Cymaclear 1.5g/5ml Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cymaclear 1.5g/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Potassium Citrate 1.5g/5ml
3 PHARMACEUTICAL FORM
Oral Solution
A clear to slightly opaque, colourless to pale yellow liquid.
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. Not recommended for use in children under 6 years.
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 Contraindications
Contraindicated in hyperkalaemia, renal dysfunction, ventricular arrhythmics and Addison’s Disease.
Contraindicated in known hypersensitivity to potassium citrate or any other ingredient.
4.4 Special warnings and precautions for use
Cymaclear 1.5g/5ml Oral Solution 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.
Citrate mobilises calcium from bones and increases its urinary excretion. This together with raised urinary pH may predispose to formation of stones in the urinary tract.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose. This product contains 2.2g of sucrose per10ml dose. This should be taken into account in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Cymaclear 1.5g/5ml Oral Solution should be used with caution in elderly.
Labels to state: If symptoms persist after 2 days, consult your doctor. Discard any unused mixture 2 months after opening.
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, cyclosporine) may lead to hyperkalaemia. May interact with cardiac glycosides.
Citrates alkalinize the urine and thus may alter the urinary excretion of a number of drugs, such as salicylates, tetracyclines and barbiturates, and prolongation of the half-life of basic drugs, such as sympathomimetics and stimulants. Particularly noteworthy is the diminished anti-bacterial activity of nitrofurantoin and methenamine.
4.6 Fertility, pregnancy and lactation
There are no adequate data from the use of Cymaclear 1.5g/5ml Oral Solution in pregnant women. Animal studies are insufficient with respect to effects on pregnancy. The potential risk to humans is unknown. Cymaclear 1.5g/5ml
Oral Solution should not be used during pregnancy unless clearly necessary and on the advice of a physician.
(Treatment with Cymaclear 1.5g/5ml Oral Solution is adjunctive and secondary to anti-bacterial treatment of urinary tract infection).
4.7 Effects on ability to drive and use machines
No effect on mental alertness.
4.8 Undesirable effects
Mild nausea and occasionally vomiting may occur due to gastric irritation. Other side effects are those due to hyperkalaemia (if this occurs).
4.9 Overdose
Overdosage is accompanied by nausea, vomiting, abdominal pain and symptoms due to hyperkalaemia and metabolic acidosis. Fluid and electrolyte balance together with ECG should be closely monitored.
Treatment is symptomatic and supportive. Moderate to severe hyperkalaemia is a medical emergency requiring prompt correction.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Citrate and Citric acid solutions are systematic and urinary alkalinizers thereby
providing symptomatic relief of dysuria.
5.2 Pharmacokinetic properties
Potassium Citrate is absorbed and the citrate is metabolised to bicarbonate. Citric acid is metabolised to carbon dioxide and water. Oxidation is virtually complete with less than 5% of citrate being excreted unchanged in the urine.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
6.1 List of excipients
Citric acid monohydrate, quillaia tincture, cranberry flavour F-10896, cranberry flavour F-11074, ethanol (96%), chloroform, purified water, syrup.
6.2 Incompatibilities
Incompatible with calcium and strontium salts.
6.3 Shelf life
60ml: 3 years unopened. 2 months after first opening.
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
60ml: Amber type III glass bottle with a 28mm R3 polypropylene white cap with EPE/aluminium/melinex liner and a double ended 2.5ml/5ml polypropylene spoon, inside a cardboard carton.
Or
60ml:Amber type III glass sirop bottle with a 28mm tamper evident polypropylene white cap with EPE/Aluminium/Melinex liner and a 15ml dosing cup, inside a cardboard container.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur
Iceland.
8 MARKETING AUTHORISATION NUMBER(S)
PL 30306/0065
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/02/2011
10 DATE OF REVISION OF THE TEXT
05/07/2013