Eykappo

Eykappo 5 mg/ml eye drops solution

Eykappo 5 mg/ml eye drops solution contains 5 mg/ml chloramphenicol.

Excipient with known effect

One ml of solution contains 2.9 mg boron.

For the full list of excipients, see section 6.1.

Eye drops, solution.

Clear, colourless, aqueous eye drops solution

Osmolality: 260-320 mOsm/Kg

pH: 6.8 -7.8

Chloramphenicol is indicated in adults and children for the treatment of acute bacterial conjunctivitis.

Considerations should be given to official guidance on the appropriate use of antibacterial agents.

Posology

Adults (including the elderly) and children

One to two drops applied topically to each affected eye up to six times daily or more frequently if required. To decrease the risk for recurrent infection, treatment should continue for an additional 2 days after symptoms disappear. The maximum recommended treatment duration is 14 days.

Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute following instillation of the drops.

Method of administration

For ocular use.

Eykappo eye drops solution is a sterile solution that does not contain a preservative.

Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures as this could cause injury to the eye.

Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

This medicinal product must not be given to a child less than 2 years old (see also section 4.4).

In severe infections topical use of chloramphenicol should be supplemented with appropriate systemic treatment.

Prolonged use should be avoided as it may increase the likelihood of sensitisation and the emergence of resistant organisms.

Contact lenses should not be worn in an infected eye. Contact lenses should be removed during the period of treatment.

Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver.

This medicinal product must not be given to a child less than 2 years old as it contains boron and may impair fertility in the future (see also section 4.3).

Since low systemic concentrations of chloramphenicol are expected after topical use, the risk for relevant interactions is expected to be low.

Pregnancy and breast-feeding

Safety for use in pregnancy and lactation has not been established, therefore, use only when considered essential by the physician. Chloramphenicol passes the placenta and is excreted in breast milk.

Fertility

No fertility data are available.

May cause transient blurring of vision on installation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

Local

Sensitivity reactions such as transient irritation, burning, stinging, itching and dermatitis, may occur.

Systemic

Angioedema.

Paediatric population

The adverse reaction profile in children is expected to be similar to adults.

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 (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

Not applicable.

Pharmacotherapeutic group: Ophthalmological antibiotic, ATC code: S01AA01

Chloramphenicol is an antibiotic which is mainly bacteriostatic in action, but exerts a bactericidal effect against some strains of gram-positive cocci and against Haemophilus influenzae and Neisseria. It has a broad spectrum of action against both gram-positive and gram-negative bacteria, rickettsiae and chlamydia.

Chloramphenicol penetrates into ocular tissues and aqueous humour. Part of the chloramphenicol administered topically may be absorbed systemically by way of the nasolacrimal duct. Limited data, however, indicate no significant increases of chloramphenicol serum concentration after topical administration.

After oral administration, chloramphenicol is rapidly absorbed. Chloramphenicol is inactivated by conjugation with glucuronic acid or by reduction to inactive aryl amines in the liver. Excretion is mainly renal, though some bile excretion occurs following oral administration. Elimination is subject to high variability but the half-life is estimated to 1.5−4 hours. The half-life is prolonged in patients with severe hepatic impairment and in neonates.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Boric acid

Borax

Sodium hydroxide or/and Hydrochloric acid (for pH adjustment)

Water for injection

Not applicable

2 years.

After opening: 28 days

Store between 2° and 8°C. Do not freeze. Protect from light.

The eye drop solution is presented as a 10 ml clear, colourless aqueous solution in a white opaque 11 ml LDPE bottle and white Novelia nozzle (HDPE and silicone) with a white HDPE cap.

Pack sizes: 1 bottle in a cardboard box.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Aspire Pharma Ltd

Unit 4, Rotherbrook Court,

Bedford Road,

Petersfield,

Hampshire,

GU32 3QG

United Kingdom

PL35533/0123

22/03/2017

21/02/2019