Patient leaflet - CODIS 500
1. What Codis 500 is and what it is used for
2. What you need to know before you take Codis 500
3. How to take Codis 500
4. Possible side effects
5. How to store Codis 500
6. Contents of the pack and other information
1. what codis 500 is and what it is used for
The active ingredients (which make Codis 500 work) are Aspirin and Codeine phosphate. Aspirin belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling, and high temperature. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Codeine is a painkiller related to morphine which acts upon the central nervous system to reduce the communication of pain messages.
Codis 500 (which contains codeine) can be used for the short-term relief of acute, moderate pain that is not relieved by other pain killers such as paracetamol, ibuprofen or aspirin alone, such as:
- Migraine, headaches
- Cramping and period pain, dental pain
- Neuralgia, rheumatic and muscular pain, and pains associated with sprains, strains, sciatica, lumbago and joint swelling.
2. what you need to know before you take codis 500
- 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 Codis 500:
- If you are allergic to aspirin or any similar products.
- If you suffer from haemophilia (An inherited blood clotting disorder).
- If you have a stomach ulcer.
- There is a possible association between aspirin and Reye’s Syndrome when given to children. Reye’s Syndrome is a very rare disease which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children under 16 years unless specifically indicated (e.g, for Kawasaki’s disease)
- If you are in the last 3 months of pregnancy or are breast feeding.
- For pain relief in children and adolescents (0–18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.
- If you know that you metabolise codeine into morphine very rapidly.
Warnings and precautions
are receiving regular medical treatment- have or have had asthma
Other medicines and Codis 500
The effect of treatment may be influenced if aspirin is taken at the same time as other medicines for:
- Thinning of the blood/prevention of clots (e.g. warfarin)
- Organ rejection after transplantation (e.g. ciclosporin, tacrolimus)
- High blood pressure (e.g. diuretics and ACE-inhibitors)
- Pain and inflammation (e.g. anti-inflammatory medicines such as ibuprofen or steroids)
- Gout (e.g. probenecid)
- Cancer or rheumatoid arthritis (e.g. methotrexate)
Before using aspirin you should inform a health professional about the medicines you are taking. If you are using aspirin regularly you should seek advice before taking any other medicine (including other medicines you may have bought)
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 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.
Metamizole (substance to decrease pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells sticking together and forming a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose of aspirin for cardioprotection.
Children and adolescents
Use in children and adolescents after surgery:
Codeine should not be used for pain relief in children and adolescents after removal or their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
Pregnancy and breast feeding
Do not take in the last 3 months of pregnancy or if you are breast feeding.
Speak to your doctor before taking Codis 500 if you are under 6 months pregnant.
Driving and Using Machines
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
- Do not drive while taking this medicine until you know how it affects you
- It may be an offence to drive when taking this medicine
- However, you would not be committing an offence if:
-
– The medicine has been taken to treat a medical or dental problem and
-
– You have taken it according to the information provided with the medicine and
-
– It was not affecting your ability to drive safely
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 driving offence concerning driving after drugs have been taken in the UK may be found here:
Codis 500 contains sodium:
Codis 500 contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‚sodium-free‘.
3. how to take codis 500
- Do not take for more than 3 days, if you need to use this medicine for more than three days you must speak to your doctor or pharmacist.
Adults, the elderly and children aged 16 years and older:
- Take 1 or 2 tablets dissolved in water.
- Leave at least four hours between doses.
- Do not take more than 8 tablets in any 24 hour period.
- Do not give to children under 16 years unless prescribed by a doctor.
- 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.
4. possible side effects
Some people may have side effects, when taking this medicine. If you have any unwanted sideeffects you should seek advice from your doctor, pharmacist or other healthcare professional.
STOP TAKING the medicine and seek immediate medical help if you develop:
- signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.
- signs of asthma or bronchospasms including unexplained wheezing, shortness of breath.
- signs of rare but serious allergic reaction such as severe skin rashes, peeling, flaking or blistering skin, facial swelling, easy bruising
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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. how to store codis 500
Keep out of the reach and sigh of children.
Do not use Codis 500 after the expiry date stated on the carton after EXP. The expiry date refers to the last date of that month. Store in a dry place below 30°C.
6. Further information
Each tablet contains the active ingredients aspirin 500mg and codeine phosphate 8mg. Also contains calcium carbonate, maize starch, citric acid, talc, sodium lauryl sulphate, and saccharin. Available in packs of 24 and 32 white tablets.
Licence Holder and Manufacturer:
Reckitt Benckiser Healthcare UK Ltd, Dansom Lane
Hull, HU8 7DS
Produce Licence No. PL 00063/0012
Dave of revision March 2020
1.3.1 Package Leaflet – Clean
eCTD Codis 500mg tablet
Page 5