Codipar 15mg/500mg Effervescent Tablets
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517;
Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep this medicine out of the sight and reach of children.
• Do not use Codipar Effervescent Tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month.
• Do not store above 25oC.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Codipar Effervescent Tablets contain
• The active substances are codeine phosphate hemihydrate, 15mg and paracetamol, 500mg
• The other ingredients are sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, sorbitol neosorb P60 W, povidone K30, sodium saccharin, macrogol 6000 and grapefruit flavour.
What Codipar Effervescent Tablets look like and contents of the pack Codipar Effervescent tablets are white circular tablets,
Codipar Effervescent tablets are available in aluminium: polyethylene foils strips packs of 100 effervescent tablets (25 strips of 4 tablets).
Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London, EC4N 7BL, UK Manufactured By:
Unither Industries, ZI du Malcourlet, 03800 Gannat, France This leaflet was last revised in: August 2014.
Codipar is the registered trademark of Mercury Pharma Group Ltd.
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Codipar® 15mg/500mg Effervescent Tablets
Codeine Phosphate Hemihydrate/Paracetamol
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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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Codipar Effervescent Tablets are and what they are used for
2. Before you take Codipar Effervescent Tablets
3. How to take Codipar Effervescent Tablets
4. Possible side effects
5. How to store Codipar Effervescent Tablets
6. Further information
Codipar Effervescent Tablets contain paracetamol and codeine. Paracetamol is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Codipar Effervescent Tablets are used in adults for the relief of mild to severe short term pain. Codipar can be used in adults for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.
Do not take with any other paracetamol-containing products. Do not take for longer than directed by your prescriber. Do not use Codipar for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids as Codeine in Codipar may cause obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses). 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.
Do not take Codipar Effervescent Tablets if:
• you know that you are allergic to paracetamol or codeine, or any of the other ingredients (refer to section 6 below)
• you suffer from breathing problems, for example chronic bronchitis or emphysema or are suffering an asthma attack
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks MAOIs, such as phenelzine, moclobemide or isocarboxazid, are medicines used to treat depression
• you have just had a head injury or suffer from increased pressure on the brain
• you have severe problems with your kidneys or liver
• you know that you metabolise very rapidly codeine into morphine
• you are breast feeding
• you drink a lot of alcohol
• you have recently had an operation to your gall bladder.
Codipar Effervescent Tablets should not be taken by children under 18 years of age.
Take special care and tell your doctor or pharmacist before taking Codipar Effervescent Tablets if:
• you have any stomach pains or other sudden problems in your abdomen (belly)
• you are elderly
• you have liver or kidney problems, because the dose might need to be lower
• your prostate is larger than normal or you have a narrowing of your urethra (tube through which urine is passed)
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• you feel you have taken Codipar Effervescent Tablets for a long time. You may develop a dependence on Codipar Effervescent Tablets which may be harmful. Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. 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. 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 should 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.
Warnings and precautions Children and adolescents
Use in children and adolescents after surgery
Codeine must not be used for pain relief in children and adolescents after
removal of their tonsils or adenoids due to Obstructive Sleep Apnoea
Syndrome (sleep disruption due to respiratory pauses).
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.
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. 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:
• Medicines to treat depression such as amitriptyline, fluoxetine, sertraline etc
• Medicines used to treat high blood pressure such as furosemide, amiloride or bendroflumethiazide
• MAOIs used to treat depression, taken within the last 14 days (refer to “do not take if” in section 2 above)
• Medicines to treat mental illness, e.g. chlorpromazine, haloperidol etc
• Sedatives and sleeping tablets, e.g. temazepam and diazepam
• Medicines for irregular heart beats (mexiletine, quinine or quinidine)
• Drugs used to dry fluids in the mouth and lungs known as anticholinergics
• Medicines to treat diarrhoea or sickness (metoclopramide, domperidone)
• Medicines to treat epilepsy (e.g. phenytoin and carbamazepine)
• Colestyramine, used to treat high levels of lipids in your blood, or for problems related to your bile duct
• Ritonavir, used to treat HIV
• Other strong painkillers called opioids
• Medicines which prevent blood clotting (anticoagulants such as warfarin) Some products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels for ingredients.
Taking Codipar Effervescent Tablets with food and drink
Do not drink alcohol whilst taking Codipar Effervescent Tablets.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to become pregnant speak to your doctor or pharmacist before taking this medicine. Codipar Effervescent Tablets should not be used during pregnancy as they can affect the baby and can cause breathing problems when the baby is born. Do not take codeine while you are breast feeding. Codeine and morphine passes into breast milk.
Driving and using machines
Codipar Effervescent Tablets may cause dizziness or drowsiness and you should not drive or operate machinery if you are affected this way. Codeine may disturb your vision.
This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected.
There is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law Important information about some of the ingredients of Codipar Effervescent Tablets
This medicine contains sorbitol (389mg per tablet), which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 379 mg sodium in each tablet. This should be taken into consideration by patients on a controlled sodium (salt) diet.
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Always take Codipar Effervescent Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking the tablets:
The tablets must be put in a glass of water and allowed to completely dissolve. Drink the resulting solution immediately. Do not chew or bite your tablets.
Dose:
The usual dosage is two tablets every six hours as needed. You should not take more than 8 tablets in 24 hours. If you feel the effect of Codipar Effervescent Tablets is too strong or too weak, speak to your doctor or pharmacist. This 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. A lower dosage may be needed if you are elderly or have other medical problems. Check with your doctor about this. Codipar Effervescent Tablets are not recommended for children under 18 years. Do not take with any other paracetamol-containing products. Do not exceed the stated dose.
If you take more Codipar Effervescent Tablets than you should 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. Bring the remaining tablets and this leaflet with you so that the medical staff know what you have taken.
If you forget to take Codipar Effervescent Tablets
Do not take more than one dose at a time. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time. If you stop taking Codipar Effervescent Tablets
Codipar Effervescent Tablets can become habit forming. This is called dependence (addiction). If you stop taking your medicine suddenly it can cause withdrawal symptoms such as restlessness and irritability. Your doctor will stop your tablets gradually to avoid you having these withdrawal symptoms. If you find you need to use this product all the time, it is important to consult your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Codipar Effervescent Tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
The following side effects are serious. Talk to your doctor straight away if you notice them:
Rarely (affecting less than 1 in 1000 people):
• Unusual bruising, or infections such as sore throats - this may be a sign of rare changes in the blood.
Commonly (affecting less than 1 in 10 people):
• feeling overly elated or depressed
• shortness of breath.
Also:
• difficulty in passing urine
• small eye pupils, problems with vision
• slow or weak breathing
• yellowing of the skin or white of the eyes (symptoms of liver damage). Other side effects include:
Commonly (affecting less than 1 in 10 people):
• feeling sick (nausea) and being sick (vomiting)
• constipation
• headache
• light headedness, dizziness, sleepiness
• stomach pains
• skin rashes or itching.
If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
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 (see details below)
United Kingdom
The Yellow Card Scheme at:
or
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