Relestat 0.5 mg/ml, eye drops, solution
*Company:
AbbVie LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company

Updated on 13 January 2025
File name
Relestat-PIL-UK + IE.pdf
Reasons for updating
- XPIL Removed
Free text change information supplied by the pharmaceutical company
No change to PIL content.
Updated on 12 April 2022
File name
Relestat-SPC-IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 April 2022
File name
Relestat-PIL-UK + IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 27 September 2021
File name
relestat-pil-clean-uk-ie-v5.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 20 January 2021
File name
relestat-spc-clean-ie-rtq-v5.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 January 2021
File name
relestat-spc-clean-ie-rtq-v5.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 2 (qualitative and quantitative composition), excipients with known effect include phosphate 4.75mg/ml.
In section 4.4 (special warnings and precautions for use), cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas (see section 4.8).
In section 4.8 (undesirable effects), see section 4.4 for further information on adverse reactions in reported in phosphate containing eye drops.
Updated on 20 March 2019
File name
20180904 EN PIL SE_H_0315_001_IB_013 -v4.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 March 2019
File name
ie-20180904 EN SmPC SE_H_0315_001_IB_013- V4.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects), adverse drug reactions were tabulated.
In section 10 (date of revision of the text), the revised date was updated.
Updated on 14 April 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 April 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To incorporate the European Medicines Agency (EMA) safety warning regarding the potential corneal calcification following treatment with products containing phosphates which are given as eye drop(s).
Updated on 02 April 2015
File name
PIL_7976_3.pdf
Reasons for updating
- New PIL for new product
Updated on 02 April 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 03 November 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 03 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
Updated on 20 October 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Summary of Changes to Relestat® Summary of Product Characteristics (SPC)
The current Relestat® SPC is dated 6th October 2011
This supersedes SPC dated 13th July 2010
Section Number |
Subject |
Change |
3 |
Pharmaceutical Form
|
Text Added Eye drops, solution. A clear colourless sterile solution.
|
4.2 |
Posology and Method of Administration |
Text Removed/Added
The recommended dose for adults is one drop instilled in each affected eye twice daily, during the symptomatic period.
There is no experience in clinical studies with the use of Relestat for more than 8 weeks.
To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic medicinal product is being used, the different medicinal products should be administered at least 10 minutes apart.
Paediatric population
Safety and efficacy in patients ≥ 12 years has been established in clinical trials. Relestat may be used in adolescents (12 years of age and older) at the same dosage as in adults.
The safety and efficacy of Relestat in children less than 3 years of age have not been established. There are limited data on the safety in children aged 3-12 years, see section 5.1.
Hepatic impairment
Relestat has not been studied in patients with hepatic impairment. Post‑marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that the incidence of adverse reactions was higher in this group compared with adult patients without hepatic impairment. The daily dose of a 10 mg epinastine hydrochloride tablet is more than 100-fold higher than the daily dose following Relestat. In addition, the metabolism of epinastine in humans is minimal (<10%). Therefore, no dosage adjustment is considered to be necessary.
Renal impairment
Relestat has not been studied in patients with renal impairment. Post‑marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicate that there are no particular safety issues for patients with renal impairment. As such, no dosage adjustment is considered to be necessary.
|
4.4 |
Special Warnings and Precautions for Use |
Text Added
Relestat is for topical ophthalmic use only and not for injection or oral use.
Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Benzalkonium chloride may be absorbed by and discolour soft contact lenses and therefore patients should be instructed to wait until 10-15 minutes after instillation of Relestat before inserting contact lenses. Relestat should not be administered while wearing contact lenses.
|
4.6 |
Fertility, pregnancy and lactation |
Text Removed/Added
Pregnancy
Data on a limited number (11) of exposed pregnancies indicate no adverse effects of epinastine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing to pregnant women.
Epinastine is excreted in the breast milk of rats, but it is not known if epinastine is excreted in human milk. Due to the lack of experience, caution should be exercised when prescribing to breast-feeding women.
Fertility
|
4.8 |
Undesirable Effects |
Text Removed/Added
In clinical studies, the overall incidence of adverse drug reactions following Relestat was less than 10%. No serious adverse reactions occurred. Most were ocular and mild. The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.
Within each frequency grouping, adverse reactions are presented according to System Organ Class in order of decreased seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The following adverse drug reactions were reported during clinical trials with Relestat:
Nervous system disorders Uncommon: headache
Eye disorders Common
Uncommon:
Respiratory, thoracic and mediastinal disorders Uncommon:
Gastrointestinal disorders Uncommon:
*Increased lacrimation and eye pain have been identified during postmarketing use of Relestat in clinical practice.
