PROCTO-GLYVENOL SUPPOSITORIES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LIDOCAINE; TRIBENOSIDE

Available from:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC code:

C05AX05

Pharmaceutical form:

SUPPOSITORIES

Composition:

TRIBENOSIDE 400 MG; LIDOCAINE 40 MG

Administration route:

RECTAL

Prescription type:

Not required

Manufactured by:

GSK CONSUMER HEALTHCARE SARL, SWITZERLAND

Therapeutic group:

TRIBENOSIDE

Therapeutic area:

TRIBENOSIDE

Therapeutic indications:

Local relief of haemorrhoids.

Authorization date:

2020-04-30

Patient Information leaflet

ProGly PT v1 401301

Summary of Product characteristics

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