Medicines
Update of the 19/03/2024
CROMABAK®
sodium cromoglicate
Forms and presentations
Eye drops in solution at 20 mg/ml (colourless to slightly yellow and opalescent): Multidose bottle of 10 ml with dropper equipped with an anti-microbial filter.Composition
| p bottle | |
| Cromoglicic acid sodium salt
|
200 mg |
Excipients with known effect: disodium phosphate dodecahydrate, monosodium phosphate dihydrate (0,0160 mg of phosphates per drop equivalent to 0,5193 mg/ml).
Indications
Symptomatic treatment of allergic conjunctivitis.Dosage and administration
Cromabak 20 mg/ml, eye drops in solution, must be administered by ocular route only.
Sodium cromoglicate must be used continuously throughout the period of allergen exposure so that symptom control is maintained.
If treatment is interrupted during the period of allergen exposure, symptoms may reappear.
Dosage- Adults:
- Depending on the severity of symptoms, 1 drop of eye drops must be instilled 2 to 6 times per day, at regular intervals, into the conjunctival sac of the affected eye.
- Paediatric population:
- The dosage is the same as for adults. In children, medical advice is required.
In case of concomitant treatment with another eye drop solution, wait 15 minutes between each instillation.
Method of administration:
The patient must be informed:
- to wash hands thoroughly before carrying out the instillation,
- to avoid contact of the tip with the eye or eyelids.
Contraindications
Hypersensitivity to the active substance (sodium cromoglicate) or to any of the excipients mentioned in section Composition.Warnings and precautions
The patient must be informed that they must not exceed the recommended dosage. If symptoms persist or worsen, the patient must be reviewed by a physician.
The absence of preservative allows use of these eye drops while wearing contact lenses. However, in allergic subjects, wearing contact lenses must be subject to medical advice.
This medicine contains 0,0160 mg of phosphates per drop equivalent to 0,5193 mg/ml (see Undesirable effects).
Fertility, pregnancy and breastfeeding
Pregnancy:Published data on a limited number of pregnant women treated with sodium cromoglicate showed no adverse effects on pregnancy or on the health of the foetus and/or newborn.
Animal studies revealed no direct or indirect toxic effect on reproduction.
Due to the low systemic passage after topical ocular administration, no adverse effects are expected and sodium cromoglicate 20 mg/ml, eye drops in solution, may be used during pregnancy.
Breastfeeding:
Due to the low systemic passage after topical ocular administration, no adverse effects are expected and sodium cromoglicate 20 mg/ml, eye drops in solution, may be used during breastfeeding.
Fertility:No effect on fertility is expected since the systemic passage of sodium cromoglicate is negligible.
Sodium cromoglicate did not affect fertility in animals, even at high systemic doses.
Driving and using machines
A transient visual disturbance may be experienced after instillation of sodium cromoglicate 20 mg/ml, eye drops in solution. In this case, the patient should be advised not to drive or use dangerous machinery until normal vision returns.Adverse effects
- Hypersensitivity reactions to sodium cromoglicate or to one of the excipients.
- Transient visual disturbance (burning, stinging) after instillation.
A few rare cases of corneal calcification have been reported in association with the use of phosphate-containing drops in some patients with severely damaged corneas.
Reporting of suspected adverse reactions: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.
Overdose
There is no available data on accidental ingestion of sodium cromoglicate 20 mg/ml, eye drops in solution.
Pharmacodynamics
Pharmacotherapeutic class: Other antiallergics (ATC code: S01GX01).
This eye drop solution does not contain a preservative.
Sodium cromoglicate possesses recognised antiallergic properties at the level of the mucous membranes; by stabilising the mast cell membrane, it prevents the release of the chemical mediators responsible for allergic/hypersensitivity reactions.
Pharmacokinetics
Sodium cromoglicate is partly absorbed by the mucous membrane, resulting in a low systemic passage. It is not metabolised and is excreted unchanged in the bile and urine.
Preclinical safety
There are no other preclinical data available considered relevant to clinical safety beyond those presented in the other sections of the SmPC.
Storage conditions
- Shelf life
- 36 months.
Store the bottle in the outer packaging, protected from light.
- After first opening of the bottle:
- 8 weeks.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400934053061 (1996, SmPC rev 10.05.2021). |
| Price: | 6,12 euros (bottle of 10 ml). |
| Social Security reimbursement at 30%. Collect. | |
THÉA PHARMA
37, rue Georges-Besse
63100 Clermont-Ferrand
http://www.theapharma.fr
Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.