Galcodine 15mg/5ml linctus

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Codeine phosphate

זמין מ:

Thornton & Ross Ltd

קוד ATC:

R05DA04

INN (שם בינלאומי):

Codeine phosphate

כמות:

3mg/1ml

טופס פרצבטיות:

Oral solution

מסלול נתינה (של תרופות):

Oral

סיווג:

Schedule 5 (CD Inv)

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 03090100; GTIN: 5011309870213

עלון מידע

_Data Matrix:_ 22873508 VERIFIED
FRONT FACE TOP
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
542865
11289
Update ingredients list to comply
with EP names. MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
2 litre
22873508
297mm x 210mm
2
12.11.2014
Process Black
Keyline (Does not print)
Galcodine Linctus
Helvetica
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
542865
11289
Update ingredients list to comply
with EP names. MHRA approved.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
2 litre
22873508
297mm x 210mm
2
12.11.2014
Process Black
Keyline (Does not print)
Galcodine Linctus
Helvetica
GALCODINE LINCTUS
(Codeine phosphate)
IMPORTANT INFORMATION ABOUT GALCODINE
LINCTUS
• This medicine relieves the symptoms of dry
coughs in adults, including the elderly.
DO NOT TAKE….
• If you have breathing problems including
bronchitis. See section 2.
• Or give to children under 18 years old.
• Avoid drinking alcohol while taking this
medicine.
NOW READ THE REST OF THE LEAFLET BEFORE YOU
USE THIS MEDICINE. IT INCLUDES OTHER
INFORMATION WHICH MIGHT BE ESPECIALLY
IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
1. WHAT THE MEDICINE IS FOR
Galcodine Linctus contains codeine phosphate
which reduces the desire to cough.
It is used to relieve dry coughs which are
without phlegm.
2. BEFORE YOU USE THIS
MEDICINE DO NOT USE THE MEDICINE IF YOU
HAVE….
• An ALLERGY to any of the ingredients listed in
section 6.
• LIVER DISEASE, or SEVERE KIDNEY PROBLEMS.
• SHALLOW BREATH or BREATHIN

מאפייני מוצר

OBJECT 1
GALCODINE LINCTUS
Summary of Product Characteristics Updated 12-Nov-2014 | Thornton &
Ross Ltd
1. Name of the medicinal product
Galcodine Linctus
Care Codeine 15mg/5ml Oral Solution Sugar Free
2. Qualitative and quantitative composition
Codeine phosphate 15mg (Per 5ml Dose)
For excipients, see 6.1
3. Pharmaceutical form
Oral Liquid
A viscous orange coloured liquid.
4. Clinical particulars
4.1 Therapeutic indications
Codeine is indicated in adults for the relief of an unproductive dry
cough.
4.2 Posology and method of administration
For oral administration.
Adult:
One 5ml spoonful four times daily.
Elderly:
Should be used 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.
4.3 Contraindications
Suspected opiate abuse, known hypersensitivity to codeine or any of
the other ingredients.
Liver or respiratory failure 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 asthma attack.
Children under 18 years of age.
In women during breastfeeding (see section 4.6)
4.4 Special warnings and precautions for use
This medicine should be used 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 MAO