- Approval Id
- 04588eca6e8f0d0b
- Drug Approval Emc Name
- Sodium Cromoglicate 2% w/v Eye Drops, solution
- Drug Name
- Sodium Cromoglicate 2% w/v Eye Drops, solution
- Company Name
- Aspire Pharma Ltd
- Company Address
- 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
- Company Website
- http://www.aspirepharma.co.uk
- Company Telephone
- +44 (0)1730 231148
- Company Medical Info Direct Line
- +44 (0)1730 231148
- Company Customer Care Direct Line
- +44 (0)1730 231148
- Atc Code
- S01GX01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Aspire Pharma Ltd
Unit 4 Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
- Authorisation Number
- PL 35533/0032
- Authorisation Date
- 21/08/2018
- Instruction Authorisation Holder
- Aspire Pharma Ltd
Unit 4 Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
- Instruction Authorisation Number
- PL 35533/0032
- Instruction Authorisation Date
- 21/08/2018
- Instruction Composition
- Each ml of eye drops contains
\*\*Active substance:\*\* 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate).
\*\*Excipients with known effect:\*\* 0.1mg benzalkonium chloride
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Eye Drops, Solution
A clear colourless to pale yellow solution for administration to the eye.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis.4.2 Posology and method of administration
\*\*Ocular use\*\*
\*\*Adults and Children:\*\*
One or two drops to be administered into each eye four times daily or as indicated by the doctor.
\*\*Elderly\*\*
There is no evidence to suggest that dosage alteration is required for elderly patients.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.
\*\*This medicine contains Benzalkonium Chloride\*\*
As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.
From the limited data available, there is no difference in the adverse event profile in children compared to adults.Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.Patients should be monitored in case of prolonged use4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
Fertility:
It is not known whether sodium cromoglicate has any effect on fertility.
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 foetal development. It should be used in pregnancy only where there is a clear need.
Lactation:
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.4.7 Effects on ability to drive and use machines
Sodium cromoglicate has a minor influence on the 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Opthalmologicals; 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.5.3 Preclinical safety data
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Disodium edetate
Benzalkonium chloride
Water for Injections6.2 Incompatibilities
Not applicable.6.3 Shelf life
30 months.
After first opening the bottle: 4 weeks
Discard any remaining solution four weeks after first opening.6.4 Special precautions for storage
Before first opening the bottle: This medicinal product does not require any special storage conditions
After first opening the bottle: Do not store above 25°C.6.5 Nature and contents of container
Low density polyethylene (LDPE) bottle with a low density polyethylene/ high density polyethylene tamper proof cap containing either 5ml or 10ml of solution.
LDPE bottle with a HDPE tamper proof cap containing 13.5ml of solution.
Pack sizes: 1x5ml, 1x10ml and 1 x 13.5ml
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements
Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
- Instruction Content
- ## Composition
Each ml of eye drops contains
\*\*Active substance:\*\* 20 mg sodium cromoglicate (2.0% w/v), (one drop contains 0.7mg sodium cromoglicate).
\*\*Excipients with known effect:\*\* 0.1mg benzalkonium chloride
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Eye Drops, Solution
A clear colourless to pale yellow solution for administration to the eye.
## Clinical Particulars
4.1 Therapeutic indications
For the prophylaxis and symptomatic treatment of acute allergic conjunctivitis, chronic allergic conjunctivitis and vernal keratoconjunctivitis.4.2 Posology and method of administration
\*\*Ocular use\*\*
\*\*Adults and Children:\*\*
One or two drops to be administered into each eye four times daily or as indicated by the doctor.
\*\*Elderly\*\*
There is no evidence to suggest that dosage alteration is required for elderly patients.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.
\*\*This medicine contains Benzalkonium Chloride\*\*
As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.
From the limited data available, there is no difference in the adverse event profile in children compared to adults.Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised.Patients should be monitored in case of prolonged use4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.4.6 Fertility, pregnancy and lactation
Fertility:
It is not known whether sodium cromoglicate has any effect on fertility.
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 foetal development. It should be used in pregnancy only where there is a clear need.
Lactation:
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.4.7 Effects on ability to drive and use machines
Sodium cromoglicate has a minor influence on the 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdosage is very unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Opthalmologicals; 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.5.3 Preclinical safety data
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Disodium edetate
Benzalkonium chloride
Water for Injections6.2 Incompatibilities
Not applicable.6.3 Shelf life
30 months.
After first opening the bottle: 4 weeks
Discard any remaining solution four weeks after first opening.6.4 Special precautions for storage
Before first opening the bottle: This medicinal product does not require any special storage conditions
After first opening the bottle: Do not store above 25°C.6.5 Nature and contents of container
Low density polyethylene (LDPE) bottle with a low density polyethylene/ high density polyethylene tamper proof cap containing either 5ml or 10ml of solution.
LDPE bottle with a HDPE tamper proof cap containing 13.5ml of solution.
Pack sizes: 1x5ml, 1x10ml and 1 x 13.5ml
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements
Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
