OXYBUTYNIN HYDROCHLORIDE

The dosage should be adapted individually. 5mg three times a day. This dose may be increased to a maximum dose of 5mg four times a day to obtain a clinical response provided that the side effects are well-tolerated. Elderly (including frail elderly) A lower dose is recommended because the elimination half-life is increased in the elderly.

5mg twice a day is likely to be adequate, particularly if the patient is frail. This dose may be increased if necessary to 5mg twice a day provided that the side effects are well tolerated. 5mg twice a day. Thereafter, the lowest effective dose should be selected.

5mg twice a day. This dose may be increased, if necessary, to 5mg two or three times daily provided that the side effects are well-tolerated. The last dose should be given before bedtime. Method of administration Oral use. The tablets are swallowed with plenty of fluid (approx.

1 glass of water), also recommended because the tablets have an unpleasant taste. The duration of treatment is guided by the occurrence of symptoms.

In clinical trials involving more than 3000 patients exposed to oxybutynin hydrochloride, side effects were caused mainly by anticholinergic effects of oxybutynin. Dry mouth was the most commonly reported side effect. 5 mg and 5 mg, and the experience gained after the drug has been marketed.

Classification of expected frequencies:

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). The following adverse events (marked with an asterisk *), which has not been observed in clinical trials but reported after the drug has been marketed, has been ranked in the frequency of "rare/unknown".

Very Common Common Uncommon Rare Not Known Infections and infestations urinary tract infection Immune System Disorders hypersensitivity Psychiatric disorders confusional state Restlessness*, disorientation, concentration difficulties, excitation.

Agitation anxiety, hallucinations, nightmares*, paranoia, agitation, Very Common Common Uncommon Rare Not Known cognitive disorders in elderly, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse) Nervous System Disorders somnolence, fatigue, headache, dizziness drowsiness Cognitive disorders*, convulsions*, disorientation Eye disorders decreased tear production /Dry eyes light hypersensitivity Narrow angle closure glaucoma*, mydriasis, ocular hypertension, blurred vision Cardiac disorders palpitation cardiac arrhythmias, tachycardia Vascular disorders flushing which may be more marked in children Gastrointestinal Disorders dry mouth, nausea, constipation diarrhoea, vomiting, dyspepsia anorexia, dysphagia, abdominal discomfort/pain, decreased appetite gastroesophageal reflux disease, pseudo- obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility) Skin and subcutaneous tissue disorders dry skin/ decreased sweating phototoxicity angioedema, rash, urticaria, hypohidrosis, Very Common Common Uncommon Rare Not Known Renal and urinary disorders Urinary retention difficulty in micturition Reproductive system and breast disorders erectile dysfunction* Injury, poisoning and procedural complications heat stroke 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.

3). Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment.

Gastrointestinal disorders:

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 tachycardia (and thus be cautious in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitive disorders and symptoms of prostatic hypertrophy.

g. hallucinations, agitation, confusion, somnolence) have been reported; monitoring recommended especially in first few months after initiating therapy or increasing the dose; consider discontinuing therapy or reducing the dose if anticholinergic CNS effects develop.

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. In the event of a urinary tract infection during treatment with oxybutynin, appropriate antibacterial treatment must be initiated.

Oxybutynin may reduce salivary secretions which could result in dental caries, parodontosis or oral candidiasis. Regular dental check-ups are therefore advisable during long-term treatment. 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. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population The use of oxybutynin in children under 5 years of age is not recommended; it has not been established whether oxybutynin can be safely used in this age group. There is limited evidence supporting the use of oxybutynin in children with monosymptomatic nocturnal enuresis (not related to detrusor over activity).

In children over 5 years of age, 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.

1. - myasthenia gravis - narrow-angle glaucoma or shallow anterior chamber. - pollakiuria or nycturia due to cardiac or renal insufficiency. - gastrointestinal obstruction including pyloric stenosis, paralytic ileus and intestinal atony.

- ileostomy, colostomy, toxic megacolon, severe ulcerative colitis. - bladder flow obstruction where urinary retention may be precipitated. - porphyria - frequent urination at night caused by heart or kidney disease - hiatus hernia with reflux oesophagitis