Land: Sverige
Språk: svenska
Källa: Läkemedelsverket (Medical Products Agency)
ketotifenvätefumarat
Orifarm AB
S01GX08
ketotifen hydrogen fumarate
0,25 mg/ml
Ögondroppar, lösning i endosbehållare
glycerol Hjälpämne; ketotifenvätefumarat 0,345 mg Aktiv substans
Receptfritt
Förpacknings: Endosbehållare, 60 x 0,4 ml (skyddspåse)
Avregistrerad
2019-03-20
For medicine without prescription
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZADITEN 0.25 MG/ML, EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINERS
Ketotifen
<[To be completed nationally]>
WHAT IS IN THIS LEAFLET
:
1.
What Zaditen is and what it is used for
2.
What you need to know before you use Zaditen
3.
How to use Zaditen
4.
Possible side effects
5.
How to store Zaditen
6.
Contents of the pack and other information
1.
WHAT ZADITEN IS AND WHAT IT IS USED FOR
Zaditen contains the active substance ketotifen, which is an
anti-allergic substance. Zaditen is used to
treat eye symptoms of hay fever.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ZADITEN
DO NOT USE ZADITEN
If you are allergic to ketotifen or any of the other ingredients of
this medicine (listed in section 6).
_
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1 1 NAME OF THE MEDICINAL PRODUCT Zaditen 0.25 mg/ml _,_ eye drops, solution in single-dose containers. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 0.4 ml contains 0.138 mg ketotifen fumarate corresponding to 0.1 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 in single-dose containers. Clear, colourless to faintly yellow solution. 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 Zaditen into the conjunctival sac twice a day. The contents of a single-dose container are sufficient for one administration into both eyes. _Paediatric population_ The safety and efficacy of Zaditen in children below the age of 3 years have not yet been established. Method of administration The contents remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the tip of the container. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE No special warning. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION If Zaditen is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the medications. 2 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 Zaditen 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 Läs hela dokumentet