AYRINAL 20 mg Coated Tablet

Зміст інструкції

1. AYRINAL 10 mg orodispersible tablets
   1. What is AYRINAL and what is it used for
   2. What you need to know before taking AYRINAL
   3. How to take AYRINAL
   4. Possible side effects
   5. How to store AYRINAL
   6. Contents of the pack and other information
2. AYRINAL 20 MG COMPRESSES
   1. What is AYRINAL and what is it used for
   2. What you need to know before you take AYRINAL
   3. How to take AYRINAL
   4. Possible side effects
   5. How to store AYRINAL
   6. Contents of the pack and other information
3. Ayrinal 20 mg orodispersible tablets
   1. What is Ayrinal and what is it used for?
   2. What you need to know before you use Ayrinal
   3. How to take Ayrinal
   4. How to store Ayrinal
   5. Package Contents and Other Information
4. AYRINAL 2.5 mg/ml oral solution
   1. What is AYRINAL and what is it used for
   2. What you need to know before taking AYRINAL
   3. How to take AYRINAL
   4. Possible side effects
   5. How to store AYRINAL
   6. Package Contents and Other Information
5. Ayrinal 6 mg/ml eye drops, solution
   1. What is Ayrinal and what is it used for
   2. What you need to know before using Ayrinal
   3. How to use Ayrinal
   4. Possible side effects
   5. How to store Ayrinal
   6. Contents of the pack and other information

AYRINAL 10 mg orodispersible tablets

For children aged between 2 and 11 years with a body weight of at least 15 kg.
Bilastine

Read this leaflet carefully before giving this medicine to your child 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 your child. Do not give it to other people, even if they have the same symptoms as your child. It could be harmful.
• If your child gets any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is AYRINAL and what is it used for

AYRINAL contains the active ingredient bilastine which is an antihistamine.
AYRINAL is used to relieve the symptoms of hay fever (sneezing, itching, runny nose,
blocked nose and redness and watering eyes) and other forms of allergic rhinitis. It can also
be used for the treatment of itchy skin rashes (such as urticaria).
AYRINAL 10 mg orodispersible tablets are indicated for children from 2 years to 11 years of
age with a body weight of at least 15 kg.

2. What you need to know before taking AYRINAL

Do not take AYRINAL

• if your child is allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYRINAL if your child has
moderate or severe kidney or liver impairment, if they have low levels of potassium, magnesium, calcium
in the blood, if your child suffers from, or has suffered from, heart rhythm problems or if their
heart rate is very low, if your child is taking medicines that can
affect the heart rhythm, if your child has, or has had, a certain abnormality in the heartbeat (known as QTc prolongation on the electrocardiogram) which can
occur in some forms of heart disease or if they are taking other medicines (see “Other
medicines and AYRINAL”).

Children
Do not give this medicine to children under 2 years of age or with a body weight of less than 15
kg as sufficient data are not available.

Other medicines andAYRINAL
Tell your doctor or pharmacist if your child is taking, has recently taken or
may take any other medicines, including those available without a prescription. Some
medicines must not be taken together and others may require an adjustment of the
dose when taken together.
Tell your doctor or pharmacist if your child has recently taken or may take
any of the following medicines in addition to AYRINAL:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of angina pectoris - chest pain or discomfort)
• Cyclosporine (to reduce the activity of the immune system in order to prevent transplant rejection or to reduce the activity of autoimmune and allergic diseases, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (to treat HIV)
• Rifampicin (an antibiotic)

AYRINAL with food, drinks and alcohol
These orodispersible tablets must notbe taken with food or grapefruit juice or other
fruit juices, as this decreases the effect of bilastine. To avoid this, you can:

• give the orodispersible tablet to your child and wait one hour before the child consumes food or fruit juice, or
• if your child has consumed food or fruit juice, wait for two hours before giving the orodispersible tablet. Bilastine, at the recommended dose in adults (20 mg), does not increase drowsiness caused by alcohol.

Pregnancy, breastfeeding and fertility
This medicine is indicated for use in children from 2 to 11 years of age with a body weight
of at least 15 kg. However, the following information regarding
the safe use of this medicine should be considered. Data relating to the use of bilastine in pregnant women and
during breastfeeding and its effects on fertility are either unavailable or limited.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It has been shown that doses of 20 mg of bilastine do not affect the ability to drive in adults.
However, the response to the medicine by each patient may be different. Therefore, you should
verify the effect of the medicine on your child before allowing them to ride a bicycle or drive
other vehicles or use machinery.

