Relestat 0.5 mg/ml, eye drops, solution

  • Name:

    Relestat 0.5 mg/ml, eye drops, solution

  • Company:
    info
  • Active Ingredients:

    Epinastine Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/03/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 19/3/2019

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Allergan Ltd

Allergan Ltd

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1 - 0 of 23 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20 March 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 March 2019 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 April 2015 SmPC

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 2 April 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 April 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 3 November 2014 SmPC

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

To update the SPC and PIL to include the latest CSP updates and PV wording regarding the ADR reporting mechanism.

Updated on 3 November 2014 PIL

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 SmPC

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.

 

Children and Adolescents

 

Relestat may be used in adolescents (12 years of age and older) at the same dosage as in adults.

 

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.

 

BreastfeedingLactation

 

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


There are no adequate data from the use of epinastine on fertility in humans.

 

 

 

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 (≥1/100 to <1/10): burning sensation/ eye irritation

 

Uncommon: (≥1/1000 to <1/100): allergic conjunctivitis, blepharoptosis, conjunctival oedema, conjunctival/ ocular hyperaemia, eye discharge, eye dryness, irritation, itching, eye prutius, increased sensitivity, photophobia, visual disturbance, increased lacrimation*, eye pain*

Nervous system disorders

Uncommon (≥1/1000 to <1/100): headache

 

Respiratory, thoracic and mediastinal disorders

Uncommon: (≥1/1000 to <1/100): asthma, nasal irritation, rhinitis

 

Gastrointestinal disorders

Uncommon: (≥1/1000 to <1/100): dysgeusia

 

Skin and subcutaneous tissue disorders

Uncommon (≥1/1000 to <1/100): pruritus

 

*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

 

            13th July 2010 6th October 2011

 

 

 

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 PIL

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 3 August 2010 SmPC

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:

The contents of the bottle remain sterile until the original closure is broken by twisting the cap to pierce the dropper tip. To avoid contamination do not touch any surface with the dropper tip.

 

 

6.5

Nature and content of container

Text added:

10

 

Text deleted:

5

 

Text deleted:

with spike device for opening the bottle.

 

Text added:

The fill volume is 5 ml.

 

 

 

 

10

Date of revision of the text

Date deleted:

2007-10-18

 

Replaced with:

13th July 2010

Updated on 3 August 2010 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 22 December 2008 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 26 August 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 25 April 2008 SmPC

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 special precautions for use

 

4.5

Interaction with other medicinal products and other forms of interaction

Text added:

No interaction studies have been performed

 

Text deleted:

Specific interaction studies with other medicinal products have not been performed with Relestat.

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 with Relestat has been reported.

5.3

Preclinical safety data

Wording change:

Preclinical

 

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:

Instructions for use and handling, and disposal (if appropriate)

 

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:

1st March 2005

 

Replaced with:

February 2008

 

Updated on 16 August 2005 SmPC

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 SmPC

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 9 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 January 2004 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)