- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- 11. Dosimetry
- 12. Instructions for preparation of radiopharmaceuticals
Cymalon Lemon flavour Granules for Oral Solution
Each sachet of 6.76g of granules contain the following actives:
Citric Acid (anhydrous) EP
Sodium Citrate dihydrate EP
Sodium Carbonate EP
Sodium Bicarbonate EP
Excipients: Each sachet contains 1.5g of sucrose.
For the full list of excipients, see section 6.1.
Granules for Oral Solution.
Cymalon Granules is indicated for the relief of symptoms due to cystitis in adult females only.
Route of administration: Oral
Adults One sachet to be taken in water, three times a day over 48 hours.
Children Cymalon Granules is not recommended for children.
Cymalon Granules should not be taken in cases of pregnancy, heart disease, high blood pressure, any form of kidney disease or whenever a restricted salt intake is indicated.
Patients should be advised against repeated use. If symptoms persist 48 hours after treatment is completed you are advised to consult your doctor. Do not exceed the stated dose. Keep out of the reach of children.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
This medicinal product contains 136.5mmol (or 3.14g) sodium per maximum daily dose (3 sachets). To be taken into consideration by patients on a controlled sodium diet.
Sodium containing preparations should be avoided by patients on lithium because sodium is preferentially absorbed by the kidney resulting in increased lithium excretion and reduced plasma levels.
Urinary alkalinisers should not be used with hexamine because it is only effective in acid urine.
The effects of a number of drugs may be reduced or increased by the alkalinisination of the urine and reduction in gastric pH brought about by the active ingredients in the product.
Do not use during pregnancy and lactation.
Sodium bicarbonate may cause flatulence.
Mild diuresis may occur.
Excessive administration of sodium citrate may cause gastrointestinal discomfort and diarrhoea. Excessive doses of sodium salts may lead to sodium overloading and hyperosmolality. Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Treatment is symptomatic and consists of appropriate correction of fluid and electrolyte balance.
Sodium Bicarbonate increases the alkali reserve of the plasma and increases excretion of urine, which is rendered less acidic. Sodium Citrate is used to make the urine alkaline in the treatment of urinary tract infections. Citric acid increases the secretion of urine and renders it less acidic. It is also used in the preparation of effervescent granules to aid effervescence.
Cymalon Granules is administered in the form of a solution.
Castor Sugar EP
Saccharin Sodium BP
Flavour Lemon Natural (F309)
There are no known records of incompatibilities.
Protect from moisture.
Cymalon granules are packed into low density polythene, aluminium foil and paper (PPFP) laminate sachets, each containing 6.76g granules. These are further packed into cardboard cartons each containing 6 sachets.
Actavis Group PTC ehf
22 July 2002
Actavis UK Ltd
Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346 106
+44 (0)1271 311 200
+44 (0)1271 385 257