Potassium citrate mixture

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Preparatomtale Preparatomtale (SPC)
02-07-2015

Aktiv ingrediens:

Potassium citrate; Citric acid monohydrate

Tilgjengelig fra:

Alliance Healthcare (Distribution) Ltd

ATC-kode:

A12BA02

INN (International Name):

Potassium citrate; Citric acid monohydrate

Dosering :

300mg/1ml ; 50mg/1ml

Legemiddelform:

Oral solution

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 07040300

Informasjon til brukeren

                                _Data Matrix:_
_ _
21518812 VERIFIED
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
573079
12041
Replace "chloroform" with "sodium
benzoate".
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Landscape peelable label
200ml
21518812
65mm x 170mm
2
14.05.2015
Process Cyan
Process Magenta
Process Yellow
Process Black
Keyline (non-printing)
Braille
Text free area (non-printing)
Potassium Citrate Mixture
Braille BQ
Helvetica
Helvetica Neue LT
Optima
_POTASSIUM_
_CITRATE MIXTURE_
RELIEVES SYMPTOMS
OF CYSTITIS & OTHER MINOR
URINARY TRACT INFECTIONS
P
200ML
PEEL
HERE
IMPORTANT: PEEL THIS LABEL
AT CORNER AND READ BEFORE
USE. DO NOT TEAR OFF, RE-FIX FOR
FUTURE USE.
For symptomatic relief of cystitis and other
mild urinary tract infections.
Take the solution by mouth.
SHAKE THE BOTTLE.
ADULTS, THE ELDERLY AND CHILDREN OVER
6 YEARS: Take 2 x 5ml spoonfuls, well diluted
with water, three times a day after meals.
CHILDREN 1-6 YEARS: Take 1 x 5ml spoonful
as above.
DO NOT GIVE TO CHILDREN UNDER 1 YEAR OLD
unless your doctor tells you to.
If symptoms persist consult your doctor.
PEEL WHERE SHOWN FOR FURTHER
PRECAUTIONS.
ACTIVE INGREDIENT PER 5ML:
potassium citrate 1.5g.
ALSO CONTAINS amongst other
ingredients: ethanol and sucrose.
Sucrose 1.1g per 5ml.
PEEL WHERE SHOWN FOR FULL LIST
OF INGREDIENTS.
Do not store above 25°C.
Once opened use within 2 months.
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.
PL 12965/0031 PIP: 102-2029
21518812
This medicine contains potassium citrate which
makes the urine less acidic, and so reduces
irritation when urinating.
1. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU OR YOUR
CHILD HAVE….
• An ALLERGY to any of the ingredients listed in
section 3.
• KIDNEY PROBLEMS.
• HEART PROBLEMS including 
                                
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Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Potassium Citrate Mixture
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Citrate 1.5g/5ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the symptomatic relief of dysuria associated with mild urinary
tract infections, especially
cystitis.
Indications stated on label: For the relief of the symptoms of
cystitis and other mild urinary
tract infections.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral:
Recommended Doses
Unless directed otherwise by a doctor:
Adults including the elderly, and children over 6 years: 10ml.
Children 1 - 6 years: 5ml.
It should be taken well diluted with water, after meals.
Shake the bottle before use.
Dosage Schedule
The dose may be taken three times a day.
4.3.
CONTRA-INDICATIONS
Contraindicated in hyperkalaemia, renal dysfunction, ventricular
arrhythmics and Addison’s
Disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Potassium Citrate Mixture provides symptomatic relief only and is not
anti-bacterial.
Effective anti-bacterial therapy should be co-prescribed. It should be
used with
caution when renal or cardiac dysfunction is present.
Labels to state: if symptoms persist consult your doctor. Discard any
unused mixture 2
months after opening.
Use with caution in the elderly
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Concurrent administration of potassium-containing drugs, potassium
sparing diuretics or other
drugs that increase potassium levels (e.g. ACE inhibitors,
ciclosporin,_ _aliskiren) may lead to
hyperkalaemia. May interact with cardiac glycosides. Citrates
alkalinise the urine and thus
may alter the urinary excretion of a number of drugs. This may lead to
increased renal
clearance of acidic drugs, such as salicylates, tetracylines and
barbiturates, and prolongation
of the half-life of basic drugs, such as sympathomimetics and
stimulants. Particularly
noteworthy is the diminishe
                                
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