Medicines
Update of 10/07/2025
CROMOPTIC® eye drops in single-dose container
sodium cromoglicate
Forms and presentations
Eye drops in solution at 2 %: Single-dose containers of 0,35 mL, box of 30.Composition
| p 100 ml | |
| Sodium cromoglicate
|
2 g |
Indications
Symptomatic treatment of allergic ophthalmic conditions.Dosage and administration
Ophthalmic use.
Dosage- Adults and children: depending on the severity of symptoms, instill 1 drop of eye drops 2 to 6 times a day, at regular intervals, into the conjunctival sac of the affected eye, looking upward, and gently pulling the lower eyelid downward.
- Systemic absorption may be reduced by nasolacrimal occlusion or by closing the eyelids for 2 minutes. This method may help to reduce systemic adverse effects and increase local efficacy.
- Paediatric population:
- Safety and efficacy data have not been established.
- In children, medical advice is required.
Method of administration:
Wash hands thoroughly before proceeding with instillation.
Avoid contact of the tip with the eye or eyelids.
Each single-dose container contains a sufficient quantity of eye drops to treat both eyes.
Discard the single-dose container after use. Do not keep it for later use.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section Composition.Warnings and precautions
- Do not inject, do not swallow.
- Do not exceed the recommended dose.
- In the absence of improvement or if symptoms persist, seek medical advice.
- Avoid contact of the tip with the eye or eyelids.
- This eye drop does not contain a preservative.
Interactions
In case of concomitant treatment with another eye drops, wait 15 minutes between each instillation.
Fertility, pregnancy and breastfeeding
Pregnancy:Studies performed in animals have not demonstrated a teratogenic effect.
In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have proven teratogenic in animals in well-conducted studies in two species.
In clinical practice, there is currently no sufficiently relevant data to assess a possible malformative or foetotoxic effect of sodium cromoglicate when administered during pregnancy.
Consequently, as a precautionary measure, it is preferable not to use sodium cromoglicate during pregnancy.
Breastfeeding:
There is no data on the passage of sodium cromoglicate into breast milk.
However, given the absence of toxicity, breastfeeding is possible during treatment with this medicine.
Driving and using machines
A temporary visual disturbance may be felt after instillation of the eye drops. In this case, wait until the symptoms have subsided before driving a vehicle or operating a machine.Adverse effects
Possible occurrence of:- reactions of hypersensitivity to sodium cromoglicate or to any of the excipients of the eye drops;
- temporary visual disturbance after instillation of the eye drops.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.
Pharmacodynamics
Pharmacotherapeutic class: Local anti-allergic (ATC code: S01GX01; S: sensory organ).
Sodium cromoglicate has recognised anti-allergic properties at the level of the mucous membranes; by stabilising the mast cell membrane, it prevents the release of the chemical mediators responsible for anaphylactic reactions.
Pharmacokinetics
Sodium cromoglicate is partly absorbed through the mucous membrane. It is not metabolised. It is excreted unchanged in the bile and urine.
Storage conditions
- Shelf life before opening:
- 2 years.
Discard the single-dose container after use.
Do not reuse a single-dose container that has already been opened.
HANDLING/DISPOSAL INSTRUCTIONS
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400935356642 (2000, SmPC rev 27.05.2021). |
| Price: | 3,37 euros (30 unit-dose vials). |
| Social Security reimbursement at 30%. Collect. | |
CHAUVIN Laboratory
416, rue Samuel-Morse. CS 99535. 34961 Montpellier
Tel: 04 67 12 30 30
Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.