ALOMIDE Eye drops, solution Ref.[9464] Active ingredients: Lodoxamide

ALOMIDE is not for injection.

The recommended frequency of administration should not be exceeded.

Patients should be advised that instillation of eye drops may initially cause discomfort or transient burning or stinging (see section 4.8). Should these symptoms persist, the patient should be advised to contact the prescribing physician.

ALOMIDE contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of ALOMIDE and wait at least 15 minutes before reinsertion.

No interaction studies have been performed.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Pregnancy

There are no or limited amount of data from the use of ALOMIDE in pregnant-women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of ALOMIDE during pregnancy.

Lactation

It is not known whether lodoxamide is excreted in human milk. There is insufficient information on the excretion of lodoxamide from ALOMIDE in animal milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ALOMIDE therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Lodoxamide has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

a. Summary of the safety profile

In clinical trials, the most common adverse reaction was ocular discomfort.

b. Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience for lodoxamide eye drops.

Nervous system disorders

Uncommon: dizziness, headache

Rare: somnolence, dysgeusia

Eye disorders

Very common: ocular discomfort

Common: vision blurred, dry eye, eye pruritus, lacrimation increased, ocular hyperaemia Uncommon: eye pain, eye oedema, asthenopia, corneal deposits, conjunctival oedema, abnormal sensation in eye, foreign body sensation in eyes, eye discharge, eye irritation

Rare: corneal erosion, corneal scar, corneal abrasion, anterior chamber cell, corneal epithelium defect, keratitis, blepharitis, eye allergy, visual impairment, eyelid oedema, conjunctival disorder

Cardiac disorders

Not known: palpitations

Respiratory, thoracic and mediastinal disorders

Rare: nasal dryness, sneezing

Gastrointestinal disorders

Uncommon: nausea

Rare: abdominal discomfort

Skin and subcutaneous tissue disorders

Uncommon: eyelid exfoliation

Rare: rash

General disorders and administration site conditions

Uncommon: feeling hot

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.

None known.