Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Danazol
Kent Pharma (UK) Ltd
G03XA01
Danazol
200mg
Oral capsule
Oral
Schedule 4 (CD Anab)
Valid as a prescribable product
BNF: 06070200
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v3/July 2017 Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info 3D Render ID 21 Mar 2019 18:30 Danazol 200 mg 56 Label Leaflet 1706719 1424941 1706719 04569/0137 N/a LL0441aK 236 N/a 370083 3 United Kingdom N/a 5016695560281 4 Myriad Pro 52 x 101 mm 7pt 6pt Keyline Varnish Free Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v3/July 2017 Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info 3D Render ID 21 Mar 2019 18:30 Danazol 200 mg 56 Label Leaflet 1706719 1424941 1706719 04569/0137 N/a LL0441aK 236 N/a 370083 3 United Kingdom N/a 5016695560281 4 Myriad Pro 52 x 101 mm 7pt 6pt Keyline Braille Varnish Free danazol capsul- es #200 mg Danazol capsul- es #200 mg Location is fixed here for Variable Data Coding (maximum five lines) along with 2D Data Matrix code. Prompt words ( (1) according to previously agreed translation), variable batch data and 2D Data Matrix code will be online printed in the following order (or matrix first then test)and layout: Standard font size is 2.0mm for online printed batch data. Keep this section as part of the artwork in keyline colour. Keep this flap blank and varnish free for online printing. Information box: *PC: 00000000000000 *SN: 00000000000000 Lot: 0000000000 EXP: MM/YYYY Variable Data Information box for online printing - United Kingdom * Will be printed only after serialisation go live Keep this section as part of the Artwork in Keyline colour. Variable Data area will Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Danazol Capsules 200mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200 mg danazol. Excipient with known effect: Each capsule contains 90 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. Size 1 capsule, white body and orange cap, marked in black “DL 200” and “G” 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Danazol capsules are recommended for the treatment of: 1. Endometriosis. To control pain, pelvic tenderness and other associated symptoms and to resolve or reduce the extent of endometriotic foci. Danazol capsules may be used as sole therapy, in preparation for or following surgery or in patients not responding to other treatments. 2. Dysfunctional uterine bleeding presenting as menorrhagia. To control excessive blood loss and to control associated dysmenorrhoea. 3. For the treatment of severe cyclical mastalgia with or without nodularity (fibrocystic disease) unresponsive to counselling or simple analgesics. To reduce pain, tenderness and nodularity. 4. For the control of benign, multiple or recurrent breast cysts in conjunction with aspiration. 5. Severe symptomatic gynaecomastia, both idiopathic as well as drug induced, to reduce the size of the breast and to control associated pain and tenderness. 6. Pre-operative thinning of the endometrium prior to hysteroscopic endometrial ablation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The usual range of dosage is 200 mg to 800 mg daily in up to four divided doses. Danazol should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient’s response. A reduction in dosage once a satisfactory response has been achieved may prove possible. In fertile females, Danazol should be started during menstruation, preferably on the first day, to avoid exposing a pregnancy to its possible effects. Where doubt exists, appropriate checks should be made to exclude pr Read the complete document