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Summary of Changes to UK Relestat® Summary of Product Characteristics (SPC)
The current UK Relestat® SPC is dated 20th September 2011
This supersedes SPC dated 12th April 2010
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Section Number
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Subject
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Change
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3
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Pharmaceutical Form
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Text Added
Eye drops, solution.
A clear colourless sterile solution.
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4.2
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Posology and Method of Administration
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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.
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4.4
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Special Warnings and Precautions for Use
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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.
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4.6
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Fertility, pregnancy and lactation
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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.
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4.8
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Undesirable Effects
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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.
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5.1
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Pharmacodynamic Properties
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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.
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6.1
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List of excipients
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Text Added
Benzalkonium chloride,
Disodium edetate,
Sodium chloride,
Sodium dihydrogen phosphate dihydrate,
Sodium hydroxide/hydrochloric acid (pH adjustment),
Purified water.
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10
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Date of Revision of the Text
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Text Removed/Added
12th April 2010 20th September 2011
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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
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