Emadine

1 

ANNEX I 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 

1. NAME OF THE MEDICINAL PRODUCT 

 

EMADINE 0.5 mg/ml, eye drops, solution 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

1 ml of solution contains emedastine 0.5 mg (as difumarate) 

 

Excipient with known effect 

 

Benzalkonium chloride 0.1 mg/ml 

 

For the full list of excipients, see section 6.1 

 

 

3. PHARMACEUTICAL FORM 

 

Eye drops, solution. 

 

Clear, colourless solution. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Symptomatic treatment of seasonal allergic conjunctivitis. 

 

4.2 Posology and method of administration 

 

EMADINE has not been studied in clinical trials beyond six weeks. 

 

Posology 

 

The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily. 

 

When used with other ophthalmic medicines, an interval of ten minutes should be allowed between 

applications of each medicinal product. Eye ointments should be administered last. 

 

Elderly population 

EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not 

recommended in this population. 

 

Paediatric population 

EMADINE may be used in paediatric patients (3 years of age and older) at the same posology as in 

adults. 

 

Hepatic and Renal impairment Use 

EMADINE has not been studied in these patients and therefore, its use is not recommended in this 

population. 



3 

 

Method of administration 

 

For ocular use. 

 

To prevent contamination of the dropper tip and solution, care should be taken not to touch the 

eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. 

 

After cap is removed, if tamper evident snap collar is loose, remove before using product. 

 

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 

 

Ocular corneal infiltrates 

 

Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal 

infiltrates, the product should be discontinued and appropriate management should be implemented. 

 

Excipients 

 

Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been 

reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since EMADINE contains 

benzalkonium chloride, close monitoring is required with frequent or prolonged use. 

 

In addition benzalkonium chloride may cause eye irritation and is known to discolour soft contact 

lenses. Contact with soft contact lenses is to be avoided. Patients must be instructed to remove contact 

lenses prior to the application of EMADINE and wait 15 minutes after instillation of the dose before 

reinsertion. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No interaction studies have been performed. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no adequate data from the use of emedastine in pregnant women. Studies in animals have 

shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Nevertheless, 

considering the absence of effects of emedastine on adrenergic, dopaminergic and serotonin receptors, 

EMADINE can be used during pregnancy if the dosage recommendation in section 4.2 is respected. 

 

Breast-feeding 

 

Emedastine has been identified in the milk of rats following oral administration. It is not known 

whether topical administration to humans could result in sufficient systemic absorption to produce 

detectable quantities in breast milk. Caution should be exercised if EMADINE is administered during 

breast-feeding. 

 

Fertility 

 

Studies in animals have shown no evidence of impaired fertility (See Section 5.3). No human fertility 

data are available. 

 



4 

4.7 Effects on ability to drive and use machines 

 

EMADINE has no or negligible influence on the ability to drive and use machines, however as with 

any ocular medication, if transient blurred vision or other visual disturbance occurs at instillation, the 

patient should wait until the vision clears before driving or using machinery. 

 

4.8 Undesirable effects 

 

Summary of safety profile 

 

In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both 

eyes for up to 42 days. In clinical trials, approximately 7% of patients experienced an adverse drug 

reaction associated with the use of Emadine; however, less than 1% of these patients discontinued 

therapy due to these adverse drug reactions. No serious ophthalmic or systemic adverse drug reactions 

were reported in the clinical trials. The most common adverse drug reactions were eye pain and eye 

pruritus occurring in 1% to 2.0% of patients. 

 

Tabulated list of adverse reactions 

 

The following adverse reactions listed below were observed in clinical studies or with post marketing 

experience. They are ranked according to system organ class and classified according to the following 

convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare 

(≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available 

data). Within each frequency grouping, adverse reactions are presented in decreasing order of 

seriousness. 

 

System Organ 

Classification 

Frequency Adverse reaction 

Psychiatric disorders Uncommon abnormal dreams 

Nervous system disorders Uncommon headache, sinus 

headache, dysgeusia 

Eye disorders Common eye pain, eye 

pruritus, conjunctival 

hyperaemia 

Uncommon corneal infiltrates, 

corneal staining, 

blurred vision, eye 

irritation, dry eye, 

foreign body 

sensation in eyes, 

lacrimation 

increased, 

asthenopia, ocular 

hyperaemia 

Cardiac disorders Not known tachycardia 

Skin and subcutaneous 

tissue disorders 

Uncommon rash 

 

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 national reporting system 

listed in Appendix V. 

 



5 

4.9 Overdose 

 

No specific reactions are to be expected with an ocular overdose of the product. 

