Co-Dydramol Tablets Bp
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PACKAGE LEAFLET: INFORMATION FOR THE USER
(Dihydrocodeine Tartrate BP and Paracetamol BP)
Co-Dydramol Tablets BP
Read this entire leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or your 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Co-Dydramol Tablets are 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. How to store Co-Dydramol Tablets
6. Further Information.
1. WHAT CO-DYDRAMOL TABLETS ARE AND WHAT ARE THEY USED FOR?
The name of your medicine is Co-Dydramol Tablets BP.
The active ingredients in Co-Dydramol Tablets are paracetamol and dihydrocodeine tartrate. They belong to a group of medicines called analgesics, which act as painkillers. Paracetamol is also an antipyretic which means that it helps to reduce fever and lower your temperature. These tablets are usually used for relief of pain.
In addition the dihydrocodeine acts as a cough suppressant.
Co-Dydramol Tablets are also used for the prevention and relief of coughs.
2. BEFORE YOU TAKE CO-DYDRAMOL TABLETS
Do not take Co-Dydramol Tablets if:
• You are allergic (hypersensitive) to paracetamol and dihydrocodeine tartrate or any of the other ingredients in the tablets (An allergic reaction may include rash, itching, swelling of face, lips or hands/feet, or breathing difficulties).
• You have severe asthma, breathing problems or if you are having an asthma attack.
• You are under 12 years of age.
• You drink excessive amounts of alcohol.
• You have suffered head injury or raised pressure in the skull (may present as painful eyes, change in vision or headache behind the eyes).
If the answer to any of these questions is YES, tell
your doctor or pharmacist before taking
Co-Dydramol Tablets.
Take special care with Co-Dydramol Tablets if you
• Have difficulty breathing or suffer from long standing lung disease (chronic obstructive pulmonary disease)
• Have low blood pressure or are in shock (weakness, or fainting causing momentary loss of consciousness )
• Suffer form long lasting progressive disease characterized by varying degrees of fluctuating muscle weakness which worsens upon activity and improves with rest (Myasthenia gravis)
• Are a male with enlarged prostate gland and have difficulty in passing urine (prostatic hypertrophy)
• Suffer from abdominal pain, vomiting, diarrhea, bright red blood in stools, weight loss and associated complaints (inflammatory bowel disorder)
• Suffer form Adrenocortical insufficiency (you may experience weakness, tiredness, dizziness, low blood pressure that falls further when standing, muscle aches, nausea, vomiting, and diarrhea)
Before taking this medicine, you need to know the
following:
• This product contains paracetamol.
• Do not take with any other paracetamol containing products.
• If your symptoms last for more than 3 days talk to your doctor.
• Do not take Co-Dydramol Tablets for longer than 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 for too long may make them worse.
Talk to your doctor or pharmacist before taking Co-Dydramol Tablets if:
• You are pregnant or breast-feeding
(see ‘Pregnancy and breast-feeding’ below).
• You have asthma.
• You have serious problems with your liver or kidneys.
• You are elderly, as you may need a lower dose.
• You have an underactive thyroid (hypothyroidism).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription. Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
• Domperidone, Metoclopramide (both used to treat nausea and vomiting)
• Cholestyramine (used to treat diarrhoea or to reduce cholesterol levels or relieve itching)
• Anti-coagulants such as Warfarin (used to thin the blood)
• Drugs, which act on the central nervous system (like medicine to treat epilepsy, medicine to treat depression, sleeping pill, MAOIs, alcohol)
Taking Co-Dydramol Tablets with food and drink
The tablets should be taken with or after food.
Do not drink alcohol whilst taking Co-Dydramol Tablets. Alcohol may increase the sedative effects of Co-Dydramol Tablets and make you very sleepy. It can also increase the risk of some side effects.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine.
Do not take Co-Dydramol Tablets during pregnancy or whilst breast-feeding, unless on the advise of your doctor.
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Driving and using machines
Co-Dydramol Tablets may cause some people to become dizzy and have blurred vision or the inability to think clearly. Make sure you are not affected before you drive or operate machinery and do not drink alcohol, as this will make these effects worse. Other medicines may also increase these effects.
3. HOW TO TAKE CO-DYDRAMOL TABLETS
Always take Co-Dydramol Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Co-Dydramol Tablets are for oral use.
The tablets should be taken with or after food.
Swallow them with a glass of water.
DOSAGE:
Adults and children over 12 years:
For relief of pain: Take one tablet every four hours. This may be increased to 2 tablets four times a day. The maximum daily dose is 8 tablets. Do not take more than eight tablets in 24 hours.
For prevention and relief of coughs: Take one tablet every four hours.
Elderly: Your doctor may have reduced the dose for you. If this is the case follow your doctor's instructions.
Children under 12 years: Not recommended.
Your doctor will assess the risk-benefit of continued use of the medicine.
You should not take any other Paracetamol containing products at the same time.
To help you remember to take your medicine, try to take your tablets at the same time each day.
Take your tablets as directed and for as long as directed; do not stop them, even if you feel better, as otherwise the symptoms may return.
If you have the impression that the effect of Co-Dydramol Tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Co-Dydramol Tablets than you should
Always take the medicine as recommended by your doctor. If you take too much medicine, tell your doctor immediately or go to your local hospital emergency department, even if you feel well. This is because there is a delayed risk of, serious liver damage.
If you forget to take Co-Dydramol Tablets
Take your usual dose as soon as you remember, provided it is at least 4 hours since your last dose. Never take a double dose to make up for a missed dose.
If you stop taking Co-Dydramol Tablets
Do not stop taking these tablets immediately; it could make you feel restless or irritable. Talk to your doctor about reducing your dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS:
Like all medicines, Co-Dydramol Tablets can cause side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell.
Very serious side effects If any of the following happen, stop taking Co-Dydramol Tablets and tell your doctor immediately and go to the casualty department at your nearest hospital.
• Rapid swelling of the eyelids, face, lips, mouth and tongue, difficulty in breathing or swallowing, rashes, hives and itching. These are symptoms of a very serious allergic reaction.
• You bruise more easily, have bleeding gums or bleed for longer from any cut or injury or you feel tired or look pale.
• You seem to be getting more infections than usual or you develop ulcers in your mouth or throat.
Other side effects that some people notice when taking Co-Dydramol Tablets are listed below:
• Constipation
• Nausea (feeling sick)
• Headache
• Dizziness
• Giddiness
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.
5. HOW TO STORE CO-DYDRAMOL TABLETS
- Keep out of the sight and reach of children.
- Do not take after the expiry date that is printed on the carton and blister strip. The expiry date refers to the last day of that month.
- Keep this medicine in a dry place
- Do not store at or below 25°C
- Protect from light
- Store in the original package.
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:
What Co-Dydramol Tablets contain
The active substance is Dihydrocodeine Tartrate BP 10 mg and Paracetamol BP 500 mg.
The other ingredients are: Maize Starch, Povidone, Purified Water, Magnesium Stearate (E572), Sodium Starch Glycollate and Colloidal Silicon Dioxide.
What Co-Dydramol Tablets look like and contents of the pack
Co-Dydramol Tablets are white circular flat bevel edged tablets embossed R113.
The tablets are available in containers of 1000, 500, 250, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20 and 10 tablets and in blister packs of 100, 90, 80, 70, 60, 50, 40, 30, 20 and l0 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co. Tipperary, Republic of Ireland.
This leaflet was last revised in February 2009