AYRINAL contains ethanol and sodium
This medicine contains 0.0015 mg of alcohol (ethanol) in each orodispersible tablet which is
equivalent to 1 mg/100 g (0.001% p/p). The amount in one orodispersible tablet is equivalent
to less than 0.00004 ml of beer or 0.00002 ml of wine. The small amount of alcohol in this
medicine will not have any noticeable effects.
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet, that is
essentially ‘sodium-free’.

3. How to take AYRINAL

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

Use in children
The recommended dose in children from 2 to 11 years of age with a body weight of at least 15 kg is
10 mg of bilastine (1 orodispersible tablet) once a day for the relief of symptoms
of allergic rhinoconjunctivitis and urticaria.
Do not administer this medicine to children under 2 years of age or with a body weight
less than 15 kg, as sufficient data are not available.
For adults, including the elderly and adolescents 12 years of age and older, the recommended dose is
20 mg of bilastine once a day. For this population of patients, a more appropriate dosage is available
in tablet form, ask your doctor or pharmacist.

• The orodispersible tablet is for oral use.
• Place the orodispersible tablet in your child's mouth. It will dissolve rapidly with saliva and can be easily swallowed.
• Alternatively, you can dissolve the orodispersible tablet in a teaspoon of water before administering it to your child. This is highly recommended in children under 6 years of age as they are prone to inhalation of foreign bodies with tablets. You must ensure that no sediment remains in the teaspoon.
• You must use only water for dispersion, do not use grapefruit juice or other fruit juices.
• You must administer the orodispersible tablet to your child one hour before or two hours after the child has taken food or fruit juice.

The duration of treatment depends on the type of illness your child suffers from, the doctor
will decide how long the child will need to take AYRINAL.

If you use more AYRINAL than you should
If your child, or someone else, has taken an excessive amount of this medicine, contact
your doctor immediately or go to the emergency room of the nearest hospital. Remember to

If you forget to use AYRINAL
If you forget to administer the daily dose to your child on time, give it to them on the same
day as soon as you remember. Then, administer the next dose the following day at the usual time
as prescribed by the doctor.
In any case, do not administer a double dose to compensate for forgetting the tablet.

If you stop using AYRINAL
Generally, no side effects occur when treatment with AYRINAL is stopped.
If you have any doubts 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.
If the child shows symptoms of allergic reactions, the signs of which may include difficulty
breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or
throat and/or swelling and redness of the skin, stop administering the medicine and
contact a doctor immediately.

Other side effects that may occur in children are:
Common: may affect up to 1 in 10 patients

• allergic conjunctivitis (eye irritation)
• headache

Uncommon: may affect up to 1 in 100 patients

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling of vomiting)
• swelling of the lips
• eczema
• urticaria
• fatigue
• rhinitis (nasal irritation)
• stomach pain (abdominal/upper abdominal pain)

The side effects that may occur in adults and adolescents are:
Common: may affect up to 1 in 10 patients

• headache
• drowsiness Uncommon: may affect up to 1 in 100 patients
• abnormal electrocardiogram (ECG)
• blood tests indicating changes in liver function
• dizziness
• stomach pains
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling of vomiting)
• anxiety
• feeling of dryness or discomfort in the nose
• stomach ache
• diarrhoea
• gastritis (inflammation of the stomach wall)
• vertigo (feeling of dizziness)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores (oral herpes)
• fever
• tinnitus (ringing in the ears)
• difficulty falling asleep
• blood tests indicating changes in kidney function
• increased fats in the blood Frequency not known: cannot be estimated based on available data
• palpitations (feeling the heartbeat)
• tachycardia (fast heartbeat)
• Vomiting

Reporting of side effects
If your child experiences any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects directly
through 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 AYRINAL

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 package and on the blister after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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 AYRINAL contains

• The active ingredient is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
• The other excipients are mannitol (E421), sodium croscarmellose, sodium stearyl fumarate, sucralose (E955), red grape flavour (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool)

Description of the appearance ofAYRINAL and contents of the pack
AYRINAL orodispersible tablets are round, slightly biconvex, white in colour and
8 mm in diameter.
The orodispersible tablets are supplied in blisters of 10, 20, 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 - Luxembourg

Sales Concessionaire
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l’Ema, 7 – Loc. Ponte a Ema, Bagno a Ripoli – Florence

