BILATEC 10 mg Tabletka Orodispersyjna

Treść ulotki

1. BILATEC 10 mg orodispersible tablets
   1. What is BILATEC and what is it used for
   2. What you need to know before taking BILATEC
   3. How to take BILATEC
   4. Possible side effects
   5. How to store BILATEC
   6. Contents of the pack and other information
2. BILATEC 20 mg orodispersible tablets
   1. What is BILATEC and what is it used for
   2. What you need to know before you take BILATEC
   3. How to take BILATEC
   4. Possible side effects
   5. How to store BILATEC
   6. Contents of the pack and other information

BILATEC 10 mg orodispersible tablets

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 you or your child only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you or your child 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 BILATEC is and what it is used for
• 2. What you need to know before you take BILATEC
• 3. How to take BILATEC
• 4. Possible side effects
• 5. How to store BILATEC
• 6. Contents of the pack and other information

1. What is BILATEC and what is it used for

BILATEC contains the active substance bilastine which is an antihistamine.
BILATEC is used to relieve the symptoms of hay fever (sneezing, itching, runny nose,
blocked nose, red, watery eyes) and other forms of allergic rhinitis. It can also be used
for the treatment of itchy skin rashes (such as urticaria).
BILATEC orally disintegrating tablets 10 mg are indicated for children from 6 years of age with a body
weight of at least 20 kg and are also indicated in adults and adolescents.

2. What you need to know before taking BILATEC

Do not take BILATEC

• if you or your child 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 BILATEC if you or your child have
moderate or severe kidney or liver impairment or if you are taking other medicines (see “Other
medicines and BILATEC”).

Children
Do not give this medicine to children under 6 years of age with a body weight less than 20 kg
as sufficient data are not available.

Other medicines and BILATEC
Tell your doctor or pharmacist if you or your child are taking, have recently taken
or might take any other medicines.
Some medicines must not be taken together and others may require an adjustment
of the dose when taken together.
Always tell your doctor or pharmacist if you or your child have recently taken or might
take any of the following medicines in addition to BILATEC:

• Ketoconazole (used to treat Cushing's syndrome, when the body produces an excess of cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of pain or tension in the chest area - angina pectoris)
• 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 (for the treatment of AIDS)
• Rifampicin (an antibiotic)

BILATEC 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:

• take or give the tablet to your child and wait one hour before consuming food or fruit juice or
• if you or your child have consumed food or fruit juice, wait for two hours before taking or giving the tablet. Bilastine, at the recommended dose in adults (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 its
effects on fertility are limited or non-existent.
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you 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 driving ability in adults.
However, the response to the medicine may vary from patient to patient.
Therefore, you should check the effect of the medicine on you or your child before driving,
using machines or riding a bicycle.

BILATEC contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
"sodium-free".

BILATEC contains sulfur dioxide
This medicine contains sulfur dioxide and may rarely cause severe hypersensitivity
reactions and bronchospasm.

3. How to take BILATEC

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

Use in adults and adolescents aged 12 years and over
The recommended dose in adults, including the elderly and adolescents aged 12 years and over, is 20 mg of
bilastine once a day (2 x 10 mg tablets).

Use in children
The recommended dose in children from 6 to 11 years of age with a body weight of at least 20 kg is
10 mg of bilastine once a day. Do not administer this medicine to children under 6
years of age with a body weight less than 20 kg, as sufficient data are not available.

• The tablet is for oral use.
• Place the tablet in your mouth or in your child’s mouth. It will dissolve rapidly with saliva and can be easily swallowed.
• Alternatively, you can dissolve the tablet in a teaspoonful of water before taking it or administering it to your child. You should ensure that no drug residue remains in the teaspoon.
• You must use only water for dispersion, do not use grapefruit juice or other fruit juices.
• The tablet should be taken one hour before or two hours after eating food or drinking fruit juice. See "BILATEC with food, drinks and alcohol".

The duration of treatment depends on the type of illness you or your child suffers from; your doctor
will decide how long you or your child will need to take BILATEC.

If you take more BILATEC than you should
If you or your child have taken an excessive amount of this medicine, contact
your doctor immediately or go to the nearest hospital emergency room. Remember to bring

If you forget to take BILATEC
Do nottake a double dose to make up for a missed tablet.
If you forget to take or administer in time to your child the daily dose, take it or
give it to them on the same day, as soon as you remember. Then, take or administer the next dose on
the following day at the usual time as prescribed by your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

If you stop taking BILATEC
Generally, no after-effects occur when stopping treatment with BILATEC.
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 or your child develop 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 or administering the medicine and contact your doctor immediately.

Side effects that may occur in children are:
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

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 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
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• pruritus
• herpes labialis (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 available data

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

Reporting of side effects
If you or your child gets any side effects, 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 BILATEC

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 waste water 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 BILATEC contains

• The active ingredient is bilastine. Each orodispersible tablet contains 10 mg of bilastine.
• The other ingredients are: Mannitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 “BILATEC contains sodium”), magnesium aluminometasilicate, sucralose, grape flavour (see section 2 “BILATEC contains sulfur dioxide”), magnesium stearate, anhydrous colloidal silica.

