Patient Leaflet Updated 03-May-2022 | Bayer plc
Paracodol Tablets
PARACODOL® TABLETS
Paracetamol (500mg)
Codeine Phosphate Hemihydrate (8mg)
Please read this leaflet carefully because it contains important information for you.
Keep this leaflet, you may need to read it again.
Paracodol Tablets can only be used in patients aged l2 years and over for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This includes muscular and rheumatic pains, headache, migraine. neuralgia, period pain, toothache, aches and pains.
This medicine contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It also contains paracetamol, another analgesic to relieve pain.
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.
Codeine is transformed into 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 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.
Do not use in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
The product is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
Consult your doctor before taking the tablets if you are pregnant or think you may be pregnant.
Do not take codeine while you are breast-feeding. Codeine and morphine passes into breast milk.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Details regarding a new UK driving offence concerning driving after taking drugs may be found at: www.gov.uk/drug-driving-law.
This medicine contains 383 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 19.15% of the recommended maximum daily dietary intake of sodium for an adult.
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.
Dissolve the tablets in water before taking.
Adults aged 18 years and over: Take 1-2 tablets, repeated if necessary every 4-6 hours with a maximum of 8 tablets a day. Children aged 12 -18 years: Take 1 tablet, repeated if necessary every 4-6 hours with a maximum of 4 tablets a day. Paracodol Tablets should not be taken by children under 12 years due to the risk of severe breathing problems.
Do not drink alcohol whilst taking this medicine.
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.
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.
Some people may have side-effects when taking this medicine.
Side effects are rare, but occasionally Paracodol Tablets can cause constipation and hypersensitivity reactions such as skin rashes.
Very rare cases of serious skin reactions have been reported. If you notice that you bruise or bleed more easily than usual or if you are more prone to infection, such as sore throats or mouth ulcers, you should speak to your doctor.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side-effects you can help provide more information on the safety of this medicine.
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:
Keep out of the sight and reach of children.
Store in the original package in order to protect from moisture. Do not use the tablets after the expiry date on the carton and blister.
Each effervescent tablet contains the active ingredients: paracetamol 500 mg and codeine phosphate hemihydrate 8 mg.
Inactive ingredients: povidone, sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous citric acid, mannitol, saccharin sodium, sodium docusate, sodium benzoate.
Available in packs of 16 and 32 effervescent tablets. Not all pack sizes may be marketed.
Manufactured by
for the Product Licence holder
Leaflet last revised: October 2019
PARACODOL®
is a registered trademark.
400 South Oak Way, Reading, Berkshire, RG2 6AD
+44 (0)118 206 3000