Codeine Phosphate Tablets 15 Mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Codeine phosphate 15 mg tablets Codeine phosphate 30 mg tablets Codeine phosphate 60 mg tablets (codeine phosphate)
Read all of this leaflet carefully before you start taking this medicine.
• 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 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 Codeine phosphate tablets are and what they are used for
2. Before you take Codeine phosphate tablets
3. How to take Codeine phosphate tablets
4. Possible side effects
5. How to store Codeine phosphate tablets
6. Further information
1. WHAT CODEINE PHOSPHATE TABLETS ARE AND WHAT THEY ARE USED FOR
Codeine phosphate tablets belong to a group of medicines called opioid analgesics. Codeine phosphate tablets are used in:
• relief of mild to moderate pain
• symptomatic relief of coughing
• symptomatic relief of prolonged diarrhoea
2. BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS Do not take Codeine phosphate tablets if:
• you know that you are allergic to Codeine phosphate, other opioid pain killers or any of the other ingredients (refer to section 6 below)
• you have just had a head injury
• you suffer from any of the following:
° liver disease
° severe breathing problems ° neck stiffness ° acute alcoholism
° diarrhoea associated with either severe inflammation of the bowel or poisoning
Take special care and tell your doctor or pharmacist before taking Codeine phosphate tablets if:
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs, such as phenelzine or isocarboxazid, are medicines used to treat depression.
• you have a history of drug dependence, irregular heartbeat or convulsions.
• you have recently undergone gastro-intestinal surgery.
• you have been diagnosed as suffering from any of the following:
° low blood pressure
° deficiency in the activity of the thyroid gland ° enlarged prostate ° acute abdominal conditions
° gallstones
° severe weakness of muscles ° asthma
° reduced function of the adrenal glands, e.g. Addison’s disease
• you have kidney problems, because the dose might need to be lower.
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.
Codeine is known to interfere with some medicines. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
• MAOIs used to treat depression (refer to “Take special care” in section 2 above)
• Phenobarbitone
• Potassium iodide
• Sedatives
• Hypnotics and alcohol
• other anti-diarrhoeal agents
• Neuromuscular blocking agents
• Anti-hypertensives
• Cimetidine
Laboratory test results may also be affected.
Taking Codeine phosphate tablets with food and drink
Do not drink alcohol whilst taking Codeine phosphate tablets.
Alcohol may increase the sedative effects of Codeine phosphate tablets and make you very sleepy. You can also take the tablets regardless of food intake.
Pregnancy and breast-feeding
Do not use this medicine if you are pregnant.
Usually it is safe to take Codeine phosphate tablets while breast feeding as the level 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or operate machinery because you may suffer from sedation (calming), dizziness. This can affect driving or the operation of machinery.
Important information about Codeine phosphate tablets
• 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 for too long can make them worse.
Important information about some of the ingredients of Codeine phosphate tablets
This medicine contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE CODEINE PHOSPHATE TABLETS
Always take Codeine phosphate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is:
For the relief of mild to moderate pain:
Adults: 30-60 mg every four hours, when necessary to a maximum of 240 mg daily.
For the relief and prevention of coughing:
Adults: 15-30 mg three or four times daily.
For the treatment of prolonged diarrhoea:
Adults: 10-60 mg every four to six hours.
Codeine phosphate tablets are not recommended for children. A lower dosage may be needed if you are elderly. Swallow these tablets with water.
If you take more Codeine phosphate tablets than you should
If you take too many tablets contact your doctor or pharmacist at once for advice.
If you forget to take Codeine phosphate tablets
Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next tablet at the usual time.
If you stop taking Codeine phosphate tablets
Prolonged use can lead to tolerance and dependence on the medicine. Taking codeine regularly for a long time can be habit forming, which might cause you to feel restless and irritable when you stop the tablets. Your doctor will stop your tablets gradually to avoid you having withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Codeine phosphate tablets can cause side effects, although not everybody gets them.
If the following happens, stop taking Codeine phosphate tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:
• Allergic reactions (itch, skin rash, facial oedema)
• Convulsions
Possible undesirable effects are:
• Sedation
• Dizziness
• Feeling sick (nausea)
• Constipation
Other possible frequent undesirable effects are:
• Sweating
• Facial flushing
• Dry mouth
• Blurred or double vision
• Low blood pressure
• Malaise (general discomfort)
• Headache
• Loss of appetite
• Slow heart beat
• Difficulty in passing water
Rare side effects are:
• Hallucinations
• Nightmares
• Uncontrolled muscle movements and rigidity
• Mental depression
• Stomach cramps
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 CODEINE PHOSPHATE TABLETS
Keep out of the reach and sight of children.
Do not use Codeine phosphate tablets after the expiry date which is stated on the label.
The expiry date refers to the last day of that month.
Store below 25°C. Store the tablets in the original packaging. Do not put them in another container. For container packaging, replace the cap securely after use.
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 protect the environment.
6. FURTHER INFORMATION
What Codeine phosphate tablets contain:
• The active substance is codeine phosphate. Each tablet contains 15 mg, 30 mg or 60 mg of codeine phosphate.
• The other ingredients are lactose, starch, magnesium stearate and sodium starch glycolate.
What Codeine phosphate tablets look like and contents of the pack
Codeine phosphate 15 mg tablets are white, circular normal biconvex tablets embossed with R114 Codeine phosphate 30 mg tablets are white, circular normal biconvex tablets embossed with R115 Codeine phosphate 60 mg tablets are white, circular normal biconvex tablets embossed with R117
The tablets are available in 15 mg, 30 mg and 60 mg strengths and in containers of 1000, 500, 100, 90, 80, 70, 60, 50, 40, 30, 20 and 10 tablets and in blister strips of 100, 90, 80, 70, 60, 50, 40, 30, 20 and 10 tablets. The 30 mg strength is also available in blister strips of 28 tablets.
Manufacturer:
Ranbaxy Ireland Ltd., Spafield, Cork Road, Cashel, Co. Tipperary,
Ireland.
Marketing Authorisation Holder:
Activase Pharmaceuticals Limited 11 Boumpoulinas, 3rd floor P.C. 1060 Nicosia Cyprus
This leaflet was last revised in March 2016