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CROMADOSES 2 % Eye drops solution single-dose container 30 units

Théa Pharma

CROMADOSES 2 % Eye drops solution single-dose container 30 units

CIP / EAN code: 3400934884627

Product information from VIDAL.

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of the 19/03/2024

CROMADOSES®
sodium cromoglicate


Forms and presentations

Eye drops in solution at 2 %: Single-dose containers, bottle-pack type, of 0,3 ml, box of 30.


Composition

  per container
Cromoglicic acid sodium salt 
6 mg
Excipients: sodium chloride, purified water.

Indications

Symptomatic treatment of allergic ophthalmic conditions.

Dosage and administration

Ophthalmic use.

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.

Adult and child:
Depending on the severity of symptoms, instil 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 eyelid downward.
In children, medical advice is required.
Discard the single-dose container after use. Do not keep it for later use.

Contraindications

Hypersensitivity to sodium cromoglicate or to any of the constituents of the eye drops.

Warnings and precautions

  • Do not inject, do not swallow.
  • The eye drops must not be administered by peri- or intraocular injection.
  • Do not exceed the recommended dose.
  • In the absence of improvement or if symptoms persist, seek medical advice.
  • Wash hands thoroughly before instilling.
  • Avoid contact of the tip with the eye or eyelids.

This eye drop does not contain a preservative.

Discard the single-dose container after use. Do not keep it for later use.


Interactions

Drug 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

Possibility of occurrence of:
  • hypersensitivity reactions to sodium cromoglicate or to one of the excipients of the eye drops;
  • transient visual discomfort after instillation of the eye drops.
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.


Pharmacodynamics

Pharmacotherapeutic class: Other antiallergics, ATC code: S01GX01.

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
3 years.

Store at a temperature not exceeding 25 °C.

Discard the single-dose container after use. Do not keep it for later use.


HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.


Prescription, supply and reimbursement

Marketing authorisation (AMM) 3400934884627 (1998, RCP rev 14.12.2021).
   
Price: 3,37 euros (30 unit-dose vials).
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.