Manufacturer
Faes Farma S.A.
Máximo Aguirre, 14 48940
Leioa (Vizcaya)
Spain
Or
A.Menarini Manufacturing Logistics and Services S.r.l.
Campo di Pile
L’Aquila
Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Germany: Bitosen 10 mg melt tablets
Italy: Ayrinal 10 mg orodispersible tablets

AYRINAL 20 MG COMPRESSES

Bilastine

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

1. What is AYRINAL and what is it used for

AYRINAL contains the active ingredient bilastine which is an antihistamine. AYRINAL is used
to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose and red and watery eyes) and other forms of allergic rhinitis. It can also
be used for the treatment of itchy skin rashes (such as urticaria).

2. What you need to know before you take AYRINAL

Do not take AYRINAL:
if you are allergic to bilastine or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYRINAL if you have moderate or severe kidney impairment, if you have low levels of potassium, magnesium, calcium in the blood, if you suffer from,
or have suffered from, heart rhythm problems or if your heart rate is very slow, if
you are taking medicines that can affect the heart rhythm, if you have, or have had, a
certain abnormality of the heartbeat (known as prolongation of the QTc interval
on the electrocardiogram) which can occur in some forms of heart disease and are
taking other medicines (see “Other medicines and AYRINAL”).

Children
AYRINAL should not be taken by children under 12 years of age.
Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and AYRINAL
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
In particular, consult your doctor if you are taking any of the following medicines:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of angina)
• Cyclosporine (to reduce the activity of the immune system to prevent rejection after transplantation or to reduce the activity of autoimmune and allergic diseases, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (to treat HIV)
• Rifampicin (an antibiotic) AYRINAL with food, drinks and alcoholThe tablets must notbe taken with food or with grapefruit juice or other fruit juices,as this decreases the effect of bilastine. To avoid this happening, you can:
• take the tablet and wait one hour before consuming food or fruit juices;
• if you have consumed food or fruit juices, wait for two hours before taking the tablet. Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.

Pregnancy, breastfeeding and fertility
Data relating to the use of bilastine in pregnant women and during breastfeeding and data
relating to the effects of bilastine on fertility are limited or unavailable.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Doses of 20 mg of bilastine have been shown not to impair the ability to drive in
adults. However, the response to the medicine by each patient may be different.
Therefore, it is important to check the effect of the medicine on yourself before driving or operating machinery.

AYRINAL contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially ‘sodium-free’.

3. How to take AYRINAL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, contact your doctor or pharmacist.
The recommended dose in adults, including the elderly and adolescents aged 12 years and over,
is 1 tablet (20 mg) per day.
The tablet is for oral use.

• The tablet should be taken one hour before or two hours after you have taken food or fruit juice (see paragraph 2, “AYRINAL with food, beverages and alcohol”).
• a. Swallow the tablet with a glass of water.
• b. The dividing line is present only to help you break the tablet if you have difficulty swallowing it whole. Regarding the duration of treatment, the doctor will establish the type of illness you suffer from and decide how long you should take AYRINAL. Use in childrenOther pharmaceutical forms of this medicine – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution – may be more suitable for children aged 6 to 11 years with a body weight of at least 20 kg, ask your doctor or pharmacist. Do not administer bilastine to children under 6 years of age with a body weightless than 20 kg, as sufficient data are not available.If you take more AYRINAL than you shouldIf you, or someone else, has taken an excessive amount of AYRINAL, contact immediatelyyour doctor or pharmacist or go to the emergency room of the nearest hospital.

If you forget to take AYRINAL
Do nottake a double dose to make up for a missed dose.
If you forget to take a dose, take it as soon as possible and then return to your regular
dosing schedule.
If you have any questions 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.
If you notice symptoms of allergic reactions, the signs of which may include difficulty
breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or
throat and/or swelling and redness of the skin, stop taking the
medicine and contact your doctor immediately.

