Tagamet 800 mg Tablets

Cimetidine

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5. Possible side effects

^{6 H}ow to store

Read all of this leaflet carefully before you start using 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before; you take ². How to talee

4.    Rossitole side effects

5.    How to store

6.    ^Rurther information

2. What this medicine is and what it is used for

Tagamet tablets contain cimetidine which is a histamine H2 antagonist. it helps ta reduce the natural production of acid in the stomach.

They are used to treat and relieve:

•    the symptoms of peptic ulcers which occur in the stomach or intestine tgut)

•    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 medical 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).

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^tt^rr^ee^aa^tt ^tt^uu^mm^oo^uu^rr^ss ^oo^rr ^cc^aaⁿn^cc^ee^rr ⁽(^ee^..^gg^.. ^cc^aa^rr^mm^uu^ss^ttⁱiⁿn^ee^,, ^ff^ll^uu^oo^rr^oo^uu^rr^aa^ccⁱi^ll^,, ^ee^ppⁱi^rr^uu^bbⁱi^ccⁱiⁿn⁾)^,, ^oo^rr ⁱi^ff ^yy^oo^uu ^aa^rr^ee ^hh^aa^vvⁱiⁿn^gg ^rr^aa^ddⁱi^aa^ttⁱi^ooⁿn ^tt^hh^ee^rr^aa^pp^yy^.. Pregnancy and breast-feeding

DO NOT take Tagamet if you are pregnant, planning to become pregnant or breast-feeding unless advised to by your doctor. Ask your doctor for advice before taking any medicine.

Driving and using machines

Tagamet tablets are unlikely to affect your ability to operate machinery or to drive.

Important information about some of the ingredients of Tagamet tablets • sodium

The sodium content per tablet is:

800 mg tablet - 1.5 mg

This should be fatem into consideration by patients on a controlled sodium diet.

3. Howtofcake

2. Before you take

Do NOT take Tagamet tablets if you:

•    are allergic to cimetidine or to any of the other ingredients (see Section 6).

If this applies to you, speak to your doctor or pharmacist.

Take special care with Tagamet tablets

Before taking the tablets, tell your doctor if you:

•    have a kidney problem

•    have a blood disease

•    have had a peptic ulcer and are also taking a non-steroidal anti-inflammatory drug (NSAID), (e.g. ibuprofen)

•    are pregnant or planning a pregnancy

•    are breast-feeding.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have

recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.

Some medicines may be affected by Tagamet or they may affect how well Tagamet will work. Tell your doctor or pharmacist if you

are taking medicines which:

•    control epilepsy (e.g. phenytoin). Your doctor will monitor you

•    thin the blood (e.g. warfarin). Your doctor will monitor you

•    treat breathing problems (e.g. theophylline)

•    may cause your blood cell count to change (e.g. antibiotics)

•    treat fungal (yeast) infections (e.g. ketoconazole, itraconazole, posaconazole)

•    treat diabetes (e.g. glipizide, metformin)

•    treat anxiety (e.g. diazepam)

•    treat depression, called tricyclic antidepressants (e.g. amitriptylline)

•    lower blood pressure or treat heart conditions (e.g. metoprolol, propranolol, nifedipine, diltiazem, procainamide)

•    numb the body such as anaesthetics used in hospital (e.g. lidocaine)

•    are strong pain relievers (e.g.morphine)

^4^^aE^aauEu tablets exactly as your doctor 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 suro.

p Swallow the tablets whole with a dr i nk of water. Take rhe tablets with meals ot at bedtime as advised by your doctor.

Doses

Adults and the elderly: the usual dose is 400 mg twice a day w^Di^oth^seb^sreakfast, and at bedtime.

Your doctor wN l teN you the corrust doso depending o n yoer cowdition.

The ruae.mum dose is 2400 mg a day.

Children: your doctor will decide on the dose according to your child's body weight.

The usual length of treatmentis atleast fourweeks though th is may tue longerin so me conditions. Your doctor will advise you.

