ZADITEN 0.2 MG/ML Syrup

Зміст інструкції

1. Zaditen 2 mg prolonged-release tablets
   1. What is Zaditen and what is it 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
2. Zaditen 0.2 mg/ml syrup
   1. What is Zaditen and what is it used for
   2. What you need to know before you take Zaditen
3. Zaditen contains liquid maltitol, sodium methylparaben, sodium propyl
   1. How to take Zaditen
   2. Possible side effects
   3. How to store Zaditen
   4. Contents of the pack and other information

Zaditen 2 mg prolonged-release tablets

ketotifene fumarate

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Zaditen and what is it used for

Zaditen contains the active ingredient ketotifen fumarate, a medicine that belongs to the class of
antihistamine medicines. It works by blocking the release of substances responsible for allergic
reactions, including histamine.
Zaditen is used for the treatment of symptoms of allergic rhinitis (hay fever).

2. What you need to know before you take Zaditen

Do not take Zaditen

• if you are allergic to ketotifen fumarate or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from epilepsy (convulsions),
• if you are being treated with medicines for diabetes taken by mouth (oral antidiabetics),
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zaditen if:

• you suffer from asthma. This medicine is not effective for the prevention or treatment of acute asthma attacks. You should not suddenly stop taking your asthma therapy, even if you start treatment with Zaditen,
• you suffer from diabetes. If you are taking oral antidiabetics you should not take Zaditen because a reduction in the number of platelets in the blood (thrombocytopenia) may occur,
• you have a history of convulsions (epilepsy). If you suffer from epilepsy you should not take Zaditen, because this medicine can lower the convulsive threshold.

Take special care:

• with drowsiness, which may occur especially in the first few days of therapy. If you experience a decrease in attention, due to the sedative effect of Zaditen, you should inform your doctor who will prescribe you a reduced dose (see sections “Driving and using machines” and “Side effects”).

Other medicines and Zaditen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Zaditen with the following medicines:

• medicines for diabetes taken by mouth (oral biguanide antidiabetics) because a reduction in the number of platelets in the blood (thrombocytopenia) may occur (see section “Do not take Zaditen”).

Inform your doctor, who will pay particular attention, if you are using or are going to use:

• medicines that depress the central nervous system including: o medicines used to induce sleep and that relax (hypnotic-sedatives) o antihistamines (medicines against allergies)
• anticoagulants (medicines that reduce blood clotting)
• medicines that dilate the bronchi (bronchodilators) and help you breathe better, because the number of doses of these medicines may need to be reduced when used together with Zaditen.

Zaditen with alcohol
Do not drink alcohol during treatment with Zaditen because the latter increases the sedative
effect of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Fertility
The effects of Zaditen on human fertility have not been studied.
Pregnancy
Zaditen should be used during pregnancy only if absolutely necessary.
Breastfeeding
Zaditen should not be used during breastfeeding (see section “Do not take Zaditen”).

Driving and using machines
Take special care if you need to drive vehicles or use machines because Zaditen may
decrease your reaction ability, especially in the first few days of treatment (see section
“Warnings and precautions”).
If you are giving Zaditen to a child, pay attention if the child rides a bicycle or uses
other vehicles.

Zaditen contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take Zaditen

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Zaditen tablets must be swallowed whole.

Use in adults
The recommended dose is 2 mg (1 tablet) daily, preferably in the evening.
If necessary, your doctor may tell you to take 2 mg (1 tablet) twice a day, i.e.
morning and evening, waiting 12 hours between administrations.

Use in adolescents and children over 3 years of age
The recommended dose is 2 mg (1 tablet) daily, preferably in the evening.

Use in elderly patients (65 years and over)
The recommended dose is the same as for adults.

Use in patients with liver problems
The effects of Zaditen in patients with liver problems have not been studied.

Use in patients with kidney problems
The effects of Zaditen in patients with kidney problems have not been studied.

If you take more Zaditen than you should
In case of accidental ingestion of an excessive dose of Zaditen, immediately inform your
doctor or go to the nearest hospital.
Ingestion of an excessive dose may cause:

• drowsiness, even severe up to sedation
• dizziness
• confusion and disorientation
• slowed heartbeat (bradycardia) or accelerated heartbeat (tachycardia)
• reduction of blood pressure (hypotension)
• excessive excitability, convulsions especially in children
• difficulty breathing (dyspnea or respiratory depression)
• reversible coma

The doctor will treat the ingestion of an excessive dose of Zaditen based on your condition.