Other side effects that may occur in adults and adolescents are the
following:
Common: may affect up to 1 in 10 people

• headache
• drowsiness Uncommon: may affect up to 1 in 100 people
• abnormal electrocardiogram (ECG)
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling of wanting to vomit)
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of spinning)
• feeling of weakness
• thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores (oral herpes)
• fever
• tinnitus (ringing in the ears)
• difficulty falling asleep
• blood tests showing changes in kidney function
• increased fats in the blood Frequency not known: cannot be estimated from the available data
• palpitations (feeling the heartbeat)
• tachycardia (fast heartbeat)
• Vomiting

The side effects that may occur in children are as follows:
Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling unwell)
• swelling of the lips
• eczema
• urticaria
• fatigue

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 AYRINAL

Keep this medicine out of the sight and reach of children.
Do not use AYRINAL beyond the expiry date which is reported on the box and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What AYRINAL contains:

• The active ingredient is bilastine. Each tablet contains 20 mg of bilastine.
• The excipients are microcrystalline cellulose, sodium starch glycolate type A (derived from potatoes), anhydrous colloidal silica, magnesium stearate. Description of the appearance of AYRINAL and contents of the packAYRINAL tablets are white, oval, biconvex and with a score line (length 10 mm, width 5 mm). The tablets are supplied in blisters of 10, 20, 30, 40 or 50 tablets. Not all pack sizes may be marketed. Marketing authorisation holder and manufacturerMarketing authorisation holderMenarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 - Luxembourg Sales representativeMalesci Istituto Farmacobiologico S.p.A. Via Lungo l’Ema, 7 - Loc. Ponte a Ema, Bagno a Ripoli - Florence ManufacturerFaes Farma S.A. Máximo Aguirre, 14 48940 Leioa (Vizcaya) Spain O A.Menarini Manufacturing Logistics and Services S.r.l. Campo di Pile L’Aquila Italy O Menarini - Von Heyden GmbH

Leipziger Strasse 7-13; 01097
Dresda
Germany

This medicinal product is authorised in the Member States of the European Economic Area
under the following designations:
Germany: Bitosen 20 mg Tablets
Italy: Ayrinal 20 mg Tablets

Ayrinal 20 mg orodispersible tablets

Bilastine
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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What is Ayrinal and what is it used for?

Ayrinal contains the active ingredient bilastine which is an antihistamine.
Ayrinal is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose, redness and watering eyes) and other forms of allergic rhinitis. It can also
be used for the treatment of itchy skin rashes (such as hives).

4. What you need to know before you use Ayrinal

Do not take Ayrinal:
if you are allergic to bilastine or to any of the other ingredients of this medicine (listed
in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ayrinal if you have moderate or severe kidney impairment, if you have low levels of potassium, magnesium, calcium in the blood, if you suffer from, or have
suffered from, heart rhythm problems or if your heart rate is very low, if you are
taking medicines that can affect the heart rhythm, if you have, or have had, a certain
abnormality of the heartbeat (known as prolongation of the QTc
interval on the electrocardiogram) which can occur in some forms of heart disease and if you are also
taking other medicines (see "Other medicines and Ayrinal").

Children
Do not give this medicine to children under the age of 12 years.
Donot exceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Ayrinal
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina pectoris - chest pain or tightness)
• Cyclosporine (to reduce the activity of the immune system, thus preventing rejection of a transplant or reducing the activity of the disease in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (to treat AIDS)
• Rifampicin (an antibiotic)

Ayrinal with food, drinks and alcohol
These orodispersible tablets should notbe taken with grapefruit juice or
other fruit juices, as this decreases the effect of bilastine. To avoid this happening,
you can:

• take the orodispersible tablet and wait one hour before taking food or fruit juice, or
• if you have consumed food or fruit juice, wait two hours before taking the orodispersible tablet. Bilastine, at the recommended dose (20 mg), does not increase drowsiness caused by alcohol.

Pregnancy, breastfeeding and fertility
Data relating to the use of bilastine in pregnant women and during breastfeeding and
on effects on fertility are limited or unavailable.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It has been shown that bilastine 20 mg does not affect driving ability in adults. However,
the response to the medicine of each patient may be different. Therefore, you should check how
this medicine affects you before driving vehicles or using machines.

Ayrinal contains sodium and ethanol
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet, i.e.
essentially "sodium-free".
This medicine contains 0.0030 mg of alcohol (ethanol) in each orodispersible tablet,
equivalent to 1.6 mg/100 g (0.0016% p/p). The amount in one orodispersible tablet weighing
185 mg is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol contained in this medicine has no noticeable effects.

5. How to take Ayrinal

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, contact your doctor or pharmacist.
The recommended dose in adults, including the elderly and adolescents aged 12 years or
over, is 1 orally disintegrating tablet (bilastine 20 mg) once a day.

