Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• This medicine is available only on prescription
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it onto 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• You are allergic (hypersensitive) to paracetamol, codeine, other opioid analgesic or any of the other ingredients of this medicine (listed in section 6). Refer to section 4 (possible side effects) for the signs and symptoms of an allergic reaction
• You drink excessive amounts of alcohol
• You have severe problems with breathing
• You have recently had a head injury or have increased pressure within your head (raised intracranial pressure)
• You are having an asthma attack
• You are under 12 years of age
• You are at risk from intestinal paralysis or have a swollen abdomen
• You are suffering from severe diarrhoea (pseudomembranous colitis)
• You are taking any other paracetamol or paracetamol-containing products
• You are under 18 years of age and suffer from pain after removal of tonsils or adenoids due to obstructive sleep apnoea syndrome
• You know that you metabolise very rapidly codeine into morphine
• You are breast-feeding.

Talk to your doctor or pharmacist before taking Co-codamol Tablets if:

• You are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)
• You are taking or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression
• You have asthma, bronchitis or emphysema.
  If your asthma is controlled you can take Co-codamol Tablets, but use with care, especially if your asthma is known to be made worse by aspirin or other painkillers. You should not take codeine if you are having an acute asthma attack
• You have serious problems with your liver or kidneys
• You are elderly
• You are being treated with depressants (medicines used to treat anxiety)
• You have an enlarged prostate (men) or have difficulty passing water
• Your alcohol consumption is excessive
• You have an under active thyroid (hypothyroidism) or adrenal glands
• You suffer from biliary tract disorders such as gallstones
• You have inflammation of the bowel or a blockage of the bowel
• You suffer from convulsions or have a seizure disorder (fits)
• You are a poor metaboliser of codeine
• You have had a drug addiction
• You suffer from low blood pressure, are in a state of severe shock or very run down
• You suffer from myasthenia gravis (a disease characterised by weakness of certain groups of muscles).

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

If you go into hospital for surgery or tests, tell your doctor you are taking Co-codamol Tablets, as they may interact with some anaesthetics and influence the results of certain tests and diagnostic procedures.

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.

Caution should be exercised when taking paracetamol prior to (less than 72 hours before) or at the same time as intravenous busulfan.

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
• 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 Co-codamol Tablets 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. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine.

Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating.

Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.

Taking higher doses or more frequent doses of opioid, may increase the risk of addiction.

Overuse and misuse can lead to overdose and/or death.

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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription. In particular you should tell your doctor if you are taking any of the following:

• Paracetamol or paracetamol-containing products
• Barbiturates (to help you sleep or treat epilepsy)
• Anticonvulsants such as carbamazepine, phenobarbital, phenytoin and primidone (drugs used to treat epilepsy)
• Antidepressants (tricyclics or MAOIs)
• Antipsychotics such as chlorpromazine and haloperidol (used to treat mental illnesses including schizophrenia)
• Anxiolytics (to help with anxiety)
• Hypnotics e.g. diazepam, nitrazepam (to help you sleep)
• Anaesthetics, particularly general anaesthetics (used in surgery to numb pain)
• Antihistamines such as benadryl (used to treat allergies e.g. hayfever)
• Sodium oxybate (used to treat narcolepsy)
• Sedatives (to help you relax)
• Cholestyramine (used to lower cholesterol)
• Cisapride, metoclopramide or domperidone (used to help stop nausea and vomiting)
• Anticoagulants (medicines used to thin the blood, such as warfarin)
• Antidiarrhoeal agents such as loperamide or kaolin
• Muscle relaxants such as atropine
• Cimetidine (used to treat stomach ulcers)
• Quinidine, mexiletine (used to regularise heart rhythm)
• Isoniazid (used to treat tuberculosis)
• Diflunisal (a pain killer)
• Oral contraceptives
• Probenecid (used to treat gout)
• Medicines which affect the liver (e.g. primidone and rifampicin)
• Opioid antagonists (buprenorphine, naltrexone, naloxone)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Concomitant use of Co-codamol 30mg/500mg 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 Co-codamol 30mg/500mg 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.

Do not drink alcohol while you are taking Co-codamol Tablets.

Alcohol may increase the sedative effects of co-codamol and make you very sleepy.

It can also increase the risk of some side effects.

Pregnancy

Do not take Co-codamol 30mg/500mg Tablets during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.

Breastfeeding

Do not take Co-codamol 30mg/500mg Tablets while you are breastfeeding. Codeine and morphine passes into breast milk.

Codeine may cause drowsiness or changes in vision, including blurred or double vision in some people. Do not drive or use any tools or machines if you are affected in this way and do not drink alcohol, as this will make these effects worse. Other medicines may also increase these effects.

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.

Adults: One to two tablets every 4 to 6 hours as required to a maximum of 8 tablets in 24 hours.

Children 16-18 years: One to two tablets every 6 hours as required to a maximum of 8 tablets in 24 hours.

Children 12-15 years: One tablet every 6 hours when necessary to a maximum of 4 tablets in 24 hours.

Children under 12 years: Not recommended for children under 12 years due to the risk of severe breathing problems.

Elderly: Your doctor may have reduced the dose for you. If this is the case follow your doctor’s instructions.

You may need a reduced dose if your kidney or liver is not working as well as it should be. You may also be given a reduced dose if you suffer from any of the conditions listed above in the section headed ‘Talk to your doctor or pharmacist before taking Co-codamol if’.

This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

Do not take more tablets than your doctor has prescribed for you.

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.

Take your usual dose as soon as you remember, provided it is at least 4 hours (6 hours if a child aged between 12 and 18 years) since your last dose. Do not take a double dose to make up for a forgotten dose.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

This medicine contains codeine which can cause addiction if you take it continuously for more than three 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 notice any of the following signs whilst taking Co-codamol 30/500mg Tablets, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again.

If you notice any of these signs, it is important you talk to your prescriber

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.

The active substances in Co-codamol Tablets are paracetamol, 500mg and codeine phosphate, 30mg

The other ingredients are pregelatinised maize starch, magnesium stearate and povidone K30.

Co-codamol Tablets are white, circular tablets marked CCD 30 on one face and CP on the reverse.

They are available in packs of 28, 30, 56, 60, 84, 90 and 100 tablets.

Not all pack sizes may be marketed.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name Reference number

Co-codamol 30mg/500mg Tablets 29831/0047