Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
oxybutynin hydrochloride, Quantity: 5 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; brilliant blue FCF aluminium lake; lactose; calcium stearate
Oral
100 tablets, 30, 90 tablets
(S4) Prescription Only Medicine
Treatment of detrusor over-activity where conservative measures have failed.
Visual Identification: Light blue, round, single scored tablet, blank on both sides; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-05-30
DITROPAN DIT-RO(H)-PAN) _oxybutynin hydrochloride (oxy-BEAUT-in-in HIGH-dro(h)-CLOR-ride)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ditropan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Ditropan against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DITROPAN IS USED FOR Ditropan is used to decrease the urgency and the frequency of urination. Ditropan works by relaxing the bladder smooth muscle and helps to decrease muscle spasm. This delays the initial desire and the urge to urinate. Your doctor may have prescribed Ditropan for another reason. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY DITROPAN HAS BEEN PRESCRIBED FOR YOU. There is no evidence that Ditropan is addictive. This medicine is available only with a doctor's prescription. Ditropan is not recommended for use in children under the age of 5 years, as there have been no studies of its effects in children. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE DITROPAN IF YOU HAVE AN ALLERGY TO DITROPAN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE DITROPAN IF YOU HAVE: • angle closure glaucoma or shallow anterior chamber - disorders of the eye • partial or complete intestinal blockage; stomach, intestinal or large bowel problems including colitis (inflammation of the colon) • myasthenia gravis - a disease of the muscles • urinary tract blockage • severe bleeding DO NOT TAKE DITROPAN IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. The safety of the use of Ditropan in women who are pregnant or may become pregnant has not been established. Like most medicines, Ditropan is not recommended for use during Lesen Sie das vollständige Dokument
ditropan-ccdsv5-piv12-22jul22 1 AUSTRALIAN PRODUCT INFORMATION – DITROPAN (OXYBUTYNIN HYDROCHLORIDE) 1 NAME OF THE MEDICINE oxybutynin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains oxybutynin hydrochloride 5 mg. EXCIPIENTS WITH KNOWN EFFECT: Sugars as lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Light blue, round, single scored uncoated tablet, blank on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of detrusor over-activity where conservative measures have failed. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults: The usual dose is one 5 mg tablet two to three times a day. The maximum recommended dose is one 5 mg tablet four times a day. In the frail and elderly patient it is advisable to initiate treatment at a low dose and, if necessary to increase the dose carefully according to tolerance and response. Initial doses for geriatric patients of 2.5 mg twice daily have been reported in the literature. Children over 5 years of age: The usual dose is one 5 mg tablet twice a day. The maximum recommended dose is one 5 mg tablet three times a day. 4.3 CONTRAINDICATIONS Ditropan is contraindicated in patients with increased intraocular pressure associated with angle closure (glaucoma) or shallow anterior chamber since anticholinergic drugs may ditropan-ccdsv5-piv12-22jul22 2 aggravate this condition. It is also contraindicated in partial or complete obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony of the elderly or debilitated patient, megacolon, toxic megacolon complicating ulcerative colitis, severe colitis, and myasthenia gravis. It is contraindicated in patients with obstructive uropathy and in patients with unstable cardiovascular status in acute haemorrhage. Ditropan is contraindicated in patients who have demonstrated hypersensitivity to the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid dosage in high environmental temperatures and excessive exercise in high tempe Lesen Sie das vollständige Dokument