Hirudoid 0.3% gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Heparinoid

Available from:

Thornton & Ross Ltd

ATC code:

C05BA01

INN (International Name):

Heparinoid

Dosage:

3mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13140000; GTIN: 5030451003331

Patient Information leaflet

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24963503
PACKAGE LEAFLET: INFORMATION FOR THE USER
HIRUDOID GEL
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 Gel
is and what it is used for
2. What you need to know before you use Hirudoid Gel
3. How to use Hirudoid Gel
4. Possible side-effects
5. How to store Hirudoid Gel
6. Contents of the pack and other information
1.WHAT HIRUDOID GEL IS AND WHAT IT IS USED FOR
Hirudoid Gel
contains the active substance heparinoid.
Hirudoid Gel
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 GEL
DO NOT USE HIRUDOID GEL:
• if you are allergic (hypersensitive) to heparinoid or any of the
other ingredients of Hirudoid Gel (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 Gel
should NOT be used on children under the age of 5 years old.
WARNINGS AND PRECAUTIONS
-
Hirudoid Gel
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 GEL
Tell your doctor or pharmacist if you are taking, have recen
                                
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Summary of Product characteristics

                                OBJECT 1
HIRUDOID GEL
Summary of Product Characteristics Updated 07-May-2015 | Genus
Pharmaceuticals
1. Name of the medicinal product
Hirudoid Gel
2. Qualitative and quantitative composition
Heparinoid 0.3% w/w (Equivalent to 25,000 Units per 100g gel).
3. Pharmaceutical form
Topical gel.
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, as a thin layer, up to four
times a day to the affected area.
Recommended when its cooling effect and rapid action are required.
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 Interaction with other medicinal products and other forms of
interaction
None known.
4.6 Pregnancy and lactation
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 Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard
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 Pharmacodyn
                                
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