Librachrom

Librachrom Hayfever Relief 2% w/v eye drops, solution

Sodium cromoglicate 2.0% w/v.

For the full list of excipients, see section 6.1.

Eye Drops, Solution (eye drops)

A clear colourless or pale yellow liquid

For the relief and treatment of the eye symptoms of hayfever.

Librachrom Hayfever Relief 2% w/v eye drops, solution should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist.

Posology

Adults and Children over 6 years: One or two drops to be administered into each eye four times daily.

In children, caregiver supervision and/or assistance may be required.

Elderly

There is no evidence to suggest that dosage alteration is required for elderly patients.

Librachrom Hayfever Relief 2% w/v eye drops, solution is a sterile solution that does not contain a preservative.

Method of administration

For ocular use

Before instillation of the eye drops

- Users should be instructed to wash their hands before opening the bottle.

- Users should also be instructed to not use this medicine if they notice that the tamper-proof seal on the bottle neck is broken before they first use it.

- When used for the first time, before delivering a drop to the eye, the patient should practise using the dropper bottle by squeezing it slowly to deliver one drop away from the eye.

- When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).

Instillation

1. The bottle should be held directly below the cap and the cap should be turned to open the bottle. To avoid contamination of the solution, the tip of the bottle must not touch anything.

2. The patient should tilt their head backwards and hold the bottle above their eye.

3. The patient should pull the lower eyelid down and look up. The bottle should be squeezed gently in the middle and a drop should be allowed to fall into the patient's eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. The bottle must not be squeezed too hard.

Patients should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine.

4. The patient should blink a few times so that the drop spreads over their eye.

5. Instructions 2. – 4. should be repeated for delivery into the other eye, if required. The patient should be clearly instructed if one eye only requires treatment, and if so, which eye is affected.

6. After each use and prior to recapping, the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid on the tip. This is necessary in order to ensure delivery of subsequent drops.

7. At the end of the 28-day in-use shelf life of the medicine, there will be some Librachrom Hayfever Relief left in the bottle. Using the excess medicine remaining in the bottle after the patient has completed the course of treatment should not be attempted. Patients must not use the eye drops for longer than 28 days after first opening the bottle.

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

Discard any remaining contents four weeks after opening the bottle.

Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

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

The carton label and patient information leaflet will state:

- The patient should consult a doctor or pharmacist if symptoms do not start to improve within 48 hours

- Librachrom Hayfever Relief 2% w/v eye drops, solution should not be used continuously for more than 14 days except on the advice of a doctor or pharmacist

No interaction studies have been performed.

Pregnancy

As with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on fetal development. It should be used in pregnancy only where there is a clear need.

Breast-feeding

It is not known whether sodium cromoglicate is excreted in human breast milk but, on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest the use of sodium cromoglicate has any undesirable effects on the baby.

Fertility

It is not known whether sodium cromoglicate has any effect on fertility.

Librachrom Hayfever Relief has a minor influence on the ability to drive and use machines.

As with all eye drops, instillation of Librachrom Hayfever Relief may cause a transient blurring of vision. Patients are advised not to drive or operate machinery if affected, until their vision returns to normal.

Eye disorders

Transient stinging, burning and blurring of vision may occur after instillation. Other symptoms of local irritation have been reported rarely.

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).

Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Pharmacotherapeutic group: Ophthalmologicals; Other antiallergics ATC code: SO1GX01

The solution exerts its effect locally in the eye.

In vitro and in vivo animal studies have shown that sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.

Sodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Sodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.

Sodium cromoglicate is poorly absorbed. When multiple doses of sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of sodium cromoglicate is absorbed following administration to the eye.

Sodium cromoglicate is not metabolised.

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

Disodium edetate

Water for Injections

Not applicable.

3 years.

After first opening the bottle: 28 days.

Store below 25°C.

Discard any remaining solution four weeks after first opening.

Librachrom Hayfever Relief 2% w/v eye drops, solution is presented as a clear, colourless to pale yellow aqueous solution in a white opaque LDPE bottle and white Novelia nozzle (HDPE and silicone) and sealed with a white HDPE cap.

The following pack sizes are available: 1 x 5ml, 1 x 10ml

Not all pack sizes may be marketed.

No special requirements.

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

Aspire Pharma Limited

Unit 4, Rotherbrook Court

Bedford Road

Petersfield

Hampshire

GU32 3QG

United Kingdom

PL 35533/0160

12/02/2020

22/02/2021