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:

•    heal and stop ulcers in the stomach, or the part it empties into, the duodenum

•    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

•    prevent ulcers from bleeding

•    improve absorption of food and reduce fluid loss in short bowel syndrome

•    reduce the breakdown of enzyme supplements, which can be taken to treat certain pancreatic problems

•    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:

•    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

•    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:

•    have kidney problems

•    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:

•    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.

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

•    swallow the tablets whole with a glass of water

•    the total daily dose should not be more than 2.4 g (2400 mg) per day

•    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:

•    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.

If you get any of the following side effects, STOP TAKING this medicine and see your doctor as soon as possible:

•    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.

Tell your doctor if you get any of these side effects:

Common (affects less than 1 in 10 people):

•    headache

•    dizziness

•    feeling tired

•    diarrhoea

•    skin rash

•    muscle pain

Uncommon (affects less than 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 (affects less than 1 in 1,000 people):

•    abnormal liver function test results (increased transaminase levels found on blood test)

Very rare (affects less than 1 in 10,000 people):

•    inflamed blood vessels (vasculitis), which can cause a skin rash

•    hair loss

•    fever

•    joint pain

•    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