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CODEINE PHOSPHATE 15MG TABLETS BP

Active substance(s): CODEINE PHOSPHATE / CODEINE PHOSPHATE / CODEINE PHOSPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Codeine Phosphate 15mg Tablets BP
Codeine Phosphate 30mg Tablets BP
Codeine Phosphate 60mg Tablets BP
(Codeine Phosphate)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.


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 only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.



If you get any side effects, talk to your doctor or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1.

What Codeine Phosphate Tablets are and what they are used for

2.

What you need to know 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.

Contents of the pack and other information

1.

WHAT CODEINE PHOSPHATE TABLETS ARE AND WHAT THEY ARE
USED FOR

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.
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.

These tablets are used to relieve pain, suppress coughs and treat diarrhoea.
2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE CODEINE PHOSPHATE
TABLETS



do not take for longer than directed by your prescriber



taking codeine regularly for a long time can lead to addiction, which might
make you feel restless and irritable when you stop the tablets



taking a painkiller for headaches too often or for too long can make them
worse

Codeine Phosphate Tablets should not be given if you:


have ever had a reaction to or been told that you are allergic to codeine
phosphate, any other opioid analgesic or any of the other ingredients in the
tablets (see section 6)



have been told you have a tumour of the adrenal gland near your kidney called
phaeochromocytoma



have severe problems with breathing



are pregnant or breast-feeding



have increased pressure on the brain, have just had a head injury or if you are
unconscious



are suffering from acute alcoholism



are at risk from a blocked intestine



have severe stomach cramps caused by a condition known as biliary colic



are suffering from severe diarrhoea



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



know that you metabolise very rapidly codeine into morphine

Speak to your doctor before you take Codeine Phosphate Tablets if you:


are using drugs or have used drugs in the past as taking codeine phosphate for
a long time can lead to addiction



are taking or have taken within the last two weeks, monoamine oxadise
inhibitors (MAOIs) such as moclobemide, or phenelzine used in the treatment of
depression



suffer from asthma (your doctor may decide to administer Codeine Phosphate
Tablets if your asthma is controlled. However, you should not be given this
medicine if you are having an acute asthma attack)



suffer from bronchitis (an inflammation of the lining of the tubes in the lungs,
resulting in coughing spells accompanied by thick phlegm and breathlessness)
or emphysema (a lung condition which leaves you struggling for breath)



suffer from cor-pulmonale (a type of heart failure)



are severely obese



have a severely deformed spine



are suffering from mental illness brought on by an infection



have liver problems



have kidney problems



have problems with your bile duct



suffer from an enlarged prostate gland (in men) or have difficulty passing urine



have an under-active thyroid or adrenal gland



have low blood pressure



are in a state of severe shock



are very run down



have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis

or a blockage in the bowel


suffer from convulsions (fits)



are a child or elderly



are feeling weak and feeble



have 'myasthenia gravis' (tiredness and weakness of some muscles e.g. eyes,
mouth and throat muscles)



are a poor metaboliser of codeine

If any of the above apply to you, speak to your doctor, nurse or pharmacist before you take Codeine
Phosphate Tablets.
Contains 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.
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.
Warnings and precautions
Codeine is transformed to morphine in the liver by an enzyme. Morphine is the
substance that produces the effect of codeine and relives 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.
Other Medicines and Codeine Phosphate Tablets
It is very important that you inform your doctor if you are taking or have taken any other medicines, as
some medicines may affect the way Codeine Phosphate Tablets work. In particular, tell your doctor if
you are taking any of the following:


monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine
used in the treatment of depression. You must also tell your doctor if you have
stopped taking any of these or related medicines in the last two weeks



tricyclic antidepressants, which are used in the treatment of depression
tranquillising drugs or sleeping tablets such as diazepam, nitrazepamand
temazepam



medicines used to treat mental illnesses, including schizophrenia (e.g.
chlorpromazine, haloperidol)



medicines used for diarrhoea (e.g. loperamide, kaolin)



medicines which are used as premedication before operations and after heart
attacks such as atropine



anaesthetics, particularly general anaesthetics (used in surgery to numb pain)



antihistamines such as benadryl (used to treat allergies e.g. hayfever)



sodium oxybate (used to treat narcolepsy)



medicines used to treat nausea and vomiting, such as metoclopramide or
Domperidone



mexiletine or quinidine, used to control heart rhythm



cimetidine, used to treat stomach ulcers and indigestion



ritonavir, used to treat HIV (a viral infection)

