Co-Codamol 8mg/500mg Tablets
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24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains
important information for you.
This medicine is available without prescription to treat
minor conditions. However, you still need to take these
tablets carefully to get the best results from it.
• For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
• 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
• Keep this leaflet; you may need to read it again.
• Ask your pharmacist if you need more information or
advice_
In this leaflet:
Q What Co-Codamol Tablets are and what they are used for
Q Before you take Co-Codamol Tablets E9 How to take Co-Codamol Tablets Q Possible side effects Q How to store Co-Codamol Tablets Q Further information
1. What Co-Codamol Tablets are and what they are used for
• Co-codamol tablets contain a combination of two ingredients paracetamol and codeine phosphate. Paracetamol is a non-narcotic analgesic (pain killer) and codeine is an opiate analgesic.
• It can be used for the short term treatment of acute moderate pain. It can be used to relieve pain caused by headache, migraine, toothache, period pain, muscular pains and backache, that is not relieved by aspirin, ibuprofen or paracetamol alone.
2. Before you take Co-Codamol Tablets
• 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 a painkiller for headaches for more than 3 days it can make them worse
Do not take these tablets if you:
• have ever been told you are allergic to paracetamol, codeine (or other opioid pain killers) or to any of the other ingredients (these are listed in Section 6, Further Information)
• have severe asthma or breathing problems
• have liver disease
• have recently suffered from a head injury or you have been told you have raised pressure on the brain
• problems with your metabolism or stomach problems
• suffer from alcoholism
• are under 12 years of age
• are pregnant
Take special care with this medicine and talk to your
pharmacist or doctor if you:
• suffer from kidney or liver problems (including alcoholic liver disease)
• suffer from asthma or other breathing problems (see above)
• have low blood pressure, are in shock or very run down
• have an under-active thyroid gland (hypothyroidism) or adrenal glands
• have suffered from convulsions or have a seizure disorder (fits)
• have hormone imbalance
• have difficulty in passing urine
• are addicted to drugs or have been in the past
• have difficulty in moving around
• are a man with prostate problems Taking other medicines
! This medicine contains paracetamol.
Do not take with any other paracetamol-containing products.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as they may interact with this medicine.
The following medicines can affect Co-codamol:
• Other pain killers such as diflunisal
• Medicines to treat irregular heartbeats (e.g. mexiletine, quinidine)
• Medicines to prevent blood clotting (e.g. warfarin)
• Medicines to treat epilepsy (e.g. phenytoin, phenobarbital, primidone, carbamazepine)
• Medicines to treat ulcers (e.g. cimetidine)
• Medicines to reduce cholesterol in the blood (e.g.colestyramine)
• Antibacterial medicines (e.g. isoniazide)
• Oral contraceptives (the ‘pill’)
• Medicines to treat gout (e.g. probenecid)
• Medicines to treat depression - such as monoamine oxidase inhibitors (MAOIs). Avoid Co-codamol tablets for 2 weeks after stopping the MAOIs
• Medicines to treat diarrhoea (e.g. loperamide, kaolin)
• Medicines to treat nausea or vomiting (e.g. metoclopramide or domperidone)
• Medicines to treat anxiety and insomnia (e.g. diazepam and nitrazepam)
• Medicines to treat mental illnesses including schizophrenia (e.g. chlorpromazine and haloperidol)
If you go into hospital for surgery or tests, tell your doctor you are taking Co-Codamol Tablets, as you may interact with some anaesthetics and influence the results of certain tests and diagnostic procedures.
Taking this medicine with alcohol
• Do NOT drink alcohol whilst taking Co-Codamol Tablets. Pregnancy and breast-feeding
• Do Not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets
• Usually it is safe to take this medicine while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
• Always ask your doctor or pharmacist for advice before taking any other medicine.
Driving and operating machinery
• Thesetabletsmaymakeyoufeeldrowsy.affectyourvision and affect your ability to drive or operate machinery.
• Do NOT drive or operate machinery if the tablets have this effect on you.
