Codeine Linctus BP

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

CODEINE PHOSPHATE

제공처:

LCM Limited Linthwaite Laboratories, Huddersfield, HD7 5QH, United Kingdom

ATC 코드:

R05DA04

INN (International Name):

CODEINE PHOSPHATE 15 mg/5ml

약제 형태:

ORAL SOLUTION

구성:

CODEINE PHOSPHATE 15 mg/5ml

처방전 유형:

POM

치료 영역:

COUGH AND COLD PREPARATIONS

승인 상태:

Withdrawn

승인 날짜:

2007-06-15

환자 정보 전단

_CODEINE_
_LINCTUS_
NEW ADVICE FOR DRIVERS - SEE REVERSE
_CODEINE PHOSPHATE_
CALMS DRY OR IRRITATING COUGHS
For symptomatic relief of dry or irritating
coughs.
Take the solution by mouth.
ADULTS: Take 1 x 5ml spoonful.
THE ELDERLY: Ask your doctor for advice.
A lower dose may be more suitable.
Repeat after 4 hours if required, but not
more than 4 doses in 24 hours.
DO NOT GIVE TO CHILDREN UNDER 18 YEARS OLD.
WARNING: DO NOT EXCEED THE
STATED DOSE.
If symptoms persist consult your doctor.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENT PER 5ML: codeine
phosphate 15mg.
ALSO CONTAINS amongst other
ingredients: ethanol, invert sugar,
sunset yellow dye (E110), sucrose 4g per
5ml, alcohol 1.8 vol%.
PEEL WHERE SHOWN FOR FULL LIST OF
INGREDIENTS.
Do not store above 25°C. Protect from light.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Manufactured by the licence holder L.C.M.
Ltd., Huddersfield, HD7 5QH, UK for
Thornton and Ross Ltd., Huddersfield,
HD7 5QH, UK.
MA213/00301 PL 12965/0009
21486616
This medicine contains codeine phosphate, which
reduces the desire to cough.
1. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU HAVE….
• An ALLERGY to any of the ingredients listed in
section 3.
• LIVER DISEASE, or SEVERE KIDNEY PROBLEMS.
• SHALLOW BREATH or BREATHING DIFFICULTIES.
• A HEAD INJURY or PERSISTENT HEADACHE.
• An ASTHMA ATTACK.
• Previously had a BLOCKED BOWEL • Previously had an
ADDICTION to medicines containing CODEINE or
MORPHINE • If you know that you metabolise very
rapidly codeine into morphine • Previously had a BAD
REACTION to CODEINE (a known "ultra-rapid
metaboliser" of codeine).
• Or are UNDER 18 years old • If you are breastfeeding.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU
HAVE….
• Kidney or liver problems (a reduced dose may be
recommended by your doctor) • A history of
asthma or other breathing problems, including
bronchitis • Low blood pressure • Irritable bowel
syndrome (IBS) or other bowel problems
• Abdominal pain • Myasthenia gravis (a

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Codeine Linctus BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine Phosphate BP 15mg/5ml dose.
3
PHARMACEUTICAL FORM
Linctus.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Codeine is indicated in adults for relief of the symptoms of dry or
irritating coughs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral.
Adults:
One 5ml spoonful.
Elderly:
Use with caution, a reduced dose can be recommended by a doctor.
Paediatric population
_:_
Codeine should not be used for the treatment of children under the age
of 18 years.
Dosage schedule
_:_
The dose may be repeated after four hours if required, but not more
than 4 doses in any
24 hours.
4.3
CONTRAINDICATIONS
Suspected opiate abuse, known hypersensitivity to codeine or to any of
the other
ingredients.
In cases of liver failure, respiratory depression
_,_
or patients at risk of paralytic ileus.
In patients with raised intracranial pressure or head injury.
In patients for whom it is known they are CYP2D6 ultra-rapid
metabolisers.
During an acute asthmatic attack
_. _
Children under 18 years of age.
In women during breastfeeding (see section 4.6)
Page
1
of
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4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in patients with renal and hepatic impairment(but
avoid if severe),
patients suffering from asthma or other respiratory disorders, or
patients with a history
of asthma, hypotension, shock, myasthenia gravis, cardiac arrhythmias,
acute
abdomen, gallstones, prostatic hypertrophy, urethral stenosis,
obstructive or
inflammatory bowel disorders, diseases of the biliary tract, and
convulsive disorders.
Administration of pethidine and possibly other opioid analgesics to
patients taking a
monoamine oxidase inhibitor (MAOI) has been associated with very
severe and
sometimes fatal reactions. If the use of codeine is considered
essential then great care
should be taken in patients taking MAOIs or within 14 days of stopping
MAOIs. (See
section 4.5).
Use with caution in the elderly, as codeine may ind