 

No data are available in humans regarding overdose by accidental or deliberate ingestion. In case of 

accidental ingestion of the content of a bottle of EMADINE, sedative effects may occur and the 

potential of emedastine to increase the QT interval should be borne in mind and appropriate 

monitoring and management should be implemented. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics, ATC code: S01G X 

06 

 

Emedastine is a potent selective and topically effective histamine H1 antagonist (Ki = 1.3 nM). In vitro 

examinations of emedastine’s affinity for histamine receptors (H1, H2, and H3) demonstrate 

10,000-fold selectivity for the H1 receptor, Ki’s = 1.3 nM, 49,064 nM and 12, 430 nM, respectively. In 

vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of 

histamine-stimulated conjunctival vascular permeability. Studies with emedastine have not shown 

effects on adrenergic, dopaminergic, and serotonin receptors. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Emedastine is absorbed systemically, as are other topically administered drug substances. In a study 

involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 mg/ml 

eye drops solution, plasma concentrations of the parent compound were generally below the 

quantitation limit of the assay (0.3 ng/ml). Samples in which emedastine was quantifiable ranged from 

0.30 to 0.49 ng/ml. 

 

The human oral bioavailability of emedastine is approximately 50% and maximum plasma 

concentrations were achieved within one-two hours after dosing. 

 

Biotransformation 

 

Emedastine is principally metabolised by the liver. The elimination half-life of topical emedastine is 

ten hours. Approximately 44% of an oral dose is recovered in the urine over 24 hours, with only 

3.6% of the dose excreted as parent drug substance. Two primary metabolites, 5-and 

6-hydroxyemedastine, are excreted in the urine as both free and conjugated forms. The 5-oxo 

analogues of 5-and 6-hydroxyemedastine and the N-oxide are also formed as minor metabolites. 

 

5.3 Preclinical Safety Data 

 

Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of 

administration. No clinically significant local or systemic effects were observed in long-term topical 

ocular studies in rabbits. 

 

Corneal limbal mononuclear cell infiltrates were noted in 1/4 male monkeys treated with 0.5 mg/ml 

and in 4/4 males and 1/4 females treated with1.0 mg/ml. Scleral mononuclear cell infiltrates were 

present in 1/4 males and 1/4 females treated with 0.5 mg/ml and in 2/4 males and 1/4 females treated 

with1.0 mg/ml. Mean peak plasma levels were approximately 1 ng/ml and 2 ng/ml for the 0.5 and 

1.0 mg/ml treatments respectively. 

 



6 

Emedastine was found to increase the QT interval in dogs; the NOEL corresponds to levels 23-fold 

higher than those found in patients (7 ng/ml as compared with 0.3 ng/ml, i.e., the limit of detection for 

emedastine). 

 

Emedastine difumarate was not found to be carcinogenic in studies in mice and rats. Emedastine 

difumarate was not genotoxic in a standard battery of in vitro and in vivo genotoxicity assays. 

 

In a teratology study in rats, foetotoxic but not teratogenic effects were observed at the highest dose 

evaluated (140 mg/kg/day); no effects were observed at a lower level (40 mg/kg/day) which 

corresponds to an exposure well in excess of that produced by the therapeutic recommended dose. No 

reproductive toxicity was observed in a study in rabbits. 

 

There was no evidence of impaired fertility or decreased reproductive capacity in rats administered 

oral dosages of Emedastine difumarate of up to 30 mg/kg/day. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Benzalkonium chloride 0.1 mg/ml 

Trometamol 

Sodium chloride 

Hypromellose 

Hydrochloric acid/sodium hydroxide (to adjust pH) 

Purified water 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

30 months. 

 

EMADINE should not be used for longer than 4 weeks after first opening. 

 

6.4 Special precautions for storage 

 

Do not store above 25°C. 

 

6.5 Nature and content of container 

 

EMADINE is supplied in 5 ml and 10 ml opaque plastic DROP-TAINER bottles. 

Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

No special requirements. 

 

 



7 

7. MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBERS 

 

EU/1/98/095/001-2 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 27 January 1999 

Date of latest renewal: 13 January 2009 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 



8 

1. NAME OF THE MEDICINAL PRODUCT 

 

EMADINE 0.5 mg/ml eye drops, solution, single-dose container. 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

1 ml of solution contains emedastine 0.5 mg (as difumarate). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Eye drops, solution. 

 

Clear, colourless solution. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

Symptomatic treatment of seasonal allergic conjunctivitis. 

 

4.2 Posology and method of administration 

 

EMADINE has not been studied in clinical trials beyond six weeks. 

 

Posology 

 

The dose is one drop of EMADINE to be applied to the affected eye(s) twice daily. 

