CLEVER 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. CLEVER 10 mg film-coated tablets
   1. WHAT IS CLEVER AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEVER
   3. HOW TO TAKE CLEVER
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CLEVER
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. CLEVER 20 mg film-coated tablets
   1. WHAT IS CLEVER AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEVER
   3. HOW TO TAKE CLEVER
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CLEVER
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
3. CLEVER 1 mg/ml syrup
   1. WHAT IS CLEVER AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEVER
   3. HOW TO TAKE CLEVER
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CLEVER
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

CLEVER 10 mg film-coated tablets

Ebastina

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

1. WHAT IS CLEVER AND WHAT IS IT USED FOR

CLEVER contains the active ingredient ebastine, an antihistamine for systemic use (with effects throughout the body).
Ebastine is indicated in adults and children over 12 years of age for the symptomatic treatment of:

• Allergic rhinitis (inflammation of the nasal mucosa of allergic origin), seasonal or perennial, with or without allergic conjunctivitis.
• Urticaria (skin condition).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEVER

Do not take CLEVER

• If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
• In case of severe hepatic impairment (decreased liver function).

The use of CLEVER is contraindicated during pregnancy and breastfeeding (see “Pregnancy, breastfeeding and fertility”).
Do not administer CLEVER to children under 12 years of age (see “Children and adolescents”).

Warnings and precautions
1
Talk to your doctor or pharmacist before taking CLEVER.
Use CLEVER with caution if:

• You have a condition that could lead to a cardiac risk such as prolonged QT interval syndrome (a disorder that affects the electrical activity of the heart that can lead to abnormal heartbeats) or hypokalaemia (decreased potassium levels in the blood).
• You are being treated with drugs that induce an increase in the QT interval.
• You are being treated with azole antifungal drugs, such as ketoconazole and itraconazole, or macrolide antibiotics, such as erythromycin (see “Other medicines and CLEVER”).
• You are being treated with anti-tuberculosis drugs such as rifampicin (see “Other medicines and CLEVER”).
• You suffer from renal impairment (decreased kidney function).
• You suffer from hepatic impairment (decreased liver function) of mild or moderate degree (see section 3 “How to take CLEVER”).

Children and adolescents
The use of CLEVER is not recommended in children under 12 years of age (see “Do not take CLEVER”).

Other medicines and CLEVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take CLEVER with caution in association with:

• Ketoconazole (antifungal drug) or erythromycin (antibiotic), both known for their QT prolongation effect. This association leads to an increase in ebastine levels in the blood and a greater prolongation of the QT interval than that observed with ketoconazole or erythromycin taken alone (see “Warnings and precautions”).
• Rifampicin (anti-tuberculosis drug). This association may lead to lower concentrations of CLEVER in the blood and therefore a reduction in the effects of the medicine.

CLEVER with food and alcohol
Taking ebastine with food does not interfere with its clinical effect.
No interactions of ebastine with alcohol have been reported.

Pregnancy and breastfeeding
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy
Do not take CLEVER during pregnancy (see “Do not take CLEVER”). Limited data are available on the use of ebastine in pregnant women.
Breastfeeding
It is not known whether ebastine is excreted in human milk.
Do not take CLEVER during breastfeeding (see “Do not take CLEVER”).
2

Driving and using machines
Ebastine, at recommended doses, has not produced adverse effects on driving and using machines. Nevertheless, check your reaction to ebastine before performing complex activities as drowsiness and dizziness may occur (see section 4 “Possible side effects”).

CLEVER 10 mg film-coated tablets contains lactose.If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

CLEVER 10 mg film-coated tabletscontains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. HOW TO TAKE CLEVER

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and children over the age of 12 years
Allergic rhinitis
The recommended dose is 10 mg to be taken orally once a day.
In patients with more severe symptoms, including perennial allergic rhinitis, a single dose of 20 mg
once a day may be of greater benefit.
Urticaria
The recommended dose is 10 mg to be taken orally once a day.
Take CLEVER during or away from meals.
Mild or moderate hepatic impairment
Do not exceed the daily dosage of 10 mg (see “Warnings and precautions”).

If you take more CLEVER than you should
In studies conducted with high doses, up to 100 mg administered once a day, no
clinically significant signs or symptoms were observed.
There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions, including an ECG (electrocardiogram)
and symptomatic treatment may be performed if necessary.
If you have taken an excessive dose of the medicine, inform your doctor immediately or
go to the nearest hospital.

If you forget to take CLEVER
Do not take a double dose to make up for a missed dose.
3
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of CLEVER, the following side effects may occur:

Very common side effects (may affect more than 1 in 10 people)

• Headache.

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

• Drowsiness.
• Dry mouth.

