Zaditen 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ketotifen fumarate

Available from:

Sigma Pharmaceuticals Plc

ATC code:

R06AX17

INN (International Name):

Ketotifen fumarate

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100

Patient Information leaflet

Zaditen tablets
1 mg
(ketotifen)
This medicine will usually be referred to as Zaditen
WHAT YOU NEED TO KNOW ABOUT ZADITEN TABLETS
Your
doctor
has
decided
that
you
need
this
medicine to help treat your condition.
START TO TAKE YOUR MEDICINE. IT CONTAINS IMPOR-
TANT INFORMATION.
because you may want to read it again.
If you have any other questions, or if there is some-
thing
you
don’t
understand,
please
ask
your
doctor or pharmacist.
This medicine has been prescribed for you. Never
give it to someone else. It may not be the right
medicine for them even if their symptoms seem to
be the same as yours.
please tell your doctor or pharmacist.
1. What Zaditen Tablets are and what they are used
for
2. Things
to
consider
before
you
start
to
take
Zaditen Tablets
3. How to take Zaditen Tablets
5. How to store Zaditen Tablets
6. Further information
1. WHAT ZADITEN TABLETS ARE AND WHAT THEY ARE
USED
FOR
Zaditen
Tablets
contains
the
active
ingredient, ketotifen. Ketotifen is an antihistamine
with anti-allergy properties.
In
allergic
conditions
certain
substances
are
released in the body.
Tablets act to dampen down these responses and
can
therefore
be
used
to
treat
various
allergic
mucous membranes in the nose) and conjunctivi-
eye).
2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
ZADITEN TABLETS
SOME PEOPLE MUST NOT TAKE ZADITEN TABLETS.
TALK TO YOUR DOCTOR IF:
•
You think you may be allergic to ketotifen or to
any of the other ingredients of Zaditen Tablets.
•
You
are
pregnant,
or
planning
to
become
pregnant. Tell your doctor straight away if you
become pregnant whilst taking Zaditen Tablets.
•
You are breast-feeding.
YOU SHOULD ALSO ASK YOURSELF THESE QUESTIONS
BEFORE TAKING ZADITEN TABLETS. IF THE ANSWER TO
ANY OF THESE QUESTIONS IS YES, TELL YOUR DOCTOR
OR PHARMACIST BECAUSE ZADITEN TABLETS MIGHT
NOT BE THE RIGHT MEDICINE FOR YOU.
•
Do you have epilepsy?
•
Do you have an inherited intolerance to some
sugars? (The tablets contain a small amount of
lactose.)
ARE YOU TAKING OTHER MEDICINES?
Some
medicines
can
inter

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ZADITEN Tablets 1mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketotifen hydrogen fumarate 1.38mg (equivalent to 1 mg ketotifen
base).
For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
White tablets, 7 mm diameter, with break-line on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic conditions including rhinitis and
conjunctivitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
1mg twice daily with food. If necessary the dose may be increased to
2mg twice
daily.
Children
(From 3 years of age): 1 mg twice daily with food. For patients for
whom a tablet
form may not be suitable, an alternative dosage form should be
considered.
Use in the elderly
No evidence exists that elderly patients require different dosages or
show different
side-effects from younger patients.
Patients known to be easily sedated should be given 0.5 -1 mg at night
for the first
few days.
4.3
CONTRAINDICATIONS
Hypersensitivity to ketotifen or any of the excipients. A reversible
fall in the
thrombocyte count in patients receiving ZADITEN® concomitantly with
oral
anti-diabetic agents has been observed in a few cases. This
combination of
drugs should therefore be avoided until this phenomenon has been
satisfactorily explained.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Zaditen Tablets contain lactose. Patients with rare hereditary
problems of galactose
intolerance, of severe lactase deficiency or of glucose-galactose
malabsorption should
not take this medicine.
Convulsions have been reported very rarely during ZADITEN® therapy.
As
ZADITEN® may lower the seizure threshold it should be used with
caution in
patients with a history of epilepsy.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
ZADITEN® may potentiate the effects of sedatives, hypnotics,
antihistamines and
alcohol. Patients should be warned not to take charge of vehicles or
machinery until
the effect of ZADITEN® treatment on the individu