Novitropan

/ CTS

The dosage should be determined individually.
Adults: The usual dose is 5 mg two or three times a day. This may be increased to a maximum of 5 mg four times a day (maximum dose 20 mg oxybutynin hydrochloride per day).
Elderly: The elimination half-life is increased in the elderly. Therefore, a dose of 2.5 mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be increased to 5 mg two times a day to obtain a clinical response provided the side effects are well tolerated.
Paediatric population: Novitropan is not recommended in children under 5 years of age due to the absence of data. The usual dose is 2.5 mg twice a day. This dose may be increased to 5 mg two or three times a day to obtain a clinical response provided the side effects are well tolerated. The last dose should be given before bedtime.

For the relief of symptoms caused by urinary incontinence
(such as: urgency, frequency, leakage, inability to control the bladder, difficulty urinating) in adults and children (5 years of age or older).

* Hypersensitivity to the active ingredient or to any of the other ingredients.
* Myasthenia gravis.
* Narrow-angle glaucoma or shallow anterior chamber
* Gastrointestinal obstructive disorders including paralytic ileus, intestinal atony
* Severe ulcerative colitis.
* Toxic megacolon
* Bladder outflow obstruction where urinary retention may be precipitated

Use with cautious in patients with:
• Kidney or liver problems.
• Autonomic neuropathy – a disease that affects the nervous system (such as: Parkinson’s disease).
• Overactive thyroid (hyperthyroidism).
• Heart disease or hypertension.
• Irregular heartbeat (palpitations, arrhythmias) and/or increased or rapid heartbeat
• Enlarged prostate gland.
• Problem in the gut or a disease called ulcerative colitis.
• Indigestion or heartburn caused by a hiatus hernia, esophageal reflux or by medical preparations that can cause or worsen esophagitis.
• High body temperature or fever.
• Hot climate.
Additional warnings:
This medicinal product may reduce the amount of saliva, which may cause tooth decay or fungal infection in the mouth.
This medicinal product may cause glaucoma (increased intraocular pressure).
This medicinal product may cause hallucinations, agitation, confusion or drowsiness.
Please refer to the license holder for further details.

Very common: Constipation, Nausea, dry mouth, dry skin, headache, somnolence, dizziness, blurred vision.
Common: Dryness in the eyes, diarrhea, vomiting, confusion, heart palpitations.
Please refer to the license holder for further details.

•  Anticholinergics or antimuscarinics.
• Sedatives.
• Medicines to treat nausea and vomiting, such as: chlorpromazine or prochlorperazine.
• Antipsychotics, such as: clozapine, phenothiazines, haloperidol or benperidol (medicines from the group of butyrophenones).
• Medicines for the treatment of dementia, such as: donepezil, rivastigmine, galantamine or tacrine (cholinesterase inhibitors).
• Antidepressants, such as: amitriptyline, imipramine or dosulepin (tricyclic antidepressants).
• Amantadine, for the treatment of Parkinson’s disease or for certain viral infections.
• L-dopa or biperiden, for the treatment of Parkinson’s disease.
• Digoxin or quinidine, for the treatment of cardiac problems.
• Atropine, used for the treatment of various poisonings, a slow heart rate, certain eye conditions or is given during surgery.
• Medicines for the treatment of problems related to the stomach or bowel, such as: domperidone, metoclopramide, bethanechol.
• Certain antihistamine medicines for the treatment of allergy symptoms.
• CYP3A4 enzyme inhibitors, such as: ketoconazole, itraconazole or fluconazole, that are used for the treatment of fungal infections, erythromycin or other macrolide antibiotics that are used for the treatment of bacterial infections.

Please refer to the license holder for further details.

Please refer to the license holder for further details.