Alomide Allergy 0.1% Eye Drops, Solution

Each ml contains 0.1% w/v lodoxamide (as 0.178% w/v lodoxamide trometamol)

For excipients, see section 6.1

Eye Drops, Solution

A clear, colourless solution.

ALOMIDE is indicated in the treatment of the ocular signs and symptoms of allergic conjunctivitis

Adults and children (4 years and above): one or two drops in each eye four times a day at regular intervals.

ALOMIDE therapy is dependent upon its administration at regular intervals, as directed.

ALOMIDE therapy should not be used for more than 4 weeks without seeking medical advice.

Improvements in signs and symptoms in response to ALOMIDE therapy (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, conjunctival redness, limbal reaction, epithelial disease, ptosis) are usually evident within a few days, but longer treatment for up to four weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

Instillation of eye drops in allergic conjunctivitis may cause discomfort initially and that this will decline with improvement of the disease (see 4.8 Undesirable Effects).

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

Children less than 4 years: The safety and effectiveness of ALOMIDE in children below the age of four years have not been established.

Elderly: There are no special precautions to be followed in prescribing ALOMIDE for the elderly.

If required, corticosteroids may be used concomitantly with ALOMIDE.

ALOMIDE is contraindicated in those persons who have a known hypersensitivity to lodoxamide or any of the excipients.

• 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, a preservative that 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, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision or visual disturbances occur, the patient must wait until the vision is clear 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.

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product.

In the event of a topical overdose, flush from the eye with lukewarm water. .

In case of accidental ingestion of doses of 0.1 mg to 10.0 mg of lodoxamide, the following side adverse effects may occur: feeling of warmth, flushing, nausea, vomiting, diaphoresis and abdominal cramping. Transient elevations of systolic and diastolic blood pressure have been noted with doses of 3.0 and 10.0 mg of oral lodoxamide, but they resolve spontaneously after a short time. Other possible adverse effects after an oral overdose are: headache, dizziness, fatigue and loose stools.

If accidentally ingested, efforts to decrease further absorption may be appropriate.

Lavage, if the overdose has been taken within 1 hour or treatment with activated charcoal should be considered.

Lodoxamide, a mast cell stabiliser inhibits the in vivo Type I immediate hypersensitivity reaction in animals and man.

In vitro studies have demonstrated the ability of lodoxamide to stabilise mast cells and prevent the antigen specific induced release of histamine. In addition, lodoxamide prevents the release of other mast cell inflammatory mediators (i.e. SRS-A, slow reacting substances of anaphylaxis also known as the peptido-leukotrienes). Lodoxamide inhibits histamine release in vitro by preventing the movement of calcium into the mast cell after stimulation.

The oral bioavailability of ¹⁴C-lodoxamide in man is 71%, approximately 87% of the absorbed drug undergoes bio transformation. The metabolic transformation of lodoxamide results from stepwise hydrolysis of the oxylamide groups to form the monoxamate and the diamine. The diamine undergoes further hydroxylation followed by conjugation to either the O-glucuronide or O-sulphate. The O-glucuronide and O-sulphate metabolites account for 79% of the biotransformed lodoxamide, with the monoxamate and diamine accounting for 5% and 3% of the excreted metabolites. Only 2.7% of the absorbed dose is recovered as unchanged drug in the urine

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

Benzalkonium chloride

Mannitol

Hypromellose

Sodium citrate

Citric acid

Disodium edetate;

Tyloxapol

Sodium hydroxide for pH adjustment and/or

Hydrochloric acid for pH adjustment

Purified water

None known.

24 months.

The contents and bottle should be discarded one month after opening the container for the first time.

Do not store above 25°C.

ALOMIDE is supplied in 5 mL, natural, low-density polyethylene bottles with natural, low density polyethylene dispensing plugs and tamper evident polypropylene screw caps.

The dispensing tip should not be touched with the fingers or by the conjunctiva when drops are instilled. The container should be kept tightly closed.

Alcon Laboratories (UK) Ltd

Pentagon Park

Boundary Way

Hemel Hempstead

Herts

HP2 7UD

United Kingdom

PL 00649/0159

12/10/2006

8 November 2010