 

When used with other ophthalmic medicines, an interval of ten minutes should be allowed between 

applications of each medicinal product. Eye ointments should be administered last. 

 

For single use only; one container is sufficient to treat both eyes. Any unused solution should be 

discarded immediately after use. 

 

Elderly Population 

EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not 

recommended in this population. 

 

Paediatric Population 

EMADINE may be used in paediatric patients (3 years of age and older) at the same posology as in 

adults. 

 

Hepatic and Renal impairment Use 

EMADINE has not been studied in these patients and therefore, its use is not recommended in this 

population. 

 

Method of administration 

 

For ocular use. 

 



9 

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 

 

Ocular corneal infiltrates 

 

Ocular corneal infiltrates were reported in conjunction with the use of EMADINE. In case of corneal 

infiltrates, the product should be discontinued and appropriate management should be implemented. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No interaction studies have been performed. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no adequate data from the use of emedastine in pregnant women. Studies in animals have 

shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Nevertheless, 

considering the absence of effects of emedastine on adrenergic, dopaminergic and serotonin receptors, 

EMADINE can be used during pregnancy if the dosage recommendation in section 4.2 is respected. 

 

Breast-feeding 

 

Emedastine has been identified in the milk of rats following oral administration. It is not known 

whether topical administration to humans could result in sufficient systemic absorption to produce 

detectable quantities in breast milk. Caution should be exercised if EMADINE is administered during 

breast-feeding. 

 

Fertility 

 

Studies in animals have shown no evidence of impaired fertility (See Section 5.3). No human fertility 

data are available. 

 

4.7 Effects on ability to drive and use machines 

 

EMADINE has no or negligible influence on the ability to drive and use machines, however as with 

any ocular medication, if transient blurred vision or other visual disturbance occurs at instillation, the 

patient should wait until the vision clears before driving or using machinery. 

 

4.8 Undesirable effects 

 

Summary of safety profile 

 

In 13 clinical studies involving 696 patients, Emadine was administered one to four times daily in both 

eyes for up to 42 days. In clinical trials, approximately 7% of patients experienced an adverse drug 

reaction associated with the use of Emadine; however, less than 1% of these patients discontinued 

therapy due to these adverse drug reactions. No serious ophthalmic or systemic adverse drug reactions 

were reported in the clinical trials. The most common adverse drug reactions were eye pain and eye 

pruritus, occurring in 1% to of 2.0% of patients. 



10 

 

Tabulated list of adverse reactions 

 

The following adverse reactions listed below were observed in clinical studies or with post marketing 

experience. They are ranked according to system organ class and classified according to the following 

convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare 

(≥1/10,000 to <1/1000), very rare (<1/10,000), or not known (cannot be estimated from the available 

data). Within each frequency grouping, adverse reactions are presented in decreasing order of 

seriousness. 

 

System Organ 

Classification 

Frequency Adverse reaction 

Psychiatric disorders Uncommon abnormal dreams 

Nervous system disorders Uncommon headache, sinus 

headache, dysgeusia 

Eye disorders Common eye pain, eye 

pruritus, conjunctival 

hyperaemia 

Uncommon corneal infiltrates, 

corneal staining, 

blurred vision, eye 

irritation, dry eye 

foreign body 

sensation in eyes, 

lacrimation 

increased, 

asthenopia, ocular 

hyperaemia 

Cardiac disorders Not known tachycardia 

Skin and subcutaneous 

tissue disorders 

Uncommon rash 

 

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 national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

No specific reactions are to be expected with an ocular overdose of the product. 

 

No data are available in humans regarding overdose by accidental or deliberate ingestion. In case of 

the deliberate ingestion of the contents of many unit doses of EMADINE, sedative effects may occur 

and the potential of emedastine to increase the QT interval should be borne in mind and appropriate 

monitoring and management should be implemented. 

 



11 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1 Pharmacodynamic properties 

 

Pharmacotherapeutic group: decongestants and antiallergics; other antiallergics. ATC code: 

S01G X 06. 

 

Emedastine is a potent selective and topically effective histamine H1 antagonist (Ki = 1.3 nM). In vitro 

examinations of emedastine’s affinity for histamine receptors (H1, H2, and H3) demonstrate 

10,000-fold selectivity for the H1 receptor, Kis = 1.3 nM, 49,064 nM and 12, 430 nM, respectively. In 

vivo topical ocular administration of emedastine produces a concentration-dependent inhibition of 

histamine-stimulated conjunctival vascular permeability. Studies with emedastine have not shown 

effects on adrenergic, dopaminergic, and serotonin receptors. 

