CODEINE PHOSPHATE TABLETS BP 30MG
Active substance: CODEINE PHOSPHATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CODEINE PHOSPHATE TABLETS BP 15MG CODEINE PHOSPHATE TABLETS BP 30MG
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, please 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 effect 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 belongs to the group of medicines called opioid analgesics and are used for the relief of: mild to moderate pain. symptoms of a dry cough or diarrhoea.
2. Before you take Codeine Phosphate tablets
Warnings: 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 regularly for headaches too often or for too long can make them worse. Do not take these tablets if you: have ever been told you are allergic to codeine phosphate, other similar (opioid) pain killers and/or any of the ingredients in the tablet (see Section 6) have breathing problems, or other chronic lung disease
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suffer with alcoholism have suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes) are having an asthma attack have liver failure are at a risk of blocked intestines Take special care with this medicine if you: Check with your doctor or pharmacist before taking Codeine Phosphate tablets if you: have kidney or liver problems are elderly or frail have suffered from alcoholism, drug abuse or dependence or mental illness have low blood pressure or are in shock have an under-active thyroid gland have diseased adrenal glands (Addisons disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma) have an enlarged prostate gland and have difficulty urinating and are male have inflammatory bowel disease including severe bloody diarrhoea (pseudomembranous colitis) have gall bladder disease or gall stones recently had surgery on your gastro-intestinal tract or urinary system have muscle weakness (myasthenia gravis) have a history of seizures or fits (epilepsy) suffer from asthma or breathing problems 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. Especially: medicines to treat depression such as monoamine oxidase inhibitors (MAOIs e.g. moclobemide, linezolid, selegiline. Avoid Codeine Phosphate tablets for 2 weeks after stopping the MAOI) or trycyclics (e.g. amitriptyline) ciprofloxacin (antibacterial medicine) metoclopramide or domperidone (to prevent sickness) mexiletine or quinidine (to treat irregular heartbeats) loperamide or kaolin (to treat diarrhoea) cimetidine (to treat stomach ulcers)
medicines to treat high blood pressure antiviral medicines such as ritonavir medicines to treat allergies (antihistamines) that can cause drowsiness atropine (anticholinergic medicines) medicines which affect the nervous system such as chlorpromazine, diazepam, temazepam anaesthetics opioid antagonists (buprenorphine, naltrexone, naloxone) Taking this medicine with alcohol DO NOT drink alcohol whilst taking Codeine Phosphate tablets. Pregnancy and breast-feeding Do not take Codeine Phosphate tablets during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn. 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 using machines These tablets may make you feel drowsy, confused or dizzy, cause fits, blurred vision or double vision or to see things that are not there. Make sure you are not affected before you drive or operate machinery Important information about some of the ingredients of these tablets. This medicine contains LACTOSE. If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
3. How to take Codeine Phosphate tablets
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water. Codeine Phosphate tablets are normally used only for short-term relief of symptoms, take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice. The usual dose is as follows: ADULTS AND CHILDREN OVER 12 YEARS: For the relief of mild to moderate pain: 30 - 60mg every four hours up to a maximum of 240mg daily For the relief of diarrhoea: 15 - 60mg three to four times daily up to a maximum of 240mg daily For cough: 15-30mg three to four times a day. Elderly with liver or kidney damage: If you are elderly and have liver or kidney damage your doctor may give you a smaller dose. It is particularly important to take this medicine exactly as directed by the doctor. Do not exceed the stated dose. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OF AGE. If you take more Codeine Phosphate tablets than you should If you (or someone else) swallow a lot of tablets at the same time,or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow breathing rate, fast heart rate. If you forget to take a dose of Codeine Phosphate tablets If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE. If you stop taking these tablets Do not stop taking these tablets without talking to your doctor. Treatment should continue for as long as your doctor feels it is needed. If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure, restlessness, irritability,
anxiety, depression, anorexia, diarrhoea, excessive tears, runny nose, sneezing, yawning, hair standing on ends, widening of the pupil,weakness, fever, muscle cramps, dehydration.
