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PARACETAMOL CODEINE AND CAFFEINE 500MG/8MG/30MG SOLUBLE TABLETS

Active substance(s): CAFFEINE / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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PATIENT INFORMATION LEAFLET

• If you know that you metabolise very rapidly codeine into morphine

The name of this medicine is Paracetamol, Codeine & Caffeine 500mg/8mg/30mg Soluble
Tablets, which will be referred to as Paracetamol, Codeine & Caffeine Tablets throughout
this leaflet.
Read all of this leaflet carefully because it contains important information for you.
• This medicine can only be used for the short term treatment of acute moderate pain
which is not relieved by paracetamol, ibuprofen or aspirin alone.
• You should only take this product for a maximum of three days at a time. If you need to
take it for longer than three days you should see your doctor or pharmacist for advice.
• This medicine contains codeine which can cause addiction if you take it
continuously for more than three days. This can give you withdrawal symptoms
from the medicine when you stop taking it.
• If you take this medicine for headaches for more than three days it can make
them worse.
• Keep this leaflet. You may need to read it again.
In this leaflet:
1. What Paracetamol, Codeine & Caffeine Tablets are and what they are used for
2. Before you take Paracetamol, Codeine & Caffeine Tablets
3. How to take Paracetamol, Codeine & Caffeine Tablets
4. Possible side effects
5. How to store Paracetamol, Codeine & Caffeine Tablets
6. Further information

1. WHAT PARACETAMOL, CODEINE & CAFFEINE TABLETS ARE AND
WHAT THEY ARE USED FOR
Paracetamol, Codeine & Caffeine Tablets contain the active ingredients paracetamol
500 mg, codeine phosphate hemihydrate 8 mg and caffeine 30 mg.
Paracetamol, Codeine & Caffeine Tablets are for the short term treatment of acute
moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They are
used to relieve migraine, headache, dental pain, period pain, backache, rheumatic pain,
strains and sprains, and sciatica.

2. BEFORE YOU TAKE PARACETAMOL CODEINE & CAFFEINE TABLETS
This medicine contains codeine which can cause addiction if you take it continuously
for more than three days. This can give you withdrawal symptoms from the medicine
when you stop taking it.
If you take a painkiller for headaches for more than three days it can make them
worse.
Do not take Paracetamol, Codeine & Caffeine Tablets if you:
• are allergic (hypersensitive) to paracetamol, codeine, caffeine, other opioid
painkillers or any of the other ingredients in the tablets (these are listed in Section 6,
Further Information).
• are taking or have recently taken any other paracetamol or codeine containing
products.

Take special care with Paracetamol, Codeine & Caffeine Tablets
Please see your doctor before you take Paracetamol, Codeine & Caffeine Tablets if you:
• have severe liver or kidney disease, including alcoholic liver disease.
• have bowel problems including blockage of the bowel.
• have had an operation to remove your gall bladder.
If your headaches become persistent, see your doctor.
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. Certain medicines can
interfere with the effectiveness of each other. It is particularly important to tell your doctor
or pharmacist before taking this medicine if you are also on:





metoclopramide or domperidone (for sickness or stomach problems)
colestyramine (used to treat high cholesterol)
monoamine oxidase inhibitors (MAOIs) (used to treat depression)
blood thinning medicines (anti coagulants) such as warfarin and you need to take a painkiller
on a daily basis over a long period. However, you can take occasional doses of Paracetamol,
Codeine & Caffeine Tablets.

It may still be alright for you to take Paracetamol, Codeine & Caffeine Tablets and your
doctor will be able to decide what is suitable for you.
Taking your medicine with food and drink
Paracetamol, Codeine & Caffeine Tablets should be dissolved in at least half a glass of
water and can be taken with or without a meal.
You should avoid drinking too much coffee or tea when taking these tablets.
Fertility pregnancy and breast-feeding
Please see your doctor before you take this medicine if you are pregnant or likely to
become pregnant. Do not use whilst breast-feeding unless advised by your doctor.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machinery
The tablets may make you feel dizzy or drowsy. If affected do not drive or operate
machinery.
Important information about some of the ingredients of Paracetamol, Codeine &
Caffeine Tablets
Each of these tablets contains about 403.24 mg of sodium and may interfere if you are on
a low sodium diet.
This product also contains aspartame (a source of phenylalanine), which should not be
given to anyone with phenylketonuria.

