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CIMETIDINE 800MG TABLETS BP

Active substance(s): CIMETIDINE

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advertising & communication services ltd.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Cimetidine 200/400/800 mg

Keyline

Market

UK

Language

English

Size

140 x 450 mm PIL

Min. Font Size

9

Version No.

7 (Page 1 of 2)

Date

08_06_16 (Cimetidine (ACC-UK)NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

PACKAGE LEAFLET –
INFORMATION FOR THE USER

Cimetidine 200mg
Tablets
Cimetidine 400mg
Tablets
Cimetidine 800mg
Tablets
(Cimetidine)
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,
ask your doctor or pharmacist.
• This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What are Cimetidine Tablets and
what are they used for
2. Before you take Cimetidine Tablets
3. How to take Cimetidine Tablets
4. Possible side effects
5. How to store Cimetidine Tablets
6. Further information

1. WHAT ARE CIMETIDINE
TABLETS AND WHAT
ARE THEY USED FOR
Cimetidine belongs to a group of
medicines called Histamine H2
receptor antagonists and is used as an
anti-ulcer drug. It works by reducing
the amount of acid in your stomach.
Cimetidine is used to treat and relieve
the following conditions:
• Ulcers in the stomach (gastric ulcer)
and in upper part of the intestine
(duodenum ulcer).
• Recurrent or stomach ulcers (ulcers
that keep coming back or which
have occurred following stomach
surgery).
• Ulcers in the stomach or duodenum
which may be caused by
non-steroidal anti-inflammatory
drugs (NSAIDs, often used to reduce
pain, fever and inflammation).
• Acid from the stomach escaping into
the food pipe causing pain,
inflammation and heartburn
(oesophageal reflux).
• Persistent heartburn and stomach
pain.
• Upper abdominal pain particularly
after meals.
• Prevention of internal bleeding from
ulcers caused by stress in seriously
ill patients.
• For patients at risk of acid inhalation
before general anaesthesia
particularly pregnant women during
labour (Mendelson's syndrome).
• Improve absorption of food and
reduce fluid loss in short bowel
syndrome.
• Reduce the breakdown of pancreatic
enzyme supplements in patients with
pancreatic problems.
• Excess acid in the stomach caused
by a tumour in the pancreas
(Zollinger- Ellison syndrome).

2. BEFORE YOU TAKE
CIMETIDINE TABLETS
Do not take cimetidine tablets:
• if you are hypersensitive (allergic) to
Cimetidine or to any of the tablet
ingredients (see section 6).
Take special care with Cimetidine
Tablets
Before taking Cimetidine Tablets,
tell your doctor if:
• you suffer from kidney problems or
from gastric cancer.
• you are suffering from liver
problems.
• you have a history of peptic ulcer,
particularly if you are taking a non
steroidal anti-inflammatory drug
(NSAIDs) e.g. aspirin, ibuprofen,
naproxen, diclofenac.
• you are middle aged or over, with
new or recently changed indigestion
symptoms (e.g. Stomach pain or
discomfort, heartburn), other causes
of your symptoms such as stomach
cancer, should be excluded.

Approved By
Quality Assurance

Taking other medicines:
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines, including those
medicines obtained without a
prescription.
In particular, tell your doctor if you are
taking any of the following:
• Anticoagulants (thin the blood) ( e.g.
warfarin)
• Anticonvulsants (prevent fits) (e.g.
phenytoin, diazepam)
• Bronchodilators (for breathing
difficulties) (e.g. theophylline)
• Immunosuppresants (to prevent
organ rejection or rheumatism) (e.g.
ciclosporin).
• Medicines that cause a fall in blood
cell count.
• Antifungals (used to treat fungal
infections) (e.g. ketoconazole,
itraconazole or posaconazole)
• Heart medicines (e.g. diltiazem,
nifedipine, lidocaine, propranolol,
metoprolol, procainamide or
quinidine)
• Antidiabetics (lowers glucose levels
in the blood) (e.g. metformin or
glipizide)
• Anti-cancer drugs (treatment of
cancer or tumor) (e.g. carmustine,
fluorouracil, epirubicin, or therapies
such as radiation)
• Strong pain killers (e.g. morphine).
• Tricyclic antidepressants (used to
treat depression) (e.g. amitriptyline).
• Antiretroviral drug (used to treat
HIV/AIDs) (e.g. atazanavir)
• Tacrolimus for eczema
Pregnancy and breast-feeding
It is preferable to avoid the use of
Cimetidine Tablets during pregnancy
unless it is essential. Tell your doctor if
you are pregnant or planning to
become pregnant.
Do not take Cimetidine Tablets during
breast feeding because cimetidine is
excreted in breast milk and can be
harmful for your child.
Ask your doctor or pharmacist for
advice before taking any other
medicine.
Driving and using machines
Cimetidine tablets will not affect your
ability to drive or to use machinery.
Important information about some
of the ingredients of Cimetidine
Tablets:
Cimetidine Tablet contains Lactose
monohydrate – If you have been told
by your doctor that you have an
intolerance to some sugars, contact
your doctor before taking this
medicine.

