Proctosedyl

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CINCHOCAINE HYDROCHLORIDE, HYDROCORTISONE

Available from:

Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta

ATC code:

C05AX03

INN (International Name):

CINCHOCAINE HYDROCHLORIDE 5 mg HYDROCORTISONE 5 mg

Pharmaceutical form:

SUPPOSITORY

Composition:

CINCHOCAINE HYDROCHLORIDE 5 mg HYDROCORTISONE 5 mg

Prescription type:

OTC

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2005-09-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROCTOSEDYL SUPPOSITORIES
Cinchocaine hydrochloride 5mg
Hydrocortisone 5mg
IS THIS LEAFL ET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START
USING THIS MEDICINE
• Keep this leafl et. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them even if their
symptoms are the same as yours.
• If any of the side eff ects gets serious, or if you notice
any side eff ects not listed in this leafl et, please tell
your doctor or pharmacist.
WHAT IS IN THIS LEAFL ET
1. What Proctosedyl Suppositories are and what they
are used for
2. What you need to know before you use Proctosedyl
Suppositories
3. How to use Proctosedyl Suppositories
4. Possible side eff ects
5. How to store Proctosedyl Suppositories
6. Contents of the pack and other information
1. WHAT PROCTOSEDYL SUPPOSITORIES ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Proctosedyl
Suppositories. Proctosedyl Suppositories contain two
diff erent medicines called: cinchocaine hydrochloride
and hydrocortisone.
• Cinchocaine hydrochloride belongs to a group of
medicines called local anaesthetics. It works by
causing numbness in the area to which it is applied.
This stops you feeling pain in this area and helps
lessen the spasm of the back passage
• Hydrocortisone belongs to a group of medicines
called corticosteroids. It works by lowering the
production of substances that cause infl ammation.
This helps lower swelling, itching and discharge
Proctosedyl Suppositories can be used for the short
term relief (not more than 7 days) of:
• Pain, irritation, discharge and itching associated
with enlarged or swollen vessels around your back
passage (haemorrhoids)
• Itching around your back passage
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PROCTOSEDYL SUPPOSITORIES
DO NOT TAKE USE THIS MEDICINE AND TELL YOUR
DOCTOR IF:
You are aller

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. TRADE NAME OF THE MEDICINAL PRODUCT
Proctosedyl
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cinchocaine hydrochloride (micro) 5 mg
Hydrocortisone (micro) 5 mg
3. PHARMACEUTICAL FORM
Smooth off-white suppositories
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The local anaesthetic cinchocaine relieves pain and relaxes
sphincteric spasm. Pruritis
and inflammation are relieved by hydrocortisone, which also decreases
serious discharge.
Proctosedyl is, therefore, useful for the short-term relief (not more
than 7 days) of pain,
irritation and pruritis associated with haemorrhoids and pruritis ani.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults (including the elderly) and children: _
A suppository is inserted morning and evening and after each stool.
The ointment may be used separately or concurrently with the
suppositories.
4.3 CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients.
Not for use in the presence of infections.
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hydrocortisone can cause thinning and damage to the skin especially of
the face.
As with all preparations containing topical steroids, the possibility
of systemic absorption
should be considered. In particular, long-term continuous therapy
should be avoided in
infants. Adrenal suppression can occur even without occlusion.
Pheochromocytoma crisis, which can be fatal, has been reported after
administration of
corticosteroids. Corticosteroids should only be administered to
patients with suspected or
identified pheochromocytoma after an appropriate risk/benefit
evaluation. (See Section
4.8).
4.5 INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
.
Co-treatment with CYP3A inhibitors, including cobicistat-containing
products, is
expected to increase the risk of systemic side-effects. The
combination should be avoided
unless the benefit outweighs the increased risk of systemic
corticosteroid side-effects, in
which case patients should be monitored for systemic corticoste