Zaditen 1 mg Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

KETOTIFEN FUMARATE

Commercializzato da:

Alfasigma S.p.A

Codice ATC:

R06AX; R06AX17

INN (Nome Internazionale):

KETOTIFEN FUMARATE

Dosaggio:

1 milligram(s)

Forma farmaceutica:

Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Other antihistamines for systemic use; ketotifen

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1979-12-19

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZADITEN® 1 MG TABLETS
{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 breastfeeding.
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.Your doctor may
reduce the dose if your reactions are slowed.
-
Zaditen may increase the effects of sedatives, anti-histamines,
medicines used to treat depression or
anxiety, anticoagulants to reduce the ability of the blood to clot and
alcohol.
-
As Zaditen may lower the sei

Scheda tecnica

Health Products Regulatory Authority
29 January 2021
CRN00C4JD
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zaditen 1 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg ketotifen (as the hydrogen fumarate).
Excipients with known effect: each tablet contains 96.88 mg of lactose
as lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
White, or yellow-tinged white, circular, flat, bevel-edged tablets
with breakline, weighing 130mg, 7mm diameter. The scoreline
is only to facilitate breaking for ease of swallowing and not to
divide into equal doses.
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. In patients susceptible to sedation, a
slow increase in dosage is recommended during the first week
of treatment, starting with ½ tablet twice daily, and increasing to
the full therapeutic dose. 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: For younger children, who cannot swallow
tablets or where the required dose cannot be
administered using tablets, Zaditen Oral Solution 1mg/5ml is
available. Dosage: 0.05 mg (=0.25 ml Zaditen Oral solution
1mg/5ml) per kilogram body weight twice daily (morning and evening).
Children over 3 years of age and adolescents: 1mg 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 sect