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CO-CODAMOL 30MG/500MG EFFERVESCENT TABLETS

Active substance(s): CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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Laetus

PACKAGE LEAFLET: INFORMATION FOR THE USER

Laetus

or

No.

Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie;
e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. How To Store Co-codamol Effervescent Tablets
• Keep this medicine out of the sight and reach of children.
• Do not use Co-codamol Effervescent Tablets after the expiry date which is
stated on the carton and the blister. The expiry date refers to the last day of
that month.
• Do not store above 25oC. Keep the tubes tightly closed in order to protect
from moisture.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the
environment.
6. Further Information
What Co-codamol Effervescent Tablets contain:
• The active substances are codeine phosphate hemihydrate 30mg and
paracetamol 500mg.
• The other ingredients are sodium hydrogen carbonate, sodium carbonate
anhydrous, citric acid anhydrous, sodium docusate, sorbitol, saccharin
sodium, dimeticone, sodium benzoate, macrogol 6000 and spray-dried natural
grapefruit flavour.
What Co-codamol Effervescent Tablets look like and contents of the pack:
Co-codamol Effervescent tablets are white circular tablets with a score line on one
face, although your tablets are scored they must not be halved as they will not give
an equal dose.
Co-codamol Effervescent tablets are available in aluminium: polyethylene foils
strips packs of 100 effervescent tablets (25 strips of 4 tablets) or in
polypropylene tubes.
Each tube contains 16 tablets and 6 tubes are packed in cardboard containers to
give a pack size of 96 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London, EC4N 7BL, UK
Manufactured By:
Unither Industries,
ZI du Malcourlet, 03800 Gannat, France.
This leaflet was last revised in July 2014.
101777/LF/4

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Co-codamol 30mg/500mg
Effervescent Tablets

No.

Laetus

United Kingdom
The Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

No.

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 (see details below)

Codeine phosphate hemihydrate/Paracetamol

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.

The name of your medicine is Co-codamol 30mg/500mg Effervescent Tablets. It will
be referred to as Co-codamol Effervescent Tablets for ease hereafter.
In this leaflet:
1. What Co-codamol Effervescent Tablets are and what they are used for
2. Before you take Co-codamol Effervescent Tablets
3. How to take Co-codamol Effervescent Tablets
4. Possible side effects
5. How to store Co-codamol Effervescent Tablets
6. Further information
1. What Co-codamol Effervescent Tablets Are And
What They Are Used For
Co-codamol Effervescent Tablets contain paracetamol and codeine. Paracetamol is an
analgesic (relieves pain) and an antipyretic (lowers raised temperatures). This product
contains codeine. Codeine belongs to a group of medicines called opioid analgesics
which act to relieve pain.
Co-codamol Effervescent Tablets are used in adults for the relief of mild to severe
short term pain.
Co-codamol can be used in adults for the short-term relief of moderate pain that is
not relieved by other painkillers such as paracetamol or ibuprofen alone.
2. Before You Take Co-codamol Effervescent Tablets
Do not take with any other paracetamol-containing products. Do not take for longer
than directed by your prescriber. Do not use Co-codamol for pain relief in children
and adolescents (0-18 years of age) after removal of their tonsils or adenoids as
Codeine in Co-codamol may cause obstructive sleep apnoea syndrome (sleep
disruption due to respiratory pauses). Taking codeine regularly for a long time can
lead to addiction, which might cause you to feel restless and irritable when you
stop the tablets. Taking a painkiller for headaches too often or for too long can
make them worse.
Do not take Co-codamol Effervescent Tablets if:
• you know that you are allergic to paracetamol or codeine, or any of the other
ingredients (refer to section 6 below)
• you suffer from breathing problems, for example chronic bronchitis or
emphysema or are suffering an asthma attack
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them
within the last two weeks. MAOIs, such as phenelzine, moclobemide or
isocarboxazid are medicines used to treat depression
• you have just had a head injury or suffer from increased pressure on the brain
• you have severe problems with your kidneys or liver
• you know that you metabolise very rapidly codeine into morphine
• you are breast feeding
• you drink a lot of alcohol
• you have recently had an operation to your gall bladder.
Co-codamol Effervescent Tablets should not be taken by children under 18 years
of age.
Take special care and tell your doctor or pharmacist before taking Co-codamol
Effervescent Tablets if:
• you have any stomach pains or other sudden problems in your abdomen (belly)
• you are elderly
• you have liver or kidney problems, because the dose might need to be lower
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• your prostate is larger than normal or you have a narrowing of your urethra
(tube through which urine is passed)
• you feel you have taken Co-codamol Effervescent Tablets for a long time. You
may develop a dependence on Co-codamol Effervescent Tablets which may
be harmful.
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the
substance that produces pain relief. Some people have a variation of this enzyme
and this can affect people in different ways. In some people, morphine is not
produced or produced in very small quantities, and it will not provide enough pain
relief. Other people are more likely to get serious side effects because a very high
amount of morphine is produced. If you notice any of the following side effects,
you must should stop taking this medicine and seek immediate medical advice:
slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being
sick, constipation, lack of appetite.
Warnings and precautions Children and adolescents
Use in children and adolescents after surgery
Codeine must not be used for pain relief in children and adolescents after removal
of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome (sleep
disruption due to respiratory pauses). Codeine is not recommended in children
with breathing problems, since the symptoms of morphine toxicity may be worse
in these children.
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. Some
medicines interact with each other and this can alter their effect. It is particularly
important to tell your doctor or pharmacist if you are taking the following
medicines:
• Medicines to treat depression such as amitriptyline, fluoxetine, sertraline etc.
• Medicines used to treat high blood pressure such as furosemide, amiloride or
bendroflumethazide
• MAOIs used to treat depression, taken within the last 14 days (refer to “do not
take if” in section 2 above)
• Medicines to treat mental illness, e.g. chlorpromazine, haloperidol etc
• Sedatives and sleeping tablets, e.g. temazepam and diazepam
• Medicines for irregular heart beats (mexiletine, quinine or quinidine)
• Drugs used to dry fluids in the mouth and lungs known as anticholinergics
• Medicines to treat diarrhoea or sickness (metoclopramide, domperidone)
• Medicines to treat epilepsy (e.g. phenytoin and carbamazepine)
• Colestyramine, used to treat high levels of lipids in your blood, or for problems
related to your bile duct
• Ritonavir, used to treat HIV
• Other strong painkillers called opioids
• Medicines which prevent blood clotting (anticoagulants such as warfarin).
Some products which can be bought without a prescription may contain
paracetamol or codeine, so always check the labels for ingredients.
Taking Co-codamol Effervescent Tablets with food and drink:
Do not drink alcohol whilst taking Co-codamol Effervescent Tablets.
Pregnancy and breast-feeding:
If you are pregnant, think you may be pregnant or are planning to become pregnant
speak to your doctor or pharmacist before taking this medicine. Co-codamol
Effervescent Tablets should not be used during pregnancy as they can affect the
baby and can cause breathing problems when the baby is born. Do not take codeine
while you are breast feeding. Codeine and morphine passes into breast milk.
Driving and using machines:
Co-codamol Effervescent Tablets may cause dizziness or drowsiness and you
should not drive or operate machinery if you are affected this way. Codeine may
disturb your vision.
This medicine can affect your ability to drive. Do not drive whilst taking this
medicine until you know how this medicine affects you. It may be an offence to
drive if your ability to drive safely is affected.
There is further information for patients who are intending to drive in Great Britain go to https://www.gov.uk/drug-driving-law
Important information about some of the ingredients of Co-codamol Effervescent
Tablets:
This medicine contains sorbitol (487mg per tablet), which is a sugar. If you have
been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
This medicine contains 413 mg sodium in each tablet. This should be taken into
consideration by patients on a controlled sodium (salt) diet.

