What it is and what it is used for

for 2. What you need to know before you take Paracetamol & Codeine Effervescent Tablets 3. How to take Paracetamol & Codeine Effervescent Tablets

What you need to know before you take it

e Paracetamol & Codeine Effervescent Tablets

• 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.
• This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
• If you take a painkiller for headaches for more than three days it can make them worse. Do not take Paracetamol & Codeine Effervescent Tablets and tell your doctor if:
• you are allergic to codeine phosphate hemihydrate, paracetamol, or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue
• you are taking medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks. MAOIs are medicines such as moclobemide, phenelzine, tranylcypromine (see 'Other medicines and Paracetamol & Codeine Effervescent Tablets')
• the person going to take the tablets is under 12 years of age. Paracetamol & Codeine Effervescent Tablets must not be given to children under 12 years of age
• you are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome
• you know that you metabolise very rapidly codeine into morphine
• you are breast-feeding or planning to breast-feed. Do not take Paracetamol & Codeine Effervescent Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Paracetamol & Codeine Effervescent Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol & Codeine Effervescent Tablets if you:

• have severe kidney or liver problems
• have a liver problem caused by alcohol
• have problems passing water or prostate problems
• have a bowel problem such as colitis or Crohn's disease or a blockage of your bowel
• have a condition called myasthenia gravis which weakens the muscles
• suffer from hypothyroidism
• have a disease of the adrenal gland called Addison's disease
• are taking a benzodiazepine
• are elderly
• suffer from seizures. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Paracetamol & Codeine Effervescent Tablets contain sodium and sorbitol Sodium: The maximum recommended daily dose of this medicinal product contains 3348.8 mg sodium (found in table salt). This is equivalent to 167.44% of the adult recommended maximum daily dietary intake for sodium. Talk to your pharmacist or doctor if you need Paracetamol & Codeine Effervescent Tablets on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet. Sorbitol (E420): This medicine contains 100 mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

How to take it

Paracetamol & Codeine Effervescent Tablets

Always take this medicine exactly as described in this leaflet, or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

• Do not take for more than three days. Paracetamol & Codeine Effervescent Tablets should be used for the 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.
• Do not take more than the recommended dose.
• Dissolve the effervescent tablets in a glass of water before taking. Adults and the elderly: 2 tablets every 4 to 6 hours when necessary up to a maximum of 8 tablets in 24 hours. Children aged 16 to 18 years: 1 to 2 tablets every 6 hours when necessary up to a maximum of 4 doses in 24 hours. Children aged 12 to 15 years: 1 tablet every 6 hours when necessary up to a maximum of 4 doses in 24 hours. Children under 12 years: Paracetamol & Codeine Effervescent Tablets should not be given to children below 12 years of age due to the risk of severe breathing problems. If you take more Paracetamol & Codeine Effervescent Tablets than you should
• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken. If you forget to take Paracetamol & Codeine Effervescent Tablets If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses for adults and 6 hours for children and adolescents aged 12 to 18 years. If you stop taking Paracetamol & Codeine Effervescent Tablets This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. GB00 0000 0 0000000

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Contents of the pack and other information

1. What Paracetamol & Codeine Effervescent Tablets are and what they are used for

Paracetamol & Codeine Effervescent Tablets contain codeine phosphate hemihydrate and paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Paracetamol & Codeine Effervescent Tablets are used in adults and children over 12 years of age for the short-term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pain when other painkillers such as paracetamol, ibuprofen or aspirin alone have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

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doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, 'If you stop taking Paracetamol & Codeine Effervescent Tablets'). 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.

Sleep-related breathing disorders

Paracetamol & Codeine Effervescent Tablets 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.

Children and adolescents over 12 years of age

Use in children and adolescents after surgery Paracetamol & Codeine Effervescent Tablets 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 Paracetamol & Codeine Effervescent Tablets are not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Other medicines and Paracetamol & Codeine Effervescent Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking or have taken within the last two weeks:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide and phenelzine used in the treatment of depression
• medicines which make you drowsy or sleepy (CNS depressants and benzodiazepines) such as medicines used to treat anxiety or anaesthetics
• medicines for depression such as dosulepin, mirtazapine (tricyclic) or chlorpromazine (phenothiazines)
• medicines known as tranquillisers, or hypnotics
• sleeping tablets, sedatives and some antihistamines. You may experience more drowsiness if you take these medicines with Paracetamol & Codeine Effervescent Tablets. Concomitant use of Paracetamol & Codeine Effervescent Tablets 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 Paracetamol & Codeine Effervescent Tablets 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. Paracetamol & Codeine Effervescent Tablets contain 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. Tell your doctor or pharmacist if you are taking any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Paracetamol & Codeine Effervescent Tablets can affect the way some other medicines work or other medicines can affect the way Paracetamol & Codeine Effervescent Tablets work.

• medicines used to thin the blood such as warfarin
• chloramphenicol – an antibiotic used for infections
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2)
• metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick (vomiting)
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics)
• muscle relaxants
• medicines to treat Parkinson's disease
• colestyramine – for lowering blood cholesterol levels
• the oral contraceptive pill
• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain). If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Paracetamol & Codeine Effervescent Tablets with alcohol You should not drink alcohol while you are taking these tablets. This is because Paracetamol & Codeine Effervescent Tablets can change the way alcohol affects you.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if you are:

• pregnant, think you may be pregnant or plan to get pregnant
• planning to breast-feed. Do not take Paracetamol & Codeine Effervescent Tablets while you are breast-feeding. Codeine passes into breast milk.

Driving and using machines

This medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive whilst taking this medicine until you know how it affects you.
• 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 prescribed to treat a medical or dental problem and
• you have taken it according to the instructions given by the prescriber or in 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.