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CIMETIDINE TABLETS BP 400MG

Active substance(s): CIMETIDINE

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

Artwork No.

200614/1

Colours Used

Customer

Ennogen

Black

Description

Zabcid Leaflet

Keyline

Market

UK

Language

English

Size

160 x 290 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

2

Date

23-06-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zabcid Tablets 200mg, 400mg and 800mg
[Cimetidine]
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 Zabcid Tablets are and what they are
used for
2. What you need to know before you take
Zabcid Tablets
3. How to take Zabcid Tablets
4. Possible side effects
5. How to store Zabcid Tablets
6. Contents of the pack and other information
1. WHAT ZABCID TABLETS ARE AND WHAT
THEY ARE USED FOR
Zabcid Tablets belong to a group of medicines called
H2-receptor antagonists which act to decrease the
natural production of acid in the stomach.
Zabcid Tablets have been prescribed to treat any of
the following:
! Ulcers in the stomach (gastric ulcer) or in the
upper part of the intestine (duodenum 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
drugs (NSAIDs), often used to reduce pain, fever
and inflammation
! Various conditions where reduction of gastric
acid by cimetidine has been shown to be
beneficial e.g.
, Indigestion symptoms (e.g. stomach pain or
discomfort, heartburn)
, Meal-related upper abdominal pain
, To prevent stress ulcers from bleeding
, To be given before general anaesthesia to
prevent damage to the lungs caused by
breathing in stomach fluids (acid aspiration)
, To improve absorption of food and reduce
fluid loss in short bowel syndrome
, Reduction of breakdown of pancreatic
enzyme supplements.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ZABCID TABLETS
Do not take Zabcid Tablets:
! If you are hypersensitive (allergic) to cimetidine
or any of the other ingredients of Zabcid Tablets
(listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Zabcid Tablets if you:
! Suffer or have suffered in the past from kidney
disease
! Have a history of peptic ulcer, particularly if you
are taking a non-steroidal anti-inflammatory drug
(NSAID) e.g. aspirin, ibuprofen, naproxen,
diclofenac
! Are taking drugs or you have an illness that could
cause a fall in blood cell count
! Are middle aged or over, with new or recently
changed indigestion symptoms (e.g stomach
pain or discomfort, heartburn), then other
causes of your symptoms such as stomach
cancer, should be excluded

!

Are taking other medicines (see Section 'Other
medicines and Zabcid Tablets ').

Other medicines and Zabcid Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular tell your doctor if you are taking any of
the following:
! Anticoagulants to thin your blood e.g. warfarin
! Anticonvulsants to prevent fits e.g. phenytoin
! Bronchodilators for breathing difficulties e.g.
theophylline
! Anti-arrhythmics to slow heart rate e.g. lidocaine,
propranolol
! Antidepressants to treat anxiety e.g. diazepam
! Immunosuppressants 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)
! Antidiabetics to lower glucose
levels in the blood (e.g. metformin
or glipizide)
! Anti-cancer drugs for the treatment
of cancer or tumors (e.g. carmustine,
fluorouracil, epirubicin, or therapies
such as radiation)
! Strong pain killers (e.g. morphine)
! Antiretroviral drugs used to treat
HIV/AIDS (e.g. atazanavir)
! Tacrolimus used to treat eczema
! Medicines to treat heart problems e.g.
diltiazem, procainamide, metoprolol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice if you are
pregnant, planning on becoming pregnant or are
breast-feeding. The use of cimetidine during
pregnancy and breast-feeding should be avoided
unless considered essential by your doctor.
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 ZABCID TABLETS
Always take Zabcid Tablets exactly as your doctor
has instructed you. You should check with your
doctor or pharmacist if you are unsure.
The usual dosage is 400mg to 1600mg cimetidine
per day. Take twice a day with breakfast and at
bedtime or as directed by your doctor.
Do not take more then 2400mg cimetidine per day.
Elderly:
The normal adult dosage may be used unless you
have kidney problems.
Patients with duodenal or gastric ulceration:
A single dose of 800mg at bedtime is recommended.
Although your doctor may recommend 200mg three
times a day with meals and 400mg at bedtime.
Patients with oesophageal reflux disease:
400mg four times a day with meals and at bedtime is
recommended.
Patients with Zollinger-Ellison syndrome:
400mg four times a day with meals and at bedtime is
recommended. Higher doses may be given.

PENC 1520

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

Artwork No.