 

5.2 Pharmacokinetic properties 

 

Absorption 

 

Emedastine is absorbed systemically, as are other topically administered drug substances. In a study 

involving ten normal volunteers dosed bilaterally twice daily for 15 days with EMADINE 0.5 mg/ml 

eye drops, solution, plasma concentrations of the parent compound were generally below the 

quantitation limit of the assay (0.3 ng/ml). Samples in which emedastine was quantifiable ranged from 

0.30 to 0.49 ng/ml. 

 

The human oral bioavailability of emedastine is approximately 50% and maximum plasma 

concentrations were achieved within one-two hours after dosing. 

 

Biotransformation 

 

Emedastine is principally metabolised by the liver. The elimination half-life of topical emedastine is 

ten hours. Approximately 44% of an oral dose is recovered in the urine over 24 hours, with only 3.6% 

of the dose excreted as parent drug substance. Two primary metabolites, 5-and 6-hydroxyemedastine, 

are excreted in the urine as both free and conjugated forms. The 5-oxo analogues of 5-and 

6-hydroxyemedastine and the N-oxide are also formed as minor metabolites. 

 

5.3 Preclinical Safety Data 

 

Emedastine difumarate demonstrated low acute toxicity in a number of species by various routes of 

administration. No clinically significant local or systemic effects were observed in long-term topical 

ocular studies in rabbits. 

 

Corneal limbal mononuclear cell infiltrates were noted in 1/4 male monkeys treated with 0.5 mg/ml 

and in 4/4 males and 1/4 females treated with 1.0 mg/ml. Scleral mononuclear cell infiltrates were 

present in 1/4 males and 1/4 females treated with 0.5 mg/ml and in 2/4 males and 1/4 females treated 

with 1.0 mg/ml. Mean peak plasma levels were approximately 1 ng/ml and 2 ng/ml for the 0.5 and 

1.0 mg/ml treatments respectively. 

 

Emedastine was found to increase the QT interval in dogs; the NOEL corresponds to levels 23 fold 

higher than those found in patients (7 ng/ml as compared with 0.3 ng/ml, i.e., the limit of detection for 

emedastine). 

 

Emedastine difumarate was not found to be carcinogenic in studies in mice and rats. Emedastine 

difumarate was not genotoxic in a standard battery of in vitro and in vivo genotoxicity assays. 



12 

 

In a teratology study in rats, foetotoxic but not teratogenic effects were observed at the highest dose 

evaluated (140 mg/kg/day); no effects were observed at a lower level (40 mg/kg/day) which 

corresponds to an exposure well in excess of that produced by the therapeutic recommended dose. No 

reproductive toxicity was observed in a study in rabbits. 

 

There was no evidence of impaired fertility or decreased reproductive capacity in rats administered 

oral dosages of Emedastine difumarate of up to 30 mg/kg/day. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Trometamol 

Sodium chloride 

Hypromellose 

Hydrochloric acid/sodium hydroxide (to adjust pH) 

Purified water 

 

6.2 Incompatibilities 

 

Not applicable. 

 

6.3 Shelf life 

 

2 years. 

 

After first opening a foil pouch: 7 days. 

 

6.4 Special precautions for storage 

 

Do not store above 30°C. 

 

6.5 Nature and content of container 

 

EMADINE is supplied in low density polyethylene single-dose containers which contain 0.35 ml. 

Five single-dose containers are then presented in a foil pouch. 

 

The following pack sizes are available: 30 x 0.35 ml single-dose containers and 60 x 0.35 ml 

single-dose containers. Not all pack sizes may be marketed. 

 

6.6 Special precautions for disposal 

 

For single use only; one container is sufficient to treat both eyes. Any unused solution should be discarded 

immediately after use. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 



13 

8. MARKETING AUTHORISATION NUMBERS 

 

EU/1/98/095/003-4 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 27 January 1999 

Date of latest renewal: 13 January 2009 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu. 



14 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH 
RELEASE 

 

B. CONDITIONS OR RESTRICIONS REGARDING SUPPLY 
AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



15 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

Names and addresses of the manufacturers responsible for batch release 

 

EMADINE 0.5 mg/ml eye drops, solution 

S.A. Alcon-Couvreur N.V., 

Rijksweg 14, 

B-2870 Puurs, 

Belgium. 

 

Alcon Cusí, S.A., 

Camil Fabra 58, 

08320 El Masnou, 

Barcelona, 

Spain. 

 

EMADINE 0.5 mg/ml eye drops, solution, single-dose container. 

 

S.A. Alcon-Couvreur N.V., 

Rijksweg 14, 

B-2870 Puurs, 

Belgium. 