• The orally disintegrating tablet is for oral use.
• Place the orally disintegrating tablet in your mouth. It will dissolve rapidly in saliva and can then be swallowed easily.
• Alternatively, you can dissolve the orally disintegrating tablet in water before taking it.
• For dispersion use only water,not grapefruit juice or other fruit juices.
• You should take the orally disintegrating tablet one hour before or two hours after taking any food or fruit juice (see section 2, "Ayrinal with food, drinks and alcohol").

Regarding the duration of treatment, the doctor will determine the type of disease you are
suffering from and decide how long you should take Ayrinal.

Use in children
Other pharmaceutical forms of this medicine - bilastine 10 mg orally disintegrating tablets or
bilastine 2.5 mg/ml oral solution - may be more suitable for children from 6 to 11 years of
age with a body weight of at least 20 kg - ask your doctor or pharmacist.

Do not administer bilastine to children under 6 years of age with a body weight of less than
20 kg, as sufficient data are not available.
If you take more Ayrinal than you should
If you or anyone else has taken too many Ayrinal orally disintegrating tablets, contact

immediatelyyour doctor or pharmacist or go to the emergency room of the nearest hospital.

If you forget to take Ayrinal
Do not take a double dose to make up for the missed dose.
If you forget to take a dose, take it as soon as possible and then return to your normal dosing
schedule.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

If you stop taking Ayrinal
Generally, there are no effects due to stopping treatment with Ayrinal.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

• 6. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
Stop taking the medicine and go to the emergency room immediately if
you experience symptoms of an allergic reaction, the signs of which may include difficulty breathing,
dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or
swelling and redness of the skin.

Other side effects that may occur in adults and adolescents are:
Common: may affect up to 1 in 10 people

• Headache
• drowsiness Uncommon: may affect up to 1 in 100 people
• Abnormal electrocardiogram
• blood tests indicating changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• increased body weight
• nausea (feeling unwell)
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach wall)
• vertigo (feeling of dizziness)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• herpes labialis (oral herpes)
• fever
• tinnitus (ringing in the ears)
• difficulty falling asleep
• blood tests indicating changes in kidney function
• increased fats in the blood

Frequency not known: cannot be estimated from the available data

• palpitations (feeling your heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Side effects that may occur in children are:
Common: may affect up to 1 in 10 people

• Rhinitis (nasal irritation)
• allergic conjunctivitis (eye inflammation caused by an allergic reaction)
• headache
• stomach pain (abdominal pain/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• Eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling unwell)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. 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.

7. How to store Ayrinal

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 box and on the blister after
“EXP”. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
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.

8. Package Contents and Other Information

What the package containsAyrinal

• The active ingredient is bilastine. Each orodispersible tablet contains 20 mg of bilastine.
• The excipients are mannitol (E421), sodium croscarmellose, sodium stearyl fumarate, sucralose (E955), red grape flavour (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, d-limonene, linalool)

Description of the appearance of Ayrinal and package contents
Ayrinal orodispersible tablets are round, flat, white, with "20" imprinted on one side and
a diameter of 8 mm.
Ayrinal is available in divisible blisters for single doses of 10, 20, 30, 40 or 50 orodispersible
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1 Avenue de la Gare
L-1611
Luxembourg
Marketing Authorisation Holder:
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l’Ema 7
Loc. Ponte a Ema, Bagno a Ripoli
Firenze

Manufacturer
Faes Farma S.A.
Máximo Aguirre 14, 48940,
Leioa (Vizcaya)
Spain

This medicinal product is authorised in the Member States of the European Economic Areawith the
following denominations:
Germany: Bitosen 20 mg Schmelztabletten
Italy: Ayrinal 20 mg orodispersible tablets

AYRINAL 2.5 mg/ml oral solution

For children aged between 2 and 11 years with a body weight of at least 15 kg.
Bilastine

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 your child. Do not give it to other people, as it may be dangerous even if their symptoms are the same as those of your child.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

3. What is AYRINAL and what is it used for

AYRINAL contains the active ingredient bilastine which is an antihistamine.
AYRINAL is used to relieve the symptoms of hay fever (sneezing, itching, runny nose,
blocked nose and redness and watery eyes) and other forms of allergic rhinitis. It can also
be used for the treatment of itchy skin rashes (such as urticaria).
AYRINAL 2.5 mg/ml oral solution is indicated for children from 2 years to 11 years of age with a
body weight of at least 15 kg.

