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CIMETIDINE TABLETS 800 MG

Active substance(s): CIMETIDINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CIMETIDINE 200 mg &
800 mg TABLETS
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 become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS
1. What Cimetidine is for
2. Before you take Cimetidine
3. How to take Cimetidine
4. Possible side effects
5. How to store Cimetidine
6. Further information

1. WHAT CIMETIDINE IS FOR
Cimetidine belongs to a group of medicines called H2
antagonists, which reduce the amount of acid in your
stomach.
This medicine is used to:
z heal and stop ulcers in the stomach, or the part it
empties into, the duodenum
z heal and stop problems caused by acid in the gullet
(oesophagus) or too much acid in the stomach.
This can cause pain or discomfort known as
indigestion or heartburn
z prevent ulcers from bleeding
z improve absorption of food and reduce fluid loss in
short bowel syndrome
z reduce the breakdown of enzyme supplements,
which can be taken to treat certain pancreatic
problems
z be given before an operation to prevent acid
coming up from the stomach whilst under
anaesthetic.
If you are not sure why you have been prescribed this
medicine then please ask your doctor.

2. BEFORE YOU TAKE CIMETIDINE
Do not take Cimetidine and tell your doctor if you:
z are allergic to Cimetidine or any of the other
ingredients in the tablets (listed in section 6 of this
leaflet). The signs of an allergic reaction include a
rash, itching or shortness of breath
z are pregnant, planning to become pregnant or are
breast-feeding.
Take special care with Cimetidine
Tell your doctor before you take this medicine if you:
z have kidney problems
z have lost weight recently and also have stomach
ache, stomach pain or indigestion at the same
time, particularly if you are over 40.
You should see your doctor regularly especially if you
are taking Cimetidine as well as medicines called
Non-Steroidal Anti-Inflammatory Drugs (often used to
treat arthritis). This is particularly important in the
elderly or those with a history of ulcers.
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking this
medicine.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, even medicines
bought without a prescription. 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:
z Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
such as Indometacin or Aspirin
z Phenytoin to treat epilepsy, as your doctor may
need to reduce your dose
z Medicines to stop the blood clotting such as
Warfarin, as your doctor may need to monitor you
closely
z Theophylline to treat asthma, as your doctor may
need to reduce your dose
z Lidocaine used as an anaesthetic or to treat an
irregular heartbeat
z Medicines that cause a fall in blood cell count, as
Cimetidine could make this effect worse
z Medicines to treat depression such as Amitriptyline
z Medicines to help you sleep or feel more relaxed
such as Diazepam
z Medicines to treat heart problems such as
Diltiazem, Nifedipine, Metoprolol, Propranolol or
Procainamide
z Medicines to treat diabetes such as Glipizide or
Metformin
z Medicines or treatments for tumours or cancer
such as Carmustine, Epirubicin, Fluorouracil or
radiation therapy
z Strong pain killers such as Morphine
z Medicines to treat fungal infections such as
Itraconazole, Ketoconazole or Posaconazole
z Atazanavir to treat viral infections such as HIV
z 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.
Important information about some of the
ingredients of Cimetidine
Cimetidine 200 mg and 800 mg tablets contain lactose
(a type of sugar). If you know 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 to.
Taking this medicine
z swallow the tablets whole with a glass of water
z the total daily dose should not be more than 2.4 g
(2400 mg) per day
z the usual length of treatment is 4 weeks.
Adults including the elderly:
The usual dose is 400 mg at breakfast and at bedtime.
This may be altered by your doctor depending upon
what this medicine is being prescribed for.
Children above 1 year old:
If prescribed for a child, the dosage depends on the
child's weight. Make sure the child takes the medicine
as the doctor says.
The usual dose is 25-30 mg per kg bodyweight per day
in divided doses.

Infants under 1 year old:
The doctor will decide if the medicine is suitable for the
infant. Follow the doctor's advice.
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.
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
the one you have missed.
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.
If you have an allergic reaction to this medicine see
a doctor immediately.
An allergic reaction may include:
z 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
z sudden wheezing, fluttering or tightness of the
chest or collapse.
If you get any of the following side effects, STOP
TAKING this medicine and see your doctor as soon
as possible:
z 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
z slow or irregular heartbeats, which can cause
dizziness, light-headedness and fainting
z heart block, which can cause dizziness, tiredness,
irregular heartbeats or fainting
z stomach and back pain, fever, feeling sick (nausea)
and being sick (vomiting). These may be a sign of
an inflamed pancreas (pancreatitis)
z 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)
z 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.
Tell your doctor if you get any of these side effects:
Common (affects less than 1 in 10 people):
z headache
z dizziness
z feeling tired
z diarrhoea
z skin rash
z muscle pain
Uncommon (affects less than 1 in 100 people):
z feeling depressed
z feeling confused. This usually stops once you stop
taking this medicine
z seeing or hearing things that are not there
(hallucinations)
z increased creatinine levels, found on blood or urine
test

z 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 (affects less than 1 in 1,000 people):
z abnormal liver function test results (increased
transaminase levels found on blood test)
Very rare (affects less than 1 in 10,000 people):
z inflamed blood vessels (vasculitis), which can
cause a skin rash
z hair loss
z fever
z joint pain
z production of breast milk
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE CIMETIDINE
Keep out of the reach and sight 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.
Medicines should not be disposed of via wastewater
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 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, 3rd Floor
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
10/2012


CIM0023&0025/0200&0800F/LEA003




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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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