Patient leaflet - Cimetidine tablets 400 mg
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. Your doctor will tell you the correct dose depending on your condition. The maximum dose is 2400 mg a day.
Children over 1 year of age:
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.
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.
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
- hair loss
- fever
- joint pain
- production of breast milk
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 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
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 400 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).
What Cimetidine looks like and contents of the pack
Cimetidine 400 mg tablets are capsule shaped, pale green film-coated tablets with the Chatfield logo engraved on one side and CIMET 400 on the other. The tablets come in blister packs and containers of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia
P.C. 1060 Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road
London SW5 9JQ, UK
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 12/2016
CL0141/O/PIL/CL2