4. What you need to know before taking AYRINAL

Do not use AYRINAL

• if your child is allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking AYRINAL if your child has
moderate or severe kidney or liver impairment, if they have low levels of potassium, magnesium, calcium
in the blood, if your child suffers from, or has suffered from, heart rhythm problems or if their
heart rate is very slow, if your child is taking medicines that can
affect the heart rhythm, if your child has, or has had, a certain heart rhythm abnormality (known as QTc interval prolongation on the electrocardiogram) which can
occur in some forms of heart disease or if they are taking other medicines (see "Other
medicines and AYRINAL").

Children
Do not give this medicine to children under 2 years of age or weighing less than 15
kg as sufficient data are not available.

Other medicines and AYRINAL
Tell your doctor or pharmacist if your child is taking, has recently taken or
may take any other medicines, including those available without a prescription. Some
medicines must not be taken together and others may require an adjustment of the
dose when taken together.
Tell your doctor or pharmacist if your child has recently taken or may take
any of the following medicines in addition to AYRINAL:

• Ketoconazole (an antifungal medicine)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of angina pectoris - chest pain or tightness)
• Cyclosporine (to reduce the activity of the immune system to prevent rejection after a transplant or to reduce the activity of autoimmune and allergic diseases, such as psoriasis, atopic dermatitis or rheumatoid arthritis)
• Ritonavir (to treat HIV)
• Rifampicin (an antibiotic)

AYRINAL with food, drinks and alcohol
The oral solution must notbe taken with food or grapefruit juice or other fruit juices,
as this decreases the effect of bilastine. To avoid this, you can:

• give the oral solution to your child and wait one hour before the child consumes food or fruit juice or
• if your child has consumed food or fruit juice, wait for two hours before giving the oral solution. Bilastine, at the recommended dose in adults (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding and fertility
This medicine is indicated for use in children from 2 to 11 years of age with a
body weight of at least 15 kg. However, the following information regarding the safe use of this medicine should be considered. Data relating to the use of bilastine in
pregnant women and during breastfeeding and its effects on fertility are limited or
unavailable.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It has been shown that doses of 20 mg of bilastine do not affect the ability to drive in adults.
However, the response to the medicine by each patient may be different. Therefore, you should
check the effect of the medicine on your child before allowing them to ride a bicycle or drive
other vehicles or use machines.

AYRINAL contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
which may cause allergic reactions (possibly delayed).

AYRINAL contains ethanol and sodium
This medicine contains 0.44 mg of alcohol (ethanol) per dose (4mL) which is equivalent to 11
mg/100 mL (0.011% v/v). The amount in 4 mL of this medicine is equivalent to less than 0.02
ml of beer or 0.005 ml of wine. The small amount of alcohol in this medicine will not produce significant
effects.
This medicine contains less than 1 mmol of sodium (23 mg) per 4 ml, i.e. essentially ‘sodium-free’.

5. How to take AYRINAL

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

Use in children
The recommended dose in children from 2 to 11 years of age with a body weight of at least 15 kg is
10 mg of bilastine (4 ml of oral solution) once a day to relieve the symptoms of
allergic rhinoconjunctivitis and urticaria.
Do not administer this medicine to children under 2 years of age or with a body weight
less than 15 kg as sufficient data are not available.
For adults, including the elderly and adolescents from 12 years of age and over, the recommended dose is
20 mg of bilastine once a day. For this patient population, a more appropriate dosage is available
in tablet form, ask your doctor or pharmacist.

• The oral solution is for oral use
• The bottle of oral solution is equipped with a child-resistant cap and must be opened as follows: press the plastic cap down and rotate it counterclockwise at the same time.
• The oral solution comes with a measuring cup for dosage with a demarcation mark for 4 ml (=10 mg of bilastine per dose), which will help to dose the oral solution correctly
• Fill the measuring cup with 4 ml of oral solution
• Administer directly from the measuring cup
• Wash the measuring cup after use
• You must administer the oral solution to your child one hour before or two hours after the child has taken food or fruit juice.

The duration of treatment depends on the type of illness your child suffers from, the doctor
will decide how long your child will need to take AYRINAL.

If you use more AYRINALthan you should
If your child, or someone else, has taken an excessive amount of this medicine, contact
your doctor immediately or go to the emergency room of the nearest hospital. Remember to

If you forget to use AYRINAL
If you forget to administer the daily dose to your child on time, give it to him on the same
day, as soon as you remember. Then, administer the next dose the following day at the usual
time as prescribed by the doctor.
In any case, do not administer a double dose to compensate for forgetting the dose.

