotten dose.

4 Possible side effects
Like all medicines, Ranitil can cause side effects,
although not everybody gets them.
If you have an allergic reaction to this medicine
see a doctor immediately.
An allergic reaction may include:
itching rash (urticaria)
swelling of the throat or face
fever
difficulty breathing, wheezing or dizziness
low blood pressure (symptoms may include
feeling faint, especially on standing up)
chest pain

The other ingredients are microcrystalline cellulose,
calcium hydrogen phosphate dihydrate, maize starch,
sodium starch glycollate (Type A), magnesium
stearate, colloidal anhydrous silica, titanium dioxide
(E171), lactose monohydrate, hypromellose and
macrogol 4000.
What Ranitil Tablets look like and the contents of
the pack
Ranitil 150mg Tablets are round, white film−coated
tablets with a score mark on one side.
They are available in pack sizes of 20, 50, 60 or 100
tablets.
Ranitil 300mg Tablets are oblong, white film coated
tablets with a score mark on both sides.
They are available in pack sizes of 20, 30, 50 or 100
tablets.

Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories Ltd
If you get the following side effects, you should
3 Howard Road,
see your doctor as soon as possible.
Eaton Socon,
Uncommon side effects (affecting less than 1 in 100 St. Neots
Cambridgeshire,
treated patients)
PE19 8ET,
abdominal pain, diarrhoea,constipation,nausea
(these symptoms usually improve during continued UK
treatment
Product Licence Numbers:
Rare side effects (affecting less then 1 in 1000
Ranitil 150mg Tablets − PL 11311/0138
treated patients)
Ranitil 300mg Tablets − PL 11311/0139
abnormal liver test results
skin rash
increase in creatinine levels(detected through a
Date of last revision:
blood test)
June 2010
Very rare side effects (affecting less than 1 in
10,000 treated patients)
blood disorders, which can cause weakness, or
increase the risk of bruising, bleeding and infections
reduced heart rate or heart block

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Phone

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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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