3. HOW TO TAKE PARACETAMOL, CODEINE & CAFFEINE TABLETS
Do not take for more than three days. If you need to use this medicine for more than
three days you must speak to your doctor or pharmacist. "Do not take anything else

containing paracetamol while taking this medicine"

• If you are under 12 years:
• Not recommended for use in children under 12 years of age.
• If you are over 12 years:

Paracetamol, Codeine & Caffeine Tablets are not recommended in children
and adolescents between 12 and 18 years who have breathing problems.
 For pain relief in children and adolescents (12-18 years of age) after removal of their
tonsils or adenoids due to obstructive sleep apnoea syndrome
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PACKAGING DEVELOPMENT

Font: Arial / Arial Bold

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PARACETAMOL, CODEINE & CAFFEINE 500mg/8mg/30mg
SOLUBLE TABLETS

Dosage
Adults, including the elderly and children 12 years and over:
Take 2 tablets dissolved in half a glass of water every 4 hours as required, up to a
maximum of 8 tablets in any 24 hour period. Do not take more frequently than
every 4 hours. Do not continue to take for more 3 days unless instructed by your
doctor. Do not take more medicine than the label tells you too. If you do not get

better, talk to your doctor".
Not recommended for use in children under 12 years of age.
Not recommended in children and adolescents between 12 and
18 years who have breathing problems
Method of Administration
For oral administration only. These tablets should be dissolved in at least half a glass of
water before taking them. Stir before use. The solution should be drunk immediately after
preparation. These tablets are meant to be dissolved first so don’t try to swallow them
whole.

The following side effects have also been reported:
• constipation
If any of these side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will
become addicted to the medicine. However, if the following apply to you it is important
that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start
taking the medicine again.
5. HOW TO STORE PARACETAMOL, CODEINE & CAFFEINE TABLETS

If symptoms persist consult your doctor.
If you take more Paracetamol, Codeine & Caffeine Tablets than you should
If you have accidentally taken more than the recommended dose, contact your nearest
hospital casualty department or tell your doctor or pharmacist immediately. Remember to
take the pack and any remaining tablets with you.

Do not store your tablets above 30°C. Store in the original package.
Do not take this medicine after the expiry date stated on the carton. The expiry date refers
to the last day of that month.

The most common symptoms of overdose are nausea (feeling sick), vomiting (being sick)
and stomach pain. You may also notice a rapid heartbeat.

Keep all medicines out of the sight and reachof children.

Immediate
Talk to a doctor at once if you take too much of this medicine even if you feel
well. This is because too much paracetamol can cause delayed, serious liver
damage.

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

Withdrawal symptoms
This medicine contains codeine and can cause addiction if you take it continuously for
more than three days. When you stop taking it you may get withdrawal symptoms. You
should talk to your doctor or pharmacist if you think you are suffering from withdrawal
symptoms.
If you have any further questions about this product ask your doctor or pharmacist.

What Paracetamol, Codeine & Caffeine Tablets contain:
The active ingredients are paracetamol, codeine phosphate hemihydrate and caffeine.
Each tablet contains paracetamol 500 mg, codeine phosphate hemihydrate 8 mg and
caffeine 30 mg.
The other ingredients are anhydrous citric acid, povidone, sodium hydrogen carbonate,
sodium saccharin, anhydrous sodium carbonate, simeticone, polysorbate 80 and
aspartame (E951).

Some people may have side effects when taking this medicine. If you have any unwanted
side effects you should seek advice from your doctor, pharmacist or other healthcare
professional. Also you can help to make sure that medicines remain as safe as possible
by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk;
alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm
Monday – Friday) or fill in a paper form available from your local pharmacy.
If you get any of the following symptoms after taking these tablets, you should contact
your doctor immediately:
• any sudden wheeziness, difficulty in breathing or dizziness, swelling of the
eyelids, face, lips or throat.
• an acute allergic reaction (anaphylaxis) or swelling of the skin
• severe abdominal pain, nausea and vomiting if you have recently had your gall
bladder removed
• unexplained bruising or bleeding
• nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin
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What Paracetamol, Codeine & Caffeine Tablets look like and the contents of the
pack:
Paracetamol, Codeine & Caffeine Tablets are white, circular, flat beveled effervescent
tablets, which are plain on both sides.
Your medicine is available in blister packs of 16, 24 or 32 tablets.

Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release: Fannin (UK) Limited,
57 High Street, Odiham, Hampshire, RG29 1LF, UK.

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4. POSSIBLE SIDE EFFECTS

This information is available in alternative formats upon request.

This leaflet was last approved in July 2015

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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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