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CODEINE PHOSPHATE TABLETS BP 30MG

Active substance(s): CODEINE PHOSPHATE

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Codeine Phosphate 15mg,
30mg and 60mg tablets
Read all of this leaflet carefully before you start taking
this medicine.
• 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. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.

Index
1 What Codeine Phosphate tablets are and what
they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further 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
Phosphate tablets are used for the relief of:
• mild to moderate pain.
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.
• symptoms of a dry cough or diarrhoea.

2 Before you take

Do not take Codeine Phosphate tablets:

• if you are allergic (hypersensitive) to codeine or other opioids, or any of the
ingredients in the tablet (see section 6)
• if you have difficulty breathing, or other chronic lung disease
• if you have suffered head injury or raised pressure in the skull (may cause
painful eyes, changes in vision or headache behind the eyes)
• if you are having an asthma attack
• if you have liver failure
• if you are at risk of blocked intestines
• if you suffer with alcoholism.
• if you are under 12 years old
• 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
• if you know that you metabolise very rapidly codeine into morphine
• if you are breastfeeding

Check with your doctor or pharmacist before taking Codeine
Phosphate tablets if you have:

• liver or kidney problems
• diseased adrenal glands (Addison’s disease) or high blood pressure caused
by a tumour near a kidney (phaeochromocytoma)
• inflammatory bowel disease including severe bloody diarrhoea
(pseudomembranous colitis)

• gall bladder disease or gall stones
• recently had surgery on your gastro-intestinal tract or urinary system
• an enlarged prostate gland and have difficulty urinating and are male
• epilepsy
• are elderly or frail
• suffer with asthma or breathing problems
• an underactive thyroid gland
• muscle weakness (myasthenia gravis)
• low blood pressure or are in shock
• suffered from alcoholism, drug abuse or dependence or mental illness.
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.
• Adolescents older than 12 years of age:
Codeine is not recommended in adolescents with compromised respiratory
function for the treatment of cough

Other important warnings

• 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription. Especially:
• medicines to treat depression such as monoamine oxidase inhibitors (MAOIs
eg moclobemide, linezolid, selegiline. Avoid Codeine Phosphate tablets for 2
weeks after stopping the MAOI) or tricyclics (eg amitriptyline)
• ciprofloxacin (antibacterial medicine)
• metoclopramide or domperidone (to prevent sickness)
• mexiletine or quinidine (to treat irregular heartbeats)
• loperamide or kaolin (to treat diarrhoea)
• cimetidine (to treat stomach ulcers)
• medicines used to treat high blood pressure
• antiviral medicines such as ritonavir
• medicines to treat allergies (antihistamines) that can cause drowsiness
• atropine (anticholinergic medicines)
• medicines which affect the nervous system such as chlorpromazine,
diazepam, temazepam
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Codeine Phosphate 15mg 30mg & 60mg tablet leaflet - UK

colours/plates:
1. Black

item no:
print proof no:

AAAI1466
2

origination date: 21.07.15
approved for print/date

originated by:

jh

revision date:

24.07.15

dimensions:

148 x 210

pharmacode:
min pt size:

JDE No.:

3.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.
6.

Technical Approval

revised by:

jh

date sent:

supplier:

UK

technically app. date: N/A

N/A

50866540

2.
4.

7

Codeine Phosphate Tablets
15, 30 & 60mg x 28’s (UK)

Non Printing Colours
1.
2.
3.

Pharmacode: 2913
Date Sent:
13/07/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Driving and using machines

Codeine Phosphate tablets may make you feel drowsy, confused or dizzy, cause fits,
blurred or double vision or to see things that are not there. Make sure you are not
affected before you drive or operate machinery.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to
drive while taking this medicine.

Pregnancy and breast-feeding

Do not take Codeine Phosphate tablets during pregnancy unless advised by your
doctor. Regular use during pregnancy may cause withdrawal symptoms in the
newborn.
Do not take codeine while you are breastfeeding. Codeine and morphine passes
into breast milk. Usually it is safe to take codeine phosphate while breast feeding
as the level of the active ingredients of this medicine in breast milk are too low to
cause your baby any problems. However, some women who are at increased risk of
developing side effects at any dose may have higher levels in their breast milk. If any
of the following side effects develop in you or your baby stop taking this medicine
and seek immediate medical advice; feeling sick, vomiting, constipation, decreased
or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or
slow breathing.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor
before taking this medicine, as it contains a type of sugar called lactose.

