This information is intended for use by health professionals

1. Name of the medicinal product

Librachrom 2% w/v eye drops, solution

2. Qualitative and quantitative composition

Sodium cromoglicate 2.0% w/v.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Eye Drops, Solution

Clear colourless to pale yellow solution

4. Clinical particulars
4.1 Therapeutic indications

Librachrom is indicated in adults and children for the relief and treatment of seasonal and perennial allergic conjunctivitis.

4.2 Posology and method of administration

Posology

Adults (including the elderly) and children

One or two drops in each eye four times a day or as indicated by the doctor.

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

Librachrom 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 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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

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.

Sodium cromoglicate can be used prophylactically. Patients should seek advice before they discontinue use of the product.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Eye disorders

Transient stinging and burning 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).

4.9 Overdose

No action other than medical observation should be necessary.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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

6. Pharmaceutical particulars
6.1 List of excipients

Disodium edetate

Water for Injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

After first opening the bottle: 28 days

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Librachrom 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.

6.6 Special precautions for disposal and other handling

No special requirements

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

7. Marketing authorisation holder

Aspire Pharma Limited

Unit 4, Rotherbrook Court

Bedford Road

Petersfield

Hampshire

GU32 3QG

United Kingdom

8. Marketing authorisation number(s)

PL 35533/0132

9. Date of first authorisation/renewal of the authorisation

13/05/2019

10. Date of revision of the text

01/06/2020