Ultraproct suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinchocaine hydrochloride; Fluocortolone caproate; Fluocortolone pivalate

Available from:

Meadow Laboratories Ltd

ATC code:

C05AX03

INN (International Name):

Cinchocaine hydrochloride; Fluocortolone caproate; Fluocortolone pivalate

Dosage:

1mg ; 630microgram ; 610microgram

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01070200

Patient Information leaflet

C. 01356
Artwork date: 16/05/2017
Version n°: 01
Bayer HealthCare Manufacturing S.r.l. (Segrate)
TEL [phone]
_Infants and Children_
Ultraproct is not for use in infants and is not recommended for
use in children under 12 years of age unless directed by a doctor.
_Using dressings over the treatment area_
Do not use waterproof dressings over the affected skin.
TAKING OTHER MEDICINES
• Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.
• Some medicines may increase the effects of Ultraproct and
your doctor may wish to monitor you carefully if you are taking
these medicines (including some medicines for HIV: ritonavir,
cobicistat).
PREGNANCY AND BREAST-FEEDING
Even at the usual dose, the possibility of a very small risk to the
development of a baby in pregnant women treated with Ultraproct
cannot be entirely ruled out. THEREFORE, THIS MEDICINE SHOULD
NOT BE USED IF YOU ARE PREGNANT, TRYING TO BECOME PREGNANT
OR ARE BREAST-FEEDING UNLESS CONSIDERED ESSENTIAL BY YOUR
DOCTOR.
DRIVING AND USING MACHINES
Ultraproct does not impair your ability to drive or operate
machinery.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF
ULTRAPROCT OINTMENT
Ultraproct Ointment contains castor oil and hydrogenated castor
oil, which may cause skin reactions.
3. HOW TO USE ULTRAPROCT
Wash your hands before and after using Ultraproct.
Do not use Ultraproct for more than 7 days.
called cinchocaine hydrochloride which is a local anaesthetic to
relieve pain.
Ultraproct can be used for the short-term (5-7 days) relief of
inflammation, swelling, itching and soreness of piles
(haemorrhoids) and to relieve itching of the anus (back passage).
This leaflet covers the following products:
• Ultraproct Suppositories
• Ultraproct Ointment
In this leaflet they are jointly referred to as Ultraproct.
Your doctor will prescribe the correct product to treat your
specific condition.
2. BEFORE YOU USE ULTRAPROCT
DO NOT USE ULTRAPROCT IF YOU:
• are ALLERG

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ultraproct® Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Each suppository contains: _
Fluocortolone pivalate BP 0.6 1mg
Fluocortolone hexanoate BP 0.63mg
Cinchocaine hydrochloride BP 1.00mg
3
PHARMACEUTICAL FORM
Suppository
Each suppository is white.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of haemorrhoids and of pruritus ani in the
short term (5-7
days).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
One suppository to be inserted daily. In severe cases, one suppository
two to
three times daily at the beginning of treatment. The suppositories
should be
inserted after defaecation.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1. Viral infections. Primary bacterial or fungal infections.
Secondary infections of
the skin in the absence of appropriate anti-infective therapy. Known
sensitivity to
local anaesthetics.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In infants, long-term continuous therapy with topical corticosteroids
should be
avoided.
Occlusion is not appropriate on the perineum. Adrenal suppression can
occur
even without occlusion. The application of unusually large quantities
of
topical corticoids may result in the absorption of systemically active
amounts
of corticoid.
Secondarily-infected dermatoses definitely require additional therapy
with
antibiotics or chemotherapeutic agents. This treatment can often be
topical but
for heavy infections systemic antibacterial therapy may be necessary.
If fungal
infections are present, a topically active anti-mycotic should be
applied.
Ultraproct should not be allowed to come into contact with the eyes.
Patients
should be advised to wash their hands carefully after use.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS 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
combi