Ketotifen stulln ud

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KETOTIFEN STULLN UD (Ketotifen Stulln® UD)

Composition:

Active substance: ketotifen fumarate;

1 tube-dropper 0.4 mL contains 0.138 mg of ketotifen fumarate, equivalent to 0.1 mg of ketotifen;

Excipients: glycerol, sodium hydroxide, water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical characteristics: clear, colorless solution.

Pharmacotherapeutic group.

Medicinal products used in ophthalmology. Anti-inflammatory and antiallergic agents.

ATC code S01GX08.

Pharmacological properties.

Pharmacodynamics.

Ketotifen is an H1-histamine receptor antagonist. Data from in vivo animal studies and in vitro experiments indicate additional effects such as mast cell stabilization and inhibition of infiltration, activation, and degranulation of eosinophils.

Pharmacokinetics.

Plasma concentrations of ketotifen after repeated instillation of the drug into the eyes over 14 days were in most cases below the lower limit of quantification (20 pg/mL).

Clinical characteristics.

Indications.

Symptomatic treatment of seasonal allergic conjunctivitis.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When using Ketotifen Shtuln UD medicinal product concurrently with other ophthalmic medicinal products, they should be administered with an interval of at least 5 minutes.

When administering ketotifen orally, potentiation of the effect of medicinal products that depress the central nervous system, antihistamines, and alcohol is possible. Although such effects have not been observed with the use of ketotifen in the form of eye drops, the possibility of their occurrence cannot be excluded.

Special precautions for use.

No special warnings.

Use during pregnancy or breastfeeding.

Pregnancy

There are no adequate data on the use of ketotifen in the form of eye drops in pregnant women. Animal studies following oral administration of the drug at doses toxic to the maternal organism showed increased pre- and postnatal mortality, but no evidence of teratogenic effects was found. Systemic drug concentrations after ocular instillation are much lower than those after oral administration. Ketotifen should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Breastfeeding

Although animal studies have shown excretion of ketotifen into milk after oral administration, it is unlikely that the drug will be excreted into human breast milk in detectable concentrations following topical ocular use. Ketotifen Stulln UD may be used during breastfeeding.

Effect on fertility

There are no data available on the effect of ketotifen hydrogen fumarate on human fertility.

Ability to affect reaction rate when driving or operating machinery.

If blurred vision or drowsiness occurs, patients should refrain from driving or operating machinery.

Method of Administration and Dosage

Dosage

For adults, elderly patients, and children aged 3 years and older: instill 1 drop of Ketotifen Stulln UD ophthalmic solution into the conjunctival sac twice daily. The contents of one single-dose container are sufficient for instilling one drop into each eye.

The contents of the single-dose container remain sterile until the original packaging is opened. To prevent contamination, do not touch the eye or any other surface with the tip of the single-dose container.

Method of Administration

For ophthalmic use only.

Children

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

Overdose

Cases of overdose have not been reported.

Ingestion of the contents of a single-dose container is equivalent to an intake of 0.1 mg of ketotifen, which corresponds to 5% of the recommended oral daily dose for a 3-year-old child. According to clinical data, no serious signs or symptoms of overdose are expected following oral intake of ketotifen at doses up to 20 mg.

Adverse Reactions

According to the MedDRA classification, adverse drug reactions are categorized by frequency as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

Adverse reactions also observed during post-marketing use of ketotifen in the form of eye drops (frequency unknown):

hypersensitivity reactions, including local allergic reactions (mainly contact dermatitis, eye swelling, itching and eyelid swelling), systemic allergic reactions, including facial swelling (sometimes accompanied by contact dermatitis), and exacerbation of pre-existing allergic conditions such as bronchial asthma and eczema.

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.

Shelf life. 2 years.

Do not use the medicinal product if more than 4 weeks have passed since opening the aluminum foil package.

Ketotifen Stulln UD does not contain preservatives. After opening, the contents of a single-use tube-dropper should be used immediately. Any solution remaining in the tube-dropper after administration of the medicinal product should be discarded.

Storage conditions.

Keep out of reach and sight of children. Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Do not store in the refrigerator. Store tube-droppers in the aluminum packaging.

Packaging.

The tube-dropper contains a single dose of 0.4 mL. 5 tube-droppers connected into a block, 1 block (No. 5), 2 blocks (No. 10), or 6 blocks (No. 30, with every 2 blocks in an aluminum package) in an aluminum foil package. The tube-droppers are packed in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Pharma Stulln GmbH.

Manufacturer's address and place of business.

Werksstrasse 3, 92551 Stulln, Germany / Werksstrasse 3, 92551 Stulln, Germany.