 

The printed package leaflet of the medicinal product must state the name and address of the 

manufacturer responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 

Medicinal product subject to medical prescription 

 

 

C. OTHER CONDITIONS OR RESTRICTIONS WITH THE MARKETING 

AUTHORISATION 

 

 Periodic Safety Update Reports 
 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

Not applicable. 



16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 



17 

A. LABELLING



18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

BOX OF 1 BOTTLE, 5 ml & 10 ml 

1. NAME OF THE MEDICINAL PRODUCT

EMADINE 0.5 mg/ml eye drops, solution 

emedastine 

2. STATEMENT OF ACTIVE SUBSTANCE

Emedastine 0.5 mg/ml as difumarate 

3. LIST OF EXCIPIENTS

Contains: benzalkonium chloride 0.1 mg/ml, trometamol, sodium chloride, hypromellose, 

hydrochloric acid/sodium hydroxide, purified water. 

4. PHARMACEUTICAL FORM AND CONTENTS

Eye drops, solution 

1 x 5 ml 

1 x 10 ml 

5. METHOD AND ROUTE OF ADMINISTRATION

Read the package leaflet before use. 

Ocular use 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children. 

7. OTHER SPECIAL WARNINGS, IF NECESSARY

8. EXPIRY DATE

EXP 

Discard four weeks after first opening. 

Opened: 

9. SPECIAL STORAGE CONDITIONS

Do not store above 25C. 



19 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBERS 

 

EU/1/98/095/001 1 x 5 ml 

EU/1/98/095/002 1 x 10 ml 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Emadine 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



20 

 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

BOTTLE LABEL 5 ml & 10 ml 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

EMADINE 0.5 mg/ml eye drops 

emedastine 

Ocular use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

Discard four weeks after first opening. 

Opened: 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

5 ml 

10 ml 

 

 

6 OTHER 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

Carton for 30 x 0.35 ml containers & carton of 60 x 0.35 ml containers 

 

 

1 NAME OF MEDICINAL PRODUCT 

 

EMADINE 0.5 mg/ml eye drops, solution, single-dose container 

emedastine 

 

 

2 STATEMENT OF ACTIVE SUBSTANCE 

 

Emedastine 0.5 mg/ml as difumarate 

 

 

3 LIST OF EXCIPIENTS 

 

Contains: trometamol, sodium chloride, hypromellose, hydrochloric acid, sodium hydroxide and 

purified water. 

 

 

4 PHARMACEUTICAL FORM AND CONTENTS 

 

Eye drops, solution 

 

0.35 ml x 30 

0.35 ml x 60 

 

 

5 METHOD AND ROUTE OF ADMINISTRATION 

 

Read the package leaflet before use. 

Ocular use 

 

 

6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7 OTHER SPECIAL WARNINGS, IF NECESSARY 

 

For single use only; one container is sufficient to treat both eyes. Preservative free. 

 

 

8 EXPIRY DATE 

 

EXP 

Discard any unused contents of a single use container immediately after use. 

Discard any unused containers one week after first opening pouch. 

 



22 

 

9 SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

 

 

10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12 MARKETING AUTHORISATION NUMBERS 

 

EU/1/98/095/003 0.35 ml x 30 

EU/1/98/095/004 0.35 ml x 60 

 

 

13 BATCH NUMBER 

 

Lot 

 

 

14 GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15 INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Emadine 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



23 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO 

OUTER PACKAGING, ON THE IMMEDIATE PACKAGING 

 

Foil Pouch 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

EMADINE 0.5 mg/ml eye drops, solution, single-dose container 

emedastine 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE 

 

Emedastine 0.5 mg/ml as difumarate 

 

 

3. LIST OF EXCIPIENTS 

 

Contains: trometamol, sodium chloride, hypromellose, hydrochloric acid, sodium hydroxide and 

purified water. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Eye drops, solution 

 

0.35 ml x 5 

 

 

5. METHOD AND ROUTE OF ADMINISTRATION 

 

Read the package leaflet before use. 

Ocular use 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNINGS, IF NECESSARY 

 

For single use only; one container is sufficient to treat both eyes. Preservative free. 

 

 

8. EXPIRY DATE 

 

EXP 

Discard any unused contents of a single use container immediately after use. 

Discard any unused containers one week after first opening pouch. 

 

 



24 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBERS 

 

EU/1/98/095/003 0.35 ml x 30 

EU/1/98/095/004 0.35 ml x 60 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

Tear open pouch at level of cut. 



25 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

Single-dose container 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 

 

EMADINE 

Ocular use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

 

6 OTHER 



26 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



27 

Package leaflet: Information for the patient 

 

EMADINE 0.5 mg/ml eye drops, solution 

emedastine 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or your pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them 

even if their signs of illness are the same as yours. 

