HIRUDOID Cream 0.3% w/w
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
26-06-2023
Summary of Product characteristics
(SPC)
26-06-2023
Active ingredient:
HEPARINOID
Available from:
Genus Pharmaceuticals Limited Linthwaite, Huddersfied HD7 5QH, United Kingdom
ATC code:
C05BA01
INN (International Name):
HEPARINOID 0.3 % (W/W)
Pharmaceutical form:
CREAM
Composition:
HEPARINOID 0.3 % (W/W)
Prescription type:
OTC
Therapeutic area:
VASOPROTECTIVES
Authorization status:
Withdrawn
Authorization date:
2005-08-30
Patient Information leaflet
TEXT FOR HIRUDOID CREAM
LEAFLET
MA085/00101
PACKAGE LEAFLET: INFORMATION FOR THE USER
HIRUDOID CREAM
HEPARINOID 0.3% W/W
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side-effects, talk to your doctor or pharmacist. This
includes any possible side-effects not listed
in this leaflet. See section 4.
- You must talk to a doctor if your signs of illness or injury do not
improve.
WHAT IS IN THIS LEAFLET:
1.What Hirudoid Cream is and what it is used for
2.What you need to know before you use Hirudoid Cream
3. How to use Hirudoid Cream
4. Possible side-effects
5. How to store Hirudoid Cream
6. Contents of the pack and other information
1.WHAT HIRUDOID CREAM IS AND WHAT IT IS USED FOR
Hirudoid Cream contains the active substance heparinoid.
Hirudoid Cream is a local anti-coagulant preparation which, when
applied to the skin, relieves pain and
inflammation in addition to promoting healing in superficial
thrombophlebitis (inflammation of the veins) and
bruising (including haematoma).
2.WHAT YOU NEED TO KNOW BEFORE YOU USE HIRUDOID CREAM
DO NOT USE HIRUDOID CREAM:
• if you are allergic (hypersensitive) to heparinoid or any of the
other ingredients of Hirudoid Cream (listed in
section 6)
• if you have broken skin, or on large areas of skin
• on or near sensitive areas such as the mouth, eyes or ano-genital
regions.
Hirudoid Cream should NOT be used on children under the age of 5 years
old.
WARNINGS AND PRECAUTIONS
- Hirudoid Cream is for external use only. Do NOT swallow.
- Do not exceed the dose stated in section 3.
- Talk to your doctor if your signs of injury or illness do not
improve or get worse.
See section 4 for information about possible side-effects.
OTHER MEDICINES AND HIRUDOID CREAM
Tell your docto
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hirudoid Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparinoid 0.3%
_wlw _
(Equivalent to 25 000 Units per 100 g cream).
3.
PHARMACEUTICAL FORM
Topical cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hirudoid is indicated for the treatment of superficial
thrombophlebitis and the soothing
relief of superficial bruising and haematoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children over 5 years of age:
Two to six inches (5-15 cm) to be applied up to four times daily to
the affected area and
gently massaged into the skin.
4.3
CONTRAINDICATIONS
Not to be used on large areas of skin, broken skin, sensitive areas of
skin or mucous
membranes. Not to be used in individuals with a known sensitivity to
any active or inactive
component of the formulation. Not to be used in children under 5 years
of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only. If symptoms persist or worsen, seek medical
advice. Do not exceed
the stated dose.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
Page
1
of
4
There is no evidence to suggest that Hirudoid should not be used
during pregnancy and
lactation.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8
UNDESIRABLE EFFECTS
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal
product. Healthcare professionals are asked to report any suspected
adverse reactions via the
ADR reporting website at: www.medicinesauthority.gov.mt/adrportal.
4.9
OVERDOSE
In the absence of any reports of the accidental ingestion of Hirudoid,
no specific advice is
available. General supportive measures may be appropriate.
5.
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES
Heparinoid is recognised as having: a weak inhibitory effect o
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