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 53886/0073.
SOLPADOL 30mg/500mg CAPLETS
Codeine Phosphate and Paracetamol
This medicine contains codeine which is an opioid, which can cause addiction.
You can get withdrawal symptoms if you stop taking it suddenly.
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1. What Solpadol is and what it is used for
2. What you need to know before you take Solpadol
3. How to take Solpadol
4. Possible side effects
5. How to store Solpadol
6. Contents of the pack and other information
The name of your medicine is Solpadol 30mg/500mg Caplets (called Solpadol throughout this leaflet). This medicine has been prescribed for you for the relief of severe pain. Solpadol 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. Solpadol contains codeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. It also contains paracetamol, another analgesic to relieve pain. 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 for longer than your doctor tells you to.
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.
Taking a painkiller for headaches too often or for too long can make them worse.
Do not take Solpadol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Solpadol
Check with your doctor before taking Solpadol if:
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. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Solpadol can affect the way some other medicines work. Also, some other medicines can affect the way Solpadol works.
Concomitant use with sedative medicines
Concomitant use of Solpadol 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 Solpadol 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.
Solpadol contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.
Do not take this medicine, and tell your doctor, if you are taking:
Tell your doctor or pharmacist if you are taking any of the following medicines, or have taken them in the past two weeks:
Tell your doctor or pharmacist if you are taking any other medicines:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Solpadol.
You should not drink alcohol while you are taking these caplets. This is because Solpadol can change the way alcohol affects you.
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.
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.
Do not take Solpadol 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 Solpadol during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Solpadol while you are breastfeeding as codeine and morphine passes into breast milk and will affect your baby.
Solpadol 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 30 mg/500 mg caplet, that is to say essentially ‘sodium-free’.
Long term usage of Solpadol may lead to tolerance and dependence. If you have taken regular daily doses of Solpadol for a long time, do not increase the dose or suddenly stop treatment without discussing this with your doctor.
Your prescriber should have discussed with you, how long the course of caplets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Always take Solpadol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults: 2 caplets every 4 to 6 hours when necessary up to a maximum of 8 caplets in 24 hours.
Elderly people may be prescribed a lower dose.
Children aged 16 to 18 years: 1-2 caplets every 6 hours when necessary up to a maximum of 8 caplets in 24 hours.
Children aged 12 to 15 years: 1 caplet every 6 hours when necessary up to a maximum of 4 caplets in 24 hours.
This medicine should not be taken for more than 3 days. If pain does not improve after 3 days, talk to your doctor for advice.
Children under 12 years: Solpadol should not be given to children below the age of 12 years, due to the risk of severe breathing problems.
If you forget to take a dose at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take two doses at or near the same time. Remember to leave at least 4 hours between doses.
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, difficultly 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Codeine-related side effects:
Frequency and severity are determined by dosage, duration of treatment and individual sensitivity:
Paracetamol-related side effects:
Very Rare (may affect up to 1 in 10000 people):
Frequency not known:
When you stop taking Solpadol, 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.
If you notice any of the following signs whilst taking Solpadol, 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 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.
Keep this medicine in a safe place out of the sight and reach of children. Do not use this medicine after the expiry date shown on the pack. Store your medicine in the original packaging in order to protect from moisture. Do not store above 25°C. 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 protect the environment.
Solpadol 30mg/500mg Caplets are white, capsule shaped tablets (caplets), marked with the word ‘SOLPADOL’ on one face. They come in cartons of 4, 10, 24, 30, 60 and 100 caplets. Not all pack sizes may be marketed.
This leaflet was last updated in November 2021
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