Important Information about some of the ingredients of these tablets
• This medicine contains ethyl hydroxybenzoate (E214),
methyl hydroxybenzoate (E218), propyl *
hydroxybenzoate (E216), which may cause allergic | reactions. *
260mm
COCODAMOLTablets INSERT
SAME SIZE ARTWORK 130 x 260 mm Front
24 mm
3. How to take Co-Codamol Tablets
• You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults and Children over 12 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 hours and not more than 4 times in any 24 hour period.
• The maximum daily dose is 8 tablets (4.0g of paracetamol and 64mg of codeine phosphate) in any 24 hour period in divided doses.
The dose should be reduced in elderly patients.
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 Take special care with this medicine and talk to your pharmacist or doctor if you’
Do not take this medicine 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.
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your pharmacist if you are suffering from withdrawal symptoms.
Do not exceed the stated dose.
DO NOT GIVE TO CHILDREN UNDER 12 YEARS OF AGE. If symptoms persist consult your doctor.
If you take more Co-Codamol Tablets than you should Contact your nearest hospital A&E (casualty department) or your doctor immediately. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of risk of delayed, serious liver damage. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
Signs of overdose include difficulty in breathing; pupils may be pin-point in size, nausea, vomiting, loss of appetite and abdominal pain.
If you forget to take Co-Codamol Tablets
If you forget to take a dose, wait and take your next dose as usual.
DO NOTTAKEADOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE
• involuntary muscular movements (convulsions), stiffness of the muscles
• mood changes (including depression and more rarely euphoria) and confusion
• tiredness, dizziness, headache, dependence (symptoms are: restlessness and irritability may result when the treatment is stopped)
• low blood pressure (which may cause fainting)
• dry mouth
• respiratory depression, slower or faster heart beat, palpitations (irregular heartbeat)
• sweating and flushing
• loss of appetite and weight (anorexia)
• wheals or itching, skin rashes and blood problems (which may cause sore throat, mouth ulcers and fever or a tendency to bleed or bruise easily)
• abdominal pain (may be caused by spasm of the bile ducts)
• pain and difficulty in passing urine and less frequent need to do so
• kidney problems
• sexual dysfunction (decrease in sex drive) in men
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
How do I know if I am addicted?
If you take the medicines 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.
5. How to store Co-Codamol Tablets
• Keep out of the reach and sight of children.
• Do not store above 25°C. Store in the original package or container to protect the tablets from light and moisture.
• Do not use these tablets after expiry date shown on the carton or label.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further Information
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4. Possible Side Effects
Like all medicines, Co-Codamol Tablets can cause side effects, although not everybody gets them.
If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to mate sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Free phone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy
STOP taking and contact your doctor at once if any signs of an allergic reaction occur such as:
• itchy skin rash
• swelling of the face, lips, tongue or throat
• breathing difficulty or swallowing
Tell your doctor If you notice any of the following side effects or notice any other effect not listed:
Common side effects include:
• feeling sick (nausea) or being sick (vomiting)
• constipation
• drowsiness
Less frequent and rare side-effects include:
• blurred or double vision
• nightmares or seeing or hearing things that are not real (hallucinations)
What Co-Codamol Tablets contain
• The active substance is codeine phosphate and paracetamol
• The other ingredients are: maize starch, potato starch, povidone, stearic acid, talc, magnesium stearate, nipasept (nipasept contains: methyl-p-hydroxy benzoate (E218), ethyl-p-hydroxy benzoate (E214) and propyl-p-hydroxy benzoate (E216)).
What Co-Codamol Tablets look like and contents of the
pack
• The tablets are white and round with a breakline on one side and <AB> debossed 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.
Marketing Authorisation Holder
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP41 EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email:
Co-Codamol 8mg/500mg Tablets; PL 17907/0162 This leaflet was last revised in July 2011
To request a copy of this leaflet in Braille, large print or audio format then please contact the licence holder at the address (or telephone, fax, email) above.
COCODAMOL Tablets INSERT
SAME SIZE ARTWORK
130 x 260 mm
Front