Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Zinc oxide; Bismuth oxide; Peru Balsam
Church & Dwight UK Ltd
C05AX02
Zinc oxide; Bismuth oxide; Peru Balsam
107.5mg/1gram ; 21.4mg/1gram ; 18mg/1gram
Rectal cream
Cutaneous; Rectal
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01070100; GTIN: 5010123727505 5010123727512
OBJECT 1 ANUSOL CREAM Summary of Product Characteristics Updated 13-Apr-2018 | Church & Dwight UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product ANUSOL Cream 2. Qualitative and quantitative composition ANUSOL cream contains - Zinc oxide Ph Eur 10.75 g Bismuth oxide 2.14 g Balsam Peru Ph Eur 1.8 g For full list of excipients, see section 6.1 3. Pharmaceutical form A buff coloured cream 4. Clinical particulars 4.1 Therapeutic indications ANUSOL cream provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions. ANUSOL cream also provides lubricating properties for use with suppositories. Indicated for the symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post-operatively in ano-rectal surgical procedures and after incision of thrombosed or sclerosed ano-rectal veins. 4.2 Posology and method of administration Topical ADULTS AND ELDERL Read the complete document