3 How to take

Always take Codeine Phosphate tablets exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist.
Do not drink alcohol whilst taking Codeine Phosphate tablets. Swallow the tablets
with water.
Codeine Phosphate tablets are normally used only for short-term relief of
symptoms, take this medicine for as long as your doctor tells you to, it may be
dangerous to stop without their advice.

Doses:

• A dults:

For pain relief – 30 - 60mg every four hours up to a maximum of 240mg a day.
For diarrhoea – 15 - 60mg three to four times a day.
For cough – 15 - 30mg three to four times a day.
• C hildren aged 12 years or above:
For pain relief - 30 - 60mg every 6 hours, as needed. Do not take more than
240mg in 24 hours. 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.
• Children under 12 years: codeine phosphate should not be taken by children
below the age of 12 years, due to the risk of severe breathing problems.
• E lderly with liver or kidney damage: your doctor may give you a smaller dose.
If you are elderly, it is particularly important to take this medicine exactly as
directed by the doctor.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a
child may have swallowed any contact your nearest hospital casualty department
or tell your doctor immediately. Symptoms of an overdose include feeling or being
sick, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow breathing rate,
fast heart rate.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a
dose take it as soon as you remember it and then take the next dose at the right
time.

If you stop taking the tablets

If you stop taking the tablets you may develop the following withdrawal symptoms:
tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate,
breathing or blood pressure, restlessness, irritability, anxiety, depression, anorexia,
diarrhoea, excessive tears, runny nose, sneezing, yawning, hair standing on ends,
widening of the pupil, weakness, fever, muscle cramps, dehydration.

4 Possible side effects

Like all medicines, Codeine Phosphate tablets can cause side effects, although not
everybody gets them.

Tell your doctor if you notice any of the following side effects or notice any other
effects not listed:
•A
 llergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating,
redness or flushed face
•G
 astrointestinal system - constipation, feeling or being sick, dry mouth,
abdominal pain (may be caused by spasm of the bile ducts)
•H
 eart - slow or fast heart rate, palpitations, low blood pressure, low blood pressure
on standing
•U
 rinary system - pain and difficulty in passing urine and a less frequent need to
do so
•N
 ervous system - drowsiness, malaise, tiredness, dizziness, ‘spinning’ sensation,
fits, increased pressure in the skull (painful eyes, changes in vision or headache
behind the eyes), headache, tolerance (medicine has less effect) or dependence
(suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate,
increased breathing rate, raised blood pressure and feeling or being sick if the
medicine is stopped too quickly)
• P sychiatric effects – mood changes, depression, hallucinations (seeing or hearing
things that are not real), restlessness, excitation, nightmares, confusion
• Eyes - blurred or double vision, extremely small pupils
•O
 thers - muscle stiffness, decrease in sex drive, difficulty breathing, low body
temperature.

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

Keep out of the reach and sight of children.
Store below 25°C in a dry place, protected from light
Do not use Codeine Phosphate tablets after the expiry date stated
on the label/carton/bottle. The expiry date refers to the last day of
that month.
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 contain

• The active substance (the ingredient that makes the tablets work)
is codeine phosphate. Each tablet contains either 15mg, 30mg or
60mg of the active ingredient.
• The other ingredients are lactose, magnesium stearate,
pregelatinised maize starch, maize starch, stearic acid.
What Codeine Phosphate tablets look like and contents of the
pack
Codeine Phosphate are white, circular, biconvex uncoated tablets.
Pack sizes are 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in July 2015

Continued top of next column
50866540

AAAI1466

148x210 Leaflet Reel Fed Profile (BST)

Codeine Phosphate 15mg 30mg & 60mg tablet leaflet - UK

colours/plates:
1. Black

item no:
print proof no:

AAAI1466
2

origination date: 21.07.15
approved for print/date

originated by:

jh

revision date:

24.07.15

dimensions:

148 x 210

pharmacode:
min pt size:

JDE No.:

3.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.
6.

Technical Approval

revised by:

jh

date sent:

supplier:

UK

technically app. date: N/A

N/A

50866540

2.
4.

7

Codeine Phosphate Tablets
15, 30 & 60mg x 28’s (UK)

Non Printing Colours
1.
2.
3.

Pharmacode: 2913
Date Sent:
13/07/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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