Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Pharmaco Distribution (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS OXYBUTYNIN CHLORIDE 5 mg
Registered
1980-06-10
DITROPAN ® PHARMACO DISTRIBUTION (PTY) LTD 1.3.2 L/5.4/104 Each tablet contains 5 mg oxybutynin chloride Amended: 15 Jan 2020 _ _ _ _ Page 1 of 8 1.3.2 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S3 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM DITROPAN, 5 mg, tablets READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DITROPAN Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. DITROPAN has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT DITROPAN CONTAINS The active substance is oxybutynin hydrochloride, 5 mg per tablet. The other ingredients are calcium stearate, cellulose (microcrystalline), Indigo carmine aluminium lake (E132) and lactose (anhydrous). Contains sugar (anhydrous lactose). WHAT DITROPAN IS USED FOR DITROPAN is used to decrease the urgency and the frequency of urination. DITROPAN is also used to decrease bed-wetting in children older than 5 years. BEFORE YOU TAKE DITROPAN DO NOT TAKE DITROPAN: if you are hypersensitive (allergic) to oxybutynin hydrochloride or any of the other ingredients of DITROPAN. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue DITROPAN ® PHARMACO DISTRIBUTION (PTY) LTD 1.3.2 L/5.4/104 Each tablet contains 5 mg oxybutynin chloride Amended: 15 Jan 2020 _ _ _ _ Page 2 of 8 if you have increased pressure in the eye (glaucoma) if your stomach or intestine are blocked, perforated or not working properly if you have a severe form of a condition known as ‘ulcerative colitis’ if you have a rare muscle illness called ‘myasthenia gravis’ if you have a blockage of your bladder that makes it difficult for your to pass water(urine) if you have severe bleeding if you have a hypotonic neurogenic bladder (an enlarged bladder in which the emptying reflex beco Baca dokumen lengkapnya
DITROPAN ® PHARMACO DISTRIBUTION (PTY) LTD 1.3.1.1 L/5.4/104 Each tablet contains 5 mg oxybutynin chloride Amended: 15 Jan 2020 _ _ _ _ Page 1 of 8 1.3.1.1 PACKAGE INSERT SCHEDULING STATUS S3 PROPRIETARY NAME AND DOSAGE FORM DITROPAN ® Tablets COMPOSITION Each tablet contains oxybutynin hydrochloride 5 mg. _Excipients _ Indigo carmine aluminium lake (E132), microcrystalline cellulose, anhydrous lactose, calcium stearate. Contains sugar (anhydrous lactose). PHARMACOLOGICAL CLASSIFICATION A 5.4 Medicines affecting autonomic functions: cholinolytics (anticholinergics). PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES: Oxybutynin hydrochloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. In patients with uninhibited neurogenic and reflex neurogenic bladder, cystometric studies have demonstrated that oxybutynin hydrochloride increases bladder capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle and delays the initial desire to void. PHARMACOKINETIC PROPERTIES: Oxybutynin is poorly absorbed from the gastrointestinal tract. It is highly bound to plasma proteins, the peak plasma level in healthy young volunteers is reached between 0,5 and 1 hour after administration. The elimination phase is biexponential, with an elimination half-life of about 2-3 hours. DITROPAN ® PHARMACO DISTRIBUTION (PTY) LTD 1.3.1.1 L/5.4/104 Each tablet contains 5 mg oxybutynin chloride Amended: 15 Jan 2020 _ _ _ _ Page 2 of 8 The elimination half-life is increased in the elderly, particularly if they are frail. Oxybutynin and its metabolites are excreted in the feces and urine. INDICATIONS DITROPAN tablets are indicated for the relief of symptoms associated with voiding in patients with uninhibited neurogenic and reflex neurogenic bladder, (i.e. urgency, frequency, urinary leakage, urge incontinence, dysuria). DITROPAN is indicated for spastic neurogenic bladder (and not hypotonic neurogenic bladder – see “CONTRAINDICATI Baca dokumen lengkapnya