Soluble Cupanol-Co Lemon Flavour
PATIENT INFORMATION LEAFLET
SOLUBLE CUPANOL-CO LEMON FLAVOUR
Soluble Cupanol-Co Lemon Flavour Tablets contain the following active ingredients:
Paracetamol 500mg Codeine Phosphate 8mg
In addition they also contain the following inactive
ingredients: Sodium Bicarbonate Sodium Carbonate (Anhydrous) Sodium Cyclamate 1968 Sodium Saccharin
Citric Acid Anhydrous Polyethylene Glycol Powder 6000 Povidone Lemon F-O-L 610406E
WHAT YOU SHOULD KNOW ABOUT SOLUBLE CUPANOL-CO LEMON FLAVOUR
Please read this leaflet carefully before you start to take this product. If you have any questions or are unsure about anything, ask your doctor or pharmacist.
PHARMACEUTICAL FORM
Cartoned strip packs containing 10, 12, 16, 24, 30, 50, 56, 60,100 or 112 tablets PRODUCT TYPE
Soluble Cupanol-Co Lemon Flavour have both pain relieving and temperature reducing properties.
MA HOLDER
Ayrton Saunders Ltd,
9 Arkwright Road, Astmoor Industrial Estate, Runcorn,
Cheshire,
WA7 1NU
MANUFACTURER
Cupal Ltd King Street, Blackburn, Lancashire,
BB22DX USES
1. For the relief of headaches, migraine, neuralgia, toothache, sore throat, rheumatic, muscular and period pain.
2. For the relief of symptoms of colds, flu and feverishness.
3. Codeine can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
4. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol.
BEFORE USING SOLUBLE CUPANOL CO- LEMON FLAVOUR
The following information should be read before using this medicine.
1. Do not use the product if you are sensitive to Paracetamol or codeine, or any of the other ingredients listed at the beginning of this leaflet.
2. Make sure these tablets are suitable for you to take - ask your doctor or pharmacist.
3. Do not take this medicine if you have kidney or liver problems.
4. Each tablet contains 430.1mg (18.7mmols) of sodium. This must be taken into consideration if you are on a sodium restricted diet.
5. Talk to your doctor before taking this product if you are taking any of the following medicines: barbiturates, anticonvulsants, tricyclic antidepressants, Chloramphenicol, Chloestyramine, Metoclopramide, Domperidone, Warfarin or other coumarin anticoagulants
6. Do not take this medicine if you are pregnant, unless your doctor tells you to.
7. This product contains paracetamol. Do not take other medicines containing Paracetamol at the same time as this medicine.
8. If symptoms persist for more than three days, consult your doctor.
9. Do not use for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.
10. Do not use if you know that you metabolise very rapidly codeine into morphine.
11. Do not use if you are breastfeeding.
12. Do not use if you are under 12 years old
13. For adolescents older than 12 years of age. Soluble Cupanol- is not recommended in adolescents with compromised respiratory function for the treatment of cough and/or colds
Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codine and relieves pain and symptoms of cough. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief or relieve their cough. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite
Children and adolescents:
Use in children and adolescents after surgery
Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
Pregnancy and breastfeeding:
Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.
DIRECTIONS FOR USE
Directions:
The tablets must be dissolved in half a glass of water (approximately 100 ml). The tablets dissolve more quickly in warm water, or if stirred.
Dosage:
Adults:
One to two tablets to be taken every four hours if necessary. Do not exceed 8 tablets in 24 hours.
Children aged 12 years or older:
Children aged 12 years or above should take one to two tablets every 6 hours, as needed. Do not take more than 8 in 24 hours.
Children 6-12 years:
Soluble Cupanol-Co Lemon Flavour Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems.
Elderly Patients:
Normal adult doses unless there is impaired kidney or liver function.
The maximum daily dose of codeine should not exceed 240mg.
The medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.
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.
UNDESIRABLE EFFECTS
If given in the stated doses, side effects are very rare. However, the following undesirable effects have been reported following use of this product:
1. Blood disorders including bleeding and bruising
2. Fever accompanied by throat and mouth ulcers
3. Severe pain in the stomach or back accompanied with shock
4. Hypersensitivity reactions including skin rashes and other allergic reactions.
5. Constipation, nausea, drowsiness and confusion.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine
STORING THIS PRODUCT
This product has a two year shelf life, its expiry date is given on the label.
Do not use Soluble Cupanol-Co Lemon Flavour after the expiry date shown on the carton. Soluble Cupanol-Co Lemon Flavour should be stored in a cool, dry place out of the reach of children.
Date of revision: January 2016