CLARITYN 10 mg Tablet

Зміст інструкції

1. Clarityn 10 mg tablets
   1. What Clarityn is and what it is used for
   2. What you need to know before taking Clarityn
   3. How to take Clarityn
   4. Possible side effects
   5. How to store Clarityn
   6. Contents of the pack and other information
2. Clarityn 10 mg oral lyophilisate
   1. What is Clarityn and what is it used for
   2. What you need to know before taking Clarityn
   3. How to take Clarityn
   4. Possible side effects
   5. How to store Clarityn
   6. Contents of the pack and other information
3. Clarityn 1 mg/ml syrup
   1. What Clarityn is and what it is used for
   2. What you need to know before taking Clarityn
   3. How to take Clarityn
   4. Possible side effects
   5. How to store Clarityn
   6. Contents of the pack and other information

Clarityn 10 mg tablets

Loratadine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• See a doctor if your symptoms do not improve or get worse. See section 4.
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• 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, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Clarityn is and what it is used for
• 2. What you need to know before you take Clarityn
• 3. How to take Clarityn
• 4. Possible side effects
• 5. How to store Clarityn
• 6. Contents of the pack and other information

1. What Clarityn is and what it is used for

The full name of this medicine is Clarityn tablets.

What Clarityn is
Clarityn tablets contains the active ingredient loratadine, which belongs to a class of medicines
called “antihistamines”.

How Clarityn works
Clarityn helps to reduce allergy symptoms by blocking the effects of a substance called “histamine” which
is produced by the human body when you are allergic to something.

When to take Clarityn
Clarityn relieves the symptoms associated with allergic rhinitis (such as hay fever) such as sneezing,
runny nose and itchy nose, burning and itchy eyes.
Clarityn is also used to relieve the symptoms of urticaria (itching, redness and number and
size of wheals).
The effect of Clarityn lasts a whole day and should help you to continue your normal daily
activities and to sleep.
See your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before taking Clarityn

Do not take Clarityn if

• you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Clarityn if:

• you suffer from liver disorders
• you need to undergo allergy skin tests. Do not take Clarityn for the two days before the tests, as this medicine may affect the results.

If any of the points above apply to you (or if you have any doubts), talk to your doctor, pharmacist or nurse before taking Clarityn.

Children
Do not give Clarityn tablets to children under 6 years of age or to children with a weight of 30 kg or less. Other formulations more suitable exist for children under 6 years of age or with a weight of 30 kg or less.
Children under 2 years of age
The safety and efficacy of Clarityn have not been established. No data are available.

Other medicines and Clarityn
The side effects of Clarityn may increase when taken together with medicines that alter the function of certain enzymes responsible for drug metabolism in the liver.
However, in clinical studies, no increase in the side effects of loratadine was observed with products that alter the function of these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including those available without a prescription

Clarityn and alcohol
It has not been shown that taking Clarityn with alcoholic beverages enhances its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid using Clarityn during pregnancy. Do not take Clarityn if you are breastfeeding.
Loratadine is excreted in breast milk.

Driving and using machines
In clinical studies conducted to assess the ability to drive vehicles, no adverse effects were observed in patients treated with loratadine. At the recommended dose, Clarityn is not expected to cause drowsiness or reduced attention. However, drowsiness has very rarely occurred in some people, which may affect the ability to drive vehicles or use machines.

Clarityn contains lactose
Clarityn contains lactose; therefore, if your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take Clarityn

Take this medicine following exactly the instructions in this leaflet or as directed by your doctor, pharmacist or nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
Take this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

What dose of Clarityn to take:

Adults and children 6 years of age and over with a body weight greater than 30 kg:
Take one tablet once a day with a glass of water, with or without food.

Body weight equal to or less than 30 kg:
Do not administer Clarityn. Other formulations are more suitable for children under 6 years of age or with a weight equal to or less than 30 kg.
Clarityn is not recommended in children under 2 years of age.

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:
Take one tablet on alternate days, with a glass of water, with or without food. However, before taking this medicine you should consult your doctor, pharmacist or nurse.

If you take more Clarityn than you should
If you take more Clarityn than you should, seek medical advice or contact your pharmacist immediately.
Serious problems should not arise, but headache, rapid heartbeat or drowsiness may occur.

If you forget to take Clarityn

• If you forget to take the medicine, take it as soon as you remember, then continue treatment as usual.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most commonly reported side effects in adults and children over 12 years of age are:

• drowsiness
• headache
• increased appetite
• difficulty sleeping.

