Co-Dydramol Tablets
PACKAGE INFORMATION
CO-DYDRAMOL TABLETS BP
Please read both sides of this leaflet carefully before you start take this medicine.
What is your medicine?
Co-dydramol Tablets BP contain Dihydrocodeine and Paracetamol both help to reduce pain.
Paracetamol also helps reduce fever and Dihydrocodeine may reduce coughing.
Co-dydramol Tablets BP contain 10mg Dihydrocodeine Tartrate and 500mg of Paracetamol in each white, circular, flat, beveledged tablets engraved LPC on one side and CODY on the other side. Each tablet is approximately 12.7 mm in diameter. The other ingredients are Povidone, Stearic Acid, Croscarmellose Sodium, Talc, Sodium Starch Glycollate Type A and Colloidal Anhydrous Silica.
Marketing Authorisation Holder: Activase Pharmaceuticals Limited
Boumpoulinas 11, 3rd Floor,
1060 Nicosia,
Cyprus
Co-dydramol Tablets BP are available in packs of 25, 50, 100, 250, 500 and 1000 in a plastic tub with a plastic tamper evident cap.
Why does your doctor want you to take this medicine?
Co-dydramol Tablets BP are used to treat one or more of the following problems:
• mild to moderate pain
• high temperature
• unproductive coughing
Doctors sometimes use Co-dydramol Tablets BP for other purposes. Consult your doctor for more information.
Before you take your medicine
You should only take this medicine if your doctor has advised you to. Co-dydramol Tablets BP should not be given to children under the age of 12 years. Tell your doctor if any of the following situations apply:
• If you are pregnant or breast feeding
• If you have suffered from asthma, lungs disease or other chest troubles
• If you have kidney or liver disease or heart failure
• If you are hypersensitive (have an allergic reaction) to paracetamol, codeine or any of the other
constituents or other opioid (narcotic) analgesics
• If you have had head injuries
• If you drink too much alcohol
• If you have intestinal obstruction
• If you are using antidepressant drugs (either currently or within past 14 days)
• If you have hereditary galactose intolerance or problem with absorption of galactose or glucose
• If you have low blood pressure, thyroid or adrenal or prostate gland problem
• If you have myasthenia gravis (a muscle disease)
• If you have a history of heart disease, any brain disorder, drug abuse or emotional instability
• If you are an elderly patient
Do not consume alcohol while taking this medicine.
• Do not take for longer than directed by your prescriber.
• Taking codeine 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 too long can make them worse.
Can you take co-dydramol Tablets BP with other medicines?
You can take Co-dydramol Tablets BP with other medicines but there are some medicines which can interfere. It is important to tell your doctor about all the medicines which you are taking, even those brought without a prescription.
Co-dydramol Tablets BP may interact with the following medicine:-
• Mexiletine-used to treat irregular heartbeat
• Sleeping tablets (including antidepressants, narcotic analgesics, anaesthetic and antipsychotic
drugs), /capsules and tranquilisers
• Monoamine-oxidase inhibitors-a type of antidepressant
• Warfarin and nicoumaline-anticoagulants used to thin the blood
• Cholestyramine-used to reduce blood cholesterol levels and treat diarrhoea
• Metoclopromide and domperidone- for the treatment of gastric disorders such as dyspepsia,
flatulence, heartburn, nausea and vomiting.
• Hepatic-enzyme inducing agents (e.g. rifampicin, barbiturates, carbamazepine, phenyltoin)
Hepatotoxic medication (e.g. analgesics, anti-diabetes, lipid-lowering medicines, antihypertensive, antiarrhythmics, antibiotics, psychotropic and hormonal medicines).
• Salicylates (analgesics)
• Quinidine used to treat heart problems
• Anticholinergics used to treat central nervous system (brain and spinal cord)
• Sildenafil (e.g. Viagra) and gabapentin used to treat epilepsy
You must not take any other Paracetamol or dihydrocodeine - containing products whilst also taking Co-dydramol Tablets BP.
If you are taking any of these products you should advise your doctor. If you are not sure if you are currently taking any of the above drugs you should seek advice from your doctor or pharmacist who will be able to assist you.
When and how to take your medicine
Your doctor has diagnosed your condition and has decided which doses of Co-dydramol Tablets BP are best for you.
Elderly patients or those with liver or kidney disease should be given a reduced dose.
Adults (including the elderly) and children over 12 years: For pain relief: One tablet every four to six hours. To alleviate or suppress coughing: One tablet every four hours. Maximum of eight tablets daily in divided doses.
Unless you have been instructed differently by your doctor you should take your medicine during or after meals. Swallow the tablets whole with a glass of water. Do not chew the tablets.
If you have forgotten to take a dose, take it as soon as you remember along with some food. However if it is almost time for your next dose, do not take the missed dose. Never double up a dose to make up for the dose you have missed.
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. If you have accidently taken an overdose of Co-dydramol Tablets BP call your doctor immediately or go to the nearest hospital casualty department. Always take any remaining medicine in the pack in which it was given to you, and also the label so that the medicine may be identified.
Always make sure that you continue to take this medicine for as long as the doctor has told you to.
Do not exceed the recommended dose especially if you have an alcoholic liver disease.
What if you take too much of these tablets.
Consult your doctor immediately in case of an overdose even if you feel well, because of the risk of delayed serious liver damage.
The symptoms of over dose may be: pallor, nausea, vomiting, anorexia and abdominal pain.
After you have taken your medicine.
Co-dydramol tablets BP are usually well tolerated. However like all medicines Co-dydramol tablets BP can cause side effects in some patients. Though uncommon these may include skin rashes or other allergic skin reactions, inflammation of skin and/or blood vessels, constipation, nausea, vomiting, headache, giddiness and drowsiness. Some uncommon adverse effects are lack of ability to urinate, some involuntary muscle movements in liver or bladder, dry mouth, mood changes, blurred vision, sweating, decreased libido (sexual desire), flushing, abdominal pain, low blood pressure, confusion, dizziness, pins and needles, hallucination, skin allergic reactions, obstruction of intestine and breathing disorders. Tolerance and dependence may occur. If Co-dydramol Tablets BP are used for a long time,liver damage may be caused.
You should not drive or operate machinery if affected by dizziness or sedation due to this tablet.
If you are worried by any side effects you may experience, or experience any other than those above, consult your doctor or pharmacist. If symptoms persist, consult you doctor.
Safe keeping of your medicine
Do not store above 25°C. Store in the original container. You must also keep the medicine in a safe place where children cannot get at it as the tablets could harm them.
Keep Co-dydramol Tablets BP in the containers in which they were given to you. Do not transfer them to other containers.
Never give Co-dydramol Tablets BP to anyone else even if they seem to have the same symptoms as you as the medicine may be harmful.
On the label you will find the letter “EXP” followed by some numbers. These numbers are the date when the medicine is no longer fit to use. Do not use the medicine after this date, but return it to your pharmacist.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has access to additional information.
The information in this leaflet applies only to Co-dydramol Tablets BP whose Product Licence Number is 28444/0141.
This leaflet was last revised in September 2013.
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