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CODEINE PHOSPHATE 15MG TABLETS BP

Active substance(s): 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 leaet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaet. 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 leaet.
What is in this leaet:
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 inammation 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 difculty 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 inammatory bowel disease, such as Crohn's disease or ulcerative colitisor a blockage in the bowel
• suffer from convulsions (ts)
• 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 rst. 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 difculties, or the baby could have difculty 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 six 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.

Artwork Same Size
Size : 180 x 600 mm
Kaypee Design
(kaypeedesign@gmail.com)
08 03 18

The Elderly: in all cases the dosage should be reduced.
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 leaet and also the box,
as this will allow easier identication 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 difculty 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. Difculty 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 ushing
• difculty breathing
• stomach cramps
• sweating
• dry mouth
• difculty 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 (inammation 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 leaet. You can also report side effects directly via the yellow card scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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
Milpharm Limited,
Ares Block, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom
This leaet was last revised in March 2018.

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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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