Boots Paracetamol & Codeine Tablets

Important things you should know about 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.
• If you take this medicine for headaches for more than 3 days it can make them worse.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Do not take Boots Paracetamol & Codeine Tablets:

• 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. Co-codamol 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.

Warnings and precautions

Take special care with this medicine and talk to your pharmacist or doctor if you have:

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

Children and adolescents

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, since the symptoms of morphine toxicity may be worse in these children.

Other medicines and Boots Paracetamol & Codeine Tablets

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.

The following medicines can affect Boots Paracetamol & Codeine Tablets:

• 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 which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental illness
• medicines to treat depression (e.g. tranylcypromine, amitriptyline)
• medicines which affect the liver (e.g. primidone and rifampicin)
• colestyramine (to treat high cholesterol levels)
• muscle relaxants
• barbiturates (e.g. phenobarbital)
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)

concomitant use of Co-codamol 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 Co-codamol 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.

Boots Paracetamol & Codeine Tablets with food, drink and alcohol

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.

• Do NOT drink alcohol whilst taking Boots Paracetamol & Codeine Tablets.

Pregnancy, breast-feeding and fertility

• Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets. Regular use during pregnancy may cause withdrawal symptoms in the newborn.
• Do not take Boots Paracetamol & Codeine Tablets while you are breastfeeding. 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

Driving and using machines

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.

Boots Paracetamol & Codeine Tablets contain Benzoates

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

The recommended dose is:

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 aged 12 to 15 years:

• One tablet every 6 hours if your 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.

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.

If you stop taking Boots Paracetamol & Codeine Tablets

• 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.

If you take more Boots Paracetamol & Codeine Tablets than you should

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, fast heartbeat or difficulty breathing.

If you forget to take Boots Paracetamol & Codeine Tablets

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.

Other side effects:

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

• Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts, abdominal pain and swelling (may be signs of liver damage or a swollen intestine)
• Heart - slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle
• Urinary system - a less frequent need to pass urine, kidney problems
• Nervous system - mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, difficulty sleeping, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)
• Eyes - blurred or double vision, extremely small pupils
• Reproductive system - lower abdominal pain (may be caused by spasms of the uterus)
• Others - trembling, unusual tiredness or weakness, general discomfort and illness, low body temperature.

Reporting of side effects

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.

How do I know if I am addicted?

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.

What Boots Paracetamol & Codeine Tablets contain

• The active substances are codeine phosphate 8mg and paracetamol 500mg.
• 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).

What Boots Paracetamol & Codeine Tablets look like and contents of the pack

• 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.

Who makes this medicine

Manufactured for

by the Marketing Authorisation holder