- If you get any of the side effects talk to your doctor or pharmacist. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What EMADINE is and what it is used for 

2. What you need to know before you use EMADINE 

3. How to use EMADINE 

4. Possible side effects 

5. How to Store EMADINE 

6. Contents of the pack and other information 

 

1. What EMADINE is and what it is used for 

 

EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis of the eye (allergic 

conditions of the eye). It works by reducing the intensity of the allergic reaction. 

 

Allergic conjunctivitis. Some materials (allergens) like pollens, house dust or animal fur may cause 

allergic reactions resulting in itching, redness as well as swelling of the surface of your eye. 

 

You must talk to a doctor if you do not feel better or if you feel worse. 

 

 

2. What you need to know before you use EMADINE 

 

Do not use EMADINE 

 if you are allergic to emedastine or any of the other ingredients of this medicine listed in 
section 6. 

 

Ask your doctor for advice. 

 

Warning and precautions 

 Do not use EMADINE in children under the age of 3 years. 

 If you wear contact lenses please see section ‘EMADINE contains benzalkonium chloride 
below’. 

 EMADINE is not recommended for use in patients over 65 years of age, as it has not been 
studied in clinical trials in this age group. 

 EMADINE is not recommended for use in patients with kidney or liver problems. 
 

Talk to your doctor or pharmacist before using EMADINE. 

 

Other medicines and EMADINE 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

If you are using other eye drops at the same time as EMADINE, follow the advice at the end of 

section 3 “How to use EMADINE”. 



28 

 

Pregnancy, breast feeding and fertility 

If you are pregnant or breast-feeding, 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 using machines 

You may find that your vision is blurred for a time just after you use EMADINE. Do not drive or use 

machines until your vision is clear. 

 

EMADINE contains benzalkonium chloride 

 

This medicine contains 0.5 mg or 1 mg benzalkonium chloride in each 5 or 10 ml, which are 

equivalent to 0.1 mg/ml. 

 

The preservative in EMADINE, benzalkonium chloride, may be absorbed by soft contact lenses and 

may change the colour of the contact lenses. You should remove contact lenses before using this 

medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye 

irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the 

eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to 

your doctor. 

 

 

3. How to use EMADINE 

 

Always use EMADINE exactly as your doctor has told you. You should check with your doctor or 

pharmacist if you are not sure. 

 

The recommended dose is in adults and children over 3 years: One drop in the eye, twice a day. 

 

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check 

with your doctor or pharmacist if you are not sure. 

 

Only use the drops in your eyes. 

 

Turn the page for more advice 

 

Now turn over> 

 

 

3. How to use EMADINE (continued) 

 

     
 1 2 

 

The recommended dose 

< see side 1 

 

 Get the EMADINE bottle and a mirror. 

 Wash your hands. 

 Take the bottle and twist off the cap. 

 After cap is removed, if tamper evident snap collar is loose, remove before using product. 

 Hold the bottle, pointing down, between your thumb and middle finger. 



29 

 Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between 
the eyelid and your eye. The drop will go in here (picture 1). 

 Bring the bottle tip close to the eye. Use the mirror if it helps. 

 Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It 
could infect the drops left in the bottle. 

 Gently press on the base of the bottle to release one drop of EMADINE at a time. 

 Don’t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed 
(picture 2). 

 If you use drops in both eyes, repeat the steps for your other eye. 

 Put the bottle cap back on firmly immediately after use. 
 

If you accidentally swallow EMADINE or inject it contact a doctor immediately. It may affect 

your heart rhythm. 

 

If a drop misses your eye, try again. 

 

If you get too much in your eyes, rinse it all out preferably with sterile saline or, if not available, with 

warm water. Don’t put in any more drops until it’s time for your next regular dose. 

 

If you forget to use EMADINE, use one drop as soon as you remember, and then go back to your 

normal routine. Do not use a double dose to make up for the one missed. 

 

If you are using other eye drops, leave at least 10 minutes between using EMADINE and the other 

drops. Eye ointments should be used last. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

You can carry on taking the drops, unless the effects are serious, If you are worried, talk to your doctor 

or pharmacist. 

 

Common side effects (may affect up to 1in 10 people ) 

 Effects in the eye: eye pain, itchy eye, eye redness 
 

Uncommon side effects (may affect up to 1 in 100 people) 

 Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired 
eyes, eye irritation, blurred vision, corneal staining, dry eye. 

 General side effects: headache, difficulty sleeping, sinus headache, bad taste, rash 
 

Not Known (frequency cannot be estimated from the available data) 

 General side effects: increased heart rate 
 

Reporting of side effects 

If you get 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 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 



30 

 

5. How to store EMADINE 

 

Keep out of the sight and reach of children. 