If you stop using AYRINAL
Generally, no side effects occur when treatment with AYRINAL is stopped.
If you have any further questions 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.
If the child shows symptoms of allergic reactions, the signs of which may include difficulty
breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or
throat and/or swelling and redness of the skin, stop giving the medicine and
contact a doctor immediately.

Other side effects that may occur in children are:
Common: may affect up to 1 in 10 people

• allergic conjunctivitis (eye irritation)
• headache

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria
• fatigue
• rhinitis (nasal irritation)
• stomach pain (abdominal/upper abdominal pain)

Side effects that may occur in adults and adolescents are:
Common: may affect up to 1 in 10 people

• headache
• somnolence Uncommon: may affect up to 1 in 100 people
• abnormal electrocardiogram (ECG)
• blood tests showing changes in liver function
• dizziness
• stomach pains
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• feeling of dryness or discomfort in the nose
• stomach ache
• diarrhoea
• gastritis (inflammation of the stomach wall)
• vertigo (a feeling of dizziness)
• feeling weak
• thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores (oral herpes)
• fever
• tinnitus (ringing in the ears)
• difficulty falling asleep
• blood tests showing changes in kidney function
• increased fats in the blood

Frequency not known: cannot be estimated from the available data

• palpitations (feeling your heartbeat)
• tachycardia (fast heartbeat)
• Vomiting

Reporting of side effects
If your child gets any side effect, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly through 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 AYRINAL

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 package and the bottle after
EXP. The expiry date refers to the last day of that month.
Do not store at temperatures above 30°C.
The period of validity after first opening is 6 months.
Do not use this medicine if you notice any visible signs of particles.
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 AYRINAL contains

• The active ingredient is bilastine. One millilitre of oral solution contains 2.5 mg of bilastine.
• The other excipients are Betadex (E459), hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sucralose (E955), raspberry flavour (main components: ethanol, triacetin, water, ethyl butyrate, linalyl acetate, hydrochloric acid 37% or 10% (for pH adjustment), sodium hydroxide (for pH adjustment), purified water.

Description of the appearance ofAYRINALand package contents
AYRINAL oral solution is a clear, colourless, slightly viscous aqueous solution, with
pH 3.0-4.0, without precipitate.
AYRINAL 2.5 mg/ml oral solution is packaged in an amber glass bottle, sealed with
an aluminium screw cap or with a cap, in polypropylene, with a child-resistant closure with
included a 15 or 25 ml measuring cup for dosing with a demarcation mark for 4 ml.
Each bottle contains 120 ml of oral solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 - Luxembourg

Sales Concessionaire
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l’Ema, 7 – Loc. Ponte a Ema, Bagno a Ripoli - Florence

Manufacturer
Faes Farma, S.A.
Parque Científico y Tecnológico de Bizkaia, Ibaizabal Bidea, Edificio 901, 48160 Derio (Bizkaia),
Spain
Or
Berlin-Chemie AG
Glienicker Weg 125; D-12489 Berlin, Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
Germany: Bitosen 2.5 mg/ml Solution for Oral Use
Italy: Ayrinal 2.5 mg/ml oral solution

Ayrinal 6 mg/ml eye drops, solution

bilastine

Read this leaflet carefully before you use 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 Ayrinal is and what it is used for
• 2. What you need to know before you use Ayrinal
• 3. How to use Ayrinal
• 4. Possible side effects
• 5. How to store Ayrinal
• 6. Contents of the pack and other information

1. What is Ayrinal and what is it used for

This medicine contains bilastine, which belongs to a group of medicines called antihistamines.
Antihistamines work by preventing the effects of a substance called histamine which the body
produces as part of an allergic reaction.
This medicine is used to treat the signs and symptoms of eye disorders that manifest
with seasonal allergic conjunctivitisin adults and children aged 2 years and over.
This medicine is also used for the treatment of signs and symptoms of eye disorders caused by
an allergy to substances such as dust mites or animal hair (perennial allergic
conjunctivitis)in adults and children aged 2 years and over.

2. What you need to know before using Ayrinal

Do not use Ayrinal

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

Warnings and precautions
Consult your doctor or pharmacist before using Ayrinal if, during treatment, you experience
undesirable effects, such as eye irritation, pain, redness or changes in vision, or if your
condition worsens. It may be necessary to stop treatment.
After instilling the Ayrinal antiallergic eye drops into the conjunctival sac of the eye,
visual acuity may worsen for a few minutes due to the formation of streaks.
In case of inflammation, including allergic conjunctivitis, ask your ophthalmologist if you can
wear contact lenses despite the symptoms.

