Boots Paracetamol and Codeine Extra Capsules

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• This medicine can only be used for the short term treatment of acute moderate pain such as headache, migraine, rheumatic pain, muscular pain, backache, neuralgia, toothache and period pain that is not relieved by aspirin, ibuprofen or paracetamol alone
• You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice
• 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 this medicine for headaches for more than 3 days it can make them worse
• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice

Tolerance, dependence, and addiction

This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Boots Paracetamol & Codeine Extra Capsules 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 Boots Paracetamol & Codeine Extra Capsules 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 Boots Paracetamol & Codeine Extra Capsules, 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 (see section ‘Possible withdrawal effects when stopping treatment’).'

Talk to your pharmacist or doctor before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal substances
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• feel you need to take more of this medicine to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it
• have kidney problems
• have liver problems (including a disease caused by drinking alcohol)
• have bowel problems, including blockage of your bowel
• have had an operation to remove your gall bladder
• have hypotension (low blood pressure) or underactive thyroid (hypothyroidism)
• have experienced a recent head injury
• have asthma and have been told by your doctor that you are sensitive to aspirin
• have Gilbert’s Syndrome (familial non-haemolytic jaundice)
• are taking other medicines that can affect liver function
• have glucose-6-phosphatase dehydrogenase deficiency
• have haemolytic anaemia
• have glutathione deficiency
• are dehydrated
• have a poor diet such that the diet causes health problems
• weigh less than 50kg
• are elderly
• have a condition called myasthenia gravis which weakens the muscles
• are taking monoamine oxidase inhibitors (for depression), or have taken them in the last 14 days.

Your doctor or pharmacist may advise you to take this medicine less regularly or leave longer between doses if you:

• weigh less than 50kg
• have liver or kidney problems
• are taking certain other medicines
• take alcohol to excess
• have acute or chronic eating problems (e.g. malnutrition, fasting, dietary restrictions, eating disorders, starvation)
• have sepsis, cachexia or a chronic illness (e.g. cystic fibrosis, liver disease, HIV, muscular dystrophy). If this is the case, follow their instructions

During treatment with this medicine, 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).

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine. Alcohol increases the risk of side effects occurring and may make you feel more drowsy.

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
• pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine. 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.

Boots Paracetamol & Codeine Extra Capsules 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.

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.

Pregnancy and Breastfeeding: Do not take this medicine if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use this medicine during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take this medicine while you are breastfeeding. Codeine and morphine passes into breast milk and will affect your baby.

Driving and using machines: This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

• Do not drive or use machines while taking this medicine until you are sure you are not affected
• It is an offence to drive if this medicine affects your ability to drive
• 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.

Important information about some of the ingredients in this medicine: The colour ponceau 4R (E124) in this medicine may cause allergic reactions.

This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodium-free'.

This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)
• Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)
• Monoamine oxidase inhibitors (MAOIs) for depression in the last 2 weeks or substances that make you drowsy (e.g. sedatives, antidepressants or alcohol) or sedated (e.g. benzodiazepines or related medicines)
• Antipsychotics including phenothiazines for mental health conditions
• Muscle relaxants
• Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis
• Medicines for epilepsy
• Probenecid for gout and hyperuricemia
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section ‘Before you take this medicine’)
• Gabapentin and pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain). There is an increased risk of respiratory depression.

If you are going to have a general anaesthetic, tell your doctor that you are taking this medicine.

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

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.

• Severe abdominal pain, dry mouth, nausea and vomiting if you have recently had your gall bladder removed
• Nervousness, dizziness, irritability, drowsiness or restlessness – do not drive or use machines if you feel drowsy or dizzy
• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• Allergic reactions which may be severe such as skin rash and itching
• Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin; mouth ulcers; itching or sweating
• Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin
• Unusual bruising or bleeding, or infections such as sore throats - this may be a sign of very rare changes in the blood
• Nausea, upset stomach, sudden weight loss, loss of appetite and yellowing of the eyes and skin
• Cloudy urine or difficulties urinating.
• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 'Before you take this medicine'). The frequency of this side effect is not known (frequency cannot be estimated from the available data).

• Constipation
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a problem affecting a valve in the intestines known as sphincter of Oddi dysfunction), e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever. The frequency of this is not known (frequency cannot be estimated from the available data).

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or 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:

• You need to take the medicine for longer periods of time
• You need to take more than the recommended amount
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

Taking higher doses or more frequent doses of opioids, such as codeine (an active ingredient of this medicine), may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor or pharmacist about your treatment. Please refer to ‘How to take this medicine’ for information on correct dosages and time intervals.