Medicines & treatments centre

CO-CODAMOL WARNINGS

Co-codamol should be used with caution in: the elderly, those with liver or kidney problems (including alcoholicliver disease), low blood pressure (hypotension), asthma, underactive thyroid (hypothyroidism), muscle weakness (myasthenia gravis), epilepsy, an enlarged prostate gland or male and having difficulty urinating or have had recent surgery on the urinary system or the gut, those with diseased adrenal glands (Addison's disease), those with alcohol dependence or diseases causing inflammation of the colon (ulcerative colitis and Crohn's disease), gall bladder disease or gall stones.

It should not be used in: children under 12 years of age unless advised differently by your doctor, people with hypersensitivity to paracetamol, codeine or other opioid analegesic, people taking other medication containing paracetamol, those with recent head injury or raised pressure in the skull, comatose patients, recent biliary tract surgery, alcohol intoxication, those with long-standing lung disease, people who are having difficulty breathing or who are having a current asthma attack and patients who have been on monoamine oxidase inhibitor therapy in the last 14 days.

Also see list of precautions and interactions.

STORAGE

Store below 25°C

CO-CODAMOL USES

Co-codamol is used to treat a number of problems.

It consists of a mixture of paracetamol plus codeine phosphate (a member of the class of drugs called opioid analgesics).

In general, co-codamol is used as required to relieve mild-to-moderate pain and to reduce fever, and so is used for the relief of headaches, migraine, toothache, back pain and period pains.

Benefits of taking this drug can include relief from pain and reduction of fever.

Listed below are the typical uses of co-codamol:

• Taken as required for relief of mild-to-moderate pain or fever.

On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

HOW TO USE/TAKE

How often do I take it?

• Take co-codamol (tablets) by mouth with a glass of water (dispersible or effervescent tablets should first be dissolved in water) as required to relieve pain or fever.
• Use this medication for the duration of prescription in order to get the most benefit from it.
• Remember to use it at the same time each day - unless specifically told otherwise by your doctor.
• It may take some time before the full benefit of this drug takes effect, depending on the dose given and the severity of the condition.
• Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

• Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

• Avoid alcohol. Co-codamol may cause drowsiness or confusion, do not operate machinery or drive if you are affected. Consult your doctor or pharmacist for more details.

When can I stop?

• It is important to continue taking this medication even if you feel well, unless your doctor tells you to stop.

CO-CODAMOL SIDE EFFECTS

• Tolerance (drug has less effect with continued use)
• Dependence (withdrawal symptoms of tremor, increased sweating, raised heart and breathing rates, raised blood pressure and feeling or being sick) when co-codamol is stopped too suddenly
• Dizziness
• Confusion
• Shortness of breath
• Sleepiness
• Feeling sick (nausea)
• Vomiting (being sick)
• Stomach pain
• Loss of appetite
• Constipation
• Dry mouth
• Blurred vision
• Liver problems
• Postural hypotension (low blood pressure on sitting or standing up)
• Slower heart rate
• Rashes
• Difficulty in urinating or pain when urinating.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the UK you may report side-effects to the MHRA

CO-CODAMOL PRECAUTIONS

Before taking co-codamol, tell your doctor or pharmacist if you are allergic to it; or to its ingredients or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have a long-standing lung disease, difficulty breathing or are having a current asthma attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially any of the following: if you regularly drink more than the recommended level of alcohol, if you have an eating disorder, cystic fibrosis, or cachexia (loss of weight and muscle caused by diseases such as cancer, AIDs etc.), have a recent head injury or raised intracranial (head) pressure, have recently had surgery on your urinary system or gut, have previously had a mental illness including any incidence of drug abuse or dependence (addiction), and if you are taking any other products that contain paracetamol.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

• Yes. Avoid alcohol.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

It is not recommended to use co-codamol during pregnancy. Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

It is not recommended to use co-codamol if you are breastfeeding. Ask your doctor or pharmacist if you have any doubts or questions about this.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

CO-CODAMOL INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

• medicines or treatments containing paracetamol.

If you are currently using any of these medications, tell your doctor or pharmacist before starting co-codamol.

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

• Alcohol
• Domperidone
• Amisulpride
• Cyclizine
• Metoclopramide
• Cemetidine
• Sodium oxybate
• Colestyramine
• Carbamazepine
• Busulfan
• Imatinib
• Rifampicin
• Ciprofloxacin
• Selegiline
• Moclobemide
• Monoamine oxidase inhibitors (MAOIs) such as phenelzine, isocarboxazid and tranylcypromine
• Blood-thinning medicines such as warfarin
• Sedating antihistamines
• Antipsychotics
• Anxiolytics
• Hypnotics
• Antimuscarinics

This information does not contain all possible interactions. Therefore, before using co-codamol, tell your doctor or pharmacist of all the products you use.

CO-CODAMOL OVERDOSE

Symptoms of an overdose include: feeling sick (nausea), vomiting, loss of appetite, stomach pain, liver damage, coma (unable to wake), clammy skin, fits confusion, sleepiness, low blood pressure (hypotension), very small pupils, slow heart beat and/or breathing rate.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of co-codamol or intentional overdose is suspected, contact your local hospital, GP or if in the UK call NHS Direct on 0845 4647.

MISSED DOSE

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.