Ebaric

Package leaflet: Information for the user

Ebaric 10 mg orodispersible tablets

Generic medicine.
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 adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ebaric is and what it is used for

Ebaric is a medicine that relieves symptoms of allergic reactions (antiallergic/antihistamine).
Ebaric is used:

• for the treatment of symptoms of seasonal and perennial allergic rhinitis, with or without allergic conjunctivitis.
• to relieve itching and hives in cases of urticaria of unknown origin (urticaria).

2. What you need to know before taking Ebaric

Do not take Ebaric

• if you are allergic to ebastine, menthol (a component of the peppermint flavoring), or any of the other ingredients of this medicine (listed in section 6)
• Ebaric must not be used for the treatment of urticaria in adolescents under 18 years of age, due to limited or no experience in this patient group, and in children under 12 years of age, respectively.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebaric:
Special caution is needed when taking ebastine:

• if you have low levels of potassium in the blood
• if you have certain ECG abnormalities (known QTc interval prolongation on ECG), which may occur in certain heart diseases
• if you are concurrently using certain antibiotics (macrolide antibiotics such as erythromycin) or medicines used to treat fungal infections (antifungals such as ketoconazole or itraconazole) or tuberculosis (e.g. rifampicin)
• if you have severe impairment of liver function (hepatic insufficiency).

In some patients, long-term treatment with ebastine may increase the risk of dental caries due to dry mouth. Therefore, oral hygiene is particularly important.
Other medicines and Ebaric
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant administration of ebastine (the active substance in Ebaric) and certain antibiotics (e.g. erythromycin) or medicines used to treat fungal infections (e.g. ketoconazole or itraconazole) may lead to increased levels of ebastine in the blood. Compared to ketoconazole or erythromycin alone, this may result in more pronounced ECG changes (increase in known QTc interval prolongation by approximately 10 msec).
Concomitant administration of ebastine with rifampicin (active substance for the treatment of tuberculosis) may lead to lower blood levels of ebastine and thus reduce its effects.
No interactions have been observed between ebastine and

• Theophylline (a substance used for the treatment of asthma),
• Warfarin (anticoagulant),
• Cimetidine (a substance used for the treatment of gastric ulcer),
• Diazepam (a substance used for the treatment of anxiety and tension), or
• Alcohol.

Ebaric with food and drinks
When Ebaric is taken with food, the blood concentration of the active metabolite of ebastine (carebastine) increases. However, clinical efficacy is not affected.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
To date, there is no human experience regarding the safety of ebastine for the fetus. Therefore, you should take Ebaric during pregnancy only if your doctor considers that the expected benefit outweighs the potential risk.
Breastfeeding
You must not take Ebaric while breastfeeding, as it is unknown whether the active substance passes into breast milk.
Driving and using machines
Most patients treated with Ebaric can drive and perform other activities requiring good reaction ability. However, to identify sensitive individuals who may experience unusual reactions to Ebaric, you should assess your individual response before driving or performing complex tasks. You may experience drowsiness or dizziness. Please also read section 4. "Possible side effects."
Important information about some components of Ebaric
Ebaric 10 mg tablets contain 0.53 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful in phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
Ebaric contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, i.e. essentially 'sodium-free'.

3. How to take Ebaric

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the usual dose for adults and children aged 12 years and older is:

Indication Age Dose
Allergic rhinitis Children aged 12 years and 1 orodispersible tablet
over (equivalent to 10 mg of
ebastine) once daily
In case of severe symptoms 2 orodispersible tablets
(equivalent to 20 mg of
ebastine) once daily
Perennial allergic rhinitis Children aged 12 years and 1–2 orodispersible tablets
over (equivalent to 10–20 mg of
ebastine) once daily
Urticaria Adults over 18 years of age 1 orodispersible tablet
(equivalent to 10 mg of
ebastine) once daily
In case of severe symptoms 2 orodispersible tablets
(equivalent to 20 mg of
ebastine) once daily

Patients with impaired liver function
No dose adjustment is required in patients with mild to moderate hepatic impairment.
In patients with severe hepatic impairment, the dose of ebastine must not exceed 10 mg.

Patients with impaired kidney function
In patients with impaired renal function, no dose adjustment is necessary for treatment periods up to 5 days.

Method of administration
Ebaric can be taken during meals or independently of meal times.
Remove the tablet from the blister pack immediately before use. Carefully push the orodispersible tablet out of the blister with dry hands and place it on the tongue. The orodispersible tablet will dissolve rapidly in the mouth and can be easily swallowed without water. No water or other liquids are required to take this medicine.

Duration of treatment
Your doctor will determine how long you should take this medicine.
If you feel that the effect of Ebaric is too strong or too weak, speak to your doctor.

If you take more Ebaric than you should
There is no specific antidote for the active substance ebastine.
If you suspect an overdose with Ebaric, inform your doctor. Depending on the severity of intoxication, the doctor will take appropriate measures (monitoring of vital functions, including ECG monitoring with QT interval assessment for at least 24 hours, symptomatic treatment, and gastric lavage), if necessary.

