Co-Dydramol Tablets Bp
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297mm
CO-DYDRAMOL TABLETS BP
(Dihydrocodeine Tartrate 10 mg and Paracetamol 500 mg)
Read all of this leaflet carefully because it contains important information for you.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What are CO-DYDRAMOL Tablets and what are they used for?
2. Before you take CO-DYDRAMOL Tablets
3. How to take CO-DYDRAMOL Tablets
4. Possible side effects
5. Storing CO-DYDRAMOL Tablets
6. Further information
The name of this medicine is CO-DYDRAMOL Tablets BP These tablets have been prescribed for you to relieve moderate to severe pain and reduce coughing over a period of 4 to 6 hours. They contain the active ingredients dihydrocodeine tartrate and paracetamol which belong to a group of medicines called strong analgesics or ‘painkillers’. The other ingredients are listed in section 6 of this leaflet.
Do not take CO-DYDRAMOL Tablets if you:
• Are allergic (hypersensitive) to dihydrocodeine, paracetamol or any of the other ingredients of the tablets (see section 6 ‘Further Information’);
• Have breathing problems, such as breathing more slowly or weakly than expected, or obstructive airways disease;
• Are having an asthma attack;
• Have liver disease.
Children under 12 years of age should not take these tablets.
Special Precautions
Check with your doctor or pharmacist before taking your medicine if you suffer from any of the following:
• Have asthma or any allergies;
• Have an under-active thyroid gland (hypothyroidism);
• Have kidney or long-term liver problems;
• Are addicted to alcohol;
Do not take the tablets for longer than as directed by your doctor. Taking dihydrocodeine regularly for a long time can lead to addiction which might cause you to feel restless and irritable when you stop the tablets. Taking a painkiller for headaches too often or for too long can make the headache worse.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Any other medicines containing paracetamol (you should not take these tablets if you are already taking another medicine containing paracetamol);
• Medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
• Medicines to treat psychiatric or mental disorders;
• A type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobamide and linezolid), or you have taken this type of medicine in the last two weeks;
• Medicines to treat depression or anxiety;
• Metoclopramide or domperidone to stop you feeling or being sick;
• Cholestyramine to treat high blood pressure or diarrhoea;
• Medicines such as warfarin to prevent your blood clotting or to help thin your blood.
If you are unsure of the types of medicines you are taking, ask your doctor or pharmacist.
Taking CO-DYDRAMOL with alcohol
Drinking alcohol during your treatment with these tablets may make you sleepy. If you are affected you should avoid drinking alcohol.
Pregnancy and breast feeding
If you are pregnant or breastfeeding do not take these tablets until you have spoken to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel dizzy when taking these tablets. If you are affected you should not drive or use machinery.
Always take this medicine exactly as your doctor or pharmacist has told you. You should check with them if you are not sure. CO-DYDRAMOL should be taken orally. The tablets should be swallowed whole with a glass of water. Take the tablets during or after a meal.
Adults and children 12 years or over:
The usual starting dose for adults and children over 12 years of age is one or two tablets every 4 to 6 hours.
Your doctor will prescribe the dose required to treat your pain and/or cough. If you find that you are still in pain and/or no change in your cough whilst taking these tablets discuss this with your doctor.
Do not take more than eight tablets in 24 hours.
Do not take these tablets if you are already taking another medicine containing paracetamol.
Elderly:
If you are elderly your doctor may suggest a lower starting dose.
Children under 12 years of age:
This product should not be taken by children under 12 years of age.
If you take more CO-DYDRAMOL Tablets than you should:
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and sick, and have abdominal pain. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. You should contact your doctor immediately even if you feel well as there is a risk of serious liver damage.
When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show the doctor.
If you forget to take CO-DYDRAMOL Tablets:
If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten tablet.
If you stop taking CO-DYDRAMOL Tablets:
You should not stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first.
You may experience withdrawal symptoms such as such as agitation, anxiety, shaking or sweating.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, CO-DYDRAMOL Tablets can have side effects, although not everybody gets them.
Contact your doctor or pharmacist immediately if you
experience any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body as these may indicate a severe allergic reaction to the product.
• Possible Side Effects
Common side effects that some people notice when taking Co-dydramol are listed below:
• Constipation (Your doctor can prescribe a laxative to overcome this problem)
• Nausea (feeling sick)
• Vomiting (being sick)
• Headache
• Vertigo (a feeling of dizziness or 'spinning').
• A need to take increasingly higher doses to obtain the same level of pain relief (tolerance).
Rare side effects on long-term use include:
• Inflammation of the pancreas (which causes severe pain in the abdomen and back).
• Abnormal cells in the blood (blood dyscrasias) characterised by pale skin color and weakness such as:
• Thrombocytopenia (increase bleeding from injury and cuts)
• Purpura (red or purple discoloration of the skin)
• Agranulocytosis (sudden fever, shakes and sore throat)
As with all strong painkillers, there is a risk you may become addicted or reliant on these tablets.
Taking a painkiller for headaches too often or for too long can make your headaches worse.
If any of the above side effects are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. Storing CO-DYDRAMOL Tablets
Keep all medicines out of the reach and sight of children
Keep this medicine in the original package and store below 25°C. Protect from light and moisture.
Do not use CO-DYDRAMOL after the expiry date on the carton, pot and blister. The expiry date refers to the last day of that month.
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.
What CO-DYDRAMOL Tablets contains:
The active ingredients are paracetamol and dihydrocodeine tartrate.
Each tablet contains 500 mg of paracetamol and 10 mg of dihydrocodeine tartrate.
The tablets also contain starch, polyvinylpyrrolidone, sodium starch glycollate, stearic acid, colloidal silicon dioxide, talc and potable water.
What CO-DYDRAMOL looks like and contents of the pack
CO-DYDRAMOL Tablets are round, white tablets with the marking ‘A476’ on one side and the company logo on the other side.
CO-DYDRAMOL Tablets are available in pots of 10, 12, 20, 24, 25, 30, 50, 100, 250, 500 or 1000 tablets and blisters of 30 or 100 tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House Bury Street Ruislip Middlesex HA4 7TL UK
Manufacturer:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House Bury Street Ruislip Middlesex HA4 7TL UK
This leaflet was last approved in May 2011.
For information in large print, on tape, on CD or in Braille, phone 01895 627 420.
P0195-11-01/1 Auden Mckenzie
© Auden Mckenzie (Pharma Division) Ltd, Mckenzie House, Bury Street, Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420 info@audemmckenzie.com