Ifyou take more than you should

1.    Tell your doctor, pharmacist or nearest hospital casualty department immediately.

2.    Take the contain er and any remaining tablets with you so that people cmn see what you have taken.

3.    IDo this even f you feel well.

If yo u forget to take

If you forget to take a dose take it as soon as you remember, but if if is almost t ime for your next dose, skip the missed dose and contin ue as usuat

Do not use a doable dose to make up for a missed dose.

If you stop taking

If you stop your treatment too soon, your symptoms may come back.

You m ay feel better alter a few days, but you should keep tolling your medicine until the prescribed course is finished.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Continued over page

Like all medicines, Tagamet tablets can cause side effects, although not everybody gets them. Do not be alarmed ^by tote Mst of possible side effects. 'You may not experience any o^f them.

S^{TOp t}a^kin^g t^he facets arte seek me^dica^{l h}e^{lp i}mmediald^{y if}

^you ^have an^y o^f t^he ^foNowto^g aNer^gic reachons:

•    ^diffⁱcu^lt^{y b}reat^hin^g or swaNowto^g, sweNto^g o^f t^he ^face, N^ps, tongue or throat

•    severe ⁱtc^hin^g o^f t^he stem wfa a re^d ras^h or rateed ^lum^ps.

^Seek ⁱmme^dia^te me^dica^l attenhon ^{if y}ou ^have an^y o^f t^he

following symptoms:

•    unusua^{l bl}ee^din^g or ^bruteto^g; or fevep sore t^hroat^, mout^h ulcers, repeated infections or infections that will not go away. This may be due to changes in your blood

•    red spots on the skin which may be painful to touch, joint pain, swollen lymph glands

•    yellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to liver changes

•    confusion, hallucinations, depression

•    in men: enlarged breasts, trouble getting or keeping an erection

•    unexpected secretion of breast milk in men or women

•    pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of the pancreas

unusually slow or fast heartbeat, irregular heartbeat and fainting

•    fever, rash, nausea, aches and pains, change in colour of urine, passing more or less urine than usual or passing urine at night. These problems may indicate kidney changes

•    aching or weak muscles, or aching joints.

Tell your doctor if you get any of the following side effects:

•    diarrhoea

•    dizziness

•    tiredness

•    m.l^d skin rash _h^me^ila^dd^sa^kcⁱhⁿe^rash

•    fa^osh.

Side effects with Tagamet tablets are usually mild and do not last _lS_oi_nd_ge_. effects with Tagamet tablets are usually mild and do not last

Reporting of side effects

If any oet ans sid e effectSe talk to your doctor, pharmaciet or nurs e.This indudes any nossidle si de (affects notNsted 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 00 the safety of this medicine.

•    Keep out of the reach and sight of children.

• Do no^t take after the expiry (fate which is steted on the bNsters and on the carton. The expiry date refers to the ^las^t da^y o^f that m onto.

• Do no^t store above 25°C. Store in toe original pac^ka^ge.

•    Do no^t throw ⁱt away with your household waste or in water. Return all the unwanted medicine to ^your pharmactet ^This wNl help to protect the environment

6. Further information

WanrTagametTrelets sontain

•    The active ingredient is cimetidine (800 mg).

•    The other ingredients are:

microcrystalline cellulose, povidone K30, sodium starch glycollate, sodium laurilsulfate, colloidal anhydrous silica, magnesium stearate, macrogol 400, hypromellose, and the colours titanium dioxide, quinoline yellow aluminium lake, indigo carmine aluminium lake and iron oxide yellow.

(See end of Section 2 for further information on sodium).

WTat    tooa like and contents o^f toe pack

•    ^Ta^gemet i300 mg Tabtets are pate green,oval film-coated rabtets, marired with Tagamet' pn one side and '800' on the revetse. ^They are avaNable to pac^ks o^{f 6}8, 3°, 60, 100, 15² or a0O._i^t

•    Not all pac⁴ sizes may be marketed.

Marveting Autoorisation Holder

Chemidex Pharma Ltd, Chemidex House,

Egham Business Village, Crabt ree Road,

Egnam, 55 urrekTW20 8RB.

ManufactuTer

Cloimel Healthcare Ltd, Waterford Road, Clonmel,

Co.Tipperary, Irela nd.

This leafle t was last revised in

June 2015

'Tagamet' and 'Chemidex' are trade marks.

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