Taking Codeine Phosphate Tablets with food, drink and alcohol

You should not drink alcohol whilst you are taking Codeine Phosphate Tablets, as they will increase its
effects. Alcohol may increase the sedative effects of codeine phosphate and make you very sleepy.
Pregnancy, breast-feeding and fertility
You should not be given codeine if you are pregnant or think you might be pregnant unless you have
discussed this with your doctor first. If you are given codeine during pregnancy and become dependent
on it, there is a risk that the new-born baby may also be dependent and suffer from withdrawal
symptoms following delivery. If you are given codeine during labour there is a risk that you could be sick
and have breathing difficulties, or the baby could have difficulty starting breathing. Do not take codeine
while you are breastfeeding. Codeine and morphine passes into breast milk.
Driving and using machines
Codeine Phosphate tablets may cause drowsiness so you should avoid driving or
operating machinery if affected.
Important information about some of the ingredients of Codeine Phosphate
Tablets:
These tablets contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars then do not take these tablets until you have consulted
your doctor.
3. HOW TO TAKE CODEINE PHOSPHATE TABLETS
Always take Codeine Phosphate Tablets exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Unless instructed differently, take your tablet(s) with a glass of water.
The usual oral dose is:
Adults
For relief of mild to moderate pain, 30mg to 60mg every four hours.
For diarrhoea, 30mg three or four times daily.
For a dry and painful cough, 15 to 30mg three or four times a day.
No more than 240mg should be taken in 24 hours.
Adolescents older than 12 years of age

Codeine phosphate tablets are not recommended in adolescents with
compromised respiratory function for the treatment of cough.
The Elderly: in all cases the dosage should be reduced.
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.
If you take more Codeine Phosphate Tablets than you should
If you or someone else swallow several of these tablets together, contact your
doctor or nearest hospital emergency department immediately. Always take any
tablets left over with you, this leaflet and also the box, as this will allow easier
identification of the tablets.
If you forget to take Codeine Phosphate Tablets
If you miss a dose, take it as soon as you remember and carry on as before. If it is
almost time for your next dose, skip the forgotten dose and continue as usual. Do
not take a double dose to make up for a forgotten dose.
If you stop taking Codeine Phosphate Tablets
You should always check with your doctor before the treatment is stopped. It is possible that you could
become dependent on codeine and have withdrawal symptoms if it is stopped suddenly. This is more
likely if you have a tendency for drug abuse or if you become dependent on Codeine Phosphate Tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines, codeine can cause side effects, but not everybody gets them. Tell your doctor or
nurse immediately if you experience the following serious side effect:


a severe allergic reaction (allergic reactions include mild symptoms such as
itching and/or rash. More severe symptoms include swelling of the face, lips,
tongue and/or throat with difficulty in swallowing or breathing). If you suffer such
a reaction, you should not be given any more codeine. Your doctor will decide
on the appropriate treatment for allergic reactions. Difficulty in breathing and
physical and psychological dependence are possible serious side effects. It is

possible that you could become dependent on codeine.
Side effects that are common include:


drowsiness



feeling sick or being sick



constipation



sweating

Apart from constipation, these side effects tend to disappear with time. Side effects that are less
common include:


dizziness



feeling faint on standing up



small pupils (in the eye)



blurred vision



double vision or other changes in vision



mental clouding or confusion



mood changes such as depression and sadness



feeling extremely happy for no particular reason



imagining things (hallucinations)



nightmares



headache



vertigo (a feeling of dizziness or being lightheaded)



facial flushing



difficulty breathing



stomach cramps



sweating



dry mouth



difficulty or pain in passing urine



passing less urine than usual



biliary spasm (causing pain in the right side of your abdomen, particularly after
eating a meal, which may spread towards your right shoulder)



palpitations (trembling, shaking, irregular heart beats)



increased pressure within your head (raised intracranial pressure)



hyperglycaemia (abnormally high levels of glucose in the blood)



pancreatitis (inflammation of the pancreas)



feeling unwell



feeling tired



hypothermia



fever



an enlarged spleen or swollen/enlarged lymph nodes



anorexia



uncontrolled muscle movements



restlessness



muscle rigidity



slower or faster pulse



skin rash



wheals or itching



reduced sexual drive or impotence after long term use.

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.
5. HOW TO STORE CODEINE PHOSPHATE TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package and keep containers tightly
closed.
Do not use Codeine Phosphate Tablets after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Codeine Phosphate Tablets contains
The active substance is Codeine Phosphate.
The other ingredients are lactose monohydrate, acacia, maize starch, magnesium
stearate and stearic acid. (see Section 2 'Important information about some of the
ingredients of Codeine Phosphate Tablets').
What Codeine Phosphate Tablets looks like and contents of the pack
Codeine Phosphate Tablets 15mg are white, circular tablets marked C15 on one
face and CP on the other.
Codeine Phosphate Tablets 30mg are white, circular tablets marked C30 on one
face and CP on the other.
Codeine Phosphate Tablets 60mg are white, circular tablets marked C60 on one
face and CP on the other.
Codeine Phosphate Tablets are available in container packs of 28,30,56,60,84,90,

100, 250 and 500 tablets. They are also available in blister packs of 28, 30, 56, 60,
84,90 and 100 tablets (Not all pack sizes may be marketed).
Marketing Authorisation Holder
Aurobindo Pharma Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
Manufacturer
CP Pharmaceuticals Limited,
Ash Road North, Wrexham Industrial Estate,
Wrexham, LL13 9UF, United Kingdom
This leaflet was last revised in 02/2017.

Expand Transcript

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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