SUMMARY OF PRODUCT FEATURES
ANSM - Updated on: 07/26/2021
1. NAME OF THE MEDICINE
OPHTACALM 2%, eye drops solution in single-dose container
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate................................................................................................................ 2 g
Per 100 mL
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops in solution in single-dose container.
4. CLINICAL DATA
4.1. Therapeutic indications
Symptomatic treatment of ophthalmic conditions of allergic origin.
4.2. Dosage and method of administration
Ophthalmic route.
Dosage
Depending on the severity of the 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 upwards, and pulling the lower eyelid slightly downwards.
Systemic passage can be reduced by nasolacrimal occlusion or by closing the eyelids for 2 minutes. This method may help reduce systemic adverse effects and increase local efficacy.
Pediatric population
Safety and efficacy data have not been established. In children, medical advice is necessary.
Mode of administration
Wash your hands thoroughly before instilling.
Avoid contact of the tip with the eye or eyelids.
Discard the unit-dose container after use. Do not store it for future use.
Each single-dose container contains enough eye drops to treat both eyes.
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
DO NOT INJECT, DO NOT SWALLOW.
Do not exceed the recommended dosage.
If there is no improvement or if symptoms persist, seek medical advice.
Avoid contact of the tip with the eye or eyelids.
This eye drop does not contain preservative.
4.5. Interactions with other medicinal products and other forms of interaction
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
4.6. Fertility, pregnancy and breastfeeding
Pregnancy
Animal studies have not shown any teratogenic effects.
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 during well-conducted studies on two species.
Clinically, there are currently no sufficiently relevant data to assess a possible malformative or fetotoxic effect of sodium cromoglicate when administered during pregnancy.
Therefore, as a precautionary measure, it is best not to use sodium cromoglicate during pregnancy.
Breastfeeding
There are no data on the passage of sodium cromoglicate into breast milk.
However, given the absence of toxicity, breastfeeding is possible during treatment with this medication.
4.7. Effects on ability to drive and use machines
Temporary visual discomfort may be experienced after instilling the eye drops. In this case, wait until the symptoms have subsided before driving a vehicle or operating machinery.
4.8. Adverse effects
Possibility of occurrence:
· hypersensitivity reactions to sodium cromoglicate or to any of the excipients of the eye drops,
· temporary visual discomfort after instillation of eye drops.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after drug authorization is important. It allows for continued monitoring of the drug's benefit/risk balance. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr .
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: LOCAL ANTI-ALLERGIC (S = sensory organ), ATC code: S01GX01 .
Sodium cromoglicate has recognized anti-allergic properties in the mucous membranes; by stabilizing the mast cell membrane, it prevents the release of chemical mediators responsible for anaphylactic reactions.
5.2. Pharmacokinetic properties
Sodium cromoglicate is partially absorbed through the mucosa. It is not metabolized. It is excreted unchanged in the bile and urine.
5.3. Preclinical safety data
Not applicable.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
Before opening: 2 years.
6.4. Special storage precautions
Discard the single-dose container after use.
Do not reuse a single-dose container that has already been opened.
6.5. Nature and contents of outer packaging
Box of 10, 20, or 30 single-dose containers of 0.35 mL (PE) presented in the form of strips. Each strip is overwrapped in a sachet (Polyester/Aluminum/PE).
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
No special requirements.
Any unused medicine or waste material should be disposed of in accordance with local regulations.
7. MARKETING AUTHORISATION HOLDER
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE - CS99535
34931 MONTPELLIER
[Tel, fax, e-mail: to be completed later by the holder]
8. MARKETING AUTHORISATION NUMBER(S)
· 34009 353 567 0 3: 0.35 mL in single-dose containers (PE), box of 10
· 34009 353 568 7 1: 0.35 mL in single-dose containers (PE), box of 20
· 34009 353 569 3 2: 0.35 mL in single-dose containers (PE), box of 30
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
Date of first authorization: {DD month YYYY}
Last renewal date: {DD month YYYY}
10. DATE OF TEXT UPDATE
[to be completed later by the holder]
{DD month YYYY}
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
NOTICE
ANSM - Updated on: 07/26/2021
Name of the drug
OPHTACALM 2%, eye drops solution in single-dose container
Sodium cromoglicate
Boxed
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse.
