Methenamine

INDICATIONS AND USAGE

Uribel Tabs are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

DOSAGE AND ADMINISTRATION

Adults One tablet orally 4 times per day followed by liberal fluid intake. Older Children Dosage must be individualized by physician. Not recommended for use in children six years of age or younger.

WARNINGS

Do not exceed recommended dosage. If rapid pulse, dizziness or blurring of vision occurs, discontinue use immediately.

CONTRADICTIONS

Hypersensitivity to any of the ingredients is possible. Risk benefits should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis, acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Methenamine Tablets is indicated in the prophylaxis of uncomplicated lower urinary tract infections: 1. As long-term prophylactic therapy after initial treatment with appropriate chemotherapeutic agent of recurrent urinary infections.

2. As long-term therapy in the prevention of recurrent cystitis. 3. To provide prophylaxis in patients with indwelling catheters, urine collector etc. and to reduce the incidence of catheter blockage. 4. To provide prophylaxis against the introduction of infection into urinary tract during instrumental procedures.

5. Asymptomatic bacteriuria.

Posology Adults: 1 g 2 times a day. In patients with catheters the dosage may be increased to 1 g three times daily. 5 g twice daily. Children over 12 years: 1 g twice daily. In cases of alkaline urine pH, supply of acidifying agent could be needed.

Method of administration For oral administration. The tablets may be halved or crushed and taken with water if the patient is unable to swallow whole tablets.

Adverse events frequencies are defined as:

Very common (≥1/l0) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥ 1/10 000 to <1/1000) Very rare (<1/10 000) Not known (cannot be estimated from the available data). System Organ Class Frequency Common Rare Not known Gastrointestinal disorders Nausea, vomiting Diarrhoea, abdominal pains Skin and subcutaneous tissue disorders Rashes Pruritus Renal and urinary disorders Irritation of the bladder Haematuria Occasionally superinfection with yeast may occur.

At high dosage, chemical cystitis leading to dysuria may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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1. ⋅ Intolerance or allergic reactions to formalin. ⋅ Renal insufficiency, severe dehydration and gout. ⋅ Hepatic impairment. ⋅ Metabolic acidosis. ⋅ Infection of the kidney. Methenamine Tablets should not be given concurrently with sulphonamides because of the possibility of crystalluria.

Alkaline agents reduce the effect of methenamine and should be avoided, antacids might cause an increase of urine pH and hence decrease the effect of methenamine.