Clever

Italy
Brand name Clever
Form tablets, film-coated
Active substance / Dosage
EBASTINE
Prescription type Prescription only
ATC code
R06AX22
Registration number 029353
Manufacturer ALMIRALL S.A.

Table of Contents

Package leaflet: Information for the user

CLEVER 10 mg film-coated tablets

Ebastine
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, 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 taking 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 CLEVER IS AND WHAT IT IS USED FOR

CLEVER contains the active substance ebastine, a systemic antihistamine (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, with or without associated allergic conjunctivitis.
  • Urticaria (skin condition).

2. WHAT YOU SHOULD KNOW BEFORE TAKING CLEVER

Do not take CLEVER

  • If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
  • If you have severe hepatic impairment (reduced 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

Talk to your doctor or pharmacist before taking CLEVER.
Exercise caution when using CLEVER if:

  • You have a condition that could lead to an increased cardiac risk, such as prolonged QT interval syndrome (a disorder affecting the heart's electrical activity that may cause irregular heartbeats) or hypokalaemia (decreased potassium levels in the blood).
  • You are taking medicines that increase the QT interval.
  • You are taking antifungal azole medications, such as ketoconazole and itraconazole, or macrolide antibiotics, such as erythromycin (see "Other medicines and CLEVER").
  • You are taking anti-tuberculosis medications such as rifampicin (see "Other medicines and CLEVER").
  • You have renal impairment (reduced kidney function).
  • You have mild or moderate hepatic impairment (reduced liver function) (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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use CLEVER with caution when taken together with:

  • Ketoconazole (an antifungal medicine) or erythromycin (an antibiotic), both known to prolong the QT interval. This combination leads to increased levels of ebastine in the blood and a greater QT interval prolongation than that observed with ketoconazole or erythromycin taken alone (see "Warnings and precautions").
  • Rifampicin (an anti-tuberculosis medicine). This combination may result in lower blood concentrations of CLEVER and therefore a reduction in its therapeutic effect.

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

Pregnancy and breastfeeding
Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.

Pregnancy
Do not take CLEVER during pregnancy (see "Do not take CLEVER"). There is limited data 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").

Driving and using machines
Ebastine, at recommended doses, has not produced negative effects on driving or operating machinery. Nevertheless, assess your response to ebastine before performing complex tasks, as drowsiness and dizziness may occur (see section 4 "Possible side effects").

CLEVER 10 mg film-coated tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

CLEVER 10 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. HOW TO TAKE CLEVER

Take this medicine exactly as instructed by 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 taken orally once daily.
In patients with more severe symptoms, including perennial allergic rhinitis, a single daily dose of 20 mg may provide greater benefit.
Urticaria
The recommended dose is 10 mg taken orally once daily.
Take CLEVER during or apart from meals.
Mild to moderate hepatic impairment
Do not exceed a daily dose of 10 mg (see "Warnings and precautions").
If you take more CLEVER than you should
In studies using high doses, up to 100 mg administered once daily, no clinically significant signs or symptoms have been observed.
There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions—including ECG (electrocardiogram)—and symptomatic treatment may be required.
If you have taken an excessive amount of this medicine, contact 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.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur with the use of CLEVER:

Very common adverse reactions (may affect more than 1 in 10 people)

  • Headache.

Common adverse reactions (may affect up to 1 in 10 people)

  • Drowsiness.
  • Dry mouth.

Rare adverse reactions (may affect up to 1 in 1,000 people)

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

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

  • Weight increased
  • Appetite increased

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, 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 stated on the packaging. The expiry date refers to the last day of that month and to the product in its original packaging, correctly stored.
Protect from light.
Do not store above 30°C.
Do not dispose of medicines via 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 PACKAGE AND OTHER INFORMATION

What CLEVER contains
Each film-coated tablet contains:
Active substance: 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 contents of the pack
Film-coated tablets, white and round in shape.
Pack sizes of 5, 10, 15, 20, and 30 film-coated tablets of 10 mg in blister packs.
Not all pack sizes may be marketed.
Marketing Authorization 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).

