Summary of Product Characteristics (SmPC) - Ketazed 0.25 mg/ml eye drops, solution
1 NAME OF THE MEDICINAL PRODUCT
Ketazed 0.25 mg/ml, eye drops, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 0.345 mg ketotifen hydrogen fumarate corresponding to 0.25 mg ketotifen.
Each drop contains 9.5 microgram ketotifen fumarate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to faintly yellow solution.
pH: 4.8 – 6.4
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic treatment of seasonal allergic conjunctivitis.
4.2 Posology and method of administration
Posology
Adults, elderly and children (from 3 years of age and older): one drop of Ketazed 0.25 mg/ml, eye drops solution into the conjunctival sac twice a day.
Paediatric population
The safety and efficacy of Ketazed 0.25 mg/ml, eye drops solution in children aged from birth to 3 years have not yet been established.
Method of administration
To avoid contamination do not touch any surface with the dropper tip.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.
4.4 Special warnings and precautions for use
No special warnings or precautions for use.
4.5 Interaction with other medicinal products and other forms of interaction
If Ketazed 0.25 mg/ml, eye drops solution is used with other eye medications, an interval of at least 5 minutes must be observed between the administration of 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 ketotifen fumarate eye drops, the possibility of such effects cannot be excluded.
4.6 Fertility, pregnancy and lactation
| Pregnancy | |
| There are insufficient data on the use of ketotifen eye drops during pregnancy. | |
| 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 is advised when prescribing to pregnant women. | |
| Breast-feeding | |
| Although animal data following oral administration show excretion into breast | |
| milk, it is unlikely that topical administration in humans leads to detectable | |
| quantities in breast milk. |
Ketazed 0.25 mg/ml, eye drops solution can be used
| during lactation. | ||
| Fertility | ||
| There are no data available on the effect of ketotifen fumarate on fertility in humans. | ||
4.7 Effects on ability to drive and use machines
Any patient who experiences blurred vision or somnolence should not drive or operate machines.
4.8 Undesirable 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).
Immune system disorders
Uncommon: Hypersensitivity reactions
Nervous system disorders
Uncommon: Headache
Eye disorders
Common: Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion.
Uncommon: Blurred vision (during instillation), dry eyes, eyelid disorder, conjunctivitis, photophobia, conjunctival bleeding.
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 during post-marketing: hypersensitivity reactions including local allergic reaction (mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema of the face (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 Yellow Card Scheme as www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
No cases of overdose have been reported.
Oral ingestion of the contents 10 ml bottle would be equivalent to 2.5 mg of ketotifen which is 125% 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals, other antiallergics ATC code: S01GX08
Ketotifen is a histamine H1-receptor antagonist. In vivo animal studies and in vitro studies suggest the additional activities of mast cell stabilization and inhibition of infiltration, activation and degranulation of eosinophils.
5.2 Pharmacokinetic properties
In a pharmacokinetic study conducted in 18 healthy volunteers who received Ketazed eye drops solution, the 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% are excreted in the form of metabolites. The main metabolite is the practically inactive ketotifen-N-glucuronide.
5.3 Preclinical safety data
Preclinical data from conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction do not indicate any special risks to humans.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
| Sodium hyaluronate | ||||
| Glycerol (E 422) | ||||
| Sodium hydroxide (E 524) | ||||
| Purified water | ||||
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
In unopened bottle: 2 years After opening: 3 months
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
| The container is a 10 ml white high density polyethylene bottle closed with a 28 µl dropper. | |
| One bottle contains 10 ml of solution. | |
6.6 Special precautions for disposal
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
HORUS PHARMA
148 avenue Georges Guynemer
Cap Var D2
06700 Saint-Laurent-du-Var
France
8 MARKETING AUTHORISATION NUMBER(S)
PL 40934/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/01/2024
10 DATE OF REVISION OF THE TEXT
04/02/2026