200614/1

Colours Used

Customer

Ennogen

Black

Description

Zabcid Leaflet

Keyline

Market

UK

Language

English

Size

160 x 290 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

2

Date

23-06-14

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Patients with acid aspiration:
A dose of 400mg can be given 90-120 minutes
before having a general anaesthetic or, in obstetric
practice, at the start of labour. While there is still a
risk of acid aspiration, a dose of up to 400mg may be
repeated at 4 hourly intervals, as required, up to the
usual daily maximum of 2.4g.
Prevention of bleeding from stress ulcers in seriously
ill patients:
200-400mg can be given every 4-6 hours.
Patients with kidney problems:
Doses may be reduced but your doctor will advise
you on the amount to take.
If you take more Zabcid Tablets than you should
This medicine is to be taken at regular intervals, as
determined by the physician. 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 Zabcid 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 Zabcid 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, this medicine can cause side
effects, although not everyone gets them.
Allergic reactions may occur rarely, with symptoms
such as rash, itching, swelling of the face,
wheeziness, shortness of breath, tightness in the
chest, fever, low blood pressure and feeling dizzy
particularly when standing up. If any of these occur
STOP taking the medicine and contact a doctor
immediately.
Common side effects (affects 1 to 10 users in
100):
! Headache
! Dizziness
! Diarrhoea
! Skin rashes
! Myalgia (muscle aches)
! Tiredness.
Uncommon side effects (affects 1 to 10 users in
1,000):
! Leukopenia - decrease in the number of white
blood cells
! Depression
! Confusion (usually in the elderly or seriously ill)
! Hallucinations (hearing and seeing things that
are not there)
! Tachycardia (fast heartbeat)
! Liver disorder (hepatitis) stomach and abdomen
tenderness, loss of appetite, with or without
jaundice (yellowing of the whites of the eyes and
skin)
! Breast enlargement in men (gynaecomastia) this is usually reversible when the medicine is
stopped
! Problems getting and maintaining an erection
(impotence).
Rare side effects (affects 1 to 10 users in 10,000):
! Thrombocytopenia - abnormally low number of
platelets in the blood
! Aplastic anaemia - bone marrow disorder
! Sinus bradycardia - slow heartbeat
! Increased serum transaminase levels which is
reversible when the medicine is stopped
! Kidney disorders (Interstitial nephritis with
symptoms such as blood in urine, increased or
decreased urine output, nausea and vomiting)
! Small increases in plasma creatinine have been
reported.

Quality Control (QC)

Production

Very rare side effects (affects less than 1 user in
10,000):
! Pancytopenia - blood disorder with low number
of red and white blood cells and platelets
! Agranulocytosis - blood disorders with very low
numbers of white blood cells
! Heart block - symptoms may include irregular
heartbeats
! Inflammation of the pancreas - symptoms
include stomach and back pain, nausea and
vomiting
! Hair loss -reversible after treatment has stopped
! Arthralgia - aching muscles and joints
! Galactorrhoea - leakage of a milky substance
from the breasts
! Fever.
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 ZABCID 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 Zabcid Tablets contain:
Zabcid Tablets 200, 400 and 800mg contain the
active substance cimetidine 200mg, 400mg or
800mg in each film-coated tablet respectively.
The other ingredients are: Microcrystalline cellulose
(E460), povidone 30, sodium starch glycollate,
sodium lauryl sulphate, colloidal silicon dioxide,
magnesium stearate, hydroxypropyl methylcellulose
(E464), polyethylene glycol, quinoline yellow
aluminium lake (E104), indigo carmine aluminium
lake (E132), titanium dioxide (E171) and iron oxide
yellow (E172).
What Zabcid Tablets look like and contents of the
pack
Zabcid 200mg Tablets are pale green, circular,
biconvex, film coated tablets, embossed with C1 on
one side.
Zabcid 400mg Tablets are pale green, oblong, film
coated tablets, embossed with C2 on one side.
Zabcid 800mg Tablets are pale green, oval, film
coated tablets, embossed with C3 on one side.
Zabcid 200mg Tablets are packed in cartons
containing 12, 24, 48, 60 or 120 tablets in foil blister
strips and in polypropylene tubes with pack sizes of
100, 250, 500 and 1000 tablets.
Zabcid 400mg Tablets are packed in cartons
containing 60 tablets in foil blister strips and in
polypropylene tubes with pack sizes of 100, 250, 500
and 1000 tablets.
Zabcid 800mg Tablets are packed in cartons
containing 30 tablets in foil blister strips and in
polypropylene tubes with pack sizes of 60, 100, 150,
and 250 tablets.
Not all pack sizes may be marketed.
Manufacturer and Marketing Authorisation
Holder:
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in June 2014.
Code: TN/Drugs/TN00002269

PENC 1520

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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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