OXYBUTYNIN HYDROCHLORIDE XL

2). Adults Starting dose: the recommended starting dose is one 5 mg tablet once daily.

Maintenance dose/dose adjustment:

In order to achieve a maintenance dose giving an optimal balance of efficacy and tolerability, after at least one week on 5 mg daily, the dose may be increased to 10 mg once daily, with subsequent incremental increases or decreases of 5 mg/day.

There should be an interval of at least one week between dose changes. Maximum dose: in patients requiring a higher dose, the total daily dose should not exceed 20 mg. For patients currently taking oxybutynin immediate release, clinical judgement should be exercised in selecting the appropriate dose of Oxybutynin hydrochloride XL.

The dosage should be adjusted to the minimum dose that achieves an optimal balance of efficacy and tolerability, taking into account the current immediate-release dose. In case of a missed dose, the patient should wait and take the next dose at the regular time.

Elderly No dosage adjustment is necessary in elderly patients. Paediatric population Children over the age of 5 years Initial dose of 5 mg once a day increased in 5mg increments up to a maximum of 15 mg once a day. 2). Method of administration Oxybutynin hydrochloride XL must be swallowed whole with the aid of liquid, and must not be chewed, divided, or crushed because the tablet is formulated to provide prolonged release.

Patients should be advised that the tablet membrane may pass through the gastrointestinal tract unchanged. This has no bearing on the efficacy of the product.

Like all medicines, oxybutynin can cause undesirable effects, although not everybody gets them. The frequency of possible undesirable effects listed below are currently defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

, placebo or active comparator) clinical trials for the management of overactive bladder, in which 759 adult subjects received doses ranging from 5 to 20 mg/day. , active comparator) clinical trial, in which 60 paediatric subjects received doses of 10 or 15 mg/day, Table 1 below reflects the adverse drug reactions reported with Oxybutynin hydrochloride XL in clinical trials in adults and from post marketing experience.

Adverse drug reactions reported in the paediatric clinical trial are shown in Table 2.

Table 1:

Adverse drug reactions reported in clinical trials in adults and from post marketing experience Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data) Infections and infestations Urinary tract infection Immune System Disorders Hypersensiti vity Anaphylactic reaction Psychiatric disorders Confusional state, Insomnia Hallucination s, Agitation, Memory impairment Psychotic disorder, Anxiety, Cognitive disorders in the elderly Nightmares, and Paranoia, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse) Nervous system disorders Dizziness, Headache, Somnolence Dysgeusia Convulsions Cognitive Disorders, Drowsiness, Disorientatio n Eye disorders Vision blurred Dry eyes Angle closure glaucoma Increased intraocular pressure, Mydriasis Cardiac disorders Palpitation, Tachycardia Arrhythmia Vascular disorders Flushing (which may be more marked in children) Hypertension Respiratory, thoracic, and mediastinal disorders Oropharynge al pain, Cough, Nasal dryness, Dry throat Dysphonia, Nasal congestion, Throat irritation Epistaxis Gastrointestinal disorders Constipation, Dry mouth, Nausea Gastroesopha geal reflux, Abdominal pain, Abdominal discomfort, Anorexia, decreased appetite, Pseudo- obstruction in patients at risk (elderly or patients Dyspepsia, Diarrhoea, Vomiting, Flatulence Dysphagia Frequent bowel movements with constipation and treated with other drugs that decrease intestinal motility) Skin and subcutaneous tissue disorders Dry skin Pruritus Urticaria, Rash Angioedema, Hypohidrosis , Photosensitiv ity Musculoskeletal and connective tissue disorders Muscle disorders manifested as muscle weakness, myalgia and/ or muscle spasms Renal and urinary disorders Urinary retention, Dysuria, Urinary hesitation Residual urine Impotence General disorders and administration site conditions Fatigue Chest discomfort, Mucosal dryness, Thirst Investigations Residual urine volume+ Injury, poisoning and procedural complications Fall Heat stroke +The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased.

Paediatric population The safety of Oxybutynin hydrochloride XL was evaluated in 60 paediatric subjects (age range 5 to 15 years; dose range 10-15 mg/day) who participated in an open-label, active control, three-arm clinical trial.

Adverse drug reactions reported by Oxybutynin hydrochloride XL -treated paediatric subjects in this clinical trial are shown in Table 2.

Table 2:

Adverse drug reactions reported in clinical trials with paediatric subjects Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1000 Metabolism and nutrition Anorexia disorders Psychiatric disorders Insomnia Nervous system disorders Headache Vascular disorders Flushing Gastrointestinal disorders Constipation Diarrhoea Skin and subcutaneous tissue disorders Rash, Pruritus 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Oxybutynin should be used with caution in patients with Parkinson’s disease who are at greater risk of occurrence of adverse reactions to the product and in patients with autonomic neuropathy (such as those with Parkinson’s disease), several gastro- intestinal motility disorders, hepatic or renal impairment.

Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis. Oxybutynin may aggravate cognitive disorders, symptoms of prostatic hypertrophy and tachycardia (thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension).

Anticholinergic CNS effects (such as hallucinations, agitation, confusion, somnolence) have been reported. Monitoring recommended, particularly in first few months after initiating therapy or increasing the dose. If anticholinergic CNS effects develop, termination of treatment or dose reduction may be considered.

Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling has the potential to become life-threatening.

If involvement of tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Since oxybutynin can cause narrow-angle glaucoma, patients should be advised to contact a physician immediately if they are aware of a sudden loss of visual acuity or ocular pain.

Oxybutynin may reduce salivary secretions, which could result in dental caries, parodontotsis, or oral candidiasis. Anticholinergic medicinal products should be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

When oxybutynin is used in high environmental temperatures, this can cause heat prostration due to decreased sweating. Elderly Anticholinergic medicinal products should be used with caution in elderly patients, especially if frail, due to the risk of cognitive impairment.

They also have a higher risk of occurrence of adverse reactions to the product. Paediatric population The use of oxybutynin hydrochloride in children under 5 years of age is not recommended. It has not been established whether oxybutynin hydrochloride can be used safely in this age group.

There is limited evidence supporting the use of Oxybutynin hydrochloride in children with mono symptomatic nocturnal enuresis (not related to detrusor over activity). In children of 5 years of age or older, Oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

Excipients Oxybutynin hydrochloride tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1 - Myasthenia gravis - Narrow-angle glaucoma or shallow anterior chamber - Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony - Toxic megacolon - Severe ulcerative colitis - Bladder outflow obstruction where urinary frequency may be precipitated - Porphyria.