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Bentifen

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Document: Bentifen, eye drops,solution SmPC change

Produktinformationen för Bentifen, 0,25 mg/ml, Ögondroppar, lösning, MTnr 16251, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn.

1NAME OF THE MEDICINAL PRODUCT


Bentifen 0.25 mg/ml, eye drops, solution.


2QUALITATIVE AND QUANTITATIVE COMPOSITION


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


Each drop contains 8.5 microgram ketotifen fumarate.


Excipients: Benzalkonium chloride (0.1 mg/ml)


For a full list of excipients, see section 6.1.


3PHARMACEUTICAL FORM


Eye drops, solution.


Clear, colourless to faintly yellow solution


4CLINICAL PARTICULARS


.4.1Therapeutic indications


Symptomatictreatment of seasonal allergic conjunctivitis


.4.2Posology and method of administration


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.


Safety and effectiveness in paediatric patients below the age of 3 years have not been established


.4.3Contraindications


Hypersensitivity to ketotifen or to any of the excipients.


.4.4Special warnings and special precautions for use


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.


.4.5Interaction with other medicinal products and other forms of interaction


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.


.4.6Pregnancy and lactation


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.


Lactation

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.


.4.7Effects on ability to drive and use machines


Any patient who experiences blurred vision or somnolence should not drive or operate machines.


.4.8Undesirable effects


Adverse reactions are ranked under heading of frequency, using the following convention: 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).


At the recommended dose, the following undesirable effects have been reported:


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.


Nervous system disorders

Uncommon: Headache


General disorders and administration site conditions

Uncommon: Somnolence


Skin and subcutaneous tissue disorders

Uncommon: Rash, eczema, urticaria


Gastrointestinal disorders

Uncommon: Dry mouth


Immune system disorders

Uncommon: Hypersensitivity


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.


.4.9Overdose


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.


5PHARMACOLOGICAL PROPERTIES


.5.1Pharmacodynamic properties


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.


.5.2Pharmacokinetic properties


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.


.5.3Preclinical safety data


Preclinical data reveal no special hazard 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.


6PHARMACEUTICAL PARTICULARS


.6.1List of excipients


Benzalkonium chloride

Glycerol (E422)

Sodium hydroxide (E524)

Water for injections


.6.2Incompatibilities


Not applicable.


.6.3Shelf‑life


In unopened bottle: 2 years.

After opening: 4 weeks.


.6.4Special precautions for storage


Do not store above 25 °C.


.6.5Nature and contents of container


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.


.6.6Special precautions for disposal and other handling


No special requirements.


7MARKETING AUTHORISATION HOLDER


<[To be completed nationally]>


8MARKETING AUTHORISATION NUMBER(S)


<[To be completed nationally]>


9DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


2000-06-30/2010-06-30




10DATE OF REVISION OF THE TEXT


2010-06-30


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