Zaditen 1mg/5ml oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

KETOTIFEN FUMARATE

Available from:

Alfasigma S.p.A

ATC code:

R06AX; R06AX17

INN (International Name):

KETOTIFEN FUMARATE

Dosage:

1 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use; ketotifen

Authorization status:

Marketed

Authorization date:

1979-11-30

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZADITEN® 1 MG/5 ML ORAL SOLUTION
Ketotifen (as Ketotifen hydrogen fumarate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Zaditen is and what it is used for
2. What you need to know before you take Zaditen
3. How to take 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
The name of your medicine is Zaditen and it contains ketotifen. It
belongs to a group of drugs which have
anti-allergic activities and it is used to treat allergic conditions
such as rhinitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZADITEN
DO NOT TAKE ZADITEN
-
If you are allergic to ketotifen or any of the other ingredients of
this medicine (listed in section 6).
-
If you have epilepsy.
-
If you are taking any oral medicines for diabetes.
-
If you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zaditen.
-
During the first few days of treatment your reactions may be impaired
(i.e. you may feel drowsy or your
reactions may be slower than usual, even if you do not feel drowsy).
You should not take charge of
vehicles or machinery until the effect of your medicine on your
reactions is known.
-
Zaditen may increase the effects of sedatives, anti-histamines,
medicines used to treat depression or
anxiety, anticoagulants and alcohol.
-
As Zaditen may lower the seizure threshold it should be used with
caution in patients with a history of
epilepsy. Convu

Summary of Product characteristics

Health Products Regulatory Authority
29 January 2021
CRN00C4JD
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zaditen 1mg/5ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral solution contains 1 mg Ketotifen (as the hydrogen
fumarate).
Excipients with known effect: each 5 ml of oral solution contains
4,000 mg of maltitol liquid (hydrogenated glucose syrup),
1.655 mg of methyl parahydroxybenzoate (E218), 0.833 mg of propyl
parahydroxybenzoate (E216) and 100 mg of ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear, colourless syrup with a strawberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic conditions including rhinitis and
conjunctivitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration.
ADULTS
1 mg twice daily with food. If necessary the dose may be increased to
2 mg twice daily.
At the higher dose, an accelerated onset of efficacy may be expected.
SPECIAL POPULATIONS
Pediatrics
Children aged 2 to 3 years:
0.05mg (=0.25 ml Zaditen Oral Solution 1mg/5ml) per kilogram body
weight twice daily (morning and evening).
Pediatrics over 3 years of age and adolescents:
1 mg twice daily with food.
Geriatrics (aged 65 years and above)
No evidence exists that elderly patients require different dosages or
show different side effects from younger patients.
Patients known to be easily sedated should begin treatment with 0.5 to
1 mg at night for the first few days.
Renal impairment
No studies have been performed in renally impaired patients and hence
no dosing recommendations can be provided for
these patients (see section 5.2).
Hepatic impairment
No studies have been performed in hepatically impaired patients and
hence no dosing recommendations can be provided for
these patients (see section 5.2).
Health Products Regulatory Authority
29 January 2021
CRN00C4JD
Page 2 of 6
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients