Co-Codamol Tablets
PACKAGE INFORMATION LEAFLET
CO-CODAMOL TABLETS BP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
- Keep this leaflet. Y ou may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to other. It may harm them; even if their symptoms are the same as yours.
WHAT IS IN YOUR MEDICINE?
The name of your medicine is Co-codamol Tablets BP. Each tablet contains paracetamol 500mg and codeine phosphate 8mg. The tablets also contain the inactive ingredients maize starch, povidone, purified water, magnesium stearate and pregelatinised starch. Co-codamol Tablets BP contain no preservatives, colouring or flavouring agents. Co-codamol Tablets BP are tablets with both analgesic and antipyretic properties. Analgesic drugs relieve the symptoms of pain and antipyretic drugs reduce (or lower) body temperature. Co-codamol Tablets BP are supplied in containers of 50, 100, 250, 500 or 1000 tablets and blister packs of 30, 32 or 100 tablets. Not all pack sizes may be marketed.
This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Codeine 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.
WHO MAKES CO-CODAMOL TABLETS BP?
GlobeGen Laboratories Ltd., 1406 Coventry Road, South Yardley, Birmingham, B25 8AE, UK.
WHAT ARE CO-CODAMOLTABLETS BP USED FOR?
Co-codamol Tablets BP are used to relieve mild to moderate pain such as headache, toothache, period pains, muscular and rheumatic pains and help to reduce (or lower) body temperature when you have a fever, relieving the symptoms of colds and flu.
BEFORE YOU TAKE CO-CODAMOL TABLETS BP
• Do not give Co-codamol Tablets BP to children who are less than 1 year old.
• Do not take Co-codamol:
• For pain relief in children and adolescents (under 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 breastfeeding
BEFORE taking Co-codamol Tablets BP carefully read the following list of questions.
If you can answer YES to any of the questions consult your doctor or pharmacist before taking the tablets.
• Are you allergic to paracetamol, codeine phosphate or any of the other listed ingredients in the tablets?
• Are you allergic to any other painkillers?
• Are you taking any other tablets or medicines, including any that have not been prescribed by your doctor?
• Are you pregnant, trying to become pregnant or breastfeeding?
• Do you have heart disease or heart failure, irregular heartbeat, blood pressure problems or lung disease?
• Do you have asthma or any other breathing difficulties?
• Do you have difficulty passing urine or known problems with your prostate gland?
• Do you have thyroid or adrenal gland disease?
• Have you suffered a recent head injury or do you have raised intracranial pressure (raised pressure in your head or on your brain)?
• Do you have liver or kidney disease?
• Do you suffer from bowel disease or have you suffered sudden severe abdominal pain (acute abdomen) or intestinal obstruction (a blocked bowel) due to lack of function of the gut (paralytic ileus)?
• Do you suffer from fits or convulsions?
• Do you suffer from myasthenia gravis (a muscle disease)?
• Are you addicted to drugs, are you an alcoholic or do you suffer from mood swings?
• Are you receiving monoamine oxidase inhibitor therapy or have you received such therapy within the last 14 days?
If any of the above apply to you, then your doctor may need to reduce the dose of Co-codamol Tablets BP or the tablets may need to be avoided altogether.
Ask your doctor or pharmacist if you do not understand any of the terms used in this section or if you are unsure whether any of these conditions apply to you.
Warnings and precautions
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
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.
Taking Other Medicines at the Same Time as Co-codamol Tablets BP
If taken with some other medicines the effects of Co-codamol Tablets BP or the effects of the other medicine may be altered. Your doctor may need to consider whether the dose of Co-codamol Tablets BP or the dose of the other medicine needs to be changed, or whether the two medicines should not be given together at all. Please be sure that your doctor knows if you are taking any other medicines, but especially if you are taking any of the following BEFORE you take Co-codamol Tablets BP.
• Monoamine oxidase inhibitors. You should not take Co-codamol Tablets BP if you are also taking monoamine oxidase inhibitors, or for at least 14 days after stopping them.
