ZADITEN

Package leaflet: Information for the patient

Zaditen 2 mg prolonged-release tablets

ketotifen fumarate
Please read all of this leaflet carefully before you 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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

Zaditen contains the active substance ketotifene fumarate, a medicine belonging to the class of antihistamine medicines. It works by blocking the release of substances responsible for allergic reactions, including histamine.
Zaditen is used to treat symptoms of allergic rhinitis (allergy-related nasal symptoms).

2. What you need to know before taking 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 have epilepsy (seizures),
• if you are being treated with oral diabetes medications (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. Do not stop your asthma therapy abruptly, even if you start treatment with Zaditen,
• you have diabetes. If you are taking oral antidiabetics, you should not take Zaditen, as it may cause a reduction in the number of platelets in the blood (thrombocytopenia),
• you have a history of seizures (epilepsy). If you have epilepsy, you should not take Zaditen, as this medicine may lower the seizure threshold.

Exercise particular caution:

• regarding drowsiness, which may occur especially during the first days of treatment. If you experience reduced alertness due to the sedative effect of Zaditen, you must inform your doctor, who may prescribe a lower dose (see sections "Driving and use of machines" and "Undesirable effects").

Other medicines and Zaditen
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Do not take Zaditen with the following medicines:

• oral diabetes medications (biguanide oral 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 special attention, if you are using or need to use:

• medicines that depress the central nervous system, including: hypnotic-sedative medicines (used to induce sleep and promote relaxation) or antihistamines (medicines for allergies),
• anticoagulants (medicines that reduce blood clotting),
• medicines that dilate the bronchi (bronchodilators) and improve breathing, because the number of doses of these medicines may need to be reduced when used together with Zaditen.

Zaditen and alcohol
Do not consume alcohol during treatment with Zaditen, as Zaditen increases the sedative effect of alcohol.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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 clearly necessary.
Breastfeeding
Zaditen must not be used during breastfeeding (see section "Do not take Zaditen").
Driving and use of machines
Exercise particular caution if you intend to drive or operate machinery, as Zaditen may reduce your reaction capabilities, especially during the first days of treatment (see section "Warnings and precautions").
If you are administering Zaditen to a child, take care if the child rides a bicycle or uses other vehicles.
Zaditen contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Zaditen

Take this medicine exactly as directed by 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) per day, preferably in the evening.
If necessary, your doctor may instruct you to take 2 mg (1 tablet) twice daily, i.e.
in the morning and evening, leaving 12 hours between doses.
Use in adolescents and children above 3 years of age
The recommended dose is 2 mg (1 tablet) per day, preferably in the evening.
Use in elderly patients (65 years and older)
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
If you accidentally take an excessive dose of Zaditen, inform your doctor immediately or go to the nearest hospital.
Taking an excessive dose may cause:

• drowsiness, even severe drowsiness up to sedation
• dizziness
• confusion and disorientation
• slowed heart rate (bradycardia) or rapid heart rate (tachycardia)
• reduced blood pressure (hypotension)
• excessive excitability, seizures, especially in children
• breathing difficulties (dyspnoea or respiratory depression)
• reversible coma

Your doctor will treat an overdose of Zaditen according to your condition.
If you forget to take Zaditen
Do not take a double dose to make up for the forgotten dose.
If you stop taking Zaditen
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody experiences them.

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

• excitement
• irritability
• insomnia
• nervousness
  These side effects have been observed mainly 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, including potentially life-threatening reactions (erythema multiforme, Stevens-Johnson syndrome)
• inflammation of the liver (hepatitis)
• changes in blood tests related to liver function (increase in liver enzymes)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

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

Drowsiness, sedation, dry mouth and dizziness usually occur at the beginning of treatment, but resolve spontaneously as treatment continues.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: 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 below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zaditen contains

• The active substance is ketotifen fumarate. One tablet contains 2.75 mg of ketotifen fumaric acid, equivalent to 2 mg of ketotifen fumarate base.
• The other components are magnesium stearate, ethylcellulose, povidone, maize 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 package contents
Each pack contains 1 blister with 15 prolonged-release tablets of 2 mg.
Marketing Authorization 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)

Patient information leaflet

Zaditen 0.2 mg/ml syrup

ketotifen fumarate
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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

Zaditen contains the active substance ketotifene 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 to treat symptoms of allergic rhinitis (allergic origin nasal symptoms).

