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Document: Bentifen eye drops, solution ENG SmPC change

• Bentifen, eye drops,solution SmPC
• Bentifen eye drops, solution ENG SmPC

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Bentifen 0.25 mg/ml, eye drops, solution.

One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen.

Each drop contains 8.5 microgram ketotifen fumarate.

Excipient(s) with known effect: Benzalkonium chloride (0.1 mg/ml)

For the full list of excipients, see section 6.1.

Eye drops, solution.

Clear, colourless to faintly yellow solution

Symptomatictreatment of seasonal allergic conjunctivitis

Adults, elderly and children (age 3 and older): one drop of Bentifeninto the conjunctival sac twice a day.

The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip.

The safety and efficacy of Bentifen in children aged from birth to 3 years have not yet been established

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

The formulation of Bentifeneye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore Bentifeneye drops should not be instilled while the patient is wearing these lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.

All eye drops preserved with benzalkonium chloride may possibly discolour soft contact lenses. Benzalkonium chloride may cause eye irritation.

If Bentifenis used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

The use of oral dosage forms of ketotifen may potentiate the effect of CNS depressants, antihistamines and alcohol. Although this has not been observed with Bentifeneye drops, the possibility of such effects cannot be excluded.

Pregnancy

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.

Breast-feeding

Although animal data following oral administration show excretion into breast milk, topical administration to human is unlikely to produce detectable quantities in breast milk. Bentifeneye drops can be used during lactation.

Fertility

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.

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).

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 disorders
	Uncommon:	Rash, eczema, urticaria
General disorders and administration site conditions
	Uncommon:	Somnolence

Adverse drug reactions from post marketing experience (Frequency not known):

The following post marketing events have also been observed: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema.

Reporting of suspected adverse reactions

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 the national reporting system listed in Appendix V.

No case of overdose has been reported.

Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of ketotifen which is 60% of a recommended oral daily dose for a 3 year old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of ketotifen.

Pharmacotherapeutic group: Ophthalmologicals, other anti-allergics

ATC code: S01GX08

Ketotifen is a histamine H₁-receptor antagonist. In vivoanimal studies and in vitrostudies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils.

In a pharmacokinetic study conducted in 18 healthy volunteers with Bentifeneye drops, plasma levels of ketotifen after repeated ocular administration for 14 days were in most cases below the limit of quantitation (20 pg/ml).

After oral administration, ketotifen is eliminated biphasically with an initial half-life of 3 to 5 hours and a terminal half-life of 21 hours. About 1% of the substance is excreted unchanged in the urine within 48 hours and 60 to 70% as metabolites. The main metabolite is the practically inactive ketotifen-N-glucuronide.

Preclinical data reveal no special hazard for which is considered relevant in connection with use of Zaditen eye drops in humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.

Benzalkonium chloride

Glycerol (E422)

Sodium hydroxide (E524)

Water for injections

Not applicable.

In unopened bottle: 2 years.

After opening: 4 weeks.

Do not store above 25 °C.

The container is a white-coloured LDPE bottle with a transparent LDPE dropper and a white HDPE screw cap with an integrated safety ring. One bottle contains 5 ml of the solution.

No special requirements.

<[To be completed nationally]>

<[To be completed nationally]>

2000-06-30/2010-06-30

2014-09-03