Cimetidine 400mg Tablets
Ref: 1640/270616/1/F
• 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)
All these side effects should disappear when treatment is stopped.
6. FURTHER INFORMATION
What Cimetidine Tablets contain
• Each film-coated tablet contains 400mg of cimetidine
• The other ingredients are lactose monohydrate, maize starch, povidone K30, sodium starch glycollate (Type A), colloidal anhydrous silica, magnesium Stearate, hypromellose (E464), titanium dioxide (E171), macrogol 400, quinoline yellow aluminium lake (E104), yellow iron oxide (E172) and indigo carmine.
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
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Store in the original package.
• Do not take Cimetidine Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any other signs of deterioration consult your pharmacist who will tell you what to do.
• 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.
What Cimetidine Tablets looks like and contents of the pack
Cimetidine Tablets are green capsule-shaped, biconvex, film coated tablet debossed CD on one side and plain on the other side.
Each pack contains 60 film-coated tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, UK and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
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.
Your medicine is called Cimetidine 400mg Tablets and will be referred to as Cimetidine Tablets throughout the rest of this leaflet. Please note that this leaflet also contains information about other strengths of this medicine Cimetidine 200mg Tablets and Cimetidine 800mg Tablets.
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
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).
POM
PL 15184/1640 Cimetidine 400mg Tablets
Leaflet revision date: 27/06/16
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.
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).
Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
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.
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.”
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.
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
Ref:1640/270616/1/B