For the local treatment of haemorrhoids
Composition and forms of issue :
Each suppository contains 400 mg ethyl- 3,5,6 – tri – 0 – benzyl – 0 -glucofuranoside (=tribenosid.), a synthetic active substan- ce belonging to the category of the glucofuranosides, and 40 mg lidocaine. 100 9 cream contains 5 9 tribenoside and 2 9 lidocaine hydrochloride.
Procto-Glyvenol affords prompt relief from the unpleasant symptoms of haemorrhoids (pain, smarting, itching, skin tension), whi- ch are chiefly due to secondary inflamma- tion in the anal region. The therapeutic activity displayed by Glyvenol in patients with haemorrhoids is attributable, firstly. to its specific pharmacological effects-Le. to its ability to reduce capillary permeabi-
lity and improve vascular tone-and, secon- dly, 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 de- velopment of inflammation and in the cau- sation of pain. The lidocaine component helps to provide rapid symptomatic relief.
Since Procto-Glyvenol 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 un the form of capsules>. Peak plasma concentrations of 1 )Jg/ml (trtbeno- slde e rnetebolites ) are recorded 2 hours after rectal administration of 1 suppository
(400 mg trtbenoside). Tribenoside is inten- sively metabolised in the body. From one suppository 20-27 % of the dose is excre- ted in the urine in the form of metabolites. Approx. 2-20% of the tribenoside contained in the cream is absorbed through the skin.
External and internal haemorrhoids.
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 sup- pository-once a day. 15 g cream C1 tube) is sufficient for approx. 10-15 applications.
Hypersensitivity to the active substances of Procto – GlyvenoJ.
Pregnancy and lactation:
As in the case of any form of drug therapy, Procto-Glyvenol 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.
Unwanted effects :
Procto-Glyvenol is well tolerated. In exce- ptional cases, a slight burning sensation, pain, or increased intestinal motility have been reported following use of the cream or suppositories
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 discom-
fort 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 haemor-
rhoids. In addition to treating your haemorrhoid.s with Procto – Glyvenol,
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.
Protect from heat.
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,