5. How to store Codeine Phosphate tablets
Keep this medicine out of the sight and reach of children. Containers and blister carton: Do not store above 250C. Store in the original container and keep the container tightly closed in order to protect the tablets from light and moisture. Do not use these tablets after the expiry date shown on the carton or label. 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. This measures will help to protect the environment.
4. Possible side effects
Like all medicines, Codeine Phosphate tablets can cause side effects, although not everybody gets them. Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make 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 Freephone 0808 100 3352 (available between 10 am - 2 pm Monday-Friday) or fill in a paper form available from your local pharmacy. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Allergic reactions skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face Gastrointestinal system constipation, feeling or being sick, dry mouth, abdominal pain (may be caused by spasm of the bile ducts) Heart slow or fast heart rate, palpitations, low blood pressure, low blood pressure on standing Urinary system pain and difficulty in passing urine and less frequent need to do so Nervous system drowsiness, malaise, tiredness, dizziness, fits, increased pressure in the skull (painful eyes, change in vision or headache behind the eye), headache, tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly) Psychiatric effect mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, nightmares, confusion Eyes blurred or double vision, extremely small pupils Others muscle stiffness, decrease in sex drive, difficulty breathing, low body temperature If you notice any side effects, they get worse, please tell your doctor or pharmacist. This includes any side effects not listed in this leaflet.
6. Further Information
What Codeine Phosphate tablets contain The active substance is codeine phosphate The other ingredients are: lactose and stearic acid Codeine Phosphate tablets come in two strengths. Each tablet contains either 15mg or 30mg of the active ingredient codeine phosphate What Codeine Phosphate tablets look like and contents of the pack The tablets are white, round and uncoated. They are available in packs of 14, 25, 28, 30, 50, 56, 60, 84, 100, 250, 500 or 1000. Not all pack sizes may be marketed. Marketing Authorisation Holder Name and address: Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717 E-mail: info@bristol-labs.co.uk Codeine Phosphate tablets BP 15mg; PL 17907/0168 Codeine Phosphate tablets BP 30mg; PL 17907/0169 This leaflet was last revised in May 2012 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.
IXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE USER
CODEINE PHOSPHATE TABLETS BP 15MG CODEINE PHOSPHATE TABLETS BP 30MG
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, please 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 effect 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 belongs to the group of medicines called opioid analgesics and are used for the relief of: mild to moderate pain. symptoms of a dry cough or diarrhoea.
2. Before you take Codeine Phosphate tablets
Warnings: 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 regularly for headaches too often or for too long can make them worse. Do not take these tablets if you: have ever been told you are allergic to codeine phosphate, other similar (opioid) pain killers and/or any of the ingredients in the tablet (see Section 6) have breathing problems, or other chronic lung disease
IXXXXXX
suffer with alcoholism have suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes) are having an asthma attack have liver failure are at a risk of blocked intestines Take special care with this medicine if you: Check with your doctor or pharmacist before taking Codeine Phosphate tablets if you: have kidney or liver problems are elderly or frail have suffered from alcoholism, drug abuse or dependence or mental illness have low blood pressure or are in shock have an under-active thyroid gland have diseased adrenal glands (Addisons disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma) have an enlarged prostate gland and have difficulty urinating and are male have inflammatory bowel disease including severe bloody diarrhoea (pseudomembranous colitis) have gall bladder disease or gall stones recently had surgery on your gastro-intestinal tract or urinary system have muscle weakness (myasthenia gravis) have a history of seizures or fits (epilepsy) suffer from asthma or breathing problems 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. Especially: medicines to treat depression such as monoamine oxidase inhibitors (MAOIs e.g. moclobemide, linezolid, selegiline. Avoid Codeine Phosphate tablets for 2 weeks after stopping the MAOI) or trycyclics (e.g. amitriptyline) ciprofloxacin (antibacterial medicine) metoclopramide or domperidone (to prevent sickness) mexiletine or quinidine (to treat irregular heartbeats) loperamide or kaolin (to treat diarrhoea) cimetidine (to treat stomach ulcers)
