CODEINE PHOSPHATE TABLETS BP 30MG

Active substance: CODEINE PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
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

Codeine Phosphate tablets belong to a group of medicines
called analgesics and are used for the relief of:
• mild to moderate pain.
• symptoms of a dry cough or diarrhoea.

2 Before you take

Do not take Codeine Phosphate tablets and tell your
doctor if you:

• are allergic (hypersensitive) to codeine or other opioids, or
any of the ingredients in the tablet (see section 6)
• have difficulty breathing, or other chronic lung disease
• have suffered head injury or raised pressure in the skull
(may cause painful eyes, changes in vision or headache
behind the eyes)
• are having an asthma attack
• have liver failure
• are at risk of blocked intestines
• suffer with alcoholism.

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
Continued top of next column
50435707









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

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

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.

Pregnancy and breast-feeding

Do not take Codeine Phosphate tablets during pregnancy or
whilst breast-feeding, unless advised by your doctor. Regular
use during pregnancy may cause withdrawal symptoms in the
newborn.
Usually it is safe to take Codeine Phosphate tablets while breast
feeding as the levels 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.

15mm

Codeine Phosphate BP 15mg/30mg/60mg tablets 28pk PIL - UK
item no:

50435707

dimensions: 148x210 Reel Fed

print proof no:

6

pharmacode:

origination date: 08.09.10

min pt size:

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by:

MOCK UP
ONLY

C
L

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)

15mm

approved for print/date

83.6mm

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.

210mm +/- 0.5mm to centre line of next eye mark

Pharmacode
Position

65mm

Codeine Phosphate 15mg,
30mg and 60mg tablets

DR

revision date:

07.12.10

Technical Approval

revised by:

DR

date sent: Lotus

supplier:

UK BST

technically app. date:

Non Printing Colours
1.
2.
3.

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:
• Adults and children over 12 years:
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.
• Children under 12 years: not recommended.
• Elderly 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.

• Psychiatric 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
• Others - muscle stiffness, decrease in sex drive, difficulty
breathing, low body temperature.
If you notice any side effects, they get worse, or if you notice any not
listed, please tell your doctor or pharmacist.

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 December 2010

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. Please tell your doctor or
pharmacist if you notice any of the following effects or any effects
not listed.
Pharmacode
Position

Tell your doctor if you notice any of the following side effects or
notice any other effects not listed:
• Allergic Reactions - skin rash or itchy skin, difficulty breathing,
increased sweating, redness or flushed face
• Gastrointestinal system - constipation, feeling or being sick,
dry mouth, abdominal pain (may be caused by spasm of the bile
ducts)
• Heart - slow or fast heart rate, palpitations, low blood pressure,
low blood pressure on standing
• Urinary system - pain and difficulty in passing urine and a less
frequent need to do so
• Nervous 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)

65mm

Continued top of next column
50435707

Actavis, Barnstaple, EX32 8NS, UK

Codeine Phosphate BP 15mg/30mg/60mg tablets 28pk PIL - UK
item no:

50435707

dimensions: 148x210 Reel Fed

print proof no:

6

pharmacode:

origination date: 08.09.10

min pt size:

MOCK UP
ONLY

1. Black
2.
3.
4.
5.
6.

originated by:
approved for print/date

colours/plates:

DR

revision date:

07.12.10

Technical Approval

revised by:

DR

date sent: Lotus

supplier:

UK BST

technically app. date:

Non Printing Colours
1.
2.
3.

Expand view ⇕

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.

Hide
(web2)