Boots Paracetamol & Codeine Tablets

• This medicine can only be used for the short term treatment of acute moderate pain when other painkillers have not worked. Do not take less than four hours after taking other painkillers.
• 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.
• This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
• If you take this medicine for headaches for more than 3 days it can make them worse.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

• Keep this leaflet. You may need to read it again.
• If you have any further queries, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Boots Paracetamol & Codeine Tablets are and what they are used for
2. What you need to know before you take Boots Paracetamol & Codeine Tablets
3. How to take Boots Paracetamol & Codeine Tablets
4. Possible side effects
5. How to store Boots Paracetamol & Codeine Tablets
6. Contents of the pack and other information

• if you are allergic to paracetamol or codeine phosphate or any of the other ingredients of this medicine (listed in section 6)
• if the person going to take the tablets is under 12 years of age. Boots Paracetamol & Codeine Tablets must not be given to children under 12 years of age.
• if you have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)
• if you have difficulty breathing, or other chronic lung disease
• if you are having an asthma attack.
• for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome
• if you know that you metabolise very rapidly codeine into morphine
• if you are breast-feeding
• if 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.

Talk to your doctor, pharmacist or nurse before taking Boots Paracetamol & Codeine Tablets if you:

• are taking a benzodiazepine
• suffer from seizures
• have kidney or liver problems
• have diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)
• have inflammatory bowel disease
• have gall bladder disease or gall stones
• have recently had surgery on your gastro-intestinal tract or urinary system
• have an enlarged prostate gland and have difficulty urinating and are male
• have epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)
• have an underactive thyroid gland
• have a condition called myasthenia gravis which weakens the muscles
• have low blood pressure or are in shock
• have suffered from alcoholism, drug abuse or dependence or mental illness.

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.

During treatment with Boots Paracetamol & Codeine Tablets, 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).

Boots Paracetamol & Codeine Tablets must not be given to children under 12 years of age.

Use in children and adolescents after surgery

Boots Paracetamol & Codeine 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

Boots Paracetamol & Codeine Tablets are not recommended in children with breathing problems (may be seen in children with neuromuscular disorders, severe heart or lung conditions, upper respiratory or lung infections, multiple trauma or after extensive surgical procedures), since the symptoms of morphine toxicity may be worse in these children.

This medicine contains paracetamol.

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

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 other medicines within the last two weeks.

The following medicines can affect Boots Paracetamol & Codeine Tablets:

• anti-depressant medicines (e.g. imipramine, amitriptyline, tranylcypromine, dosulepin, mirtazapine (tricyclic) or chlorpromazine (phenothiazines))
• ciprofloxacin, isoniazid (antibacterial medicine)
• diflunisal (pain killer)
• probenecid (used to treat gout)
• monoamine oxidase inhibitors (MAOIs, e.g. moclobemide)
• oral contraceptives (the “pill”)
• medicines to prevent blood clotting such as warfarin
• cyclizine, metoclopramide or domperidone (to prevent sickness)
• guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high blood pressure)
• mexiletine (to treat irregular heartbeats)
• loperamide or kaolin (to treat diarrhoea)
• selegiline (for Parkinson’s disease)
• phenytoin (to treat epilepsy)
• cimetidine (to treat stomach ulcers)
• atropine or hyoscine (anticholinergic medicines)
• cisapride (to treat gastro-oesophageal reflux disease)
• medicines to treat mental illness
• medicines which affect the liver (e.g. primidone and rifampicin)
• colestyramine (to treat high cholesterol levels)
• muscle relaxants
• opioid antagonists (buprenorphine, naltrexone, naloxone)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Concomitant use of Boots Paracetamol & Codeine Tablets and the following types of medicine increases the risk of drowsiness, difficulties in breathing (respiratory depression) and coma and may be life-threatening:

• benzodiazepines (e.g. diazepam)
• other pain relievers
• sleeping tablets
• cough medicines
• antihistamines
• sedatives, tranquilisers, hypnotics and barbiturates (e.g. phenobarbital)
• medicines used to treat anxiety (hydroxyzine) or high blood pressure
• anaesthetics.

Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Boots Paracetamol & Codeine 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.

If you go into hospital for surgery or tests, tell your doctor you are taking Boots Paracetamol & Codeine Tablets, as you may interact with some anaesthetics and influence the results of certain tests and diagnostic procedures.

• If your diet is poor or you have a low protein intake, you may be at a higher risk of serious paracetamol poisoning when taking Boots Paracetamol & Codeine Tablets.
• Drinking alcohol whilst taking Boots Paracetamol & Codeine Tablets may result in drowsiness, difficulties in breathing, coma and may be life-threatening. It is recommended not to take alcohol while you are taking Boots Paracetamol & Codeine Tablets.

• 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.

Pregnancy

• Do not take Boots Paracetamol & Codeine Tablets during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause breathing problems and withdrawal symptoms in the newborn.

Breast-feeding

• Do not take Boots Paracetamol & Codeine Tablets while you are breast-feeding. Codeine and morphine passes into breast milk.

If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.

Boots Paracetamol & Codeine Tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you drive or operate machinery.

• The 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 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 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.

• This medicine contains ethyl hydroxybenzoate (E214), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Adults over 18 years:

• The usual dose is one or two tablets to be swallowed with water.
• The dose should not be taken more frequently than every 4-6 hours and not more than 4 times in any 24 hour period.
• The maximum daily dose is 8 tablets (4g of paracetamol and 64mg of codeine phosphate) in any 24 hour period in divided doses.

Children aged 16 to 18 years:

• Take one or two tablets every 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children 12 to 15 years:

• One tablet every 6 hours if you need to.
  Don't take more than 4 tablets in any 24 hours.

Children aged less than 12 years:

• Do not take, due to the risk of severe breathing problems.

Elderly:

• Dosage is usually reduced in the elderly with liver damage.

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.

• This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms such as tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Do not exceed the stated dose. If symptoms persist consult your doctor.

Seek immediate medical advice in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain, coma, pale skin, low blood pressure, pinpoint pupils, irregular slow or fast heartbeat, liver or kidney damage or difficulty breathing.

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time.

Remember to leave at least 4 to 6 hours between doses for adults and 6 hours for children aged 12 to 18 years.

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 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 to 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.

• The active substances are codeine phosphate 8 mg and paracetamol 500 mg.
• The other ingredients are: maize starch, potato starch, povidone, stearic acid, talc, magnesium stearate, methyl-p-hydroxy benzoate (E218), ethyl-p-hydroxy benzoate (E214) and propyl-p-hydroxy benzoate (E216).

• The tablets are clean, white, bevelled edged, debossed with ‘8’ and broken breakline on one side and ‘BL’ on the other side.
• They are available in packs of 8, 10, 12, 16, 20, 24, 28, 30 and 32 tablets.
• Not all pack sizes may be marketed.

Manufactured for

by the Marketing Authorisation holder