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RANITIDINE TABLETS 150MG

Active substance(s): RANITIDINE / RANITIDINE HYDROCHLORIDE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

181011/8

Colours Used

Customer

Ennogen

Black

Description

Ranitidine 300-600mg Leaflet

Keyline

Market

UK

Language

English

Size

160 x 270 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

11

Date

17-06-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ranitidine Tablets 150mg and 300mg
[Ranitidine hydrochloride]
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 or nurse.
! 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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Ranitidine Tablets are and what they
are used for
2. What you need to know before you take
Ranitidine Tablets
3. How to take Ranitidine Tablets
4. Possible side effects
5. How to store Ranitidine Tablets
6. Contents of the pack and other information
1. WHAT RANITIDINE TABLETS ARE AND
WHAT THEY ARE USED FOR
Ranitidine Tablets belong to a group of medicines
called H2-receptor antagonists which act to
decrease the natural production of acid in the
stomach.
Ranitidine Tablets have been prescribed to treat
any of the following:
! Ulcers in the upper part of the intestine
(duodenal ulcer) including those associated
with infections caused by Helicobacter pylori.
! Benign stomach ulcer
! Acid from the stomach escaping into the food
pipe causing pain, inflammation and heartburn
(oesophageal reflux disease)
! Excess acid in the stomach caused by a tumor
in the pancreas (Zollinger-Ellison syndrome)
! Ulcers in the stomach or duodenum which may
be caused by non-steroidal anti-inflammatory
medicines (NSAIDs) which are used to treat
pain, fever and inflammation
! Various conditions where reduction of stomach
acid and secretions is considered beneficial
e.g. for indigestion symptoms (e.g. stomach
pain or discomfort, heartburn), which are
related to meals and disturbed sleep
! To prevent stress ulcers in seriously ill patients
! To prevent stomach ulcers from bleeding
! Before general anaesthesia, to prevent
damage to the lungs in patients at risk of
breathing in stomach fluid during surgery.
Children (3-18 years):
! Peptic ulcers
! Oesophageal reflux disease (see above)
For dosage see Section 3 How to take
Ranitidine Tablets.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RANITIDINE TABLETS
Do not take Ranitidine Tablets:
! If you are hypersensitive (allergic) to ranitidine
or any of the other ingredients of Ranitidine
Tablets.
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before
taking Ranitidine Tablets if you:
! Suffer or have suffered in the past from severe
kidney disease
! Have a history of peptic ulcer, particularly if you
are elderly and are taking a non-steroidal antiinflammatory drug (NSAID) e.g. aspirin,
ibuprofen, naproxen, diclofenac
! Are middle aged or over, with new or recently
changed indigestion symptoms e.g stomach
pain or discomfort, heartburn - because other

!
!
!
!

possible causes of your symptoms (such as
stomach cancer) should be investigated before
taking or continuing to take Ranitidine Tablets
Suffer from or have a history of porphyria
Have lung disease
Are diabetic
Have any problems with your immune system.

Other medicines and Ranitidine Tablets:
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you can
buy without a prescription and herbal medicines.
This is because Ranitidine Tablets can affect the
way some other medicines can work. Also some
other medicines can affect the way Ranitidine
Tablets work.
In particular tell your doctor or pharmacist if you
are taking any of the following medicines:
! Lidocaine, a local anaesthetic
! Propranolol, procainamide or
n-acetylprocainamide, for heart problems
! Diazepam, for worry or anxiety problems
! Phenytoin, for epilepsy
! Theophylline, for breathing problems (asthma)
! Warfarin, for thinning your blood
! Glipizide, for lowering blood glucose
! Atazanavir or delaviridine, for treating HIV
infection
! Triazolam, for insomnia
! Gefitinib, for lung cancer
! Ketoconazole, an anti-fungal medicine,
sometimes used for treating thrush.
Midazolam is a medicine that may be given to you
just before an operation. Tell the doctor you are
taking Ranitidine Tablets before your operation in
case he or she wants to give you Midazolam.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice if you are
pregnant, planning on becoming pregnant or are
breast-feeding. You should not take this medicine
unless your doctor advises it is essential.
Driving and using machines
These tablets can cause some people to feel dizzy
or drowsy. If you are affected do not drive or
operate machinery.
3. HOW TO TAKE RANITIDINE TABLETS
Always take Ranitidine Tablets exactly as your
doctor has instructed you. You should check with
your doctor or pharmacist if you are unsure.
The usual dosage is 150mg twice daily. As an
alternative, 300mg can be taken as a single dose
at bedtime.
Elderly:
The normal adult dosage may be used unless the
patient has kidney problems.
Patients with duodenal ulcers associated with
NSAID treatment: 150mg twice daily during
NSAID treatment.
Patients with duodenal ulcers associated with
Helicobacter pylori:
The usual dose of ranitidine 150mg should be
given together with amoxicillin 750mg three times
daily and metronidazole 500mg three times daily
for a period of two weeks. Ranitidine should then
be continued for two weeks.
Patients with oesophageal reflux disease:
150mg twice daily or 300mg at bedtime for 8 to 12
weeks. The dose may be increased by your doctor.
Ranitidine is not recommended for long term
treatment of patients with unhealed oesophagitis.
Patients with Zollinger-Ellison syndrome:
Initially 150mg three times daily. The dose may be
increased up to 6000mg daily.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

181011/8

Colours Used

Customer

Ennogen

Black

Description

Ranitidine 300-600mg Leaflet

Keyline

Market

UK

Language

English

Size

160 x 270 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

11

Date

17-06-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

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
30kg:
Your doctor will work out the correct dose for your
child.
Peptic ulcers: 2mg/kg to 4mg/kg twice daily to a
maximum of 300mg daily.
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.
Stop taking Ranitidine Tablets and see a doctor
immediately, if you notice any of the following
serious side effects, you may need urgent
medical treatment:
! Rash, itching or hives on the skin
! Swelling of your face, lips, tongue or other
parts of the body
! Chest pain, shortness of breath, wheezing or
having trouble breathing
! Unexplained fever and feeling faint, especially
when standing up
! Kidney problems, which can lead to back pain,
fever, pain when passing urine, blood in the
urine and changes in blood tests
! Severe stomach pain, this may be a sign of a
condition called 'pancreatitis'
! A slow or irregular heart beat.
Check with your doctor at your next visit if you
notice any of the following:
Uncommon (affects less than 1 in 100 people)
! Stomach pain
! Constipation
! Feeling sick (nausea).

Quality Control (QC)

Production

Rare (affects up to 1 in 1,000 people)
! Skin rash.
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.
What Ranitidine Tablets look like and contents
of the pack:
Ranitidine 150mg Tablets: Circular biconvex, white
to yellowish film coated tablets with R1 debossed
on one side.
Ranitidine 300mg Tablets: Oblong, white to
yellowish film coated tablets with R2 debossed on
one side.
Ranitidine 150mg and 300mg Tablets are packed
in blister strips in pack sizes of: 7, 14, 15, 20, 21,
28, 30, 56, 60, 84, 90, 100, 112, 120, 168 and 240.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last amended in June 2015

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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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