Zalerg 0,25 mg/ml Ögondroppar, lösning i endosbehållare

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

ketotifenvätefumarat

Available from:

Orifarm AB

ATC code:

S01GX08

INN (International Name):

ketotifen hydrogen fumarate

Dosage:

0,25 mg/ml

Pharmaceutical form:

Ögondroppar, lösning i endosbehållare

Composition:

glycerol Hjälpämne; ketotifenvätefumarat 0,345 mg Aktiv substans

Prescription type:

Receptfritt

Product summary:

Förpacknings: Endosbehållare, 60 x 0,4 ml (skyddspåse)

Authorization status:

Avregistrerad

Authorization date:

2019-03-20

Patient Information leaflet

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.
>
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).
_

Read the complete document

Summary of Product characteristics

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