3. HOW TO TAKE
CIMETIDINE TABLETS
Always take Cimetidine Tablets
exactly as your doctor has told you.
You should check with your doctor
or pharmacist if you are not sure.
For oral administration only.
The maximum daily dose of 2.4g (i.e.
2,400mg) should not be exceeded.
Dosage should be reduced in patients
with kidney problems. Treatment
should be given for at least 4 weeks
(duodenal ulceration), 6 weeks (benign
gastric ulceration) and 8 weeks (ulcer
associated with continued non
steroidal anti-inflammatory drug). If the
ulcer has not healed, your doctor may
recommend another course.
Adults:
(Usual dose)
The usual dose is 400mg twice a day
at breakfast and at bedtime or one
200mg tablet three times a day with
meals followed by 400mg at bedtime.
If inadequate 400mg four times a day
with meals and at bedtime.
Your doctor will decide the right dose
for you, depending on your condition.
Elderly:
As per adults dosage, unless you have
serious kidney problems.
Children over 1 year of age:
“Your doctor will decide the right dose,
depending on your child’s weight.”

advertising & communication services ltd.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Cimetidine 200/400/800 mg

Keyline

Market

UK

Language

English

Size

140 x 450 mm PIL

Min. Font Size

9

Version No.

7 (Page 2 of 2)

Date

08_06_16 (Cimetidine (ACC-UK)NEW-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

If you take more Cimetidine tablets
than you should
If you or someone else swallows
several of these tablets all together, or
you think a child has swallowed any of
these tablets, contact your doctor or
pharmacist or hospital emergency
department immediately. Always take
any tablets left over with you, also the
box and leaflet as this will allow easier
identification of the tablets.
If you forget to take Cimetidine
tablets
If you forget to take a dose, take it as
soon as you remember. If it is almost
time for your next dose, do not take
the missed dose and just carry on as
before. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, cimetidine can
cause side-effects, although not
everybody gets them.
Very rarely allergic reactions might
occur. If any of the following symptoms
occur soon after taking your tablets,
stop taking your tablets and tell your
doctor immediately.
• Rash
• itching or hives on the skin
• swelling of the face, or other parts of
the body
• shortness of breath, wheezing or
trouble breathing.
Some male patients may notice
enlarging of the breasts. Very rarely
male or female patients may
experience unexpected secretion of
breast milk. Contact your doctor if
these occurs.
The most common side effects are
diarrhoea, headache, dizziness, rash
or tiredness, muscle pain, joint pain,
which are usually mild and do not last
long.
Other effects occurring rarely are:
• hair loss
• mouth ulcers, infections of the throat
• fever
• kidney problems (symptoms may
include changes in the amount of
urine passed and its colour, nausea,
vomiting, confusion, fever and rash)
• confusion (usually in the elderly or ill
patients)
• A rare type of anaemia in which the
red and white blood cells and
platelets are all reduced in number
(symptoms might include tiredness,
being short of breath, looking pale,
frequent infections, bruising more
easily or nose bleeds)
• liver inflammation, which might
cause one of the following: nausea
(feeling sick), vomiting (being sick),
loss of appetite, feeling generally
unwell, fever, itching, yellowing of
the skin and eyes and dark coloured
urine
• slowing of heartbeat, irregular
heartbeat or fainting
• trouble getting or keeping an
erection (impotence)
• feelings of sadness, depression
• hallucinations seeing/feeling/hearing things that
are not there.
• inflammation of the pancreas
(sudden onset of abdominal pain,
nausea and vomiting)

Approved By
Quality Assurance

Keep out of the reach and sight of
children.
Do not use your tablets after the expiry
date stated on the label or carton.
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 will help to protect the
environment.

6. FURTHER INFORMATION
What Cimetidine Tablet contains?
The Active substance in your tablet is
Cimetidine.
The Other ingredients are Lactose
Monohydrate, Maize Starch,
Magnesium Stearate (E572), Povidone
K30, Sodium Starch Glycollate,
Colloidal anhydrous silica,
Hypromellose (E464) Titanium Dioxide
(E171), Quinoline Yellow (E104), Iron
Oxide Yellow (E172), Indigo Carmine
(E132), Polyethylene glycol 400 (see
section 2 for Important information
about some of the ingredients of
Cimetidine tablets).
What Cimetidine Tablet looks like
and contents of the pack?
Cimetidine 200mg Tablets are pale
green coloured, round, biconvex, film
coated, debossed with 'CC' on one
side and plain on other side.
Cimetidine 400mg Tablets are pale
green coloured, capsule shaped,
biconvex, film coated, debossed with
'CD' on one side and plain on other
side.
Cimetidine 800mg Tablets are pale
green coloured, capsule shaped,
biconvex, film coated, debossed with
'CE' on one side and plain on other
side.
They are available in container packs
of 100, 250, 500 and 1000 tablets and
are also available in blister packs of
60,120 (200mg), 30, 60 (400mg) and
30 (800mg) tablets.
(Not all pack sizes may be marketed).
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
This leaflet was last approved in
04/2016.

All these side effects should disappear
when treatment is stopped.
Reporting of side effects
If you get any 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
CIMETIDINE TABLETS
Do not store above 25°C. Store in the
original package. Keep the container
tightly closed.
INP054
10 00000 0 000000

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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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