Description of the appearance of BILATEC and contents of the pack
BILATEC 10 mg orodispersible tablets are round, biconvex tablets approximately 7.5 mm in diameter, from
white to off-white in colour, from smooth to mottled, with "10" imprinted on one side and smooth on the other side.
The orodispersible tablets are supplied in blisters of 10, 20, 30 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Alfred E. Tiefenbacher (GmbH & Co. KG)
Van-der-Smissen-Strasse 1
22767 Hamburg
Germany
Manufacturer:
Saneca Pharmaceuticals a. s.,
Nitrianska 100, Hlohovec,
Trnava, 920 27, Slovakia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Sweden: Bilatec

BILATEC 20 mg orodispersible tablets

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

1. What is BILATEC and what is it used for

BILATEC contains the active ingredient bilastine which is an antihistamine.
BILATEC is used to relieve the symptoms of hay fever (sneezing, itching, runny nose,
blocked nose, red, watering eyes) and other forms of allergic rhinitis. It can also be used
for the treatment of itchy skin rashes (such as hives).
BILATEC orodispersible tablets 20 mg are indicated in adults and adolescents.

2. What you need to know before you take BILATEC

Do not take BILATEC

• 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 BILATEC if you have moderate or severe kidney
or liver impairment and are taking other medicines (see “Other medicines and BILATEC”).

Children
Do not give this medicine to children under 12 years of age.

Other medicines and BILATEC
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, consult your doctor if you are taking any of the following medicines:

• Ketoconazole (used to treat Cushing's syndrome, when the body produces an excess of cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of pain or tension in the chest area - angina pectoris)
• 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 (for the treatment of AIDS)
• Rifampicin (an antibiotic)

BILATEC 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:

• take the tablet on an empty stomach and wait one hour before consuming food or fruit juice or
• if you have consumed food or fruit juice, wait for two hours before taking the tablet.

Bilastine, at the recommended dose in adults (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 its
effects on fertility are limited or unavailable.
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you 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 you before driving or using machines.

BILATEC contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially
"sodium-free".

BILATEC contains sulphur dioxide
This medicine contains sulphur dioxide and may rarely cause severe hypersensitivity reactions
and bronchospasm.

3. How to take BILATEC

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

Use in children
Other pharmaceutical forms of this medicine - bilastina 10 mg orodispersible tablets or bilastina

• 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 this medicine to children under 6 years of age with a body weight less than 20 kg, as sufficient data are not available.
• The tablet is for oral use.
• Place the tablet in your mouth. It will dissolve rapidly with saliva and can be easily swallowed.
• Alternatively, you can dissolve the tablet in a teaspoon of water before taking it. You should ensure that no drug residue remains in the teaspoon.
• You must use only water for dispersion, do not use grapefruit juice or other fruit juices.
• The tablet should be taken one hour before or two hours after eating food or drinking fruit juice. See "BILATEC with food, drinks and alcohol". Regarding the duration of treatment, your doctor will determine the type of illness you have and decide how long you should take BILATEC.

If you take more BILATEC than you should
If you, or someone else, has taken an excessive amount of this medicine, contact
your doctor or pharmacist immediately or go to the nearest hospital emergency room. You

If you forget to take BILATEC
Do nottake a double dose to make up for a missed tablet.
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 doubts about using this medicine, ask your doctor or pharmacist.

If you stop taking BILATEC
Generally, no adverse effects occur when stopping treatment with BILATEC.
If you have any doubts 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.
If you experience 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

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 (ECG)
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling unwell)
• anxiety
• sensation 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
• dyspnea (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

Side effects that may occur in children are:
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 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 BILATEC

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 BILATEC contains

• The active ingredient is bilastine. Each orodispersible tablet contains 20 mg of bilastine.
• The other ingredients are: Mannitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 “BILATEC contains sodium”), magnesium aluminometasilicate, sucralose, grape flavour (see section 2 “BILATEC contains sulfur dioxide”), magnesium stearate, anhydrous colloidal silica.

Description of the appearance of BILATEC and contents of the pack
BILATEC 20 mg orodispersible tablets are oval, biconvex tablets approximately 10.3 x 5.5 mm in size,
from white to off-white in colour, from smooth to mottled, with "20" imprinted on one side and smooth on the other side.
The orodispersible tablets are supplied in blisters of 10, 20, 30 or 50 tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder:
Alfred E. Tiefenbacher (GmbH & Co. KG)
Van-der-Smissen-Strasse 1
22767 Hamburg
Germany
Manufacturer:
Saneca Pharmaceuticals a. s.,
Nitrianska 100, Hlohovec,
Trnava, 920 27, Slovakia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Sweden: Bilatec