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

• Hypersensitivity reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia.
• Dizziness, dysesthesia (sensory disturbance), hypoesthesia (decreased sensitivity), dysgeusia (altered taste).
• Palpitations, tachycardia (increased heart rate).
• Vomiting, abdominal pain, nausea, digestive problems.
• Liver problems, abnormalities in liver function tests (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin).
• Urticaria (skin condition), rash (sudden redness of the skin), dermatitis (skin inflammation).
• Menstrual disorders.
• Edema (fluid retention), asthenia (weakness, lack of strength).

Frequency not known (the frequency cannot be estimated from the available data)

• Weight increased
• Appetite increased

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.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 CLEVER

4
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month and the product in intact packaging, correctly stored.
Protect from light.
Do not store at a temperature above 30° C.
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. PACKAGE CONTENTS AND OTHER INFORMATION

What CLEVER contains
Each film-coated tablet contains:

Active ingredient:Ebastine 10 mg

Other components:

• Core: Lactose, Microcrystalline cellulose, Pregelatinized corn starch, Sodium croscarmellose, Magnesium stearate.
• Coating: Hypromellose, Macrogol 6000, Titanium dioxide.

Description of the appearance of CLEVER and package contents
Film-coated tablets, white and round in shape.
Packs of 5, 10, 15, 20, 30 film-coated tablets containing 10 mg in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ALMIRALL SA, Ronda General Mitre 151 - 08022 Barcelona, Spain.

Manufacturer
INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A., Ctra.. Nacional II, km 593 – 08740 Sant
Andreu de la Barca – Barcelona (Spain).
5

CLEVER 20 mg film-coated tablets

Ebastine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could 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 CLEVER is and what it is used for
• 2. What you need to know before you take CLEVER
• 3. How to take CLEVER
• 4. Possible side effects
• 5. How to store CLEVER
• 6. Contents of the pack and other information

1. WHAT IS CLEVER AND WHAT IS IT USED FOR

CLEVER contains the active ingredient ebastine, an antihistamine for systemic use (with effects throughout the body).
Ebastine is indicated in adults and adolescents over 12 years of age for the symptomatic treatment of allergic rhinitis (inflammation of the nasal mucosa of allergic origin), seasonal or perennial,
associated or not with allergic conjunctivitis.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEVER

Do not take CLEVER

• If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
• In case of severe hepatic insufficiency (decreased liver function).

The use of CLEVER is contraindicated during pregnancy and breastfeeding (see “Pregnancy, breastfeeding and fertility”).
Do not administer CLEVER to children under 12 years of age (see “Children and adolescents”).
6

Warnings and precautions
Talk to your doctor or pharmacist before taking CLEVER.
Use CLEVER with caution if:

• You have a condition that could lead to a cardiac risk such as prolonged QT interval syndrome (a disorder that affects the electrical activity of the heart that can lead to abnormal heartbeats) or hypokalaemia (decreased potassium levels in the blood).
• You are being treated with drugs that induce an increase in the QT interval.
• You are being treated with azole antifungal drugs, such as ketoconazole and itraconazole, or macrolide antibiotics, such as erythromycin (see “Other medicines and CLEVER”).
• You are being treated with drugs against tuberculosis such as rifampicin (see “Other medicines and CLEVER”).
• You suffer from renal insufficiency (decreased kidney function).
• You suffer from hepatic insufficiency (decreased liver function) of mild or moderate degree (see section 3 “How to take CLEVER”).

Children and adolescents
The use of CLEVER is not recommended in children under 12 years of age (see “Do not take CLEVER”).

Other medicines and CLEVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take CLEVER with caution in association with:

• Ketoconazole (antifungal drug) or erythromycin (antibiotic), both known for their QT interval prolongation effect. This combination leads to an increase in ebastine levels in the blood and a greater prolongation of the QT interval than that observed with ketoconazole or erythromycin taken alone (see “Warnings and precautions”).
• Rifampicin (antitubercular drug). This combination may lead to lower concentrations of CLEVER in the blood and therefore a reduction in the effects of the medicine.

CLEVER with food and alcohol
Taking ebastine with food does not interfere with its clinical effect.
No interactions of ebastine with alcohol have been reported.

Pregnancy and breastfeeding
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy
Do not take CLEVER during pregnancy (see “Do not take CLEVER”). Limited data are available on the use of ebastine in pregnant women.
Breastfeeding
It is not known whether ebastine is excreted in human milk.
7
Do not take CLEVER during breastfeeding (see “Do not take CLEVER”).

Driving and using machines
Ebastine, at recommended doses, has not produced adverse effects on driving and using machines. Nevertheless, check your reaction to ebastine before performing complex activities as drowsiness and dizziness may occur (see section 4 “Possible side effects”).