Package leaflet: information for the user

CLEVER 20 mg film-coated tablets

Ebastine
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 other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, consult 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 taking 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 CLEVER IS AND WHAT IT IS USED FOR

CLEVER contains the active substance ebastine, a systemic antihistamine (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 associated with allergic conjunctivitis.

2. WHAT YOU NEED TO KNOW BEFORE TAKING CLEVER

Do not take CLEVER

  • If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
  • If you have severe hepatic impairment (severely reduced 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

Talk to your doctor or pharmacist before taking CLEVER.

Use CLEVER with caution if:

  • You have a condition that could increase the risk of heart problems, such as long QT syndrome (a disorder affecting the heart's electrical activity that may lead to abnormal heart rhythms) or hypokalaemia (low potassium levels in the blood).
  • You are taking medicines that increase the QT interval.
  • You are taking antifungal azole medications such as ketoconazole and itraconazole, or macrolide antibiotics such as erythromycin (see "Other medicines and CLEVER").
  • You are taking anti-tuberculosis medicines such as rifampicin (see "Other medicines and CLEVER").
  • You have renal impairment (reduced kidney function).
  • You have mild or moderate hepatic impairment (reduced liver function) (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.

Use CLEVER with caution when taken together with:

  • Ketoconazole (an antifungal medicine) or erythromycin (an antibiotic), both known to prolong the QT interval. This combination may increase ebastine blood levels and cause a greater QT interval prolongation than with ketoconazole or erythromycin taken alone (see "Warnings and precautions").
  • Rifampicin (an anti-tuberculosis medicine). This combination may lead to lower blood concentrations of CLEVER and thus reduce its effectiveness.

CLEVER with food and alcohol

Taking ebastine with food does not interfere with its clinical effect.
No interactions between ebastine and 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").

Driving and using machines

Ebastine, at the recommended doses, has not produced negative effects on driving or operating machinery. Nevertheless, assess your response to ebastine before performing complex tasks, as drowsiness and dizziness may occur (see section 4 "Possible side effects").

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

CLEVER 20 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. HOW TO TAKE CLEVER

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Adults and children aged 12 years and over
Allergic rhinitis
The recommended dose is 20 mg taken orally once daily.
In patients with less severe symptoms, a single daily dose of 10 mg is recommended.
Take CLEVER during or apart from meals.
Mild or moderate hepatic impairment
Do not exceed a daily dose 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 daily, no clinically significant signs or symptoms have been observed.
There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions including ECG (electrocardiogram), and symptomatic treatment may be required.
If you have taken an excessive amount of the medicine, contact 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.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur with the use of CLEVER:

Very common adverse reactions (may affect more than 1 in 10 patients)

  • Headache.

Common adverse reactions (may affect up to 1 in 10 patients)

  • Drowsiness.
  • Dry mouth.

Rare adverse reactions (may affect up to 1 in 1,000 patients)

  • Hypersensitivity reactions (such as anaphylaxis and angioedema)
  • Nervousness, insomnia.
  • Dizziness, dysesthesia (sensory disturbance), hypoesthesia (reduced 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 reddening of the skin), dermatitis (skin inflammation).
  • Menstrual disorders.
  • Edema (fluid retention), asthenia (weakness, lack of strength).

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

  • Weight increased
  • Appetite increased

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, 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 stated on the packaging. The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging stored correctly.
Do not store above 30°C.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CLEVER contains
Each film-coated tablet contains:
Active substance: Ebastine 20 mg.
Other components:

  • Core: Microcrystalline cellulose, Lactose, Pregelatinized maize 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, round in shape.
Pack sizes of 5, 10, 15, 20, 30 film-coated 20 mg tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorization 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).

Package leaflet: information for the user

CLEVER 1 mg/ml syrup

Ebastine
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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 CLEVER IS AND WHAT IT IS USED FOR

CLEVER contains the active substance ebastine, a systemic antihistamine (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, with or without associated allergic conjunctivitis.
  • Urticaria (a skin disorder).

2. WHAT YOU NEED TO KNOW BEFORE TAKING CLEVER

Do not take CLEVER

  • If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
  • If you have severe hepatic impairment (reduced 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").

