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PATIENT INFORMATION LEAFLET

Co-codamol Tablets

(Paracetamol BP 500mg, Codeine Phosphate BP 8mg)

H What Co-codamol is and what it ■ is used for

Co-codamol Tablets belongs to a group of medicines called analgesics. Analgesic drugs relieve the symptoms of pain. Co-codamol Tablets contain a combination of paracetamol and codeine phosphate, which help relieve pain. Paracetamol also helps reduce fever.

Co-codamol can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

[2 What you need to know ^ before you take Co-codamol

Warnings:

■    Do not take this medicine for longer than directed by your prescriber

■    Taking codeine regularly for a long time can lead to addiction (dependency), which might cause you to feel restless and irritable when you stop taking the tablets

■    Taking a painkiller for headaches too often or for too long can make them worse

Do not take Co-codamol Tablets:

■    If you are allergic (hypersensitive) to codeine, paracetamol or to any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information")

■    If you have sudden or short-lived (acute) problems with your breathing, such as an asthma attack or another lung disease

■    If you have diarrhoea due to inflammation of the bowel or poisoning

■    If you suffer from alcoholism

■    If you suffer from severe liver problems

■    If you suffer from obstruction of the intestines

■    If you have a head injury or have increased pressure in the brain

■    If you know that the patient is unconscious

■    If you have recently had an operation on your liver, gallbladder or bile duct (biliary tract)

■    For pain relief in children or adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome (see "Children and adolescents" section)

■    Codeine is not recommended for use in children with breathing problems including neuromuscular disorders, severe heart problems, upper respiratory or lung infections, multiple injuries or extensive operations as these conditions may worsen symptoms of toxic reaction of the body (morphine toxicity) (see "Children and adolescents" section)

■    If you are a woman who is breastfeeding (See Pregnancy and breast-feeding section)

■    If you know that you metabolise very rapidly codeine into morphine

Warnings and precautions

Talk to your doctor before taking Co-codamol:

■    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

■    If you suffer from kidney or liver problems, including alcoholic liver disease

■    If you are elderly or frail

■    If you drink alcohol (see 'Co-codamol and alcohol' section)

■    If you suffer from asthma or breathing problems

■    If you have low blood pressure

■    If you have an under active thyroid gland

■    If you suffer from problems with your adrenal glands

■    If you have an enlarged prostate gland

■    If you suffer from urinary problems e.g. difficulty passing water

■    If you are suffering from shock

■    If you suffer from inflammatory or obstructive bowel problems or gall bladder disease

■    If you suffer from muscle weakness (myasthenia gravis)

■    If you have a history of irregular heartbeat

■    If you have a history of seizures or fits

■    If you have a history of drug abuse, dependence or mental illness

■    If you suffer from a condition that may cause glutathione depletion such as an eating disorder, cystic fibrosis, HIV infection, wasting illness (cachexia)

Children and adolescents

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 for use in children with breathing problems as the symptoms of morphine toxicity may be worse in these children.

Other medicines and Co-codamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Other medicines may influence the effect of or be influenced by paracetamol or codeine, (the active ingredients of Co-codamol).

Medicines which should not be taken with Co-codamol Tablets

■    Other products containing paracetamol

■    Monoamine oxidase inhibitors (MAOIs), used to treat depression, such as iscarboxazid, moclobemide and linezolid and also, selegiline, used to treat Parkinson's disease. You should not take Co-codamol Tablets if you are currently taking MAOIs or have stopped taking them in the last 14 days.

Medicines which may interact with or be affected by Co-codamol Tablets:

■    Medicines which affect the liver, such as primidone and rifampicin

■    Medicines used to treat epilepsy, such as phenytoin, phenobarbital and carbamazepine

■    Medicines used to prevent the clotting of blood (anticoagulants), such as warfarin

■    Other pain-relieving medicines, such as aspirin (salicylates)

■    Medicines used to treat anxiety such as diazepam

■    Medicines used to treat depression, such as clomipramine

■    Medicines used to treat sleep disorders, such as nitrazepam

■    Medicines used to treat mental illness, such as chlorpromazine

■    Medicines used to prevent sickness, such as Metoclopramide or domperidone

■    Cholestyramine, used to reduce cholesterol in the blood

■ Other opioid analgesics used to relieve pain such as fentanyl

■    Anaesthetics

■    Cisapride, used to treat heartburn

■    Cimetidine, used to treat stomach ulcers

■    Quinidine and Mexiletine, used to treat an irregular heart beat

■    Ritonavir, used to treat HIV infection

■    Water tablets (thiazide diuretics) such as chlortalidone

■    Medicines used to treat high blood pressure, such as guanethidine

■    Buprenorphine, naltrexone, naloxone (opioid antagonists)

■    Medicines used to prevent muscle spasm, such as atropine, hyoscine (anticholinergics)

■    Chloramphenicol, used to treat infections (antibiotic)

■    Oral contraceptive pill

■    St John's Wort (herbal remedy)

Co-codamol and alcohol

You should avoid drinking alcohol whilst taking Co-codamol Tablets as codeine may enhance the effects of alcohol. Paracetamol may increase the risk of liver damage in people who have been dependent on alcohol for a long time.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

continued....

