BROLENE Eye drops Ref.[27603] Active ingredients: Propamidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aventis Pharma Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, United Kingdom

4.3. Contraindications

Hypersensitivity to propamidine or any other component of the preparation.

4.4. Special warnings and precautions for use

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days' therapy, discontinue use and consult a physician.

The eye drops are unsuitable for use with hard or soft contact lenses.

The drops should be discarded 28 days after first opening for domiciliary use or, when used under hospital conditions, seven days after first opening.

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

None known.

4.6. Pregnancy and lactation

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

4.7. Effects on ability to drive and use machines

May cause blurring of vision on instillation. Patients should not drive or operate hazardous machinery unless vision is clear.

4.8. Undesirable effects

Hypersensitivity may occur.

Eye pain or irritation, usually in the form of a stinging or burning sensation, may also occur. In such cases, use should be discontinued immediately and a physician should be consulted.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

6.2. Incompatibilities

None known.

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