 

Do not use EMADINE after the expiry date which is stated on the bottle and box after “EXP”. The 

expiry date refers to the last day of the month. 

 

Do not store above 25°C. 

 

You must throw away the bottle four weeks after you first opened it, to prevent infections. Write 

down the date you opened each bottle in the space below and in the space on the bottle label and box. 

 

Opened: 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What EMADINE contains 

- The active substance is emadastine 0.5 mg/ml as difumarate. 
- The other ingredients are benzalkonium chloride, trometamol; sodium chloride; hypromellose; 

purified water. Tiny amounts of hydrochloric acid or sodium hydroxide are sometimes added to 

keep acidity levels (pH levels) normal 

 

What EMADINE looks like and the contents of the pack 

EMADINE is a liquid (a solution) supplied in a pack containing a 5 ml or 10 ml plastic 

(DROP-TAINER) bottle with a screw cap. Not all pack sizes may be marketed. 

 

Marketing authorisation holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon-Couvreur N.V., 

Rijksweg 14, 

B-2870 Puurs, 

Belgium 

 

Manufacturer 

Alcon Cusí, S.A., 

Camil Fabra 58, 

08320 El Masnou, 

Spain 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA „Novartis Baltics“ Lietuvos filialas 

Tel: +370 5 269 16 50 



31 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

Nederland 

Novartis Pharma B.V. 

Tel: +31 26 37 82 111 

 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

Portugal 

Novartis Farma - Produtos Farmacêuticos, 

S.A. 

Tel: +351 21 000 8600 

 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: + 421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 



32 

 

This leaflet was last revised in 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu. 



33 

Package leaflet: Information for the patient 

 

EMADINE 0.5 mg/ml eye drops, solution, single-dose container 

emedastine 

 

Read all of this leaflet carefully before you start using this medicine because it contains 

important information for you. 

- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or your pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them 

even if their signs of illness are the same as yours. 

- If you get any of the side effects talk to your doctor or pharmacist. This includes any possible 
side effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What EMADINE is and what it is used for 

2. What you need to know before you use EMADINE 

3. How to use EMADINE 

4. Possible side effects 

5. How to Store EMADINE 

6. Contents of pack and other information 

 

1. What EMADINE is and what it is used for 

 

EMADINE is a medicine for the treatment of seasonal allergic conjunctivitis of the eye (allergic 

conditions of the eye). It works by reducing the intensity of the allergic reaction. 

 

Allergic conjunctivitis. Some materials (allergens) like pollens, house dust or animal fur may cause 

allergic reactions resulting in itching, redness as well as swelling of the surface of your eye. You must 

talk to a doctor if you do not feel better or if you feel worse. 

 

 

2. What you need to know before you use EMADINE 

 

Do not use EMADINE 

 if you are allergic to emedastine or any of the other ingredients of this medicine listed in 
section 6. 

 

Ask your doctor for advice. 

 

Warning and precautions 

 Do not use EMADINE in children under the age of 3 years. 

 EMADINE is not recommended for use in patients over 65 years of age, as it has not been 
studied in clinical trials in this age group. 

 EMADINE is not recommended for use in patients with kidney or liver problems. 
 

Talk to your doctor or pharmacist before using EMADINE. 

 

Other medicines and EMADINE. 

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 

 

If you are using other eye drops at the same time as EMADINE, follow the advice at the end of 

section 3 (How to use EMADINE). 

 



34 

Pregnancy, breast feeding and fertility 

If you are pregnant or breast-feeding, 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 using machines 

You may find that your vision is blurred for a time just after you use EMADINE. Do not drive or use 

machines until your vision is clear. 

 

 

3. How to use EMADINE 

 

Always use EMADINE exactly as your doctor has told you. You should check with your doctor or 

pharmacist if you are not sure. 

 

The recommended dose is in adults and children over 3 years: One drop in the eye, twice a day. 

 

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check 

with your doctor or pharmacist if you are not sure. 

 

Only use the drops in your eyes. 

 

Turn the page for more advice 

 

Now turn over> 

 

 

3. How to use EMADINE (continued) 

 

     
 

1    2    3 

 

The recommended dose 

< see side 1 

 

Do not use a container you’ve already opened. Do not use any sealed containers from a foil 

wrapper that was opened more than a week ago. 

 

 Tear off the foil wrapper and take out the strip of 5 containers. 

 Do not use if the solution is cloudy or has bits in it. 

 Hold the strip with the long flat end uppermost and separate off one container by pulling it 
towards you while holding the others firm. You will need to snap it apart where it joins the 

others (picture 1). 

 Keep the single container out. Put the others back in the foil wrapper. 