If you forget to take Ebaric
Do not take a double dose to make up for the missed dose. Continue treatment as usual.

If you stop taking Ebaric
If you stop or discontinue treatment prematurely, the typical symptoms of the condition are likely to return soon.

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 everyone will experience them.

Possible side effects

The following side effects have been reported very commonly (may affect more than 1 in 10 people):

• Headache

The following side effects have been reported commonly (may affect up to 1 in 10 people):

• Dry mouth
• Drowsiness

The following side effects have been reported rarely (may affect up to 1 in 1,000 people):

• Allergic reactions (such as anaphylaxis (a severe, life-threatening allergic reaction requiring immediate medical treatment) and swelling, for example of the throat, lips or hands (angioedema))
• General nervousness, insomnia
• Dizziness, reduced sensitivity to touch or sensation, altered sense of taste
• Palpitations, rapid pulse
• Abdominal pain, vomiting, nausea, dyspepsia
• Liver disorders, cholestasis, elevated liver parameters in blood (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin)
• Urticaria, skin rash, skin inflammation
• Menstrual disorders
• Edema (tissue swelling), fatigue

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

• Weight gain
• Increased appetite

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 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 Ebaric

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister pack after "EXP". The expiry date refers to the last day of that month.
Storage precautions
Store the medicine in its original packaging to protect it from light.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ebaric contains

• The active substance is: ebastine. Each orodispersible tablet contains 10 mg of ebastine.
• The other components are: Mannitol (Ph. Eur.), maize starch, anhydrous colloidal silica, sodium stearil fumarate (Ph. Eur.), aspartame (E 951), peppermint flavouring.

Description of the appearance of Ebaric and packaging
Ebaric orodispersible tablets are white and round.
Aluminum-PVC/PVDC blisters.
Available in packages containing 10, 20, 30, 50 and 100 orodispersible tablets.

Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Str. 8 - 10
13435 Berlin, Germany

Manufacturer
Laboratorios Medicamentos Internacionales, S.A.
C/Solana, 26, Torrejón de Ardoz, 28850 Madrid
Spain

Marketing Authorization Holder in Italy
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Ebastin Aristo
Germany: Ebastin Aristo 10 mg Schmelztabletten
Italy: Ebaric
Spain: Ebastine Aristo 10 mg comprimido bucodispersable EFG

Package leaflet: information for the user

Ebaric 20 mg orodispersible tablets

Equivalent medicine
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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ebaric is and what it is used for
2. What you need to know before taking Ebaric
3. How to take Ebaric
4. Possible side effects
5. How to store Ebaric
6. Package contents and other information

1. What Ebaric is and what it is used for

Ebaric is a medicine that relieves symptoms of allergic reactions (antiallergic/antihistamine).
Ebaric is used:

• for the treatment of symptoms of seasonal and perennial allergic rhinitis, with or without allergic conjunctivitis.
• to relieve itching and hives in urticaria of unknown origin (urticaria).

2. What you need to know before taking Ebaric

Do not take Ebaric

• if you are allergic to ebastine, menthol (a component of the peppermint flavour), or to any of the other ingredients of this medicine (listed in section 6).
• Ebaric must not be used for the treatment of urticaria in adolescents under 18 years of age, due to limited or no experience in this patient group, and in children under 12 years of age, respectively.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ebaric:
You need to be cautious when taking ebastine

• if you have low potassium levels in the blood
• if you have certain ECG abnormalities (known QTc interval prolongation on ECG), which may occur in certain forms of heart disease
• if you are concurrently using certain antibiotics (macrolide antibiotics such as erythromycin) or medicines used to treat fungal infections (antifungals such as ketoconazole or itraconazole) or tuberculosis (e.g. rifampicin)
• if you have severe impairment of liver function (hepatic insufficiency).

In some patients, long-term treatment with ebastine may increase the risk of dental caries due to dry mouth. Therefore, oral hygiene is particularly important.
Other medicines and Ebaric
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant administration of ebastine (the active ingredient in Ebaric) and certain antibiotics (e.g. erythromycin) or medicines used to treat fungal infections (e.g. ketoconazole or itraconazole) may result in increased levels of ebastine in the blood. Compared to administration of ketoconazole or erythromycin alone, this may lead to more pronounced ECG changes (increase in known QTc interval prolongation by approximately 10 msec).
Concomitant administration of ebastine with rifampicin (active ingredient for the treatment of tuberculosis) may lead to lower levels of ebastine in the blood and thus reduce its effects.
No interactions have been observed between ebastine and

• Theophylline (a substance used to treat asthma),
• Warfarin (an anticoagulant),
• Cimetidine (a substance used to treat gastric ulcers),
• Diazepam (a substance used to treat anxiety and tension), or
• Alcohol.

