ZADITEN TABLETS 1MG

Active substance: KETOTIFEN HYDROGEN FUMARATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Are you taking other medicines?
Some medicines can interfere with your treatment. Make sure your
doctor knows if you are taking any of the following:
• Oral medicines for diabetes
• Medicines to treat sleeplessness or anxiety
• Anti-histamines to treat allergic reactions such as itching, rash or
runny nose.
Always tell your doctor about all the medicines you are taking. This
meansmedicines you have bought yourself as well as medicines on
prescription from your doctor.

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.)

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. (These are listed in Section 6 of the
leaflet.)
• 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.

In allergic conditions certain substances are released in the body.
These trigger inflammatory responses. Zaditen Tablets act to dampen
down these responses and can therefore be used to treat various
allergic conditions such as rhinitis (inflammation of the mucous
membranes in the nose) and conjunctivitis (inflammation of the
mucous membranes in the eye).

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 this leaflet:
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
4. Possible side effects
5. How to store Zaditen Tablets
6. Further information

What you need to know about Zaditen Tablets
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to take your
medicine. It contains important information. Keep the leaflet in a
safe place because you may want to read it again.
If you have any other questions, or if there is something 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.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Patient Information Leaflet
This medicine will usually be referred to as Zaditen Tablets or Zaditen
in this leaflet.

Up to 1 in 100 people have experienced:
Cystitis (a burning or pain when passing urine), feeling dizzy
orhaving a dry mouth

The side effects listed below have also been reported:
Up to 1 in 10 people have experienced:
Feeling hyperactive, irritable or nervous, disturbed sleep.

Tell your doctor immediately if you have a fit.

Some side effects can be serious
Stop taking the tablets and tell your doctor immediately if
you notice any of the following rare symptoms:
• A severe skin reaction with blistering or peeling. These might
be the symptoms of an allergic reaction.

4. Possible side effects
Zaditen Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects.

What if you take too many tablets?
All tablets can be risky if you take too many. If you take too
many Zaditen Tablets, tell your doctor or hospital casualty
department as soon as possible. Take your medicine pack with
you so that people can see what you have taken.

What if you forget to take a dose?
If you forget to take a dose of Zaditen, take another one as
soon as you remember, unless it is almost time for your next
dose. If it is almost time for your next dose, just take the next
dose as you would do normally and miss out the tablets that
you have forgotten to take. Do not take a double dose of
Zaditen to make up for the tablets you forgot.

Zaditen Tablets should not be given to children under 3 years
of age.
The doctor may decide to start with a lower dose.

Children (aged over 3 years)
The usual dose is 1 mg (1 tablet) twice a day.

Adults
The usual dose is 1 or 2 mg (1 or 2 tablets) twice a day.

Swallow the tablets with a drink of water. Take them at the
same time as you are eating.

3. How to take Zaditen Tablets
The doctor will decide what dose of Zaditen Tablets you should take.
Always take the tablets exactly as your doctor has told you to. The
dose will be on thepharmacist’s label. Check the label carefully. It
should tell you how many tablets to take, and how often. If you
are not sure, ask your doctor or pharmacist. Keeptaking the
tablets for as long as you have been told unless you have any
problems. In that case, check with your doctor.

Other special warnings
The effects of alcohol may be increased by Zaditen Tablets. Do not
drink alcohol when you are taking them.

Will there be any problems with driving or using machinery?
During the first few days of treatment you may feel that your reactions
are slower than usual. Some people can feel drowsy or dizzy. If you
are affected in any way you should not drive or do anything that
requires you to be alert (such as operate tools or machinery) until any
problems clear up.

Zaditen Tablets are made by Mipharm S.p.A., Via Bernardo Quaranta,
12, 20141 Milan (Ml), Italy.

ZADITEN is a registered trade mark
Licensed to Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

The product licence holder is Sigma-Tau Industrie Farmaceutiche
Riunite S.p.A., Viale Shakespeare 47, 00144 Rome, Italy

The tablets come in blister packs of 60.

6. Further information
Zaditen Tablets 1 mg are white, flat tablets with a breakline on one
side.
They contain 1 mg of the active ingredient ketotifen (as 1.38 mg of
ketotifen hydrogen fumarate). The tablets also contain the inactive
ingredients magnesium stearate, pre-gelatinised corn starch, lactose
and maize starch.

If your doctor tells you to stop taking Zaditen Tablets, please take any
unused tablets back to your pharmacist to be destroyed. Only keep
the tablets if the doctor tells you to. Do not throw them away with
your normal household water or waste.
This will help to protect the environment.

5. How to store Zaditen Tablets
Keep your tablets in the foil. Only remove them when it is time to take
your medicine. Store below 25°C.
Keep all medicines out of the reach and sight of children.
Do not take the tablets after their expiry date which is printed on the
outside of the pack.

The sleepiness, dry mouth and dizziness usually go away a few days
after you have started taking Zaditen. If any of the symptoms become
troublesome, or if you notice anything else not mentioned here,
please go and see your doctor. He/she may want to give you a
different medicine.

Very rare side effects (likely to affect fewer than 1 in 10,000
people):
Severe skin reactions including rashes, blistering or peeling,
convulsions (fits) or problems with their liver including hepatitis
or an increase in liver enzymes (this wil only show in a blood test).

Up to 1 in 1,000 people have experienced:
Weight gain, feeling sleepy.

930727

20023853

SIZE 160 x 254 mm
LEAFLET
MATERIAL NUMBER 932707

ZADITEN® Tablets 1 mg (ketotifen)

20023853
SIGMA-TAU MATERIAL NUMBER

PLANT: MIPHARM
U.K.
ZADITEN TABLS 1 ML
PN 714026

NEW PN
Pantone
314 C
NUMBER OF COLORS: 1

APPROVAL
Version 2
26 -11-13
Version 1
11-11-13

SIGMA-TAU APPROVAL
TECHNICAL APPROVAL
TEXT APPROVAL

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)