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Page 1: care codeine - .NET Framework

Codeine PhosphateCalms dry or irritating coughs

Sugar Free

Can cause addictionContains opioid

syndrome (IBS) or other bowel problems• Abdominal pain • Myasthenia gravis (a disease of

the muscles) • Underactive thyroid or adrenalgland problems (a reduced dose may berecommended by your doctor) • Gallstones or bileduct problems • Prostate problems • Problemspassing urine • Irregular heartbeat • Fits • Or youare suffering from shock • Or you are elderly, aselderly people can react differently to the medicine.See section 2.

Talk to your doctor or pharmacist if youare taking….

• MAOIs (monoamine oxidase inhibitors) fordepression, selegiline for Parkinson's Disease, orthe antibiotic linezolid, or you have taken themwithin the last two weeks • Alcohol

• Metoclopramide or domperidone for nausea andvomiting • Quinidine, or mexiletine for irregularheartbeat • Any tranquillisers, antidepressants,sedatives, painkillers, general anaesthetics,sedating antihistamines or sleeping tablets • Anymedicine for mental illness • Cimetidine forstomach ulcers • Sodium oxybate for sleepingdisorders • Rifampicin for tuberculosis.

• Muscle twitching or stiffness • Drowsiness• Disturbed sleep • Difficulty in passing water • Drymouth • Sweating • Headache • Facial flushing

• Fluid retention (e.g. swollen ankles and feet)• Abnormal heartbeat • Feeling faint when standing

up • Slow, shallow breathing • Low body heat• Hallucinations • Mood changes • Feeling restless or

confused • Pinpoint pupils or other problemswith eyesight • Abdominal pain(including paincaused by inflammation of the pancreas (pancreatitis)or bile duct problems (biliary spasm))

• Prolonged use may worsen irritable bowelsyndrome • Ureteric spasm (urine tube problemcausing abdominal or lower back pain) • Lowsexual urge • Allergic reactions such as itching anda rash • Elderly people may experience diarrhoea,stomach pain or a blocked bowel. Prolonged usemay lead to addiction, dependence and tolerance(the medicine loses its effect).

If you notice these or any other side effects, stopuse and tell your doctor or pharmacist. They will tellyou what to do.Reporting of side effectsIf you get any side effects, talk to your doctor,pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. You can also reportside effects directly via the Yellow Card Scheme at:

This medicine contains codeine phosphate, whichreduces the desire to cough.1. Before you use this medicine

Do not use the medicine if you have….• An allergy to any of the ingredients listed in

section 3.• Liver disease or severe kidney problems.• Shallow breath or breathing difficulties.• A head injury or persistent headache.• An asthma attack.• Previously had a blocked bowel • Previously had

an addiction to medicines containing Codeine orMorphine • If you know that you metabolise veryrapidly codeine into morphine • Previously had abad reaction to codeine (a known "ultra-rapidmetaboliser" of codeine) • Or are under 18 yearsold • If you are breastfeeding.

Talk to your doctor or pharmacist if youhave….

• Kidney or liver problems (a reduced dose may berecommended by your doctor) • A history ofasthma or other breathing problems, includingbronchitis • Low blood pressure • Irritable bowel

200ml

Peel

Here

IMPORTANT: Peel this labelat corner and read BEFOREuse. Do not tear off, re-fix forfuture use.

P

For the relief of unproductive dry coughs.Take the solution by mouth.Adults: Take 1 x 5ml spoonful, four times aday.The elderly: Ask your doctor for advice. Alower dose may be more suitable.Do not give to children under 18 years old.

WARNING: DO NOT EXCEED THE STATEDDOSE.

If symptoms persist consult your doctor.Peel where shown for furtherprecautions.Active ingredient per 5ml: codeinephosphate 15mg.

