Lioton 100,000 I.U./100 g Gel

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HEPARIN SODIUM

Available from:

A. Menarini Industrie Farmaceutiche Riunite S.r.L. Via Sette Santi 3, 50131, Florence, Italy

ATC code:

C05BA03

INN (International Name):

HEPARIN SODIUM 2.5 IU/g

Pharmaceutical form:

GEL

Composition:

HEPARIN SODIUM 2.5 IU/g

Prescription type:

OTC

Therapeutic area:

VASOPROTECTIVES

Authorization status:

Authorised

Authorization date:

2005-09-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIOTON 1000 IU/G GEL
HEPARIN SODIUM
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 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 you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1.
What Lioton 1000 gel is and what it is used for
2.
What you need to know before you use Lioton 1000 gel
3.
How to use Lioton 1000 gel
4.
Possible side effects
5.
How to store Lioton 1000 gel
6.
Contents of the pack and other information
1.
WHAT LIOTON 1000 GEL IS AND WHAT IT IS USED FOR
Lioton 1000 gel is a preparation of heparin in the form of gel for
external use; it is therfore
useful for the treatment, alone or in combination with systemic
therapy, of those morbid
phlogistic or traumatic affections which benefit by a percutaneous
antiexudative, anti –oedema,
anticoagulat and disifiltrating activity.
Lioton 1000 gel covers a wide and pecular field of application mainly
in the domain of venous
phlogistic
pathology
pertaining
to
internal
medicine
or
vascular
surgery,
and
in
the
traumatologic-orthopedic field.
Lioton 1000 gel is used for varicosee syndromes and their
complications; phlebothrombosis;
thrombophlebitis,
superficial
periphlebitis;
varicose
ulcers.
Post-surgical
varicophlebitis;
aftermath of saphenectomy. Traumas and contusions; localised
infiltrates and oedemas;
subcutaneous hematoma. Traumatic affections of the muscle-tendon and
capsulo-ligamentous
apparata.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LIOTON
DO NOT USE LIOTON 1000 GEL IF
-
if you are hypersensitive (allergic) to heparin sodium or any of the
other ingredients of
Lioton.
WARNING AN

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lioton 100,000 I.U./100 g Gel
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of gel contain Heparin sodium 100,000 I.U.
Excipient(s) with known effect:
1 g gel contains 233 mg ethanol.
Methyl-4-hydroxybenzoate (0.12 g in 100g of product) and
Propyl-4-hydroxybenzoate (0.03 g in
100g of product) as conservatives.
Neroli fragrance and lavandin oil as fragrances containing citral,
citronellol, coumarin, d-limonene,
farnesol, geraniol and linalool.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Gel
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Varicose syndromes and their complications; phlebothrombosis;
thromboph1ebitis
, superficial
periphlebitis; varicose ulcers, post-operative varicophlebitis;
sequelae of saphenectomy.
Traumas and contusions; infiltrates and local edemas; subcutaneous
hematoma.
Traumatic affections of the musculotendinous and capsulo-ligamentous
apparatuses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One to three applications a day, by applying 3-10 cm of gel on the
affected area and massaging gently.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of Lioton in presence of haemorrhagic phenomena should be
closely evaluated.
Lioton should not be applied in case of bleeding, on open wounds or
mucosae, or on infection sites
in case of suppurative processes.
Ethanol may cause burning sensation on damaged skin.
This medicine contains methyl-4-hydroxybenzoate and
propyl-4-hydroxybenzoate as conservatives.
They may cause allergic reactions (possibly delayed).
This medicine contains fragrances with citral, citronellol, coumarin,
d-limonene, farnesol, geraniol
and linalool. Citral, citronellol, coumarin, d-limonene, farnesol,
geraniol and linalool may cause
allergic reactions.
4.5
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The use of heparin may fu