LIOTON Gel Ref.[28231] Active ingredients: Heparin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: A. Menarini Industrie Farmaceutiche Riunite S.r.l., Via Sette Santi 3, 50131, Firenze Italy, Tel.: 0039 055 5680336

4.3. Contraindications

Lioton 1000 gel should not be used in cases of known hypersensitivity to heparin or any of the other ingredients of the product.

4.4. Special warnings and precautions for use

The use of Lioton 1000 gel in the presence of haemorrhagic phenomena should be closely evaluated.

Lioton 1000 gel should not be applied in cases of bleeding, on open wounds or on mucosae, nor on sites of infection in case of suppurative processes.

Lioton 1000 gel contains the excipients methyl- and propyl p-hydroxybenzoate and it should not be used in patients with paraben allergy.

4.5. Interaction with other medicinal products and other forms of interaction

The use of heparin can further prolong prothrombin time in patients treated with oral anticoagulants.

4.6. Fertility, pregnancy and lactation

No specific data on the use of this medicinal product during pregnancy and lactation are available.

4.7. Effects on ability to drive and use machines

Lioton 1000 gel does not affect alertness and therefore does not exert an effect on the ability to drive vehicles or use machinery.

4.8. Undesirable effects

Allergic reactions to heparin following application onto the skin are very rare. However, hypersensitivity reactions such as reddening of the skin and itching, which usually disappear rapidly upon withdrawal, may occur in isolated cases.

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 national reporting system listed below.

Cyprus: Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs

6.2. Incompatibilities

Not applicable.

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