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CIMETIDINE TABLETS 400MG

Active substance(s): CIMETIDINE

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CP.CMT.JNT.T.DX.V1P2

CIMETIDINE TABLETS 200mg
CIMETIDINE TABLETS 400mg
CIMETIDINE TABLETS 800mg
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 further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What CIMETIDINE TABLETS are and what they are used for
2. Before you take CIMETIDINE TABLETS
3. How to take CIMETIDINE TABLETS
4. Possible side effects
5. Storing CIMETIDINE TABLETS
6. Further information
1. WHAT CIMETIDINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Cimetidine Tablets 200mg, 400mg or 800mg (referred to as
Cimetidine Tablets throughout this leaflet).
Cimetidine Tablets belong to a group of medicines called H2-receptor antagonists which act
to decrease the natural production of acid in the stomach.
Cimetidine 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);
• Recurrent and stomal ulceration;
• Ulcers in the stomach or duodenum which may be caused by non-steroidal antiinflammatory 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 disease);
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Elison syndrome);
• 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. BEFORE YOU TAKE CIMETIDINE TABLETS
Do not take Cimetidine Tablets
- If you are hypersensitive (allergic) to cimetidine or any of the other ingredients of
Cimetidine Tablets.
Take special care with Cimetidine Tablets
Consult your doctor before taking Cimetidine Tablets:
- If you suffer or have suffered in the past from kidney or liver disease.
- If you have a history of peptic ulcer, particularly if you are taking a non-steroidal antiinflammatory drug (NSAID) e.g.: aspirin, ibuprofen, naproxen, diclofenac.
- If you are taking drugs or you have an illness that could cause a fall in blood cell count.
- If 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.
Pregnancy
Ask your doctor for advice before taking Cimetidine Tablets if you are pregnant or trying to
become pregnant.
Breast-feeding
Ask your doctor for advice before taking Cimetidine Tablets if you are breast-feeding.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those not prescribed.
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
- Immunodepressants (to prevent transplant rejection) e.g. ciclosporin
Cimetidine may worsen the fall in blood count which some medicines can cause. Check
with your doctor or pharmacist if this applies to any medicines you may be taking.

3. HOW TO TAKE CIMETIDINE TABLETS
Always take Cimetidine 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, in divided doses. Do not take
more than 2400mg cimetidine per day. If you suffer from kidney or liver problems, you may
require a lower dose. The usual duration of treatment is 4-8 weeks.
Dosage and duration of treatment depend upon the symptoms treated, and their severity.
Read the label for the dosage your doctor has prescribed for you.
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.
The tablets should be taken with meals and at bedtime and swallowed whole with a glass of
water. Unless specifically directed by your physician, do not halve these film-coated tablets.
If you take more Cimetidine 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, any side effects (see below) may be worse than usual – in this
case, see your doctor.
In the event of an accidental overdose, contact your nearest hospital casualty department or
tell your doctor immediately. Take your tablet pack with you.
If you forget to take Cimetidine 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, Cimetidine Tablets can cause side effects, although not everybody 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.
If you suffer from the following side effects inform your doctor:
Side effects that have been reported: diarrhoea, dizziness, skin rash, tiredness, breast
enlargement in men, hair loss and confusion.
Infrequent: depression.
Rare side effects are:
• hallucinations
• liver disorders [characterized mainly by stomach and abdominal tenderness, loss of
appetite with or without jaundice (yellowing of the skin and whites of the eyes)]
• blood disorders (characterized mainly by sore throat, ulcers in the mouth and throat,
unusual tiredness or weakness, unusual bleeding and unexplained bruises)
Very rare side effects are:
• kidney disorders (including symptoms such as: blood in the urine, increased or
decreased urine output, nausea, vomiting)
• inflammation of the pancreas (stomach and back pain, nausea and vomiting)
• headache
• aching muscles and/or joints
• heart effects (irregular, slow or fast heart beats)
• impotence
Many of the above mentioned side effects should disappear when treatment is stopped.
Tell your doctor if you have any other unwanted effects not mentioned above.
5. STORING CIMETIDINE TABLETS
Check the expiry date printed on the label. Do not use after the expiry date stated on the
label.
Do not store above 25oC.
In case of any visible signs of deterioration, you should discard the package.
Keep out of the reach and sight of children.
6. FURTHER INFORMATION
What Cimetidine Tablets contain
Cimetidine Tablets 200, 400 & 800mg contain the active substance cimetidine 200mg,
400mg or 800mg in each film-coated tablet respectively.
The other ingredients are: Microcrystalline cellulose, Sodium starch glycollate, Povidone,
Maize starch, Hypromellose, Magnesium stearate, Titanium dioxide (E171), Sodium lauryl
sulphate, Macrogol 400, Yellow lake (E104), Blue lake (E132) and Carnauba wax.
What Cimetidine Tablets look like and contents of the pack
Cimetidine Tablets 200mg are greenish-yellow, film-coated round tablets.
Cimetidine Tablets 400mg are greenish-yellow, film-coated capsule shaped tablets.
Cimetidine Tablets 800mg are greenish-yellow, film-coated oval shaped tablets.
Cimetidine Tablets are packed in cartons containing 56, 60 or 120 tablets for the 200mg
dosage, 30, 56 or 60 tablets for the 400mg dosage, or 30 or 28 tablets for the 800mg
dosage, in foil blister strips.
Marketing Authorization Holder/Manufacturer:
Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire,
NN11 8PB, UK
Distributed By:
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT
This leaflet was last revised in May 2012.
CP.CMT.JNT.T.DX.V1P2

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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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