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RANITIDINE TABLETS 150MG

Active substance(s): RANITIDINE / RANITIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ranitidine Tablets 150mg and 300mg
[Ranitidine hydrochloride]

Read all of this leaflet carefully before you start
possible causes of your symptoms (such as
taking this medicine because it contains
stomach cancer) should be investigated before
important information for you.
taking or continuing to take Ranitidine Tablets
Keep this leaflet. You may need to read it
!
Suffer from or have a history of porphyria
!
again.
Have lung disease
!
If you have any further questions, ask your
!
!
Are diabetic
doctor, or pharmacist or nurse.
!
Have any problems with your immune system.
This medicine has been prescribed for you
!
only. Do not pass it on to others. It may harm
Other medicines and Ranitidine Tablets:
them, even if their signs of illness are the same
Tell your doctor or pharmacist if you are taking,
as yours.
have recently taken or might take any other
If you get any side effects, talk to your doctor,
!
medicines. This includes medicines that you can
or pharmacist or nurse. This includes any
buy without a prescription and herbal medicines.
possible side effects not listed in this leaflet.
This is because Ranitidine Tablets can affect the
See section 4.
way some other medicines can work. Also some
other medicines can affect the way Ranitidine
What is in this leaflet:
Tablets work.
1. What Ranitidine Tablets are and what they
In particular tell your doctor or pharmacist if you
are used for
are taking any of the following medicines:
2. What you need to know before you take
!
Lidocaine, a local anaesthetic
Ranitidine Tablets
!
Propranolol, procainamide or
3. How to take Ranitidine Tablets
n-acetylprocainamide, for heart problems
4. Possible side effects
!
Diazepam, for worry or anxiety problems
5. How to store Ranitidine Tablets
!
Phenytoin, for epilepsy
6. Contents of the pack and other information
!
Theophylline, for breathing problems (asthma)
!
Warfarin, for thinning your blood
1. WHAT RANITIDINE TABLETS ARE AND
!
Glipizide, for lowering blood glucose
WHAT THEY ARE USED FOR
!
Atazanavir or delaviridine, for treating HIV
infection
Ranitidine Tablets belong to a group of medicines
!
Triazolam, for insomnia
called H2-receptor antagonists which act to
!
Gefitinib, for lung cancer
decrease the natural production of acid in the
!
Ketoconazole, an anti-fungal medicine,
stomach.
sometimes used for treating thrush.
Ranitidine Tablets have been prescribed to treat
Midazolam is a medicine that may be given to you
any of the following:
just before an operation. Tell the doctor you are
Ulcers in the upper part of the intestine
!
taking Ranitidine Tablets before your operation in
(duodenal ulcer) including those associated
case he or she wants to give you Midazolam.
with infections caused by Helicobacter pylori.
Benign stomach ulcer
!
Pregnancy and breast-feeding
Acid from the stomach escaping into the food
!
Ask your doctor or pharmacist for advice if you are
pipe causing pain, inflammation and heartburn
pregnant, planning on becoming pregnant or are
(oesophageal reflux disease)
breast-feeding. You should not take this medicine
Excess acid in the stomach caused by a tumor
!
unless your doctor advises it is essential.
in the pancreas (Zollinger-Ellison syndrome)
Ulcers in the stomach or duodenum which may
!
Driving and using machines
be caused by non-steroidal anti-inflammatory
These tablets can cause some people to feel dizzy
medicines (NSAIDs) which are used to treat
or drowsy. If you are affected do not drive or
pain, fever and inflammation
operate machinery.
Various conditions where reduction of stomach
!
acid and secretions is considered beneficial
3. HOW TO TAKE RANITIDINE TABLETS
e.g. for indigestion symptoms (e.g. stomach
pain or discomfort, heartburn), which are
Always take Ranitidine Tablets exactly as your
related to meals and disturbed sleep
doctor has instructed you. You should check with
To prevent stress ulcers in seriously ill patients
!
your doctor or pharmacist if you are unsure.
To prevent stomach ulcers from bleeding
!
Before general anaesthesia, to prevent
!
The usual dosage is 150mg twice daily. As an
damage to the lungs in patients at risk of
alternative, 300mg can be taken as a single dose
breathing in stomach fluid during surgery.
at bedtime.
Children (3-18 years):
Elderly:
!
Peptic ulcers
The normal adult dosage may be used unless the
!
Oesophageal reflux disease (see above)
patient has kidney problems.
For dosage see Section 3 How to take
Ranitidine Tablets.
Patients with duodenal ulcers associated with
NSAID treatment: 150mg twice daily during
2. WHAT YOU NEED TO KNOW BEFORE YOU
NSAID treatment.
TAKE RANITIDINE TABLETS
Patients with duodenal ulcers associated with
Do not take Ranitidine Tablets:
Helicobacter pylori:
If you are hypersensitive (allergic) to ranitidine
!
The usual dose of ranitidine 150mg should be
or any of the other ingredients of Ranitidine
given together with amoxicillin 750mg three times
Tablets.
daily and metronidazole 500mg three times daily
for a period of two weeks. Ranitidine should then
Warnings and precautions
be continued for two weeks.
Talk to your doctor, or pharmacist or nurse before
taking Ranitidine Tablets if you:
Patients with oesophageal reflux disease:
Suffer or have suffered in the past from severe
!
150mg twice daily or 300mg at bedtime for 8 to 12
kidney disease
weeks. The dose may be increased by your doctor.
Have a history of peptic ulcer, particularly if you
!
Ranitidine is not recommended for long term
are elderly and are taking a non-steroidal antitreatment of patients with unhealed oesophagitis.
inflammatory drug (NSAID) e.g. aspirin,
ibuprofen, naproxen, diclofenac
Patients with Zollinger-Ellison syndrome:
Are middle aged or over, with new or recently
!
Initially 150mg three times daily. The dose may be
changed indigestion symptoms e.g stomach
increased up to 6000mg daily.
pain or discomfort, heartburn - because other

