CODEINE PHOSPHATE 30MG TABLETS

Active substance: CODEINE PHOSPHATE

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P150XXXX

P150XXXX

A/s : 22/09/14

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.
·
Keep this leaflet. You may need to read it again.
· any further questions, ask your doctor or pharmacist.
If you have
·
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.
· side effects gets serious, or if you notice any side effects not listed
If any of the
in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Codeine Phosphate Tablets are and what they are used for
2. 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. Further information
1.

WHAT CODEINE PHOSPHATE TABLETS ARE AND WHAT THEY ARE
USED FOR

Codeine Phosphate belongs to a group of medicines known as opioid analgesics
used to relieve pain, suppress coughs and treat diarrhoea.
2.

BEFORE YOU TAKE CODEINE PHOSPHATE TABLETS

Do not take Codeine Phosphate Tablets:
·
If you are allergic to Codeine Phosphate or to any of the other ingredients of
Codeine Phosphate tablets.
· that you metabolise very rapidly codeine into morphine.
If you know
·
If you are breastfeeding.
· liver disease.
If you have
Warnings and precautions
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 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.

Take special care with Codeine Phosphate Tablets:
Please tell your doctor before you start to take your tablets:
· had a drug addiction.
If you have
· liver or kidney problems.
If you have
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
other medicines including those medicines obtained without a prescription.

any

In particular tell your doctor if you are taking:
· to prevent you feeling sick or being sick e.g. metoclopramide or
Drugs used
domperidone.
· to regularise heart rhythm e.g. flecainide and mexiletine
Drugs used
·
Sleeping tablets, sedatives, tricylic antidepressants or phenothiazine
tranquillisers (you may feel more sleepy if you take these medicines)
If you are unsure about interactions with any other medicines, talk to your
pharmacist. This includes medicines prescribed by your doctor and medicine you
have bought for yourself, including herbal and homeopathic remedies.
Taking Codeine Phosphate Tablets with food and drink
You should avoid alcohol while taking these tablets.
Pregnancy and Breastfeeding
If you are pregnant or planning to become pregnant then consult your doctor or
pharmacist before taking these tablets.
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take codeine while you are breast feeding. Codeine and morphine passes in
to 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.
The Elderly: in all cases the dosage should be reduced.
Children(1-12years):
For relief of mild to moderate pain 3mg/kg daily in divided doses.
For dry or painful cough 15mg three to four times a day.
Diarrhoea: Not recommended.
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
Do not stop taking this medicine without telling your doctor first.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Codeine Phosphate Tablets may cause side effects in some
patients particularly when treatment is first started.
If you develop an allergic (hypersensitive) reaction e.g. skin rash or itching,
swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing, then
stop taking Codeine Phosphate Tablets and tell your doctor immediately.
· effects are dizziness, feeling sick, constipation and sweating.
Usual side
·
Unusual bruising, or infections such as sore throats – this may be a sign of
very rare changes in the blood
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5.

HOW TO STORE CODEINE PHOSPHATE TABLETS

Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package and keep containers tightly
closed.
Do not use the tablets after the expiry date is stated on the label.
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.

FURTHER 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 approved in 09/2014.

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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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