CLEVER 20 mg film-coated tablets contains lactose.If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

CLEVER 20 mg film-coated tabletscontains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. HOW TO TAKE CLEVER

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and children over 12 years of age
Allergic rhinitis
The recommended dose is 20 mg to be taken orally once a day.
In patients with less severe symptoms, a single dose of 10 mg once a day is recommended.
Take CLEVER during or away from meals.
Mild or moderate hepatic impairment
Do not exceed a daily dosage of 10 mg (see “Warnings and precautions”).

If you take more CLEVER than you should
In studies conducted with high doses, up to 100 mg administered once a day, no clinically significant signs or symptoms have been observed.
There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions, including an ECG (electrocardiogram), and symptomatic treatment may be performed if necessary.
If you have taken an excessive dose of the medicine, inform your doctor immediately or go to the nearest hospital.

If you forget to take CLEVER
Do not take a double dose to make up for the missed dose.
8
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of CLEVER, the following side effects may occur:

Very common side effects (may affect more than 1 in 10 people)

• Headache.

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

• Somnolence.
• Dry mouth.

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

• Hypersensitivity reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia.
• Dizziness, dysesthesia (sensory disturbance), hypoesthesia (decreased sensitivity), dysgeusia (altered taste).
• Palpitations, tachycardia (increased heart rate).
• Vomiting, abdominal pain, nausea, digestive problems.
• Liver problems, abnormalities in liver function tests (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin).
• Urticaria (skin condition), rash (sudden redness of the skin), dermatitis (skin inflammation).
• Menstrual disorders.
• Edema (fluid retention), asthenia (weakness, lack of strength).

Frequency not known (the frequency cannot be estimated from the available data)

• Weight increased
• Increased appetite

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.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 CLEVER

Keep this medicine out of the sight and reach of children.
9
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging, correctly stored.
Do not store at a temperature above 30° C.
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 CLEVER contains
Each film-coated tablet contains:

Active substance:Ebastine 20 mg.

Other ingredients:

• Core: Microcrystalline cellulose, Lactose, Pregelatinized corn starch, Sodium croscarmellose, Magnesium stearate.
• Coating :Hypromellose, Macrogol 6000, Titanium dioxide.

Description of the appearance of CLEVER and contents of the pack
Film-coated tablets, white and round in shape.
Packs of 5, 10, 15, 20, 30 film-coated tablets containing 20 mg in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ALMIRALL SA, Ronda General Mitre 151 - 08022 Barcelona, Spain.

Manufacturer
INDUSTRIAS FARMACÉUTICAS ALMIRALL, S.A., Ctra. Nacional II, km 593 – 08740 Sant
Andreu de la Barca – Barcelona (Spain).
10

CLEVER 1 mg/ml syrup

Ebastina

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

1. WHAT IS CLEVER AND WHAT IS IT USED FOR

CLEVER contains the active ingredient ebastine, an antihistamine for systemic use (with effects throughout the body).
Ebastine is indicated in adults and children over 6 years of age for the symptomatic treatment of:

• Allergic rhinitis (inflammation of the nasal mucosa of allergic origin), seasonal or perennial, associated or not with allergic conjunctivitis.
• Urticaria (skin condition).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLEVER

Do not take CLEVER

• If you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
• In case of severe hepatic insufficiency (decreased liver function).

The use of CLEVER is contraindicated during pregnancy and breastfeeding (see “Pregnancy, breastfeeding and fertility”).
Do not administer CLEVER to children under 6 years of age (see “Children and adolescents”).
11

Warnings and precautions
Talk to your doctor or pharmacist before taking CLEVER.
Use CLEVER with caution if:

• You have a condition that could lead to a cardiac risk such as prolonged QT interval syndrome (a condition affecting the electrical activity of the heart that can lead to abnormal heartbeats) or hypokalaemia (decreased potassium levels in the blood).
• You are being treated with drugs that induce an increase in the QT interval.
• You are being treated with azole antifungal drugs, such as ketoconazole and itraconazole, or macrolide antibiotics, such as erythromycin (see “Other medicines and CLEVER”).
• You are being treated with drugs for tuberculosis such as rifampicin (see “Other medicines and CLEVER”).
• You suffer from renal insufficiency (decreased kidney function).
• You suffer from hepatic insufficiency (decreased liver function) of mild or moderate degree (see section 3 “How to take CLEVER”).

Children and adolescents
The use of CLEVER is not recommended in children under 6 years of age (see “Do not take CLEVER”).

Other medicines and CLEVER
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take CLEVER with caution in association with:

• Ketoconazole (antifungal drug) or erythromycin (antibiotic), both known for their QT prolongation effect. This combination leads to an increase in ebastine levels in the blood and a greater prolongation of the QT interval than that observed with ketoconazole or erythromycin taken alone (see “Warnings and precautions”).
• Rifampicin (antitubercular drug). This combination may lead to lower concentrations of CLEVER in the blood and therefore a reduction in the effects of the medicine.

