Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cinchocaine hydrochloride; Fluocortolone caproate; Fluocortolone pivalate
Meadow Laboratories Ltd
C05AX03
Cinchocaine hydrochloride; Fluocortolone caproate; Fluocortolone pivalate
5mg/1gram ; 950microgram/1gram ; 920microgram/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01070200
C. 01356 Artwork date: 16/05/2017 Version n°: 01 Bayer HealthCare Manufacturing S.r.l. (Segrate) TEL 02 937228 3 _Infants and Children_ Ultraproct is not for use in infants and is not recommended for use in children under 12 years of age unless directed by a doctor. _Using dressings over the treatment area_ Do not use waterproof dressings over the affected skin. TAKING OTHER MEDICINES • Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. • Some medicines may increase the effects of Ultraproct and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). PREGNANCY AND BREAST-FEEDING Even at the usual dose, the possibility of a very small risk to the development of a baby in pregnant women treated with Ultraproct cannot be entirely ruled out. THEREFORE, THIS MEDICINE SHOULD NOT BE USED IF YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR ARE BREAST-FEEDING UNLESS CONSIDERED ESSENTIAL BY YOUR DOCTOR. DRIVING AND USING MACHINES Ultraproct does not impair your ability to drive or operate machinery. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF ULTRAPROCT OINTMENT Ultraproct Ointment contains castor oil and hydrogenated castor oil, which may cause skin reactions. 3. HOW TO USE ULTRAPROCT Wash your hands before and after using Ultraproct. Do not use Ultraproct for more than 7 days. called cinchocaine hydrochloride which is a local anaesthetic to relieve pain. Ultraproct can be used for the short-term (5-7 days) relief of inflammation, swelling, itching and soreness of piles (haemorrhoids) and to relieve itching of the anus (back passage). This leaflet covers the following products: • Ultraproct Suppositories • Ultraproct Ointment In this leaflet they are jointly referred to as Ultraproct. Your doctor will prescribe the correct product to treat your specific condition. 2. BEFORE YOU USE ULTRAPROCT DO NOT USE ULTRAPROCT IF YOU: • are ALLERG Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ultraproct® Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1g of ointment contains: Fluocortolone pivalate BP 0.92 mg Fluocortolone hexanoate BP 0.95 mg Cinchocaine hydrochloride BP 5.00 mg 3 PHARMACEUTICAL FORM Ointment 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of haemorrhoids and of pruritus ani in the short term (5-7 days). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply in a thin layer twice daily. In order to obtain a more rapid improvement, Ultraproct Ointment may be applied three or four times on the first day. The nozzle provided facilitates intrarectal application. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Viral infections. Primary bacterial or fungal infections. Secondary infections of the skin in the absence of appropriate anti-infective therapy. Known sensitivity to local anaesthetics. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In infants, long-term continuous therapy with topical corticosteroids should be avoided. Occlusion is not appropriate on the perineum. Adrenal suppression can occur even without occlusion. The application of unusually large quantities of topical corticoids may result in the absorption of systemically active amounts of corticoid. Secondarily-infected dermatoses definitely require additional therapy with antibiotics or chemotherapeutic agents. This treatment can often be topical but for heavy infections systemic antibacterial therapy may be necessary. If fungal infections are present, a topically active anti-mycotic should be applied. Ultraproct should not be allowed to come into contact with the eyes. Patients should be advised to wash their hands carefully after use. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination Read the complete document