Panadol Ultra tablets – patient leaflet, side effects, dosage

1. What Panadol Ultra does

Panadol Ultra tablets are for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica. The tablets contain two active ingredients. Paracetamol and codeine are painkillers. By working on your body in different ways, they combine to relieve pain.

Codeine 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 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.

2. Check before you take Panadol Ultra

• This medicine contains codeine which can cause addiction if you take it continuously for more than 3 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 3 days it can make them worse.

[Cross symbol] Do not take Panadol Ultra:

• If you have ever had an allergic reaction to paracetamol, codeine, other opioid painkillers or to any of the other ingredients (listed in Section 6)
• If you are taking other medicines containing paracetamol or codeine

• If you are breast-feeding.

[Exclamation symbol] Ask your doctor before you take this medicine:

• If you have liver or kidney disease, including alcoholic liver disease

• If you have bowel problems including blockage of your bowel
• If you have had an operation to remove your gall bladder
• If you have been told by your doctor that you have an intolerance to some sugars

During treatment with Panadol Ultra, tell your doctor straight away if:

• you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin.

Symptoms of metabolic acidosis may include:

• serious breathing difficulties with deep rapid breathing
• drowsiness
• feeling sick (nausea) and being sick (vomiting).
• have some or all of the following symptoms: mental disorder, nausea, fever, fast heart beat and muscle disorder. These may be symptoms of a condition called serotonin syndrome, which has been reported in patients taking opioids such has codeine containing products, particularly with concomitant use of certain antidepressants such as tricyclic agents, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs).
• You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Sleep-related breathing disorders

Panadol Ultra can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

[Exclamation symbol] Warnings and Precautions

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.

Tolerance, dependence, and addiction

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Panadol Ultra can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Panadol Ultra if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Panadol Ultra, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose

-You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain

• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely.

[Exclamation symbol] Driving and operating machinery

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 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: www.gov.uk/drug-driving-law.

[Exclamation symbol] If you are taking other medicines

This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]); colestyramine (to lower blood cholesterol); monoamine oxidase inhibitors (MAOIs prescribed for depression) or medicines that make you drowsy or sleepy including sleeping tablets, sedatives to treat depression (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants), flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Panadol Ultra at the same time as anticoagulants.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

[Exclamation symbol] Children and adolescents

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.

[Exclamation symbol] Pregnancy and breast feeding

Talk to your doctor before taking Panadol Ultra if you are pregnant. Do not use whilst breast-feeding.

3. How to take Panadol Ultra

[Tick symbol]

Adults aged 18 years and over:

Swallow 2 tablets every 4 hours as needed. Do not take more frequently than every 4 hours. Do not take more than 8 tablets in 24 hours.

Children aged 16 to 17 years:

Swallow 2 tablets every 6 hours as needed. Do not take more frequently than every 6 hours. Do not take more than 8 tablets in 24 hours.

Children aged 12 to 15 years:

Swallow 1 tablet every 6 hours as needed. Do not take more frequently than every 6 hours. Do not take more than 4 tablets in 24 hours.

[Exclamation symbol]

• Do not take more than the recommended dose.
• Do not give to children under 12 years.
• Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist. Panadol Ultra should be used for 3 days only to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a healthcare professional.
• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Panadol Ultra, when and how long you need to take it, when to contact your doctor, and when you need to stop it.

Possible withdrawal effects

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 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 take too many tablets

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.

If your symptoms continue or your headache becomes persistent, see your doctor.

4. Possible side effects

Some people may have side effects when using this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.

When using this product you may experience:

• Constipation.

Stop taking this medicine and tell your doctor immediately if you experience:

• Severe abdominal pain, nausea and vomiting if you have recently had your gall bladder removed
• Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
• Skin rash or peeling or mouth ulcers
• Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding
• Confusion
• Sleepiness
• Small pupils
• Nausea, vomiting, sudden weight loss, loss of appetite and yellowing of the eyes and skin. The frequency of these reactions is not known but likely to be very rare (<1/10,000).

Other possible side effects

Not known (frequency cannot be estimated from the available data):

•problem affecting a valve in the intestines (sphincter of Oddi dysfunction)

• a serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

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. By reporting side effects you can help provide more information on the safety of this medicine.

[Exclamation symbol] How do I know if I am addicted?

If you take this medicine according to the instructions on the pack, it is unlikely 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 Panadol Ultra

Keep out of the sight and reach of children.

Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them. Do not use this medicine after the ‘EXP’ date shown on the pack.

6. Further information

Active ingredients: Each tablet contains Paracetamol 500 mg and Codeine Phosphate Hemihydrate 12.8 mg.

Other ingredients: Starch pregelatinised, povidone, potassium sorbate (E 202), maize starch, talc, magnesium stearate, stearic acid, microcrystalline cellulose, croscarmellose sodium, Opadry II Pink 31F24615 (containing lactose monohydrate, hypromellose, macrogol, quinoline yellow (E 104), erythrosine (E 127) and titanium dioxide (E 171)).

Packs of Panadol Ultra contain 20 tablets.

The marketing authorisation holder is Haleon UK Trading Limited, Weybridge, KT13 0NY, U.K. and all enquiries should be sent to this address.

The manufacturer is SmithKline Beecham S.A. Carretera de Ajalvir, Km 2,500, Alcala de Henares, 28806 Madrid, Spain.

This leaflet was last revised in March 2026.

Trade Marks are owned by or licensed to the Haleon group of companies.