CLEVER with food and alcohol
Taking ebastine with food does not interfere with its clinical effect.
No interactions of ebastine with alcohol have been reported.

Pregnancy and breastfeeding
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy
Do not take CLEVER during pregnancy (see “Do not take CLEVER”). Limited data are available on the use of ebastine in pregnant women.
Breastfeeding
It is not known whether ebastine is excreted in human milk.
12
Do not take CLEVER during breastfeeding (see “Do not take CLEVER”).

Driving and using machines
Ebastine, at recommended doses, has not produced adverse effects on driving and using machines. Nevertheless, check your reaction to ebastine before performing complex activities as drowsiness and dizziness may occur (see section 4 “Possible side effects”).

CLEVER 1 mg/ml syrup contains liquid sorbitol.This medicine contains 70 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients are unable to metabolize fructose, talk to your doctor before you (or your child) take this medicine.

CLEVER 1 mg/ml syrup contains hydrogenated polyoxylated castor oil.It may cause gastrointestinal disturbances and diarrhoea.

CLEVER 1 mg/ml syrup contains sodium propyl p-hydroxybenzoate and sodium methyl p-hydroxybenzoate.They may cause allergic reactions (including delayed ones) and, exceptionally, bronchospasm (breathing problems).

CLEVER 1 mg/ml syrupcontains less than 1 mmol (23 mg) of sodium per 10 ml (the maximum daily dose of solution), i.e. it is essentially ‘sodium-free’.

3. HOW TO TAKE CLEVER

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults and children over 12 years of age
Allergic rhinitis
The recommended dose is 10 mg (10 ml) to be taken orally once a day.
In patients with more severe symptoms, including perennial allergic rhinitis, a single dose of 20 mg
once a day may be of greater benefit.
Urticaria
The recommended dose is 10 mg (10 ml) to be taken orally once a day.
Mild or moderate hepatic impairment
Do not exceed the daily dose of 10 mg (10 ml) (see “Warnings and precautions”).

Children aged 6 to 11 years
The recommended dose is 5 mg (5 ml) to be taken orally once a day.

Method of administration
13
Insert the syringe applicator into the bottle and draw up the solution to the indicated dose.
Take the syrup orally directly or mixed with water, during or away from meals.

If you take more CLEVER than you should
In studies conducted with high doses, up to 100 mg administered once a day, no
clinically significant signs or symptoms were observed.
There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions, including an ECG (electrocardiogram)
and symptomatic treatment may be performed if necessary.
If you have taken an excessive dose of the medicine, immediately inform your doctor or
go to the nearest hospital.

If you forget to take CLEVER
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of CLEVER, the following side effects may occur:

Very common side effects (may affect more than 1 in 10 people)

• Headache.

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

• Drowsiness.
• Dry mouth.

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

• Hypersensitivity reactions (such as anaphylaxis and angioedema)
• Nervousness, insomnia.
• Dizziness, dysesthesia (sensory disturbance), hypoesthesia (decreased sensitivity), dysgeusia (altered taste).
• Palpitations, tachycardia (increased heart rate).
• Vomiting, abdominal pain, nausea, digestive problems.
• Liver problems, abnormalities in liver function tests (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin).
• Urticaria (skin condition), rash (sudden redness of the skin), dermatitis (skin inflammation).
• Menstrual disorders.
• Edema (fluid retention), asthenia (weakness, lack of strength).

14

Frequency not known (the frequency cannot be estimated from the available data)

• Weight increased
• Appetite increased

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.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 CLEVER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
Do not use after 30 days from the date of first opening.
Store the product in the original packaging to protect it from light.
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 CLEVER contains
1 ml of syrup contains:

Active ingredient: Ebastina 1 mg

Other components: Glycerol (E422), Sorbitol liquid (E420), Hydrogenated polyoxyl castor oil
lactic acid (E270), Sodium methyl p-hydroxybenzoate (E219), Neohesperidin
dihydrochalcone (E959), Sodium propyl p-hydroxybenzoate (E217), Anethole, Polydimethylsiloxane,
Sodium hydroxide, Purified water.

Description of the appearance of CLEVER and contents of the pack
Syrup, colorless liquid.
120 ml bottle with a 5 ml syringe applicator for oral administration.

Marketing Authorisation Holder
ALMIRALL SA, Ronda General Mitre 151 - 08022 Barcelona, Spain.

Manufacturer
15
Industrias Farmacéuticas Almirall, S.A., Carretera Nacional II, km. 593, 08740 Sant Andreu de la
Barca – Barcelona (SPAIN).
16