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3. How To Take Co-codamol Effervescent Tablets
Always take Co-codamol Effervescent Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Taking the tablets:
The tablets must be put in a glass of water and allowed to completely dissolve.
Drink the resulting solution immediately. Do not chew or bite your tablets.
Dose:
The usual dosage is one or two tablets every six hours as needed. You should not
take more than 8 tablets in 24 hours. If you feel the effect of Co-codamol
Effervescent Tablets is too strong or too weak, speak to your doctor or pharmacist.
This medicine should not be taken for more than 3 days. If the pain does not

improve after 3 days, talk to your doctor for advice.
A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Co-codamol Effervescent Tablets are not recommended for children under 18
years.
Do not take with any other paracetamol-containing products.
If you take more Co-codamol Effervescent Tablets than you should:
Immediate medical advice should be sought in the event of an overdose, even if
you feel well, because of the risk of delayed, serious liver damage. Bring the
remaining tablets and this leaflet with you so that the medical staff know what you
have taken.
If you forget to take Co-codamol Effervescent Tablets:
Do not take more than one dose at a time. If you forget to take a dose then take
your next dose at the usual time. Never take two doses at the same time.
If you stop taking Co-codamol Effervescent Tablets:
Co-codamol Effervescent Tablets can become habit forming. This is called
dependence (addiction), if you stop taking your medicine suddenly it can cause
withdrawal symptoms such as restlessness and irritability. Your doctor will stop
your tablets gradually to avoid you having these withdrawal symptoms. If you find
you need to use this product all the time, it is important to consult your doctor. If
you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Co-codamol Effervescent Tablets can cause side effects,
although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions
are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially affecting your whole body)
should be reported to a doctor immediately.
The following side effects are serious. Talk to your doctor straight away if you
notice them:
Rarely (affecting less than 1 in 1000 people):
• Unusual bruising, or infections such as sore throats - this may be a sign of rare
changes in the blood.
Commonly (affecting less than 1 in 10 people):
• shortness of breath
• feeling overly elated or depressed.
Also:
• difficulty in passing urine
• small eye pupils, problems with vision
• slow or weak breathing
• yellowing of the skin or white of the eyes (symptoms of liver damage).
Other side effects include:
Commonly (affecting less than 1 in 10 people):
• feeling sick (nausea) and being sick (vomiting)
• constipation
• headache
• light headedness, dizziness, sleepiness
• stomach pains
• skin rashes or itching.
If any of the side effects become serious, or if you notice any side effect not listed
in this leaflet, please tell your doctor or pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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