• Any other painkillers (including aspirin)
• Any drug used to treat anxiety or depression
• Tranquillisers or sleeping tablets
• Primidone or phenobarbitone (used to treat epilepsy)
• Drugs used to thin the blood (anticoagulants), such as warfarin, since regular use of Co-codamol Tablets BP could increase the risk of bleeding
• Cisapride, metoclopramide or domperidone (used to treat nausea (feeling sick), vomiting or other stomach problems)
• Cholestyromine (used to treat high blood lipid (fat) levels)
• Drugs for treating high blood pressure or water retention
• Cimetidine (used to treat ulcers or other stomach problems)
• Quinidine (used usually for heart disease)
• Mexiletine (used to treat irregular heart beat)
• Ritonavir (an HIV treatment)
• Anticholinergic drugs (also called antimuscarinics), which are most often used to treat urinary incontinence, urgency or frequency (e.g. oxybutynin, flavoxate), gastrointestinal problems or travel sickness (e.g. atropine, propantheline, dicyclomine, hyoscine) or Parkinson’s disease (e.g. benzhexol, benztropine, biperiden, orphenadrine, procyclidine). If you are unsure whether any other medicine you are taking is an anticholinergic (antimuscarinic) drug, ask your doctor or pharmacist.
• If you need to have an anaesthetic (e.g. for surgery), tell your doctor if you are taking Co-codamol Tablets BP
Note:
• Co-codamol Tablets BP should not be taken with any other medicines containing paracetamol.
• Co-codamol Tablets BP should not be taken with any other medicines containing codeine or codeine phosphate.
• You should avoid alcohol whilst you are taking Co-codamol Tablets BP.
Use during Pregnancy and Breast-feeding:
• Ask your doctor or pharmacist for advice before taking these tablets if you are pregnant, trying to become pregnant or breast-feeding.
• Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk
Driving and Using Machinery:
• Co-codamol Tablets BP may occasionally cause drowsiness. Do not drive or operate machinery if you are affected in this way.
HOW TO TAKE CO-CODAMOL TABLETS BP Adults:
Take one or two tablets four times a day. Leave at least four hours between doses.
Do not take more than 2 tablets at anyone time or more than 8 tablets in any 24-hour period.
Lower doses may be more suitable for the elderly and those who are weak and feeble.
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.
Co-codamol should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.
DO NOT EXCEED THE STATED DOSE.
If you take more Co-codamol Tablets BP than you should:
It is extremely important to follow the dosage instructions. Do not change the dose prescribed without discussing this first with your doctor. If you accidentally take more than the recommended dose or know someone who has, contact your doctor or hospital immediately.
Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed serious liver damage.
There may be no symptoms during the first 24 hours, although pallor, nausea, vomiting and abdominal pain may occur.
If you forget to take Co-codamol Tablets BP:
If you have forgotten to take a dose, take it as soon as you remember. NEVER take a double dose to make up for the dose you have missed. If symptoms persist for more than three days you should see your doctor.
POSSIBLE SIDE EFFECTS OF CO-CODAMOL TABLETS BP
Like all medicines, Co-codamol Tablets BP can have side effects.
The most common side effects with Co-codamol Tablets BP are constipation and drowsiness.Less frequent effects which may occur include allergic reactions (such as skin rashes, hives or itching), feeling sick or being sick, sweating, facial flushing, dry mouth, blurred or double vision, dizziness, tiredness or weakness, general malaise (generally feeling unwell), headache, anorexia (eating disorder), vertigo (feeling of spinning or tilting), slow or fast heartbeat, breathing difficulties, difficulty in passing urine, fits, hallucinations, nightmares, uncontrolled muscle movement or stiffening of muscles, mental depression, stomach cramps, dizziness on standing up (due to low blood pressure), and euphoria (mood changes).
There have been a few reports of blood disorders in patients taking paracetamol, but these were not necessarily due to the paracetamol treatment. The effects of Co-codamol Tablets BP may slowly begin to get less as time goes on (tolerance). If you take Co-codamol Tablets BP for a long time it is possible you could become dependent on them. If you notice any of the above effects or any other unusual effects, tell your doctor or pharmacist. Do not take any more Co-codamol Tablets BP in the meantime. If these tablets make you feel drowsy do not drive or operate machinery.
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 By reporting side effects you can help provide more information on the safety of this medicine.
STORING CO-CODAMOL TABLETS BP
• Keep Co-codamol Tablets BP out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original container.
Use by date: Do not use Co-codamol Tablets BP after the expiry date printed on the label. Marketing Authorisation Holder:
GlobeGen Laboratories Ltd., 1406 Coventry Road, South Yardley, Birmingham, B25 8AE, UK. PL 41318/0040
This leaflet was last revised in March 2015
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