Ebaric with food and drinks
When Ebaric is taken with food, the blood concentration of the active metabolite of ebastine (carebastine) increases. However, clinical efficacy is not affected.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
To date, there is no human experience regarding safety for the fetus. Therefore, you should take Ebaric during pregnancy only if your doctor considers that the expected benefit outweighs the potential risk.
Breastfeeding
You must not take Ebaric while breastfeeding, as it is not known whether the active ingredient passes into breast milk.
Driving and using machines
Most patients treated with Ebaric can drive or perform other activities requiring good reaction ability. However, to identify sensitive individuals who may experience unusual reactions to Ebaric, you should assess your individual response before driving or performing complex tasks. You may experience drowsiness or dizziness. Please also read section 4. "Possible side effects"
Important information on some ingredients of Ebaric
Ebaric 20 mg tablets contain 1.06 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful in phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
Ebaric contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, i.e. essentially ‘sodium-free’.

3. How to take Ebaric

Take this medicine exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the usual dose for adults and children aged 12 years and older is:

| Indication | Age | Dose | |----------------|---------|----------| | Allergic rhinitis | Children aged 12 years and older, and adults | 10 mg of ebastine once daily* | | | In case of severe symptoms | 20 mg of ebastine once daily | | Perennial allergic rhinitis | Children aged 12 years and older, and adults | 10–20 mg of ebastine once daily | | Urticaria | Adults aged over 18 years | 10 mg of ebastine once daily* | | | In case of severe symptoms | 20 mg of ebastine once daily |

* For this dosage, Ebaric 10 mg is available.

Patients with impaired liver function
No dose adjustment is required in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of ebastine should not exceed 10 mg.

Patients with impaired renal function
In patients with impaired renal function, no dose adjustment is necessary for treatment periods up to 5 days.

Instructions for use
Ebaric may be taken during meals or independently of meal times.
Remove the tablet from the blister pack immediately before use. Carefully push the orodispersible tablet out of the blister with dry hands and place it on the tongue. The orodispersible tablet will dissolve rapidly in the mouth and can be easily swallowed without water. No water or other liquid is required to take this medicine.

Duration of treatment
Your doctor will determine the duration of therapy.
Contact your doctor if you feel that the effects of Ebaric are too strong or too weak.

If you take more Ebaric than you should
There is no specific antidote for the active substance ebastine.
If you suspect an overdose with Ebaric, inform your doctor. Depending on the severity of intoxication, your doctor will take appropriate measures (monitoring of vital functions, including ECG monitoring with assessment of the QT interval for at least 24 hours, symptomatic treatment, and gastric lavage), if necessary.

If you forget to take Ebaric
Do not take a double dose to make up for the missed dose. Continue treatment as usual.

If you stop taking Ebaric
If you interrupt or discontinue treatment prematurely, the typical symptoms of the condition are likely to return soon.

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 everyone experiences them.

Possible side effects

The following side effects have been reported very commonly (may affect more than 1 in 10 people):

• Headache

The following side effects have been reported commonly (may affect up to 1 in 10 people):

• Dry mouth
• Drowsiness

The following side effects have been reported rarely (may affect up to 1 in 1,000 people):

• Allergic reactions (such as anaphylaxis (a severe, life-threatening allergic reaction requiring immediate medical treatment) and swelling, for example of the throat, lips or hands (angioedema))
• General nervousness, Insomnia
• Dizziness, reduced sensitivity to touch or sensation, altered sense of taste
• Palpitations, Rapid pulse
• Abdominal pain, Vomiting, Nausea, Dyspepsia
• Liver disorders, Cholestasis, Elevated liver parameters in blood (increased transaminases, gamma-GT, alkaline phosphatase and bilirubin)
• Urticaria, Skin rash, Skin inflammation
• Menstrual disorders
• Edema (swelling of tissues), Fatigue

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

• Weight increased
• Appetite increased

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 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 Ebaric

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister pack after "EXP". The expiry date refers to the last day of that month.
Storage precautions
Store the medicine in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater. 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 Ebaric contains
The active substance is: ebastine
One orodispersible tablet contains 20 mg of ebastine.
The other components are:
mannitol (Ph. Eur.), maize starch, anhydrous colloidal silica, sodium stearyl fumarate (Ph. Eur.),
aspartame (E 951), peppermint flavour.

Description of the appearance of Ebaric and the contents of the pack
Ebaric orodispersible tablets are white and round.
Aluminum-PVC/PVDC blisters.
Available in packs of 10, 20, 30, 50 and 100 orodispersible tablets.

Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Str. 8 - 10
13435 Berlin, Germany

Manufacturer
Laboratorios Medicamentos Internacionales, S.A.
C/Solana, 26, Torrejón de Ardoz, 28850 Madrid
Spain

Sales Licensee
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Ebastin Aristo
Germany: Ebastin Aristo 20 mg Schmelztabletten
Italy: Ebaric
Spain: Ebastine Aristo 20 mg comprimido bucodispersable EFG