Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Pharma Stulln GmbH, Werksstrasse 3, 92551 Stulln, Germany
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
No special warning.
If Ketofall is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the medications.
The use of oral dosage forms of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although this has not been observed with ketotifen eye drops, the possibility of such effects cannot be excluded.
There are no adequate data from the use of ketotifen eye drops in pregnant women. Animal studies using maternally toxic oral doses showed increased pre- and postnatal mortality, but no teratogenicity. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women.
Although animal data following oral administration show excretion into breast milk, topical administration to human is unlikely to produce detectable quantities in breast milk. Ketofall can be used during lactation.
There is no data available on the effect of ketotifen hydrogen fumarate on fertility in humans.
Any patient who experiences blurred vision or somnolence should not drive or operate machines.
Adverse drug reactions from clinical trials (table 1) are listed by MedDRA system organ class.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (MedDRA): 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).
Table 1. Adverse reactions:
| System Organ Class | Frequency | Adverse Reaction |
|---|---|---|
| Immune system disorders | Uncommon | Hypersensitivity |
| Nervous system disorders | Uncommon | Headache |
| Eye disorders | Common | Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion |
| Uncommon | Vision blurred (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage | |
| Gastrointestinal disorders | Uncommon | Dry mouth |
| Skin and subcutaneous tissue disorers | Uncommon | Rash, eczema, urticaria |
| General disorders and administration site conditions | Uncommon | Somnolence |
Adverse reactions from post marketing experience (frequency not known).
The following post marketing events have also been observed with ketotifen eye drops: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritus and oedema), systemic allergic reactions including facial swelling/oedema (in some cases associated with contact dermatitis) and exacerbation of preexisting allergic conditions such as asthma and eczema.
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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