Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AbbVie Limited, Citywest Business Campus, Co Dublin 24, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 15 minutes after instillation of Relestat before inserting contact lenses. Relestat should not be administered while wearing contact lenses.
Relestat also contains phosphates. 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).
No interaction studies have been performed.
No drug-drug interactions are anticipated in humans since systemic concentrations of epinastine are extremely low following ocular dosing. In addition, epinastine is mainly excreted unchanged in humans indicating a low level of metabolism.
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.
There are no adequate data from the use of epinastine on fertility in humans.
Based on the pharmacodynamic profile, reported adverse reactions and specific psychometric studies, Relestat has no or negligible influence on the ability to drive and use machines.
If transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
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:
| System Organ Class | Frequency | Adverse Reaction |
|---|---|---|
| Nervous system disorders | Uncommon | Headache |
| Eye disorders | Common | Burning sensation, eye irritation |
| Uncommon | Conjunctival/ocular hyperaemia, eye discharge, eye dryness, eye pruritus, visual disturbance | |
| Respiratory, thoracic and mediastinal disorders | Uncommon | Asthma, nasal irritation, rhinitis |
| Gastrointestinal disorders | Uncommon | Dysgeusia |
The following adverse drug reactions were reported during post marketing use of epinastine in clinical practice:
| System Organ Class | Frequency | Adverse Reaction |
|---|---|---|
| Immune system disorders | Not known | Hypersensitivity reaction including symptoms or signs of eye allergy and extra-ocular allergic reactions, including angioedema, skin rash and redness |
| Eye disorders | Not known | Increased lacrimation, eye pain, eye swelling, eyelid oedema |
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 aged 3-12 years regarding frequency, type and severity of adverse reactions.
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 4.4).
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: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie.
Not applicable.
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