If you forget to take Zaditen
Do not take a double dose to make up for a missed dose.

If you stop taking Zaditen
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• excitation
• irritability
• insomnia
• nervousness These side effects have been observed especially in children.

Uncommon side effects (may affect up to 1 in 100 people)

• inflammation of the bladder (cystitis)
• dizziness
• dry mouth

Rare side effects (may affect up to 1 in 1,000 people)

• sedation
• weight gain

Very rare side effects (may affect up to 1 in 10,000 people)

• skin reactions that may potentially be fatal (erythema multiforme, Stevens-Johnson syndrome)
• inflammation of the liver (hepatitis)
• alteration of blood tests related to liver function (increased liver enzymes)

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• drowsiness
• nausea
• vomiting
• headache
• convulsions
• urticaria
• skin rashes

Drowsiness, sedation, dry mouth and dizziness usually appear at the beginning of the
treatment, but disappear spontaneously as therapy progresses.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the
national reporting system at http: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Zaditen

Store at a temperature below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zaditen contains

• The active ingredient is ketotifen fumarate. 1 tablet contains 2.75 mg of ketotifen fumarate acid equivalent to 2 mg of ketotifen fumarate base.
• The other ingredients are magnesium stearate, ethylcellulose, povidone, corn starch, glyceryl palmitostearate, lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol 6000, talc, anhydrous colloidal silica, yellow iron oxide pigment.

Description of the appearance of Zaditen and contents of the pack
Each pack contains 1 blister of 15 prolonged-release 2 mg tablets.

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
Mipharm S.p.A. - Via Bernardo Quaranta, 12 - 20141 Milano (MI)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)

Zaditen 0.2 mg/ml syrup

ketotifene fumarate

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Zaditen and what is it used for

Zaditen contains the active ingredient ketotifen fumarate, a medicine that belongs to the class of
antihistamine medicines. It works by blocking the release of substances responsible for allergic
reactions, including histamine.
Zaditen is used for the treatment of symptoms of allergic rhinitis (hay fever).

2. What you need to know before you take Zaditen

Do not take Zaditen

• if you are allergic to ketotifen fumarate or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from epilepsy (seizures),
• if you are being treated with medicines for diabetes taken by mouth (oral antidiabetics),
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zaditen if:

• you suffer from asthma. This medicine is not effective for the prevention or treatment of acute asthma attacks. You should not suddenly stop taking your asthma therapy, even if you start treatment with Zaditen;
• you suffer from diabetes. If you are taking oral antidiabetics, you should not take Zaditen because a reduction in the number of platelets in the blood (thrombocytopenia) may occur;
• you have a history of seizures (epilepsy). If you suffer from epilepsy, you should not take Zaditen, because this medicine can lower the seizure threshold.

Take special care:

• with drowsiness, which may occur especially in the first few days of therapy. If you experience a decrease in attention, due to the sedative effect of Zaditen, you should inform your doctor who will prescribe a reduced dose (see sections “Driving and using machines” and “Side effects”).

Other medicines and Zaditen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Zaditen with the following medicines:

• medicines for diabetes taken by mouth (oral biguanide antidiabetics) because a reduction in the number of platelets in the blood (thrombocytopenia) may occur (see section “Do not take Zaditen”).

Inform your doctor, who will pay particular attention, if you are using or have to use:

• medicines that depress the central nervous system including: o medicines used to induce sleep and that relax (hypnotic-sedatives) o antihistamines (medicines against allergies)
• anticoagulants (medicines that reduce blood clotting)
• medicines that dilate the bronchi (bronchodilators) and make it easier to breathe, because the number of administrations of these medicines may need to be reduced when used together with Zaditen.

Zaditen with alcohol
Do not drink alcohol during treatment with Zaditen because the latter increases the sedative
effect of alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Fertility
The effects of Zaditen on human fertility have not been studied.
Pregnancy
Zaditen should be used during pregnancy only if absolutely necessary.
Breastfeeding
Zaditen should not be used during breastfeeding (see section “Do not take Zaditen”).

Driving and using machines
Take special care if you need to drive vehicles or use machines because Zaditen may
decrease your ability to react, especially in the first few days of treatment (see
section “Warnings and precautions”).
If you are giving Zaditen to a child, pay attention if the child rides a bicycle or
uses other vehicles.