 Make sure you have a mirror handy and wash your hands. 

 Hold the long flat end of the container between your thumb and forefinger and open it by 
twisting off the other end (picture 2). 

 Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between 
the eyelid and your eye. The drop will go in here. 

 Hold the container between your thumb and fingers with the open end pointing down. 

 Bring the container tip close to the eye. Use the mirror if it helps. 



35 

 Don’t touch your eye or eyelid, surrounding areas or other surfaces with the container tip. 
It could infect the drops. 

 Gently squeeze the container to release one drop into the pocket between the eyelid and eye 
(picture 3). 

 If your doctor has told you to use drops in both eyes, repeat the steps for your other 
eye-using the same container. 

 Throw away the container and any leftover solution at once. 

 Throw away any unused containers one week after opening the foil wrapper-even if the 
containers are still sealed. 

 

If you accidentally swallow EMADINE or inject it contact a doctor immediately. It may affect 

your heart rhythm. 

 

If a drop misses your eye, try again. 

 

If you get too much in your eyes, rinse it all out preferably with sterile saline or, if not available, with 

warm water. Don’t put in any more drops until it’s time for your next regular dose. 

 

If you forget to use EMADINE use one drop as soon as you remember, and then go back to your 

normal routine. Do not use a double dose to make up for the one missed. 

 

If you are using other eye drops, leave at least 10 minutes between using EMADINE and the other 

drops. Eye ointments should be used last. 

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 

 

 

4. Possible side effects 

 

Like all medicines this medicine can cause side effects although not everybody gets them. 

 

You can carry on taking the drops, unless the effects are serious. If you are worried, talk to your doctor 

or pharmacist. 

 

Common side effects (may affect up to 1 in 10 people) 

 Effects in the eye: eye pain, itchy eye, eye redness 
 

Uncommon side effects (may affect up to 1 in 100 people) 

 Effects in the eye: corneal disorder, abnormal eye sensation, increased tear production, tired 
eyes, eye irritation, blurred vision, corneal staining, dry eye. 

 General side effects: headache, difficulty sleeping, sinus headache, bad taste, rash 
 

Not Known (frequency cannot be estimated from the available data) 

 General side effects: increased heart rate 
 

Reporting of side effects 

If you get 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 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 

this medicine. 

 



36 

 

5. How to store EMADINE 

 

Keep out of the sight and reach of children 

 

Do not use EMADINE after the expiry date which is stated on the bottle and box after “EXP”. The 

expiry date refers to the last day of the month. 

 

Do not store above 30°C. 

 

You must throw away the container as soon as you have used it. Once the foil wrapper has been 

opened any unused containers must be thrown away one week after you first opened it. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 

throw away medicines you no longer use. These measures will help protect the enviroment. 

 

 

6 Contents of the pack and other information 

 

What EMADINE contains 

- The active substance is emedastine 0.5 mg/ml as difumarate. 
- The other ingredients are trometamol; sodium chloride; hypromellose; purified water. Tiny 

amounts of hydrochloric acid or sodium hydroxide are sometimes added to keep acidity levels 

(pH levels) normal. 

 

What EMADINE looks like and the contents of the pack 

EMADINE is a liquid (a solution) supplied in single-dose plastic containers which contain 0.35 ml. 

Five single-dose containers are provided in a pouch. EMADINE is supplied in packs containing 30 or 

60 units. Not all pack sizes may be marketed. 

 

Marketing authorisation holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

S.A. Alcon-Couvreur N.V., 

Rijksweg 14, 

B-2870 Puurs, 

Belgium 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 

SIA „Novartis Baltics“ Lietuvos filialas 

Tel: +370 5 269 16 50 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 

Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 

Novartis s.r.o. 

Tel: +420 225 775 111 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 



37 

 

Danmark 

Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

 

Deutschland 

Novartis Pharma GmbH 

Tel: +49 911 273 0 

Nederland 

Novartis Pharma B.V. 

Tel: +31 26 37 82 111 

 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 

Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 

Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 

Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Novartis Farmacéutica, S.A. 

Tel: +34 93 306 42 00 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

Portugal 

Novartis Farma - Produtos Farmacêuticos, 

S.A. 

Tel: +351 21 000 8600 

 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

 

Ireland 

Novartis Ireland Limited 

Tel: +353 1 260 12 55 

Slovenija 

Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: + 421 2 5542 5439 

 

Italia 

Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

 

Suomi/Finland 

Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

Latvija 

SIA “Novartis Baltics” 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

This leaflet was last revised in 

 

Other sources of information 

Detailed information on this medicine is available on the European Medicines Agency website: 

http://www.ema.europa.eu 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS OR RESTRICTIONS WITH THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET