Ketotifen Stulln 0.25 mg/ml eye drops, solution – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Ketotifen Stulln 0.25 mg/ml eye drops, solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml solution contains 0.25 mg ketotifen (as hydrogen fumarate).

Each drop contains approximately 9.3 microgram ketotifen (as hydrogen fumarate).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution

Clear, colourless solution, with a pH of 5.0 – 6.0 and an osmolality of 230 – 300 mOsm/kg.

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 (age 3 and older): one drop of Ketotifen Stulln into the conjunctival sac twice a day.

Paediatric population

The safety and efficacy of Ketotifen Stulln in children below the age of 3 years have not been established.

Method of administration

Ocular use.

Ketotifen Stulln is an unpreserved sterile medicinal product in a multidose container. Patients should be instructed to avoid contamination and not to touch the eye or any other surface with the tip of the bottle. The first drop prior to each use should be discarded (see section 4.4).

Patients should be informed of the correct handling of the bottle. When using for the first time, before delivering a drop to the eye, the patient should first of all practice using the bottle by squeezing it slowly to deliver one drop away from the eye. The patient should practice until being confident to deliver one drop at a time.

Patients should be instructed to avoid allowing the container to come into contact with the eye or surrounding structures as this could cause injury to the eye. The residual liquid remaining at the dropper tip after application of the eye drops should immediately be removed by shaking the bottle once downwards. The dropper tip should not be touched or wiped.

Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

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

Prior to each application, the first drop released from the bottle should be discarded by the patient. After use, any residual liquid should be removed by shaking the bottle once downwards. The patient should not touch the dropper tip to avoid microbiological contamination.

4.5 Interaction with other medicinal products and other forms of interaction

If Ketotifen Stulln is used concomitantly with other eye medicinal products there must be an interval of at least 5 minutes between the administrations.

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.

4.6 Fertility, pregnancy 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.

Breastfeeding

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

Fertility

There is no data available on the effect of ketotifen hydrogen 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 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

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 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:

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9 Overdose

No case of overdose has been reported.

Oral ingestion of the contents of a 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 of overdose 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

Mechanism of action

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

5.2 Pharmacokinetic properties

In a pharmacokinetic study conducted in 18 healthy volunteers with ketotifen-containing eye 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 a practically inactive ketotifen-N-glucuronide.

5.3 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glycerol (E422)

Sodium hydroxide 1 M (E524) (for pH-adjustment)

Water for injections

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened bottle: 2 years

After opening: 2 months

6.4 Special precautions for storage

Do not store above 25 °C.

Do not refrigerate or freeze.

6.5 Nature and contents of container

Ketotifen Stulln is an eye drops, solution without preservative.

The eye drops, solution is presented in transparent multidose 10 ml bottles (LDPE) with white ophthalmic squeeze dispenser (OSD) consisting of an applicator (HDPE), a thermoplastic elastomer spray pin, and a centerpiece (PP) containing an anti-microbial filter (PP/PTFE/PET) to protect the eye drops, solution against microbial contamination during the period of use. The dispenser is closed with a blue transparent LDPE cap with tamper-evident seal.

Each bottle contains 10 ml solution (approximately 270 drops), which is sufficient for 4 weeks of treatment.

Pack sizes: 1 x 10 ml.

6.6 Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

8 MARKETING AUTHORISATION NUMBER(S)

PL 20905/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

14/03/2025

10 DATE OF REVISION OF THE TEXT

14/03/2025