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CIMETIDINE TABLETS 800 MG

Active substance(s): CIMETIDINE / CIMETIDINE

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Product:

Cimetidine 200 mg &
800 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Chelonia

PL No.:

33414/0023 & 0025

Pack Size:

All Pack

Dimensions:

148 x 297 mm

Livery:

Chelonia

Created By:

Vdalvi

Manufacturer:

-

Artwork Code:

CL0023-0025/O/PIL/CL1

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
9 pt

Final Preparation Date For Submission: 20/12/2016

Packing Site Technical Approval:

Market:

UK

Component:

Leaflet

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

CIMETIDINE 200 mg TABLETS
CIMETIDINE 800 mg TABLETS

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.
- 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. This includes any side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1. What Cimetidine is and what it is used for
2. What you need to know before you take
Cimetidine
3. How to take Cimetidine
4. Possible side effects
5. How to store Cimetidine
6. Contents of the pack and other information

1. What Cimetidine is and what it is
used for
Cimetidine belongs to a group of medicines called H2
antagonists, which reduce the natural production of
acid in your stomach.
They are used to treat and relieve:
 the symptoms of peptic ulcers which occur in the
stomach or intestine (gut)
 oesophageal reflux disease which can be caused
when food and acid from the stomach washes back
into the food pipe (oesophagus). This can cause a
burning feeling in the chest known as heartburn
 a rare condition called Zollinger-Ellison syndrome
when the stomach produces very large amounts of
acid
This medicine may also be prescribed for a range of
other medicinal conditions where a reduction of acid
production in the stomach is needed, or to protect your
stomach from other medicines (such as non-steroidal
anti-inflammatories).
If you are not sure why you have been prescribed this
medicine then please ask your doctor.

2. What you need to know before
you take Cimetidine
Do not take Cimetidine if you:
 are allergic to Cimetidine or any of the other
ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor before taking Cimetidine if you:
 have kidney problems
 have a blood disease
 have had a peptic ulcer and are also taking a
non-steroidal anti-inflammatory drug (NSAID), (e.g.
ibuprofen)
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking this
medicine.
Other medicines and Cimetidine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
is because Cimetidine can affect the way some other
medicines work. Also, some medicines can affect the
way Cimetidine works.

In particular, tell your doctor or pharmacist if you are
taking any of the following medicines:
 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
such as Indometacin or Aspirin
 Phenytoin to treat epilepsy, as your doctor may
need to reduce your dose
 Medicines to stop the blood clotting such as
Warfarin, as your doctor may need to monitor you
closely
 Theophylline to treat asthma, as your doctor may
need to reduce your dose
 Lidocaine used as an anaesthetic or to treat an
irregular heartbeat
 Medicines that cause a fall in blood cell count, as
Cimetidine could make this effect worse
 Medicines to treat depression such as Amitriptyline
 Medicines to help you sleep or feel more relaxed
such as Diazepam
 Medicines to treat heart problems such as
Diltiazem, Nifedipine, Metoprolol, Propranolol or
Procainamide
 Medicines to treat diabetes such as Glipizide or
Metformin
 Medicines or treatments for tumours or cancer such
as Carmustine, Epirubicin, Fluorouracil or radiation
therapy
 Strong pain killers such as Morphine
 Medicines to treat fungal infections such as
Itraconazole, Ketoconazole or Posaconazole
 Atazanavir to treat viral infections such as HIV
 Ciclosporin or Tacrolimus used to stop the rejection
of organs after transplants
Pregnancy and breast-feeding
DO NOT take Cimetidine if you are pregnant, planning
to become pregnant or are breast-feeding, unless your
doctor has told you to.
Driving and using machines
Cimetidine should not affect your ability to drive or use
machines.
Cimetidine contains lactose
Cimetidine contains lactose (a type of sugar). 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
Always take Cimetidine exactly as your doctor or
pharmacist has told you and always read the label.
Your doctor will decide on the appropriate dose to suit
your condition. Ask your doctor or pharmacist if you
are not sure.
Taking this medicine
 swallow the tablets whole with a glass of water.
Take the tablets with meals or at bedtime as
advised by your doctor.
Adults including the elderly:
The recommended dose is 400 mg twice a day, with
breakfast and at bedtime. You doctor will tell you the
correct dose depending on your condition.
The maximum dose is 2400 mg a day.
Children above 1 year:
Your doctor will decide on the dose according to your
child’s body weight. A liquid form of this medicine can
be used in children aged above 1 year.
The usual length of treatment is at least four weeks
though this may be longer in some conditions. Your
doctor will advise you.
People with kidney problems
The dose may be lowered if you have kidney problems
as you may be more sensitive to the effects of the
medicine.

