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PACKAGE LEAFLET -INFORMATION FOR THE USER

Cimetidine 200mg Tablets

Cimetidine 400mg Tablets

Cimetidine 800mg Tablets

(Cimetidine)

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.

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

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.

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).

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).

Take special care with Cimetidine

Tablets

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.

4. POSSIBLE SIDE EFFECTS

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

•    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)

Keep out of the reach and sight of children.

Do not use your tablets after the expiry date stated on the label or carton.

Medicines should not be disposed of via waste water 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 Tablet contains?

The Active substance in your tablet is Cimetidine.

The Other ingredients are Lactose Monohydrate, Maize Starch, Magnesium Stearate (E572), Povidone K30, Sodium Starch Glycollate, Colloidal anhydrous silica, Hypromellose (E464) Titanium Dioxide (E171), Quinoline Yellow (E104), Iron Oxide Yellow (E172), Indigo Carmine (E132), Polyethylene glycol 400 (see section 2 for Important information about some of the ingredients of Cimetidine tablets).

What Cimetidine Tablet looks like and contents of the pack?

Cimetidine 200mg Tablets are pale green coloured, round, biconvex, film coated, debossed with 'CC' on one side and plain on other side.

Cimetidine 400mg Tablets are pale green coloured, capsule shaped, biconvex, film coated, debossed with 'CD' on one side and plain on other side.

Cimetidine 800mg Tablets are pale green coloured, capsule shaped, biconvex, film coated, debossed with 'CE' on one side and plain on other side.

They are available in container packs of 100, 250, 500 and 1000 tablets and are also available in blister packs of 60,120 (200mg), 30, 60 (400mg) and 30 (800mg) tablets.

(Not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last approved in 04/2016.

All these side effects should disappear when treatment is stopped.

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

Do not store above 25°C. Store in the original package. Keep the container tightly closed.

INP054

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