What does this leaflet contain?
1. What is OPHTACALM 2%, eye drops, solution in single-dose container and what is it used for?
2. What information should you know before using OPHTACALM 2%, eye drops, solution in single-dose container?
3. How to use OPHTACALM 2%, eye drops solution in single-dose container?
4. What are the possible side effects?
5. How to store OPHTACALM 2%, eye drops solution in single-dose container?
6. Package contents and other information.
1. WHAT IS OPHTACALM 2%, eye drops, solution in single-dose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic group LOCAL ANTI-ALLERGIC (S = sensory organ) - ATC code: S01GX01.
This eye drop is indicated for eye diseases of allergic origin (allergic conjunctivitis).
2. WHAT YOU NEED TO KNOW BEFORE USING OPHTACALM 2%, eye drops, solution in single-dose container?
Never use OPHTACALM 2%, eye drops solution in single-dose container:
· if you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Talk to your doctor or pharmacist before using OPHTACALM 2%, eye drops solution in single-dose container .
Wash your hands thoroughly before instilling.
NEVER LEAVE WITHIN REACH OF CHILDREN.
DO NOT INJECT, DO NOT SWALLOW.
Do not exceed the recommended dosage.
If there is no improvement or if symptoms persist, seek medical advice.
Children
In children, medical advice is necessary.
Other medicines and OPHTACALM 2%, eye drops solution in single-dose container
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
OPHTACALM 2%, eye drops solution in single-dose container with food
Not applicable.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
Temporary visual discomfort may be experienced after instilling the eye drops. In this case, wait until the symptoms disappear before driving a vehicle or operating machinery.
OPHTACALM 2%, eye drops solution in single-dose container contains {name the excipient(s)}
Not applicable.
3. HOW TO USE OPHTACALM 2%, eye drops solution in single-dose container?
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
Depending on the severity of symptoms, instill 1 drop in each eye, 2 to 6 times a day, at regular intervals.
Do not exceed the recommended dosage.
Use in children
In children, medical advice is necessary.
Mode of administration
Ophthalmic route.
Each single-dose unit contains enough eye drops to treat both eyes.
· Wash your hands thoroughly before instilling.
· Avoid contact of the tip with the eye or eyelids
· Instill 1 drop of eye drops into the conjunctival sac of the affected eye while looking upwards and pulling the lower eyelid slightly downwards.
· Then, press with a finger in the corner of your eye located on the side of the nose for 2 minutes. This will reduce the passage of the active ingredient ( sodium cromoglicate) into the rest of your body.
· With your eye closed, wipe off the excess.
Discard the unit-dose container after use. Do not store it for future use.
In case of concomitant treatment with another eye drop, wait 15 minutes between each instillation.
Processing time
Do not prolong treatment without medical advice.
If there is no improvement or if symptoms persist, seek medical advice.
If you use more OPHTACALM 2%, eye drops, solution in single-dose container than you should
Consult your doctor or pharmacist.
If you forget to take OPHTACALM 2%, eye drops solution in single-dose container
Do not take a double dose to make up for a forgotten single dose.
If you stop taking OPHTACALM 2%, eye drops, solution in single-dose container
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possibility of occurrence:
· allergic reaction to the components of the product,
· temporary visual discomfort after instillation of eye drops.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE OPHTACALM 2%, eye drops solution in single-dose container?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the bottle after EXP. The expiry date refers to the last day of that month.
Discard the single-dose container after use.
Do not reuse a single-dose container that has already been opened.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What OPHTACALM 2% contains, eye drops in solution in single-dose container
· The active substance is:
Sodium cromoglicate................................................................................................................ 2 g
Per 100 mL
· The other component is: purified water.
What is OPHTACALM 2%, eye drops, solution in single-dose container and contents of the outer packaging?
0.35 mL in single-dose container (PE).
This medication comes in the form of eye drops in a single-dose container, in a box of 10, 20, or 30 single-dose containers of 0.35 mL presented in the form of a strip overwrapped in a sachet.
Not all presentations may be marketed.
Marketing Authorisation Holder
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS99535
34931 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS99535
34931 MONTPELLIER
Manufacturer
CHAUVIN LABORATORY
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