If you take more Cimetidine than you should
Contact your doctor or go to a hospital immediately.
Take the package or container with you so the doctor
knows what you have taken.

 hair loss
 fever
 joint pain
 production of breast milk

If you forget to take Cimetidine
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for
a forgotten dose.

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.

If you stop taking Cimetidine
It is important that you keep taking this medicine until
you finish the full course of treatment, unless you get
any of the side effects listed in section 4 below.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Cimetidine can cause side effects,
although not everybody gets them.
Stop taking the tablets and seek medical help
immediately if you have any of the following allergic
reactions:
 any kind of skin rash, red and raised lumps (hives),
flaking skin, boils or sore lips, swelling (of the face,
eyelids, lips, mouth or tongue), fever
 sudden wheezing, fluttering or tightness of the
chest or collapse
Seek immediate medical attention if you have any of
the following symptoms:
 fever, sore throat, ulcers in the mouth and throat,
unusual tiredness or weakness, unusual bleeding
and unexplained bruises. These may be a sign of a
blood disorder. Your doctor may wish to test your
blood
 slow or irregular heartbeats, which can cause
dizziness, light-headedness and fainting
 heart block, which can cause dizziness, tiredness,
irregular heartbeats or fainting
 stomach and back pain, fever, feeling sick (nausea)
and being sick (vomiting). These may be a sign of
an inflamed pancreas (pancreatitis)
 nausea, loss of appetite and yellowing of the skin
or whites of the eyes (jaundice). These may be a
sign of an inflamed liver (hepatitis)
 kidney problems, which may include a change in
the amount of urine passed, blood in the urine,
swollen ankles, nausea, vomiting, confusion, fever
or rash
Other Side effects:
Common (may affect up to 1 in 10 people):
 headache
 dizziness
 feeling tired
 diarrhea
 skin rash
 muscle pain
Uncommon (may affect up to 1 in 100 people):
 feeling depressed
 feeling confused. This usually stops once you stop
taking this medicine
 seeing or hearing things that are not there
(hallucinations)
 increased creatinine levels, found on blood or urine
test
 if you are a man, breast tenderness, breast
enlargement or inability to achieve or maintain an
erection (impotence). Impotence usually gets better
once you stop taking this medicine
Rare (may affect up to 1 in 1,000 people):
 abnormal liver function test results (increased
transaminase levels found on blood test)
Very rare (may affect up to 1 in 10,000 people):
 inflamed blood vessels (vasculitis), which can
cause a skin rash

5. How to store Cimetidine
Keep this medicine sight and reach of children.
Do not store above 25°C. Store in the original package
or container. Keep the container tightly closed or keep
the blister strips in the outer carton.
Do not use the tablets after the expiry date, which is
stated on the package or container. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other
information
What Cimetidine contains
The active ingredient in Cimetidine 200 mg and
800 mg tablets is cimetidine.
The other ingredients are lactose, maize starch,
povidone K30, magnesium stearate, sodium starch
glycollate, hypromellose, polyethylene glycol, titanium
dioxide (E171), quinoline yellow (E104), iron oxide
yellow (E172) and indigo carmine (E132). The 800 mg
tablets also contain colloidal anhydrous silica.
What Cimetidine looks like and contents of the
pack
Cimetidine 200 mg tablets are round, pale green
film-coated tablets with a logo engraved on one side
and CIMET 200 on the other.
Cimetidine 800 mg tablets are oblong, pale green
film-coated tablets with a logo engraved on one side
and CIMET 800 on the other.
Cimetidine 200 mg tablets come in containers of 100,
250, 500 and 1000 tablets and in blister packs of 60
and 120 tablets. Cimetidine 800 mg tablets come in
containers of 100, 250, 500 and 1000 tablets and in
blister packs of 30 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
Boumpoulinas 11, Nicosia
P.C. 1060 Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road
London SW5 9JQ
For more information about this product, please
contact the Marketing Authorisation Holder.
This leaflet was last approved in 12/2016

CL0023-0025/O/PIL/CL1

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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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