medicines to treat high blood pressure antiviral medicines such as ritonavir medicines to treat allergies (antihistamines) that can cause drowsiness atropine (anticholinergic medicines) medicines which affect the nervous system such as chlorpromazine, diazepam, temazepam anaesthetics opioid antagonists (buprenorphine, naltrexone, naloxone) Taking this medicine with alcohol DO NOT drink alcohol whilst taking Codeine Phosphate tablets. Pregnancy and breast-feeding Do not take Codeine Phosphate tablets during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn. 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 using machines These tablets may make you feel drowsy, confused or dizzy, cause fits, blurred vision or double vision or to see things that are not there. Make sure you are not affected before you drive or operate machinery Important information about some of the ingredients of these tablets. This medicine contains LACTOSE. If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
3. How to take Codeine Phosphate tablets
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water. Codeine Phosphate tablets are normally used only for short-term relief of symptoms, take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice. The usual dose is as follows: ADULTS AND CHILDREN OVER 12 YEARS: For the relief of mild to moderate pain: 30 - 60mg every four hours up to a maximum of 240mg daily For the relief of diarrhoea: 15 - 60mg three to four times daily up to a maximum of 240mg daily For cough: 15-30mg three to four times a day. Elderly with liver or kidney damage: If you are elderly and have liver or kidney damage your doctor may give you a smaller dose. It is particularly important to take this medicine exactly as directed by the doctor. Do not exceed the stated dose. DO NOT GIVE TO CHILDREN UNDER 12 YEARS OF AGE. If you take more Codeine Phosphate tablets than you should If you (or someone else) swallow a lot of tablets at the same time,or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow breathing rate, fast heart rate. If you forget to take a dose of Codeine Phosphate tablets If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE. If you stop taking these tablets Do not stop taking these tablets without talking to your doctor. Treatment should continue for as long as your doctor feels it is needed. If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure, restlessness, irritability,
anxiety, depression, anorexia, diarrhoea, excessive tears, runny nose, sneezing, yawning, hair standing on ends, widening of the pupil,weakness, fever, muscle cramps, dehydration.
5. How to store Codeine Phosphate tablets
Keep this medicine out of the sight and reach of children. Containers and blister carton: Do not store above 250C. Store in the original container and keep the container tightly closed in order to protect the tablets from light and moisture. Do not use these tablets after the expiry date shown on the carton or label. 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. This measures will help to protect the environment.
4. Possible side effects
Like all medicines, Codeine Phosphate tablets can cause side effects, although not everybody gets them. Some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make 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 Freephone 0808 100 3352 (available between 10 am - 2 pm Monday-Friday) or fill in a paper form available from your local pharmacy. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Allergic reactions skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face Gastrointestinal system constipation, feeling or being sick, dry mouth, abdominal pain (may be caused by spasm of the bile ducts) Heart slow or fast heart rate, palpitations, low blood pressure, low blood pressure on standing Urinary system pain and difficulty in passing urine and less frequent need to do so Nervous system drowsiness, malaise, tiredness, dizziness, fits, increased pressure in the skull (painful eyes, change in vision or headache behind the eye), headache, tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly) Psychiatric effect mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, nightmares, confusion Eyes blurred or double vision, extremely small pupils Others muscle stiffness, decrease in sex drive, difficulty breathing, low body temperature If you notice any side effects, they get worse, please tell your doctor or pharmacist. This includes any side effects not listed in this leaflet.
6. Further Information
What Codeine Phosphate tablets contain The active substance is codeine phosphate The other ingredients are: lactose and stearic acid Codeine Phosphate tablets come in two strengths. Each tablet contains either 15mg or 30mg of the active ingredient codeine phosphate What Codeine Phosphate tablets look like and contents of the pack The tablets are white, round and uncoated. They are available in packs of 14, 25, 28, 30, 50, 56, 60, 84, 100, 250, 500 or 1000. Not all pack sizes may be marketed. Marketing Authorisation Holder Name and address: Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717 E-mail: info@bristol-labs.co.uk Codeine Phosphate tablets BP 15mg; PL 17907/0168 Codeine Phosphate tablets BP 30mg; PL 17907/0169 This leaflet was last revised in May 2012 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.
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
