Procto-Glyvenol suppository omposition and forms of issue :
Each suppository contains 400 mg ethyl- 3,5,6 – tri – 0 – benzyl – 0 -glucofuranoside (=tribenosid.), a synthetic active substance belonging to the category of the glucofuranosides, and 40 mg lidocaine. 100 g cream contains 5 g tribenoside and 2 g lidocaine hydrochloride.
Procto-Glyvenol suppository properties :
It affords prompt relief from the unpleasant symptoms of haemorrhoids (pain, smarting, itching, skin tension), which are chiefly due to secondary inflammation in the anal region. The therapeutic activity displayed by Glyvenol in patients with haemorrhoids is attributable, firstly to its specific pharmacological effects, due to its ability to reduce capillary permeability and improve vascular tone, and secondly to its local anti-inflammatory proper- ties and to the antagonistic action it exerts on a number of endogenous substances which play a role as mediators in the development of inflammation and in the causation of pain. The lidocaine component helps to provide rapid symptomatic relief.
Procto-Glyvenol suppository pharmacokinetics :
Since it is designed to exert a local action, it is desirable that systemic absorption of its active substance, tribeno- side, should be confined to a minimum. The systemic bioavailability of tribenoside from suppositories amounts to only 30 % of that attained when the substance is given orally in the form of capsules. Tribenoside is inten- sively metabolised in the body. From one suppository 20-27 % of the dose is excreted in the urine in the form of metabolites. Approx. 2-20% of the tribenoside contained in the cream is absorbed through the skin.
Procto-Glyvenol suppository indication :
External and internal haemorrhoids.
Procto-Glyvenol suppository dosage :
Until the acute symptoms have disap peared, the cream – or 1 suppository –
should be applied morning and evening; the dosage can subsequently be reduced to the application of cream or of 1 suppository-once a day. 15 g cream tube) is sufficient for approx. 10-15 applications.
Procto-Glyvenol suppository contra-indication:
Hypersensitivity to the active substances of Procto – GlyvenoJ.
Procto-Glyvenol suppository during pregnancy and lactation:
As in the case of any form of drug therapy, it should beemployed with caution during pregnancy, especially in the first 3 months. It is not known whether the active substances pass into the breast milk. The benefits for the mother must be weighed against the risks for the child.
Procto-Glyvenol suppository unwanted effects :
It is well tolerated. In exceptional cases, a slight burning sensation, pain, or increased intestinal motility have been reported following use of the cream or suppositories
Procto-Glyvenol suppository Information for the patient :
To treat internal haemorrhoids. the cream can be applied by screwing on of course, first be removed and then replaced again after use. If the discomfort proves persistent. or if any unu- sual signs or symptoms occur, it is
recommended that you should consult your doctor in order to exclude the possibility that the condition may be due to some cause other than haemorrhoids. In addition to treating your haemorrhoids with it, you are advised to keep the anal re- gion in a good state of hygiene, to get sufficient exercise, and to take whate- ver measures you can to ensure that your stools remain of soft consistence.
Storage :
Protect from heat.
Packages :
Cream: Tubes of 15 9
Suppositories: Packs of 5
Medicines should be kept out of the reach of children.
Produced by :
NOVARTlS PHARMA S.A.E.- Cairo
under licence from
Novartis Consumer Health SA,
Nyon,Switzerland.