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Co-Codaprin Aspirin And Codeine Tablets

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PATIENT INFORMATION LEAFLET

CO-CODAPRIN TABLETS - ASPIRIN AND CODEINE TABLETS

Please read this leaflet carefully before you start to take Co-Codaprin Tablets. It gives you important information about your treatment. If you have any questions, or if you are not sure about anything, ask your doctor or pharmacist.

What is in the pack?

The name of your medicine is Co-Codaprin Tablets. They are supplied in packs of 25 tablets. The tablets contain the active ingredients Aspirin BP 400mg and Codeine Phosphate BP 8mg. They also contain the following inactive ingredients:

Starch and Talc

What is in your medicine?

Co-Codaprin Tablets contain aspirin which has pain killing and temperature reducing properties (helps fight fever) and codeine phosphate which is also a pain killer and helps relieve the symptoms of coughs.

Who supplies Co-Codaprin Tablets?

Product licence holder is Cupal Limited, Tubiton House, Oldham, OL1 3HS Product manufacturer is Cupal Limited, King Street, Blackburn BB2 2DX

What are Co-Codaprin Tablets used for?

Co-Codaprin Tablets are used to provide relief from pain in headaches and menstruation (period pains). Co-Codaprin Tablets also provide relief from colds, flu and feverishness.

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).

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 Co-Codaprin Tablets

The following information should be read before using this product.

   Have you ever had a reaction after using Co-Codaprin Tablets or to any of its ingredients?

•    Do you suffer from stomach problems (e.g. stomach ulcer)?

•    Do you suffer from dyspepsia (indigestion)?

•    Do you have haemophilia?

•    Are you sensitive to aspirin (particularly if you suffer from asthma)?

•    Do you suffer from respiratory depression (breathing problems)?

•    Are you taking any of the following medicines: Metaclopramide, Mexiletine, Heparin, Phenindione, Warfarin, Methotrexate, Probenecid or Sulphinpyrazone?

If the answer is YES to any of the above questions, do not take this medicine. Talk to your doctor or pharmacist. Do not exceed the stated dose.

•    Do not take if you have or have had a stomach ulcer.

•    Do not drink alcohol while taking this medicine.

•    There is a possible association between aspirin and Reye’s Syndrome when given to children. Reye’s Syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.

•    If you need to use this medicine for more than three days at a time, see your doctor, pharmacist or healthcare professional. Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop taking the tablets. Taking a painkiller for headaches too often or for too long can make them worse.

•    Do not take if you are under 12 years old.

•    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.

•    Do not use if you know that you metabolise very rapidly codeine into morphine.

•    Do not use if you are breastfeeding.

Adolescents older than 12 years of age

•    Codeine is not recommended in adolescents with compromised respiratory function for the treatment of cough and cold.

Warnings and precautions

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine 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.

How to take Co-Codaprin Tablets

Follow these instructions and never change the dose yourself. Adults and the Elderly

Take one or two tablets every three or four hours. Do not take more than 10 tablets in a day.

Do not give to children aged under 16 years, unless on the advice of a doctor.

Children aged 16 years - 18 years

One to two tablets every six hours. Do not take more than 8 tablets in a day.

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.

Co-Codaprin Tablets should not be taken by children below the age of 12 years, due to the risk of severe breathing problems if the body transforms rapidly codeine into morphine

Overdose

If you take too many Co-Codaprin Tablets, contact your doctor or the nearest accident and emergency (casualty) department. Take along any tablets that are left and the pack so that the hospital staff can easily tell what medicine you have taken.

Side Effects

Although side effects are uncommon, sometimes they may occur. These can include:

1.    Nausea (feeling sick), vomiting (being sick), dyspepsia (indigestion) and constipation.

2.    Asthma attack, bronchospasm (breathing difficulties) and hypersensitivity reactions (skin reactions, runny nose).

3.    Drowsiness and confusion.

4.    Irritation of the stomach lining e.g. erosion (wearing away) bleeding and ulcers.

5.    Aspirin increases bleeding time and delays blood clotting.

6.    Urination (passing water) may be difficult as aspirin can sometimes have an anti-diuretic effect (reduces the passing of urine).

Should you experience any of the above side effects, or any other unusual effects, stop taking the medicine and tell your doctor or pharmacist at once.

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

How to store Co-Codaprin Tablets

•    Do not use this product after its expiry date, which is given on the carton.

•    Keep the pack in a dry place at normal room temperature (25°C), protected from light.

•    Keep Co-Codaprin Tablets well out of the reach of children.

Date of leaflet: September 2015