Warnings and precautions

Talk to your doctor or pharmacist before taking CLEVER.
Exercise caution when using CLEVER if:

  • You have a condition that may increase cardiac risk, such as QT interval prolongation syndrome (a disorder affecting the heart's electrical activity that may lead to abnormal heart rhythms) or hypokalaemia (low potassium levels in the blood).
  • You are taking medicines that increase the QT interval.
  • You are taking azole antifungal medicines such as ketoconazole and itraconazole, or macrolide antibiotics such as erythromycin (see "Other medicines and CLEVER").
  • You are taking anti-tuberculosis medicines such as rifampicin (see "Other medicines and CLEVER").
  • You have renal impairment (reduced kidney function).
  • You have mild or moderate hepatic impairment (reduced liver function) (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.
Use CLEVER with caution when taken together with:

  • Ketoconazole (an antifungal medicine) or erythromycin (an antibiotic), both known to prolong the QT interval. This combination may lead to increased levels of ebastine in the blood and a greater prolongation of the QT interval than with ketoconazole or erythromycin alone (see "Warnings and precautions").
  • Rifampicin (an anti-tuberculosis medicine). This combination may result in lower blood concentrations of CLEVER and therefore a reduction in its therapeutic effect.

CLEVER with food and alcohol

Taking ebastine with food does not interfere with its clinical effect.
No interactions between ebastine and 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"). Only 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").

Driving and using machines

Ebastine, at recommended doses, has not produced negative effects on driving or operating machinery. Nevertheless, assess your response to ebastine before performing complex tasks, as somnolence 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 informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before taking this medicine.

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

CLEVER 1 mg/ml syrup contains sodium propyl p-hydroxybenzoate and sodium methyl p-
hydroxybenzoate. These may cause allergic reactions (including delayed reactions) and, very rarely, bronchospasm (a breathing problem).

CLEVER 1 mg/ml syrup contains 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 exactly as directed by 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) taken orally once daily.
In patients with more severe symptoms, including perennial allergic rhinitis, a single daily dose of 20 mg
may provide greater benefit.
Urticaria
The recommended dose is 10 mg (10 ml) taken orally once daily.
Mild to moderate hepatic impairment
Do not exceed a 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) taken orally once daily.
Method of administration
Insert the syringe dosing device into the bottle and draw up the solution to the indicated dose.
Take the syrup orally, either directly or mixed with water, with or without food.
If you take more CLEVER than you should
In studies using high doses of up to 100 mg administered once daily, no clinically significant signs or symptoms were observed.
There is no specific antidote for ebastine. Gastric lavage, monitoring of vital functions, including ECG (electrocardiogram), and symptomatic treatment may be required.
If you have taken an excessive amount of this medicine, contact 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.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The following adverse reactions may occur with the use of CLEVER:

Very common adverse reactions (may affect more than 1 in 10 people)

  • Headache.

Common adverse reactions (may affect up to 1 in 10 people)

  • Drowsiness.
  • Dry mouth.

Rare adverse reactions (may affect up to 1 in 1,000 people)

  • Hypersensitivity reactions (such as anaphylaxis and angioedema)
  • Nervousness, insomnia.
  • Dizziness, dysesthesia (sensory disturbance), hypoesthesia (reduced sensation), dysgeusia (taste disturbance).
  • 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 (hives), rash (sudden reddening of the skin), dermatitis (inflammation of the skin).
  • Menstrual disorders.
  • Edema (fluid retention), asthenia (weakness, lack of strength).

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

  • Weight increased
  • Appetite increased

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse reactions, 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 stated on the packaging. The expiry date refers to the last day of that month and to the product in its original, undamaged packaging, properly stored.
Do not use more than 30 days after first opening.
Store the product in its original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CLEVER contains
1 ml of syrup contains:
Active substance: Ebastine 1 mg
Other components: Glycerol (E422), Liquid sorbitol (E420), Polyoxyl 40 hydrogenated castor oil,
Lactic acid (E270), Sodium methyl p-hydroxybenzoate (E219), Neohesperidin dihydrochalcone (E959),
Sodium propyl p-hydroxybenzoate (E217), Anethole, Dimethicone,
Sodium hydroxide, Purified water.

Description of the appearance of CLEVER and contents of the pack
Syrup, colourless liquid.
120 ml bottle with a 5 ml oral dosing syringe.

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

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