Children and adolescents
Ayrinal is indicated for adults and children aged 2 years and over.
Do not administer this medicine to children under 2 years of age, because efficacy and
safety in these populations have not been studied.

Other medicines and Ayrinal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are using other medicines for ocular use, allow at least 5 minutes to pass between one medicine and
the other. Ophthalmic ointments should be administered last.

Pregnancy, breastfeeding and fertility
Ayrinal can be used during pregnancy and breastfeeding. If you are pregnant, suspect or are planning a
pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Temporary blurred vision or other visual disturbances that affect the ability to drive or operate machinery may occur after instillation of this medicine. Please wait
until your vision clears before driving or using machinery.

Contact lenses
The use of this medicine does not alter the properties of contact lenses. You can continue to wear
contact lenses while using this medicine.
Remove contact lenses before use and do not reinsert them until at least 15 minutes after
administration of the eye drops.

3. How to use Ayrinal

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adults and for children aged 2 years or older is one drop in
each affected eye/eyes once a day.
This medicine can be used for a maximum of 8 weeks. Your doctor will decide and
advise how long you should use it based on your condition.
For ocular use only.

Method of administration

• 1. Always wash your hands and dry them with a clean towel before administering this medicine.
• 2. Gently clean the eyelids if they are encrusted with discharge by rubbing the eyelid from the inner corner to the outer corner with your eye closed, using a cotton wool ball moistened with warm water .
• 3. Open the bottle and avoid touching the eye or anything else with the tip of the dropper: eye drops and droppers must be kept clean.
• 4. Tilt your head back or lie down and look up (Figure 1). With a finger, gently pull down the lower eyelid (Figure 2).
• 5. Look up and instill one drop of eye drops into the eye.
• 6. Release the lower eyelid and keep your eye closed for a few moments so that the drop spreads over the ocular surface (Figure 3).
• 7. Repeat the above for the other eye, if necessary.

To avoid contamination during use of this medicine, do not touch any surface
(eyelids, areas around the eye or other surfaces) with the tip of the dropper and, after use,
wipe the tip with a clean cloth to remove any residual liquid.

If you use more Ayrinal than you should
You can rinse with warm water .

If you forget to use Ayrinal
Do not use a double dose to make up for a missed dose.
If you forget to apply the drop in time, apply the forgotten drop as soon as possible and
then return to your normal dosing schedule.

If you stop using Ayrinal
Treatment with this medicine should be carried out regularly, if possible, until
symptom relief is achieved. If you stop using Ayrinal while still exposed
to the allergen (or allergens), you should expect typical allergic symptoms to return.
If you have any questions about using 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.
The following side effects have been reported.
Uncommon side effects (may affect up to 1 in 100 people):
Altered sense of taste (dysgeusia), headache.
Dry eye, eye secretion, eye irritation, increased tearing, eye discomfort.
If you experience any of the side effects described above, stop using this
medicine and consult your doctor directly. The mentioned side effects are usually mild and
disappear quickly in all cases. Therefore, no specific measures are necessary.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Ayrinal

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 label or the packaging after
Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.

After the first opening of the bottle:do not use this medicine if the bottle has been opened for more
than 2 months.
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 pack and other information

What Ayrinal contains

• The active ingredient is bilastine 6 mg/ml. One drop contains 0.2 mg of bilastine.
• The other ingredients are hydroxypropyl β-cyclodextrin, methylcellulose, sodium hyaluronate, glycerol (E 422), sodium hydroxide 1 N (for pH adjustment), water for injections.

Description of the appearance of Ayrinal and contents of the pack
The contents of the Ayrinal eye drops are clear and colorless, contained in a white low-density polyethylene multidose bottle containing 5 ml of preservative-free solution, with a white high-density polyethylene dropper with a tamper-evident cap.
Pack sizes: 1 bottle of 5 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 - Luxembourg

Sales Concessionaire
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo l’Ema, 7 – Loc. Ponte a Ema, Bagno a Ripoli - Florence

Manufacturer
FAMAR Health Care Services Madrid S.A.U.
Avenida de Leganés 62, 28923
Alcorcón,
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following denominations:
Germany: Bitosen 6 mg/ml Augentropfen, Lösung
Italy: Ayrinal 6 mg/ml eye drops, solution