Paediatric population
Frequency, type and severity of adverse reaction in adolescents ≥ 12 years of age are expected to be the same as in adults. There is limited experience in children 3-12 years of age regarding frequency, type and severity of adverse reactions.
|
5.1 |
Pharmacodynamic Properties |
Text Added
Pharmacotherapeutic group: Ophthalmologicals; Decongestants and Antiallergics; Other antiallergics ATC code: S01G X10
Epinastine is a topically active, direct H1-receptor antagonist. Epinastine has a high binding affinity for the histamine H1-receptor and a 400 times lower affinity for the histamine H2-receptor. Epinastine also possesses affinity for the a1-, a2-, and the 5-HT2 –receptor. It has low affinity for cholinergic, dopaminergic and a variety of other receptor sites. Epinastine does not penetrate the blood/brain barrier and, therefore, does not induce side effects of the central nervous system, i.e., it is non-sedative.
Following topical eye application in animals, epinastine showed evidence for antihistaminic activity, a modulating effect on the accumulation of inflammatory cells, and mast cell stabilising activity.
In provocation studies with allergens in humans, epinastine was able to ameliorate ocular symptoms following ocular antigen challenge. The duration of the effect was at least 8 hours. Paediatric population
A 6-week, randomised, double-masked, vehicle controlled study (2:1) involving 96 ocular-wise non-symptomatic, healthy children aged 3-12 years, indicated that Relestat was well tolerated and did not identify any significant differences between the groups for any safety variable. Treatment related reactions were conjunctival follicles (6.3% in both epinastine and vehicle-treated subjects) and conjunctival hyperaemia (1.6% of epinastine treated subjects and none in the vehicle group). Safety and efficacy in patients ≥ 12 years has been established in clinical trials.
|
6.3 |
List of excipients |
Text Added
Benzalkonium chloride, Disodium edetate, Sodium chloride, Sodium dihydrogen phosphate dihydrate, Sodium hydroxide/hydrochloric acid (pH adjustment), Purified water. .
|
10 |
Date of Revision of the Text
|
Text Removed/Added
|
Key:
Unchanged text appears as follows: eg Paediatric population
Added text appears as follows: eg Uveitis
Deleted (Removed) text appears as follows: eg Not applicable
Updated on 20 October 2011
Reasons for updating
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 03 August 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 |
Posology and method of administration
|
Text added:
To avoid contamination of the eye or eye drops do not allow the dropper tip to come into contact with any surface.
Text deleted:
|
6.5 |
Nature and content of container |
Text added: 10
Text deleted:
…
The fill volume is 5 ml.
|
10 |
Date of revision of the text |
Date deleted:
Replaced with: 13th July 2010 |
Updated on 03 August 2010
Reasons for updating
- Change to, or new use for medicine
Updated on 22 December 2008
Reasons for updating
- Change due to harmonisation of patient information leaflet
- Change due to user-testing of patient information
Updated on 26 August 2008
Reasons for updating
- Change to date of revision
Updated on 25 April 2008
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Summary of Changes to Relestat ® Irish Summary of Product Characteristics (SPC)
The current Relestat ® SPC is dated 18th October 2007
This supersedes SPC dated 1st February 2005
Section Number |
Subject |
Change |
2 |
Qualitative and quantitative composition |
Text added: Excipient: benzalkonium chloride 0.1 mg/ml Words inserted: For a full list of excipients, see section 6.1 |
4.3 |
Contraindications |
Words inserted: Hypersensitivity to epinastine or to any of the excipients. |
4.4 |
Special warnings and precautions for use |
Words deleted: Special warnings and |
4.5 |
Interaction with other medicinal products and other forms of interaction |
Text added: No interaction studies have been performed Text deleted:
|
4.8 |
Undesirable effects |
Changes made: (>1/100, <1/10) changed to (≥1/100 to <1/10) (>1/1000, <1/100) changed to (≥1/1000 to <1/100) |
4.9 |
Overdose |
Words deleted: No case of overdose |
5.3 |
Preclinical safety data |
Wording change:
Replaced with: Non clinical |
6.1 |
List of excipients |
Re formatted: Excipients displayed in list format rather than a sentence. |
6.6 |
Special precautions for disposal |
Text deleted:
Replaced with: Special precautions for disposal Text added: Any unused product or waste material should be disposed of in accordance with local requirements. |
9 |
Date of first authorisation/renewal of the authorisation |
Text added: Date of last renewal: 18th October 2007 |
10 |
Date of revision of the text |
Text deleted:
Replaced with: February 2008 |
Updated on 16 August 2005
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2005
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 15 January 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
AbbVie Limited

Address:
Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 428 7900Fax:
+353 1 428 7940