2. What you need to know before taking 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 have epilepsy (seizures),
• if you are being treated with oral medicines for diabetes (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. Do not stop your asthma treatment suddenly, even if you start treatment with Zaditen;
• you have diabetes. If you are taking oral antidiabetics, you should not take Zaditen, as a reduction in the number of platelets in the blood (thrombocytopenia) may occur;
• you have a history of seizures (epilepsy). If you have epilepsy, you should not take Zaditen, as this medicine may lower the seizure threshold.

Take particular care:

• regarding drowsiness, which may occur especially during the first days of treatment. If you experience reduced alertness due to the sedative effect of Zaditen, you must inform your doctor, who may prescribe a lower dose (see sections "Driving and using machines" and "Undesirable effects").

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

• oral medicines for diabetes (biguanide oral 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 special attention, if you are using or need to use:

• medicines that depress the central nervous system, including: medicines used to induce sleep and that relax (hypnotic-sedatives) or antihistamines (medicines for 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 and alcohol
Do not consume alcohol during treatment with Zaditen, as it increases the sedative effect of alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist 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 clearly needed.
Breastfeeding
Zaditen must not be used during breastfeeding (see section "Do not take Zaditen").
Driving and using machines
Take particular care if you are driving or using machinery, as Zaditen may reduce your reaction ability, especially during the first days of treatment (see section "Warnings and precautions").
If you are administering Zaditen to a child, take care if the child rides a bicycle or uses other vehicles.
Zaditen contains maltitol liquid, methyl parahydroxybenzoate sodium, propyl parahydroxybenzoate sodium, sodium and benzyl alcohol
This medicine contains liquid maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains methyl parahydroxybenzoate sodium and propyl parahydroxybenzoate sodium, 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 (gasping syndrome), in young children. Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist. Consult your doctor or pharmacist if you are pregnant, because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease, because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Zaditen

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take or administer Zaditen using the dosing 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) twice daily,
i.e. in the 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 body weight (0.05 mg per kg of body weight) twice daily, i.e. in the morning and evening.
Example: for a child weighing 10 kg, administer 2.5 ml (=1 dosing 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) twice daily, i.e. in the morning and evening.

Use in elderly patients (65 years and older)
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 overdose, contact your doctor immediately or go to the nearest hospital.
Taking an excessive dose may cause:

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

Your doctor will treat an overdose of Zaditen according to your condition.

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

If you stop taking Zaditen
If you have any questions 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)

• excitement
• irritability
• insomnia
• nervousness
  These side effects have been observed mainly 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, even potentially life-threatening (erythema multiforme, Stevens-Johnson syndrome)
• inflammation of the liver (hepatitis)
• changes in blood tests relating to liver function (increased liver enzymes)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• drowsiness
• nausea
• vomiting
• headache
• seizures
• hives
• skin rashes

Drowsiness, sedation, dry mouth and dizziness usually occur at the beginning of treatment, but resolve spontaneously as treatment continues.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website 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 below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zaditen contains

• The active substance is ketotifene fumarate. 1 ml of syrup contains 0,276 mg of ketotifene fumarate acid, equivalent to 0,2 mg of ketotifene fumarate base.
• The other components are strawberry flavour (contains benzyl alcohol), propyl parahydroxybenzoate sodium, methyl parahydroxybenzoate sodium, anhydrous citric acid, anhydrous dibasic sodium 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 dosing 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)