Prevention of Mendelson's syndrome:
150mg two hours before induction of anaesthesia
can be given to patients at risk from acid
aspiration. An additional dose of 150mg given the
night before anaesthesia is desirable.
In obstetric patients during labour, 150mg dose
should be given at 6 hourly intervals. Patients
needing emergency anaesthesia should be given a
non-particulate antacid, while maintaining standard
precautions for the prevention of inhalation of
gastric contents.
To prevent stress ulceration (in seriously ill
patients) and to prevent ulcers from
bleeding:
When oral administration is appropriate 150mg
twice daily may be given.
Patients with kidney problems:
150mg at bedtime for 4 to 8 weeks, as a
maintenance dose, if necessary.
If the ulcer has not healed after treatment, 150mg
twice daily should be taken. If necessary, followed
by a maintenance treatment of 150mg at night.
Children 12 years and over:
For children 12 years and over after the adult
dosage is given.
Children 3 -11 years or weighing more than
30 kg:
Your doctor will work out the correct dose based on
your child's weight.
Oesophageal reflux disease: 5mg/kg to
10mg/kg/day administered in two divided doses up
to a maximum of 600mg (this is likely to apply to
heavier children or adolescents with severe
symptoms).
If you take more Ranitidine Tablets than you
should
This medicine is to be taken at regular intervals, as
determined by the doctor. If you take too many
tablets by mistake contact your nearest hospital
casualty department or tell your doctor
immediately. Take your tablet pack with you.
If you stop taking Ranitidine Tablets
You may feel better after a few days, but you
should keep taking your tablets until the prescribed
course is finished. Your symptoms may come back
if you stop your treatment too soon.
If you forget to take Ranitidine Tablets
If you have forgotten to take a dose, leave out that
dose completely. Take your next dose at the
normal time. If you have trouble remembering to
take the tablets, tell your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine Tablets can cause
side effects. Although not everybody gets them.

Check with your doctor as soon as
possible if you notice any of the
following:

Very rare (affects less than 1 in 10,000
people)
!
There can be changes in the level of
certain substances in your blood. This
can lead to you feeling unusually tired
or short of breath and being more
likely to bruise or get an infection
!
Feeling depressed, confused, seeing or
hearing unexplained things (hallucinations)
!
Headache (sometimes severe)
!
Feeling dizzy or having blurred vision
!
Your joints or muscles are painful or swollen or
you cannot control their movement
!
Your small blood vessels can become swollen
(known as vasculitis). Signs of this can include
a rash, swollen joints or kidney problems
!
Your liver can become swollen. This can lead to
nausea (feeling sick) or vomiting (being sick),
loss of appetite or generally felling unwell,
itching, fever, yellowing of the skin and eyes or
dark coloured urine
!
Flushing or marks on your skin that look like
targets
!
Unexplained hair loss
!
Impotence
!
Breast tenderness and/or breast enlargement
!
Breast discharge
!
Increase of serum creatinine in the blood
(kidney function test)
!
Changes to liver function
!
Diarrhoea.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 TABLETS
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date stated
on the label.
Do not store above 25°C. Store in the original
package.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Ranitidine Tablets contain:
Ranitidine Tablets 150mg and 300mg contain the
active substance ranitidine hydrochloride 150mg
and 300mg respectively.
The other ingredients are:- Croscarmellose
sodium, magnesium stearate, microcrystalline
cellulose, hypromellose, titanium dioxide, talc,
macrogol 6000, polymethacrylate.

Stop taking Ranitidine Tablets and see a doctor
immediately, if you notice any of the following
What Ranitidine Tablets look like and contents
serious side effects, you may need urgent
of the pack:
medical treatment:
Ranitidine 150mg Tablets: Circular biconvex, white
!
Rash, itching or hives on the skin
to yellowish film coated tablets with R1 debossed
!
Swelling of your face, lips, tongue or other
on one side.
parts of the body
Ranitidine 300mg Tablets: Oblong, white to
yellowish film coated tablets with R2 debossed on
!
Chest pain, shortness of breath, wheezing or
one side.
having trouble breathing
!
Unexplained fever and feeling faint, especially
Ranitidine 150mg and 300mg Tablets are packed
when standing up
in blister strips in pack sizes of: 7, 14, 15, 20, 21,
!
Kidney problems, which can lead to back pain,
28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 240.
fever, pain when passing urine, blood in the
Not all pack sizes may be marketed.
urine and changes in blood tests
!
Severe stomach pain, this may be a sign of a
Marketing Authorisation Holder
condition called 'pancreatitis'
Ennogen Pharma Limited
!
A slow or irregular heart beat.
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Check with your doctor at your next visit if you
Manufacture
notice any of the following:
Delta Ltd
Uncommon (affects less than 1 in 100 people)
Reykja Vikurvegi 78
!
Stomach pain
IS-220 Hafnarfjordur
!
Constipation
Iceland
!
Feeling sick (nausea).
This leaflet was last amended in October 2013
Rare (affects up to 1 in 1,000 people)
!
Skin rash.

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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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