Thursday, September 15, 2016

Codeine Phosphate Tablets BP (Wockhardt UK Ltd)






CODEINE PHOSPHATE TABLETS


Please read this leaflet carefully before you start to take this medicine. It gives a broad outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.



THE NAME OF YOUR MEDICINE IS CODEINE PHOSPHATE TABLETS


The active ingredient in Codeine Phosphate Tablets is Codeine Phosphate. The tablets contain 15mg, 30mg or 60mg of the active ingredient.


Codeine Phosphate 15mg Tablets are white circular tablets marked C15 on one face and CP on the other.


Codeine Phosphate 30mg Tablets are white circular tablets marked C30 on one face and CP on the other.


Codeine Phosphate 60mg Tablets are white circular tablets marked C60 on one face and CP on the other.


Codeine Phosphate 15mg and 30mg Tablets are available in strip packs of 28 and 30 tablets. Codeine Phosphate 60mg Tablets are available in strip packs of 30 tablets.


Other ingredients are lactose, acacia spray-dried, maize starch, magnesium stearate and stearic acid.


Codeine phosphate belongs to a group of medicines known as opioid analgesics used to relieve pain, suppress coughs and treat diarrhoea.



Marketing Authorisation Holder:



Wockhardt UK Limited

Ash Road North

Wrexham

LL13 9UF

UK




Manufacturer:



CP Pharmaceuticals Limited

Ash Road North

Wrexham

LL13 9UF

UK





What Are Codeine Phosphate Tablets For?


Codeine Phosphate Tablets are taken for the relief of mild to moderate pain, for dry or painful cough and diarrhoea.




Before Taking This Medicine



  • 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.

You should not take Codeine Phosphate Tablets if:-


  • You have severe problems with breathing.

  • You have been told you are allergic to codeine or any of the other ingredients in the tablet (check by reading the list of ingredients above).

  • You have been told you have liver disease.

  • You have recently suffered from a head injury or you have been told you have raised pressure on the brain.

  • You are suffering from acute alcohol poisoning.

  • You are at risk from intestinal paralysis or have a swollen abdomen.

  • You are suffering from severe diarrhoea.

Please tell your doctor before you take your tablets if any of the following apply to you.


  • You suffer from asthma. If your asthma is controlled you can take codeine, but use with care. You should not take codeine if you are having an acute asthma attack.

  • You have liver problems (but not actual liver disease).

  • You are a man who suffers from prostate problems. If so, codeine may make this condition worse.

  • You have low blood pressure.

  • You have kidney trouble.

  • You have an under-active thyroid (hypothyrodism).

  • You have had a drug addiction.

  • You are pregnant or breast-feeding or wish to become pregnant or start breast-feeding.

These tablets may cause drowsiness so you should avoid driving or operating machinery if affected.


Codeine Phosphate Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


There may be some problems when codeine phosphate tablets are taken with other medicines. These include:


  • drugs used to prevent feeling sick and being sick (e.g. metoclopramide and domperidone).

  • drugs used to regularise heart rhythm (mexiletine and quinidine).

  • drugs used to treat depression, tricyclic antidepressants.

  • drugs used to treat anxiety and insomnia (e.g. diazepam, nitrazepam).

  • Antipsychotics, used to treat mental illnesses including schizophrenia (e.g. chlopromazine, haloperidol).

It may be necessary to alter the dose of Codeine Phosphate Tablets or your other medicine.


  • You should not normally take codeine together with one of a group of medicines called ‘monoamine oxidase inhibitors’ (MAOIs), used to treat depression. Your doctor will advise you about this.

  • You should avoid alcohol or anything containing alcohol whilst taking these tablets.

If you have any doubts about whether you should take these tablets, talk to your doctor or pharmacist before
taking them.




Taking This Medicine


The usual adult starting dose for relief of mild to moderate pain is 30mg to 60mg every four hours when necessary.


The usual adult starting dose for diarrhoea is 30mg, three or four times daily.


The usual adult starting dose for a dry and painful cough is 15 to 30mg three or four times a day.


No more than 240mg should be taken in 24 hours.


In all cases, dosage will be reduced for elderly. Codeine Phosphate 30mg and 60mg Tablets are not recommended for children. Codeine Phosphate 15mg Tablets are not recommended for the treatment of diarrhoea in children.


Your doctor will decide the dose that is best for you. Always follow your doctor's instructions completely. Also, follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. If you do not understand or are in any doubt, ask your pharmacist.


Unless instructed differently, take your tablet(s) with a glass of water.


If you have been given a blister pack, to obtain a tablet, press on the tablet from the blister (or bubble) pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.


You should continue to take your medicine for as long as your doctor tells you to. If you forget a dose, take
another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all.
NEVER double the next dose to make up for the one missed. Do not stop taking the medicine without telling your doctor first.


If you accidentally take too many tablets you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.




After Taking This Medicine


Like many medicines, codeine phosphate tablets may cause side effects in some patients, particularly when
treatment is first started. Usual side effects are dizziness, slight drowsiness, feeling sick or being sick and
constipation.


Most people will not have any problems.


In a few people one of the following side effects may occur; headache, mood changes, slower or faster heart beat, palpitations, abdominal pain (caused by spasm in the tubes that carry urine to the bladder or bile to the
intestines), difficulty in passing water, rashes, wheals or itching, blurred vision, double vision or other problems with vision.


If you have to take these tablets for a long time, you may need higher doses as lower doses are no longer as
effective. You could become dependent on them. You should talk to your doctor if you think you are.


If you experience any other side effects or think you may be reacting badly in any way, tell your doctor or
pharmacist immediately.




Safe Keeping For Your Medicine


Do not take the tablets if the expiry date on the label has passed or if they show signs of deterioration such as discoloration. Do not store above 25°C. Store in the original package or container in which they were given to you in order to protect from light. Do not transfer them to another container. KEEP THEM IN A SECURE PLACE OUT OF THE REACH AND SIGHT OF CHILDREN. REMEMBER this medicine is for YOU only. Never give it to anyone else. It may harm them, even if the symptoms are the same as yours. Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to the pharmacist.



Other formats:


To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:



0800 198 5000 (UK Only)


Please be ready to give the following information:



  • Codeine Phosphate 15mg Tablets - Reference Number 29831/0048


  • Codeine Phosphate 30mg Tablets - Reference Number 29831/0049


  • Codeine Phosphate 60mg Tablets - Reference Number 29831/0050


This is a service provided by the Royal National Institute of the Blind.


DATE OF REVISION September 2007



CP1


103215/1






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