The most commonly reported side effects in children aged between 2 and 12 years are:

• headache
• nervousness
• fatigue.

The following side effects very rare(may affect up to 1 in 10,000 people) have also been
observed during the marketing of loratadine:

• severe allergic reaction (including swelling)
• dizziness
• convulsions
• fast or irregular heartbeat
• nausea (feeling unwell)
• dry mouth
• stomach discomfort
• liver disorders
• hair loss
• skin rash
• fatigue. Frequency not known:
• Weight gain

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor, pharmacist or nurse. You can also report side effects directly through the national reporting
system at: 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 Clarityn

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the blister after EXP. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice changes in the appearance of the tablet.
• 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 Clarityn contains

• The active ingredient is loratadine. Each tablet contains 10 mg of loratadine.
• The other ingredients are lactose monohydrate, corn starch and magnesium stearate.

Description of the appearance of Clarityn and contents of the pack
Tablet.
Ovoid tablet, of a colour from white to almost white, with imprinted on one side a flask and a
mortar, an incision line and the number “10”.
Clarityn tablets is available in packs of 2, 5, 7, 10, 14, 15, 20, 21, 28, 30, 50, 60 or
100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Bayer Spa Viale Certosa 130 , 20156 MIlano
Manufacturer:
Schering-Plough Labo NV,
Industriepark, 30
B-2220 Heist-op-den-Berg,
Belgium
Schering-Plough
Rue Louis Pasteur, 2
F-14200 Herouville Saint Clair,
France

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Denmark, Finland, Iceland, Ireland, Norway, Sweden: Clarityn
Belgium, Luxembourg: Claritine
Italy: Clarityn
France, Greece, Spain: Clarityne
Germany: Lisino S
Netherlands: Claritine
Portugal: Claritine, Alertrin
United Kingdom: Clarityn (Allergy)

Clarityn 10 mg oral lyophilisate

Loratadine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse. See section 4.

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, pharmacist or nurse.
• 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 any side effect occurs, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Clarityn is and what it is used for
• 2. What you need to know before you take Clarityn
• 3. How to take Clarityn
• 4. Possible side effects
• 5. How to store Clarityn
• 6. Contents of the pack and other information

1. What is Clarityn and what is it used for

The full name of this medicine is Clarityn oral lyophilisate. Clarityn is an “oral lyophilisate”,
meaning a tablet that can dissolve in the mouth instantly.

What is Clarityn
Clarityn contains the active ingredient loratadine, which belongs to a class of medicines called
“antihistamines”.

How Clarityn works
Clarityn helps to reduce allergy symptoms by blocking the effects of a substance called “histamine” which
is produced by the human body when you are allergic to something.

When to take Clarityn
Clarityn relieves the symptoms associated with allergic rhinitis (such as hay fever) such as sneezing,
runny nose and itchy nose, burning and itchy eyes in adults and children from 2 years of age
weighing more than 30 kg.
Clarityn is also used to relieve the symptoms associated with urticaria (itching, redness and
number and size of wheals).
The effect of Clarityn lasts a whole day and should help you continue your normal daily
activities and sleep.
See your doctor if you do not feel better or if your symptoms worsen.

2. What you need to know before taking Clarityn

Do not take Clarityn if

• you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Clarityn if:

• you suffer from liver disorders
• you are going to undergo allergy skin tests. Do not take Clarityn in the two days before the tests, as this medicine may affect the results.

If any of the above points apply to you (or if you have any doubts), talk to your doctor, the
pharmacist or nurse before taking Clarityn.

Children
Do not give Clarityn to children under 2 years of age or to children between 2 and 12
years of age weighing less than 30 kg. Other formulations more suitable are available for children between 2 and 12 years of age and weighing
less than 30 kg.

Other medicines and Clarityn
The side effects of Clarityn may increase when taken together with medicines that
alter the function of some enzymes responsible for the metabolism of the drug in the liver.
However, in clinical studies, no increase in the side effects of loratadine was observed
with products that alter the function of these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.

Clarityn and alcohol
It has not been shown that taking Clarityn with alcoholic beverages enhances its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid using Clarityn during pregnancy.
Do not take Clarityn if you are breastfeeding. Loratadine is excreted in breast milk.

Driving and using machines
In clinical studies conducted to assess the ability to drive vehicles, no adverse effects were observed
in patients treated with loratadine. At the recommended dose, Clarityn is not expected to
cause drowsiness or reduced alertness. However, drowsiness has very rarely occurred in some people, which may affect the ability to drive vehicles or use
machinery.