Also contains amongst otheringredients: ethanol, sunset yellowdye (E110), sodium methyl, ethyland propyl parahydroxybenzoates(E219, E215, E217).Peel where shown for full list ofingredients.Do not store above 25°C.Keep out of the sight and reach ofchildren.Manufactured by the licence holderThornton and Ross Ltd., Huddersfield,HD7 5QH, UK.PL 00240/0099 92767871905 PIP: 296-4633

Pregnant or breastfeeding….Codeine Oral Solution Sugar Free should not beused in pregnancy unless the doctor has told you todo so. Do not take codeine while you arebreastfeeding. Codeine and morphine passes intobreast milk.

Driving and using machines….This medicine may cause drowsiness or dizziness.If you are affected do not drive or operate machinery.The medicine can affect your ability to drive as itmay make you sleepy or dizzy.• Do not drive while taking this medicine until you

know how it affects you.• It is an offence to drive if this medicine affects your

ability to drive.• However, you would not be committing an offence if:◦ The medicine has been prescribed to treat a

medical or dental problem and◦ You have taken it according to the instructions given

by the prescriber or in the information providedwith the medicine and

◦ It was not affecting your ability to drive safely.Talk to your doctor or pharmacist if you are not surewhether it is safe for you to drive while taking thismedicine.

Important ingredient information• This product contains parahydroxybenzoates and

sunset yellow dye which may cause allergicreactions (possibly delayed).

• It contains a small amount of ethanol (alcohol),less than 100mg per 5ml.

2. Possible side effectsLike all medicines, Codeine Linctus Oral SolutionSugar Free can have side effects, although thesedon’t affect everyone.Important side effectsCodeine is transformed to morphine in the liver by anenzyme. Morphine is the substance that producespain relief. Some people have a variation of thisenzyme and this can affect people in different ways.In some people, morphine is not produced orproduced in very small quantities, and it will notprovide enough pain relief. Other people are morelikely to get serious side effects because a very highamount of morphine is produced. If you notice any ofthe following side effects, you must stop taking thismedicine and seek immediate medical advice: slow orshallow breathing, confusion, sleepiness, small pupils,feeling or being sick, constipation, lack of appetite.Other possible side effects are:• Feeling or being sick • Dizziness or vertigo• Constipation • Loss of appetite • Fits • Feeling unwell

www.mhra.gov.uk/yellowcard. By reporting sideeffects you can help provide more information on thesafety of this medicine.3. Further information

If you accidentally take too much see a doctorstraight away. Take the pack with you to show whichmedicine you have swallowed.• Do not use after the expiry date. The expiry date

refers to the last day of that month.• Return any unused medicine to the pharmacy for

disposal.The active ingredient per 5ml is: codeinephosphate 15mg.The other ingredients are: citric acid monohydrate(E330), sodium methyl, ethyl and propylparahydroxybenzoates (E219, E215, E217), ethanol,sunset yellow dye (E110), saccharin sodium,carmellose sodium, levomenthol, condensed milkflavour (contains propylene glycol), orange flavour,glycerol (E422) and purified water.What the medicine looks likeCodeine Oral Solution Sugar Free is a yellow syrupyliquid.It is supplied in 200ml bottles.Text revised: May 2019

92767871905

92767871905

LOT, MAN & EXPoverprint area

Braille reads:

c a r e c o d e i n e

no’s 1 5 m g / no’s 5 m l

o r a l s o l u t i o n

s u g a r f r e e

care codeine

åae mg åe ml

oral solution

sugar free

Datamatrix

PCP Header Box

Product Title

Component

Pack Size

IG Code

Dimensions

Proof No. DateColours Used Fonts Used

CRN

Reasonfor Change

Suffix Approved by Date

Issued by Date

Point Sizes UsedMin Max

Pharmacode

Barcode

Veri�cation

Reference Pro�le Number

BODY TEXT ONLY

Local Authoritysubmissionrequired

Landscape peelable label

200ml

1 31/05/2019Care Codeine 15mg/5ml Oral Solution Sugar Free

92767871905

65mm x 170mm

7pt 9ptHelveticaCyan

Magenta

Yellow

Black

Braille

Keyline (Non-printing)

Print free area (Non-printing)

Universal

Cirrus_Info_Box

16039

Addition of addiction warning.

Yes

B

EAN 13 5011309015614

N/A

2767871905

2767871905

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