Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Heparinoid
Thornton & Ross Ltd
C05BA01
Heparinoid
3mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13140000; GTIN: 5030451003331
9240363 1411 GB 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 Read the complete document
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 Read the complete document