− Coli-urinal relieves pain associated with kidney stone passage.
− Coli-urinal is indicated in the prevention of stone formation associated with hyperoxaluria.
− Coli-urinal acts as a prophylactic treatment for recurrent urinary tract infections.

− Recommended dosage for Coli-urinal effervescent granules:
−1 tablespoonful dissolved in a half glass of water after meals three times daily.
− Do not exceed the recommended dose of Coli-urinal.

− Hypersensitivity to the active substance or to any of the excipients. − In the case of hereditary conditions that may be incompatible with any of the excipients (see section 6.1). − Coli-urinal is contraindicated in patients with renal insufficiency or severe hepatic insufficiency. − Coli-urinal is Contraindicated during pregnancy and lactation (see section 4.6).

− Large doses of hexamine (8 g daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

− Due to containing piperazine citrate, Coli-urinal may potentiate the extrapyramidal effects in patients receiving phenothiazines.
− The concomitant administration of Coli-urinal and sulfonamides is liable to result in formation of a precipitate in the urine.

− Hexamine causes seriousbirth defects when administered during pregnancy.
− Coli-urinal is contraindicated (section 4.3) in pregnancy.
− Women of childbearing potential have to use effective contraception during treatment.
− Coli-urinal is contraindicated during breastfeeding.

− No studies on the effects on the ability to drive and use machines have been performed.

a. Summary of the safety profile
- At the beginning of the treatment, gastro-intestinal disturbances including nausea and vomiting may occur; these reactions usually disappear within a few days.
- Other uncommon undesirable effects may include:
- Drowsiness, confusion, ataxia, reduced muscle tension(uncommon).
- Abdominal cramps, headaches, dizziness, tremors, choreirformmovements, hyporeflexia, nystagmus, seizures, blurred vision, paralytic strabismus and rarely, cataracts.
- Clonic contractions have occurred but are only likely if neurological abnormalities or renal disease exist.
− To report any side effect(s):

− The National Pharmacovigilance and Drug Safety Centre(NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc

− Coli-urinal may cause some neurological effects in case of over dosage, symptomatic treatment is recommended

− Pharmacotherapeutic group:
Not yet assigned.
− Mechanism of action.
Coli-urinal contains Hexamine which is a urinary tract antiseptic agent. It distributes widely into body fluids, but very little is hydrolyzed prior to excretion in the kidney and thus has minimal systemic toxic potential. Coli-urinal acts as urinary antiseptic due to the hydrolysis of hexamine to formaldehyde in acid urine. Microorganisms do not develop resistance to formaldehyde.
Coli-urinal also contains piperazine citrate a molecule believed to have solubilizing action of uric acid.
Coli-urinal contains Khellin-the active ingredient present in the fruits of Ammivisnaga- which is effective in preventing the formation of calcium oxalate stones.

Pharmacokinetic properties of Coli-urinal have not been fully studied.

Not applicable

Citric acid anhydrous 16.62 gm
Sodium bicarbonate 21.78 gm
Essence citron (Lemon oil) 78 mg
Sucrose powder 13.116 gm
Sodium saccharin 30 mg
F.D & C yellow no. 6 0.6mg
F.D & C yellow no. 10 12mg
Ethyl alcohol 95% 2.4 ml

na

3 years

Store at temperature not exceeding 30°C in a dry place away from heat and light, close tightly after use.

Carton box containing glass bottle of 60 gm effervescent granules and an inner leaflet.

na