The recommended dose for adults and children aged 12-18 years of age is:

1-2 tablets every 4 hours. No more than 4 doses (maximum of 8 tablets) should be taken in 24 hours.

Treatment should be limited to 3 days. If effective pain relief is not achieved during this time, you should seek the advice of your doctor.

Use in children aged less than 12 years:

Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity.

If you take more Co-codamol Tablets than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of paracetamol overdose in the first 24 hours are: pale skin, feeling &/or being sick, loss of appetite and stomach pain. Signs of liver damage may show 12 to 48 hours after taking the tablets. In severe cases, liver failure may progress to altered function of the brain, profuse bleeding from ruptured blood vessels (haemorrhage), low blood sugar levels, fluid on the brain and death. Kidney failure could also develop.

Immediate treatment is essential if there is a possibility of paracetamol overdose. Even if there appears to be a lack of significant early symptoms, you should contact your nearest hospital urgently for immediate medical attention. Symptoms may only be feeling or being sick and may not reflect the severity of overdose or the risk of organ damage.

Symptoms of codeine overdose in the first 24 hours are: feeling &/or being sick are the most common symptoms. Other overdose symptoms include a drop in body temperature, confusion, fits, severe dizziness, severe drowsiness, low blood pressure and faster heartbeat (possible but unlikely), nervousness or restlessness, excitement, hallucinations, slower heartbeat, slow or troubled breathing, severe weakness.

If you forget to take Co-codamol Tablets

Take it as soon as you remember, unless it is time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.

If you stop taking Co-codamol Tablets

It is important that you keep on taking Co-codamol Tablets for as long as your doctor has told you to. Do not stop or change your treatment before talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Loss of appetite

Mood changes (including depression or excitement) Seeing things that are not there (hallucinations) Confusion

Unusual excitement in children

Restlessness

Nightmares

Dizziness (light-headedness)

Headache (prolonged use can make it worse)

Fit or seizure

Muscle spasms or uncontrolled movements Shaking

Constriction of the pupil and other eye problems Dizziness or feeling of 'spinning' (vertigo)

Faster, slower or irregular heartbeat or feeling your heartbeat

Low blood pressure (associated with large doses) Light-headedness, fainting or dizziness especially when going from sitting or lying position to standing up Flushing

Shallow or slow breathing (associated with larger doses) Feeling or being sick Constipation Dry mouth

Abdominal pain (may be caused by spasm of the bile ducts) Sweating

Firm, tight muscles, especially of the chest Problems passing urine (increased or decreased frequency or painful)

Low abdominal pain (may be caused by spasm of the urinary system)

Lack of sexual desire or inability to achieve/maintain

an erection

Drowsiness

Very rare side effects (may affect up to 1 in 10,000 people)

■ Inflammation of the pancreas, which causes severe pain in the abdomen and back

Risk of dependency

If you have taken these tablets regularly and for a long time, it is possible that you could become dependent on them (addicted) and your normal response to the medicine (tolerance) may be reduced. When you stop your treatment you may feel restlessness and irritable.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Co-codamol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from heat, light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.

[6 Contents of the pack and other information

What Co-codamol Tablets contain:

■    Each tablet contains 500mg of Paracetamol BP and 8mg of Codeine Phosphate BP

■    The other ingredients are: maize starch, povidone, potable water, magnesium stearate and pregelatinised starch.

What Co-codamol Tablets look like and contents of the

pack:

Co-codamol Tablets are white, flat, bevelled edge tablets of

12.5 - 12.9mm diameter with a breakline on one face and

"CO-MOL" logo on the other.

Co-codamol Tablets are available in:

■    Securitainers with plastic caps of 50, 100, 250, 500 or 1000 tablets

■    Blister packs of 32 or 100 tablets

B Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Co-codamol Tablets and seek medical advice immediately if you develop the following symptoms:

■    Allergic reactions: skin rashes, itching or itchy rash, swelling of the face, throat or tongue, breathlessness or difficulty in breathing or dizziness

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

■    Blood disorders which may increase the risk of bleeding or bruising (thrombocytopenia)

■    More prone to infections due to a severe reduction in number of white blood cells (agranulocytosis)

■    Kidney or urine problems

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road,

Eaton Socon, St. Neots,

Cambridgeshire PE19 8ET,

UK

Additional Manufacturer:

Bristol Laboratories Ltd.

Laporte Way,

Luton,

Bedfordshire LU4 8WL,

UK

Product Licence Number:

PL 11311/0153: Co-codamol Tablets

This leaflet was last revised in: February 2014

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