Flospasm 200 mg FC tablets.

FLOSPASM is indicated for its antispasmodic action in urological disorders.

Posology

Adult: One tablet three times a day (600 mg flavoxate hydrochloride daily) for as long as required.

Paediatric population

FLOSPASM is not recommended for use in children (see section 4.3).

Method of administration

Oral administration. FLOSPASM should be taken after a meal in order to prevent nausea.

FLOSPASM is contraindicated in:

• Patients with hypersensitivity to flavoxate hydrochloride or to any excipients in FLOSPASM (see section 6.1).
• Patients with pyloric or duodenal obstruction, obstructive intestinal lesions, ileus, achalasia or other gastrointestinal obstructive conditions.
• Patients with gastrointestinal haemorrhage.
• Patients with obstructive uropathies of the lower urinary tract or urinary retention.
• Patients with glaucoma
• Patients with myasthenia gravis.
• Children under 12 years of age.
• Pregnancy and lactation (see section 4.6).

Renal impairment

Since the renal clearance of the active metabolite accounts more than 50 % of the dose, renal impairment may significantly affect the product kinetics. Caution is therefore required in patients with renal impairment (see section 4.3).

Glaucoma

FLOSPASM is contraindicated in patients with suspected glaucoma, especially narrow angle glaucoma (see section 4.3).

Urinary tract disorders

FLOSPASM should be used with caution in patients with serious, uncontrolled, obstructive disorders of the lower urinary tract (see section 4.3).

Drowsiness

If a patient experiences drowsiness, the time between administration of doses should be extended.

Paediatric population

The use in children below the age of 12 years is contraindicated (see sections 4.2 and 4.3).

Excipients

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take FLOSPASM.

No interaction studies have been performed.

Safety in pregnancy and lactation has not been established (see section 4.3).

Pregnancy

There are no or a limited amount of data for the use of flavoxate in pregnant woman. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. FLOSPASM should not be used during pregnancy (see section 4.3).

Breastfeeding

It is unknown whether flavoxate (metabolites), as contained in FLOSPASM, is excreted in human milk. A risk to the suckling child cannot be excluded. FLOSPASM should not be used during breastfeeding (see section 4.3).

Fertility

There are no data on the effect of flavoxate, as contained in FLOSPASM, on human fertility. Flavoxate has no effect on animal fertility.

Since adverse reactions such as drowsiness, somnolence, vertigo and blurred vision have been reported in patients receiving FLOSPASM, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that FLOSPASM does not adversely affect their ability to do so (see sections 4.4 and 4.8).

a. Tabulated list of adverse reactions for FLOSPASM

System organ class Frequent Less frequent Frequency unknown

• Blood and lymphatic disorders Eosinophilia, leukopenia
• Immune system disorders Angioedema Hypersensitivity, anaphylactic reaction, anaphylactic shock
• Psychiatric disorders Mental confusion (especially in the elderly), nervousness
• Nervous system disorders Somnolence, drowsiness, dizziness, headache
• Eye disorders Visual impairment, blurred vision, disturbances in eye accommodation, increased ocular tension Glaucoma
• Ear and labyrinth disorders Vertigo
• Cardiac disorders Palpitations, tachycardia
• Gastrointestinal disorders Nausea Vomiting, dry mouth, dyspepsia, diarrhoea, dysphagia
• Hepatobiliary disorders Jaundice, liver disorder, abnormal hepatic enzyme
• Skin and subcutaneous tissue disorders Urticaria and other dermatoses, rash, pruritus, Erythema
• Renal and urinary disorders Urinary retention, dysuria
• General disorders and administration site conditions Fatigue, hyperpyrexia

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/

Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

Symptoms

The most likely symptoms of overdose are blurred vision, dry mouth, drowsiness and diarrhoea or constipation.

Treatment

Treatment of overdosage is symptomatic and supportive.