Zaditen contains liquid maltitol, sodium methylparaben, sodium propyl

paraben, sodium and benzyl alcohol
This medicine contains liquid maltitol. If your doctor has diagnosed you with an intolerance
to certain sugars, contact them before taking this medicine.
This medicine contains sodium methylparaben and sodium propylparaben
which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of syrup, i.e.
essentially “sodium-free”.
This medicine contains 0.013 mg of benzyl alcohol per 1 ml of syrup. Benzyl alcohol may
cause allergic reactions. Benzyl alcohol has been associated with the risk of serious adverse
effects including breathing problems (acute respiratory distress syndrome) in young children. Do not
use for more than one week in young children (under 3 years of age) unless otherwise
recommended by your doctor or pharmacist. Ask your doctor or pharmacist for advice if you are
pregnant. This is because large amounts of benzyl alcohol can accumulate in the body and
cause undesirable effects (such as metabolic acidosis). Ask your doctor or
pharmacist for advice if you have a liver or kidney condition. This is because large amounts of benzyl
alcohol can accumulate in the body and cause undesirable effects (such as metabolic
acidosis).

3. How to take Zaditen

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Take or administer Zaditen using the measuring spoon provided in the package.

Use in adults
The recommended dose is 5 ml of syrup (2 teaspoons of 2.5 ml corresponding to 1 mg) 2 times
a day, i.e. morning and evening.

Use in adolescents and children
Children between 6 months and 3 years of age
The recommended dose is 0.25 ml of syrup per kilogram of weight (0.05 mg per kilogram
of body weight) 2 times a day, i.e. morning and evening.
Example: to a child weighing 10 kg administer 2.5 ml (=1 measuring spoon) of Zaditen
syrup, in the morning and evening.
Adolescents and children over 3 years of age
The recommended dose is 5 ml of syrup (2 teaspoons of 2.5 ml corresponding to 1 mg) 2 times
a day, i.e. morning and evening.

Use in elderly patients (65 years and over)
The recommended dose is the same as for adults.

Use in patients with liver problems
The effects of Zaditen in patients with liver problems have not been studied.

Use in patients with kidney problems
The effects of Zaditen in patients with kidney problems have not been studied.

If you take more Zaditen than you should
In case of accidental ingestion of an excessive dose of Zaditen, immediately inform your
doctor or go to the nearest hospital.
Ingestion of an excessive dose may cause:

• drowsiness even severe up to sedation
• dizziness
• confusion and disorientation
• slowed (bradycardia) or accelerated (tachycardia) heartbeat
• reduction of blood pressure (hypotension)
• excessive excitability, seizures especially in children
• difficulty breathing (dyspnea or respiratory depression)
• reversible coma

The doctor will treat the ingestion of an excessive dose of Zaditen according to your conditions.

If you forget to take Zaditen
Do not take a double dose to make up for a missed dose.

If you stop taking Zaditen
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• excitation
• irritability
• insomnia
• nervousness These side effects have been observed especially in children.

Uncommon side effects (may affect up to 1 in 100 people)

• inflammation of the bladder (cystitis)
• dizziness
• dry mouth

Rare side effects (may affect up to 1 in 1,000 people)

• sedation
• weight increase

Very rare side effects (may affect up to 1 in 10,000 people)

• skin reactions that may be potentially fatal (erythema multiforme, Stevens-Johnson syndrome)
• inflammation of the liver (hepatitis)
• alteration of blood tests related to liver function (increased liver enzymes)

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• drowsiness
• nausea
• vomiting
• headache
• convulsions
• urticaria
• skin rashes

Drowsiness, sedation, dry mouth and dizziness usually appear at the beginning of the
treatment, but disappear spontaneously as therapy progresses.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at http: //www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Zaditen

Store at a temperature below 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zaditen contains

• The active ingredient is ketotifen fumarate. 1 ml of syrup contains 0.276 mg of ketotifen fumarate acid equivalent to 0.2 mg of ketotifen fumarate base.
• The other components are strawberry flavour (contains benzyl alcohol), sodium propyl parahydroxybenzoate, sodium methyl parahydroxybenzoate, anhydrous citric acid, anhydrous disodium phosphate, liquid maltitol, purified water.

Description of the appearance of Zaditen and contents of the pack
Each pack contains 1 bottle with 200 ml of syrup and a measuring spoon.

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
DELPHARM ORLEANS - 5, Avenue de Concyr - 45071 Orleans Cedex 2 (France)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)