3. How to take Clarityn

Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor, pharmacist or nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

What dose to take with Clarityn:
Adults and children over 12 years of age:
Take one orally disintegrating tablet once a day.

In children from 2 to 12 years of age the dosage is established based on weight:
Body weight over 30 kg:
Take one orally disintegrating tablet once a day.

Body weight less than or equal to 30 kg:
Do not administer Clarityn. Other formulations are more suitable for children aged between 2 and 12 years and weighing less than or equal to 30 kg.
Clarityn is not recommended in children under 2 years of age.

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:
Take a dose of orally disintegrating tablet on alternate days. Before taking this medicine you should however consult your doctor, pharmacist or nurse.

How to take this medicine:

• Carefully open a unit of the blister pack by removing the foil.
• Extract the dose of orally disintegrating tablet from the blister unit without breaking it.
• Place the dose of orally disintegrating tablet in your mouth: it will dissolve instantly.
• No water or other liquids are needed to swallow the orally disintegrating tablet.
• The orally disintegrating tablet can be taken with or without food.

If you take more Clarityn than you should
If you take more Clarityn than you should, seek immediate medical advice from your doctor or pharmacist.
Serious problems should not occur, but headache, rapid heartbeat or drowsiness may occur.

If you forget to take Clarityn

• If you forget to take the medicine, take it as soon as you remember, then continue the treatment as usual.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are:

• drowsiness
• headache
• increased appetite
• difficulty sleeping.

The most commonly reported side effects in children aged between 2 and 12 years are:

• headache
• nervousness
• fatigue.

The following side effects very rare(may affect up to 1 in 10,000 people) have also been
observed during the marketing of loratadine:

• severe allergic reaction (including swelling)
• dizziness
• convulsions
• fast or irregular heartbeat
• nausea (feeling sick)
• dry mouth
• stomach discomfort
• liver disorders
• hair loss
• skin rash
• fatigue. Frequency not known:
• Weight gain

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

5. How to store Clarityn

• Keep this medicine out of the sight and reach of children.
• Store in the original container to protect it from moisture; this medicine does not require any particular storage temperature.
• Do not use this medicine after the expiry date which is stated on the blister after EXP. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice changes in the appearance of the oral lyophilisate.
• 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 Clarityn contains

• The active ingredient is loratadine. Each orally disintegrating tablet contains 10 mg of loratadine.
• The other ingredients are gelatin, mannitol (E421), anhydrous citric acid and mint flavour.

Description of the appearance of Clarityn and contents of the pack
Orally disintegrating tablet.
Unit in the form of a white, round tablet, engraved with “C10”.
Clarityn is available in packs of 7, 8, 10, 20 or 30 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
BAYER S.P.A Viale Certosa , 130 – Milano
Manufacturer:
Schering-Plough Labo NV,
Industriepark, 30
B-2220 Heist-op-den-Berg,
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium, Luxembourg: Claritine Reditabs
Greece: Clarityne
Ireland:Clarityn Rapide Allergy
Italy: Clarityn
Portugal: Claritine Zydis
United Kingdom: Clarityn Rapide (Allergy)

Clarityn 1 mg/ml syrup

Loratadine

Read this leaflet carefully before 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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Clarityn is and what it is used for
• 2. What you need to know before you take Clarityn
• 3. How to take Clarityn
• 4. Possible side effects
• 5. How to store Clarityn
• 6. Contents of the pack and other information

1. What Clarityn is and what it is used for

The full name of this medicine is Clarityn syrup.

What Clarityn is
Clarityn syrup contains the active ingredient loratadine, which belongs to a class of medicines
called “antihistamines”.

How Clarityn works
Clarityn helps to reduce allergy symptoms by blocking the effects of a substance called “histamine” which
is produced by the human body when you are allergic to something.

When to take Clarityn
Clarityn relieves the symptoms associated with allergic rhinitis (such as hay fever) such as sneezing,
runny nose and itchy nose, burning and itchy eyes, in adults and children from 2 years of age.
Clarityn is also used to relieve the associated symptoms of urticaria (itching, redness and
number and size of wheals).
The effect of Clarityn lasts a whole day and should help you to continue your normal daily
activities and to sleep.
See your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before taking Clarityn

Do not take Clarityn if

• you are allergic (hypersensitive) to loratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Clarityn if:

• you suffer from liver disorders
• you need to undergo skin tests for allergies. Do not take Clarityn for the two days before the tests, as this medicine could influence the result.

If any of the points above apply to you (or if you have any doubts), talk to your doctor, your
pharmacist or nurse before taking Clarityn.

