The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0413.
Codipar 15mg/500mg Capsules
Codipar® 15mg/500mg Capsules
This medicine contains codeine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The product is known by the name above but will be referred to as Codipar Capsules throughout the rest of this leaflet.
1. What Codipar Capsules are and what they are used for
2. What you need to know before you take Codipar Capsules
3. How to take Codipar Capsules
4. Possible side effects
5. How to store Codipar Capsules
6. Contents of the pack and other information
This medicine has been prescribed for you for relief of moderate pain. Codipar Capsules contains codeine. Codeine belongs to a class of medicines called opioid, which are ‘pain relievers’. It also contains Paracetamol which is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). Codipar Capsules can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Do not take with any other paracetamol-containing products. Do not take for longer than directed by your prescriber. Taking a painkiller for headaches too often or for too long can make them worse.
Do not use Codipar Capsules for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids as Codeine in Codipar Capsules may cause obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses).
Talk to your doctor or pharmacist before taking Codipar Capsules if:
Talk to your prescriber before taking this medicine if you:
Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.
Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
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.
Use in children and adolescents after surgery
Codeine should 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). They may be at increased risk of severe side effects in case of morphine toxicity.
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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:
Some products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels for ingredients.
Codipar Capsules can interfere with some laboratory tests used for determining some diseases.
The CNS depressant action of this medicine may be enhanced by coadministration with any other drug which has a CNS depressant effect (e.g. anxiolytics, hypnotics, antidepressants, antipsychotics and alcohol). Concomitant use of any drug with a CNS depressant action should be avoided. If combined therapy is necessary, the dose of one or both agents should be reduced.
Concomitant use of Codipar Capsules and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Codipar Capsules together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Do not drink alcohol whilst taking Codipar Capsules.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Codipar Capsules if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Codipar Capsules during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Codipar Capsules while you are breastfeeding as codeine passes into breast milk and will affect your baby.
Codipar Capsules may cause dizziness or drowsiness and you should not drive or operate machinery if you are affected this way. Codeine may disturb your vision.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your prescriber should have discussed with you, how long the course of capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
The recommended dose is:
Adults: The recommended dose is one or two capsules every four to six hours as required, up to a maximum of 8 capsules in any 24 hour period.
If you feel the effect of Codipar Capsules 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. Do not take with any other Paracetamol containing products.
Elderly: A reduced dosage may be necessary.
Children aged 16-18 years: The recommended dose is one to two capsules every 6 hours when necessary up to a maximum of 8 capsules in 24 hours.
Children aged 12 – 15 years: The recommended dose is one capsule every 6 hours when necessary up to a maximum of 4 capsules in 24 hours.
Codipar Capsules should not be used in children below the age of 12 years, due to the risk of severe breathing problems.
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 capsules and this leaflet with you so that the medical staff knows what you have taken.
Symptoms of paracetamol overdose are usually seen in the first 24 to 48 hours, such as pale appearance of the skin, nausea, vomiting, loss of appetite and pain in the abdomen. In severe poisoning, liver failure may occur which may progress to change in mental status, signs of bleeding, low blood sugar, brain swelling, and death. Kidney failure suggested by symptoms of flank pain, blood in the urine or frothy urine (excess proteins in the urine), may be seen even in the absence of severe liver damage.
Symptoms of codeine overdose are usually seen when very large dosage are ingested, or other sedative agents have been co-ingested including alcohol. There may be brain function slow down and depressed or difficulty in breathing. Pin-point pupils; nausea and vomiting are common symptoms. Low blood pressure and increased heart rate may be possible.
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. Do not take a double dose to make up for a forgotten dose.
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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, skin rashes, redness or itching (especially affecting your whole body) should be reported to a doctor immediately.
Lying down may help these effects if they happen.
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
When you stop taking Codipar Capsules, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
Not known: frequency cannot be estimated from the available data
If you notice any of the following signs whilst taking Codipar Capsules, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber.
If a pain killer is used too long for headaches, it can make them worse. .
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 website:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Codipar Capsules are red (cap) and white (body) coloured hard gelatin oblong capsules with no markings.
Codipar Capsules are available in packs of 30, 32 or 100 capsules. Not all pack sizes may be marketed.
This leaflet was last revised in February 2023.
Codipar is the registered trade mark of Mercury Pharma Group Ltd.