Procto-Glyvenol Rectal Cream 5%w/w, 2%w/w

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

TRIBENOSIDE, LIDOCAINE HYDROCHLORIDE

Disponível em:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

Código ATC:

C05AX03

DCI (Denominação Comum Internacional):

TRIBENOSIDE 5 % (W/W) LIDOCAINE HYDROCHLORIDE 2 % (W/W)

Forma farmacêutica:

RECTAL CREAM

Composição:

TRIBENOSIDE 5 % (W/W) LIDOCAINE HYDROCHLORIDE 2 % (W/W)

Tipo de prescrição:

OTC

Área terapêutica:

VASOPROTECTIVES

Status de autorização:

Authorised

Data de autorização:

2008-07-23

Folheto informativo - Bula

PROCTO-GLYVENOL
RECTAL CREAM
For how long you should take Procto-Glyvenol
1. WHAT PROCTO-GLYVENOL IS AND WHAT IT IS USED FOR
Tell your doctor or pharmacist before taking Procto-Glyvenol if you
are
pregnant or breastfeeding, or if you intend to become pregnant.
You should not use Procto-Glyvenol during the first 3 months of
pregnancy.
You may use Procto-Glyvenol after the 4
th
month of pregnancy or while you
are breastfeeding, however you should not exceed the recommended
dosing.
Procto-Glyvenol and children
Do not administer it to children without consulting a doctor.
Driving and using machines
Proctoglyvenol should not affect your ability to drive a car or
operate machines.
There is no known experience of overdose with Procto-Glyvenol.
However, if
you have used more Procto-Glyvenol than you should, talk to a doctor
or
pharmacist immediately.
Like all medicines, Procto-Glyvenol can have side effects.
Procto-Glyvenol is generally well tolerated. However, in rare cases it
might
cause skin reactions such as burning, itching or redness where you
applied the
product, or even spread beyond this area. Tell your doctor if you have
any of
those symptoms.
In very rare cases it might cause severe allergic reactions
(anaphylactic
reactions) such as swelling of the face, lips, tongue and/or throat
(which may
cause difficulty in swallowing), difficulty in breathing, severe
itching of the
skin or irregularities of the heartbeat.
CONTACT A DOCTOR IMMEDIATELY and STOP using the product if you
have any of those symptoms.
Possible side-effects due to the presence of certain excipients in
Procto-
Glyvenol Cream:
 Cethyl Alcohol and Cetostearyl ether may cause local skin
reactions (e.g.
contact dermatitis).
If you notice any side effects not mentioned in this leaflet, please
inform your
doctor or pharmacist.
5. STORING PROCTO-GLYVENOL
If you forget to take Procto-Glyvenol
If you forgot to use Procto-Glyvenol at the time due, don’t worry:
Just use it as
usual at the time you were supposed to use it next. Do not take a
double dose

Características técnicas

1
1.
NAME OF THE MEDICINAL PRODUCT
Procto-Glyvenol rectal cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100g of rectal cream contains 5%w/w of tribenoside and 2%w/w of
lidocaine hydrochloride
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, homogeneous cream, with a weak, characteristic odour.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Local treatment of external and internal haemorrhoids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The rectal cream should be applied morning and evening until acute
symptoms have diminished,
after which the dosage can be reduced to once a day.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
of Procto-Glyvenol.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Procto-Glyvenol should be used with precaution in patients suffering
from severe hepatic damage.
Due to the presence of Cetostearyl ether and Cethyl Alcohol,
Procto-Glyvenol Rectal Cream may
cause local skin reactions (e.g. contact dermatitis). Some allergic
reactions possibly delayed may be
due to the presence of Methyl parahydroxybenzoate and Propyl
parahydroxybenzoate.
The container of Procto-Glyvenol rectal cream contains latex rubber.
This may cause severe
allergic reactions.
There is no clinical experience with Procto-Glyvenol in children.
4.5.
INTERACTION
WITH
OTHER
MEDICINAL
PRODUCTS
AND
OTHER
FORMS OF INTERACTION
None reported.
4.6.
PREGNANCY AND LACTATION
Procto-Glyvenol should not be used during the first 3 months of
pregnancy.
Procto-Glyvenol may be used as from the 4th month of pregnancy and
during breast-feeding,
however the recommended dosing should not be exceeded
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
There is no known effect on the ability to drive or operate machines
caused by the use of Procto-
Glyvenol.
4.8.
UNDESIRABLE EFFECTS
2
IMMUNE SYSTEM DISORDERS
Very rare (<1/10,000): Anaphylactic reactions, including angioneurotic
oedema, face oedema,
bronchospasm and cardiovascular disorders.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rare