Children
Do not give Clarityn to children under 2 years of age.

Other medicines and Clarityn
The side effects of Clarityn may increase when taken together with medicines that
alter the function of some enzymes responsible for the metabolism of the drug in the liver.
However, in clinical studies, no increase in the side effects of loratadine has been observed
with products that alter the function of these enzymes.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.

Clarityn and alcohol
It has not been shown that taking Clarityn with alcoholic beverages enhances
its effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor
or pharmacist for advice before taking this medicine.
As a precaution, it is preferable to avoid using Clarityn during pregnancy.
Do not take Clarityn if you are breastfeeding.
Loratadine is excreted in breast milk.

Driving and using machines
In clinical studies conducted to assess the ability to drive vehicles, no adverse effects were observed
in patients treated with loratadine. At the recommended dose, Clarityn is not expected to
cause drowsiness or reduced alertness. However, drowsiness has been reported
very rarely in some people, which may affect the ability to drive vehicles or use
machinery.

Clarityn contains sucrose
Clarityn syrup contains 6g of sucrose per dose; this must be taken into consideration in
patients who suffer from diabetes. Therefore, if your doctor has diagnosed you with an intolerance to some
sugars, contact them before taking this medicine.

3. How to take Clarityn

Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor, pharmacist or nurse. If you have any doubts, ask your doctor, pharmacist or nurse.
Take this medicine following exactly the instructions in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

What dose to take of Clarityn:
Adults and children over 12 years of age:
Take two teaspoons (10 ml) once a day.

In children from 2 to 12 years of age the dosage is established based on weight:
Body weight over 30 kg:
Take two teaspoons (10 ml) once a day.

Body weight less than or equal to 30 kg:
Administer one teaspoon (5 ml) once a day.
Clarityn is not recommended for children under 2 years of age.

Adults and children with severe liver problems:

Adults and children weighing more than 30 kg:
Take two teaspoons (10 ml) on alternate days.

Children weighing 30 kg or less:
Administer one teaspoon (5 ml) on alternate days.
Before taking this medicine, however, you should consult your doctor, pharmacist or nurse.

How to take this medicine

• No water or other liquids are needed to take the syrup
• The syrup can be taken both on an empty stomach and with food.

If you take more Clarityn than you should
If you take more Clarityn than you should, seek immediate medical advice from your doctor or pharmacist.
Serious problems should not arise, but headache, rapid heartbeat or drowsiness may occur.

If you forget to take Clarityn

• If you forget to take the medicine, take it as soon as you remember, then continue treatment as usual.
• Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects in adults and children over 12 years of age are:

• drowsiness
• headache
• increased appetite
• difficulty sleeping.

The most commonly reported side effects in children aged between 2 and 12 years are:

• headache
• nervousness
• fatigue.

The following side effects very rare(may affect up to 1 in 10,000 people) have also been
observed during the marketing of loratadine:

• severe allergic reaction (including swelling)
• dizziness
• convulsions
• fast or irregular heartbeat
• nausea (feeling sick)
• dry mouth
• stomach discomfort
• liver disorders
• hair loss
• skin rash
• fatigue.

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

5. How to store Clarityn

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any particular storage conditions. Do not freeze. Store the bottle in the outer packaging to protect the medicine from light.
• Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.
• Clarityn syrup must be used within 1 month after opening.
• Do not use this medicine if you notice changes in the appearance of the syrup.
• 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 Clarityn contains

• The active ingredient is loratadine. 10 ml of syrup contain 10 mg of loratadine.
• The other ingredients are propylene glycol (E1520), glycerol (E422), anhydrous citric acid, sodium benzoate (E211), sucrose, artificial peach flavour and purified water.

Description of the appearance of Clarityn and contents of the pack
Syrup.
Transparent syrup, from colourless to light yellow.
Clarityn syrup is available in amber glass bottles of 60, 70, 100 or 120 ml with a tamper-evident polypropylene cap and child-resistant closure. A 5 ml plastic spoon is included.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BAYER S.P.A Viale Certosa , 130 – Milano
Manufacturer:
Schering-Plough Labo NV,
Industriepark, 30
B-2220 Heist-op-den-Berg,
Belgium
Schering-Plough S. A.
Km. 36, A-1
28750 San Agustin de Gaudalix
Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium, Luxembourg, Netherlands, Portugal: Claritine
Denmark, Iceland, Ireland, Italy, Sweden: Clarityn
France, Greece, Spain: Clarityne
United Kingdom: Clarityn (Allergy)