Страна: Израел
Език: английски
Източник: Ministry of Health
LIDOCAINE HYDROCHLORIDE; TRIBENOSIDE
GSK CONSUMER HEALTHCARE, ISRAEL LTD
C05AX05
CREAM
TRIBENOSIDE 5 %; LIDOCAINE HYDROCHLORIDE 2.12 %
TOPICAL ANNAL
Not required
NOVARTIS CONSUMER HEALTH SA, SWITZERLAND
TRIBENOSIDE
TRIBENOSIDE
External & internal haemorrhoids
2020-04-30
ProGly PT v1 401301 Прочетете целия документ
1 _The format of this leaflet was determined by the Ministry of Health and its content was checked and _ _approved in May 2017 _ PROCTO-GLYVENOL ® SUPPOSITORIES PROCTO-GLYVENOL ® CREAM _ _ _COMPOSITION _ _Active ingredients_: tribenoside, lidocaine hydrochloride/ lidocaine. _EXCIPIENTS _ _Suppositories_: Hard fat #2 (Witepsol W35), Hard fat #1 (Witepsol E85) _Cream_: Purified water, Paraffin, liquid, Stearic acid, Sorbitol liquid (non crystallizing), Cetyl Alcohol, Macrogol cetostearyl ether (Cetomacrogol-1000), Isopropyl Palmitate, Sorbitan stearate (Arlacel-60),Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, _PHARMACEUTICAL FORMS AND QUANTITY OF ACTIVE INGREDIENT PER UNIT _ 1 suppository (2 g) contains 400 mg of tribenoside and 40 mg of lidocaine. Yellowish-white and torpedo-shaped suppositories. 1 g of cream contains 50 mg of tribenoside and 21.2 mg of lidocaine hydrochloride. White and homogenous cream. _INDICATIONS/POSSIBLE USES _ Suppositories: Local relief of haemorrhoids. Cream: External & internal haemorrhoids. _POSOLOGY/METHOD OF ADMINISTRATION _ _Adults_: During the acute phase of the disorder, apply the cream or suppository in the morning and evening; subsequently, reduce to one application of cream or one suppository a day. 30g of cream (1 tube) are enough for approximately 20-30 applications. Avoid contact with the eyes. Intended for adult use only; not suitable for children. _CONTRAINDICATIONS _ Hypersensitivity to the active ingredients or excipients, according to the composition. _WARNINGS AND PRECAUTIONS _ Where there is bleeding in the anal area or where faecal blood is suspected as well as in the onset of other unusual symptoms, a medical examination with a view to diagnosis is advised. If symptoms appear for the first time, self-medication should not last longer than 7 days. Repeated treatments should only take place following diagnosis confirmed by a doctor. Procto-Glyvenol should be used with caution in patients with severely impaired liver function. There is no clinical experienc Прочетете целия документ