Bilatec

Italy
Brand name Bilatec
Form tablets, orodispersible
Active substance / Dosage
BILASTINE
Prescription type Prescription only
ATC code
R06AX29
Registration number 050321
Manufacturer ALFRED E. TIEFENBACHER GMBH & CO. KG

Table of Contents

PACKAGE LEAFLET

Package leaflet: information for the patient

BILATEC 10 mg orodispersible tablets

Bilastine
Please read this entire 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you or your child only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you or your child experience any side effects, including those not listed in this leaflet, consult 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 taking 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 BILATEC is and what it is used for

BILATEC contains the active substance bilastine, which is an antihistamine.
BILATEC is used to relieve symptoms of hay fever (sneezing, itching, runny nose,
nasal congestion, 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).
BILATEC orodispersible 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 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 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 weighing 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 should not be taken together, and others may require dose adjustments when taken together.
Always inform 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 (used to treat chest pain or pressure—angina pectoris)
  • Cyclosporine (to reduce the activity of the immune system to prevent transplant rejection or to reduce the activity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
  • Ritonavir (used to treat AIDS)
  • Rifampicin (an antibiotic)

BILATEC with food, drinks, and alcohol
These orodispersible tablets must not be taken with food or grapefruit juice or other fruit juices, as this reduces the effect of bilastine. To avoid this, you may:

  • take or administer 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 two hours before taking or administering the tablet.
    Bilastine, at the recommended dose in adults (20 mg), does not increase alcohol-induced drowsiness.

Pregnancy, breastfeeding, and fertility
Data on the use of bilastine in pregnant women and during breastfeeding, and its effects on fertility, are lacking or limited.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It has been shown that 20 mg doses of bilastine do not affect driving ability in adults.
However, individual patient responses to the medicine may vary.
Therefore, you should assess how the medicine affects you or your child before driving, operating machinery, 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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Use in adults and adolescents aged 12 years and older
The recommended dose in adults, including the elderly, and adolescents aged 12 years and older is 20 mg of
bilastine once daily (2 tablets of 10 mg).
Use in children
The recommended dose in children aged 6 to 11 years with a body weight of at least 20 kg is 10 mg of
bilastine once daily. Do not administer this medicine to children under 6 years of age with a body weight
below 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 may dissolve the tablet in a teaspoon of water before taking it or giving it to your child. Make sure no drug residue remains in the teaspoon.
  • Use water only for dispersing the tablet; 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 affecting you or your child; your doctor
will decide how long you or your child should take BILATEC.
If you take more BILATEC than you should
If you or your child has taken an excessive amount of this medicine, contact your doctor immediately or go
to the nearest hospital emergency department. Remember to bring the package or the package leaflet of this medicine with you.
If you forget to take BILATEC
Do not take a double dose to make up for the missed tablet.
If you forget to take or give your child the daily dose on time, take it or give it as soon as you remember, on the same day. Then, take or give the next dose the following day at the usual time, as prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
If you stop taking BILATEC
Generally, no withdrawal effects occur when stopping treatment with BILATEC.
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 everybody gets them.
If you or your child experience symptoms of allergic reactions, which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or skin swelling and redness, 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 pain/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
  • drowsiness

Uncommon: may affect up to 1 in 100 people

  • abnormal electrocardiogram (ECG)
  • blood tests indicating changes in liver function
  • dizziness
  • stomach pain
  • tiredness
  • increased appetite
  • irregular heartbeat
  • weight gain
  • nausea (feeling of vomiting)
  • anxiety
  • sensation of dryness or discomfort in the nose
  • abdominal pain
  • diarrhoea
  • gastritis (inflammation of the stomach lining)
  • vertigo (dizziness)
  • feeling of weakness
  • thirst
  • dyspnoea (difficulty breathing)
  • dry mouth
  • indigestion
  • itching
  • cold sore (oral herpes)
  • fever
  • tinnitus (ringing in the ears)
  • difficulty falling asleep
  • blood tests indicating changes in kidney function
  • increase in blood fats

Frequency not known: cannot be estimated from the available data

  • palpitations (awareness of heartbeat)
  • tachycardia (rapid heartbeat)
  • vomiting

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BILATEC contains

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

Description of the appearance of BILATEC and package contents
BILATEC 10 mg orodispersible tablets are round, biconvex tablets of approximately 7.5 mm, white to off-white, smooth to slightly mottled, with "10" engraved on one side and plain on the other.
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 European Economic Area countries under the following names:
Sweden: Bilatec

Patient information leaflet

BILATEC 20 mg orodispersible tablets

Bilastine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 BILATEC is and what it is used for

BILATEC contains the active substance bilastine, which is an antihistamine.
BILATEC is used to relieve symptoms of hay fever (sneezing, itching, runny nose,
nasal congestion, 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).
BILATEC orodispersible tablets 20 mg are indicated for use in adults and adolescents.

2. What you need to know before taking 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 renal or hepatic 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
Inform 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 chest pain or pressure – angina pectoris)
  • Cyclosporine (to reduce the activity of the immune system 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 AIDS)
  • Rifampicin (an antibiotic)

BILATEC with food, drinks and alcohol
These orodispersible tablets must not be taken with food or grapefruit juice or other fruit juices, as this reduces the effect of bilastine. To avoid this, you may:

  • give the tablet to your child and wait one hour before consuming food or fruit juice, or
  • if food or fruit juice has been consumed, wait two hours before taking the tablet.

Bilastine, at the recommended adult dose (20 mg), does not increase drowsiness caused by alcohol.
Pregnancy, breastfeeding and fertility
Data on the use of bilastine in pregnant women and during breastfeeding, and its effects on fertility, are lacking or limited.
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.
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, individual patient response to the medicine may vary.
Therefore, you should assess how this medicine affects you before driving or operating machinery.
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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose in adults, including elderly and adolescents aged 12 years and older, is 20
mg of bilastine once daily.
Use in children
Other 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. Please consult your doctor or pharmacist.
Do not administer this medicine to children under 6 years of age with a body weight below
20 kg, as sufficient data are not available.

  • The tablet is for oral use.
  • Place the tablet in the mouth. It will dissolve rapidly with saliva and can be easily swallowed.
  • Alternatively, you may dissolve the tablet in a teaspoon of water before taking it. You must ensure that no residue of the medicine 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 food or fruit juice. See "BILATEC with food, beverages and alcohol". Regarding the duration of treatment, your doctor will determine the type of condition 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 department.
Remember to bring the package or the leaflet of this medicine with you.
If you forget to take BILATEC
Do not take a double dose to make up for the forgotten 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 how to use this medicine, consult your doctor or pharmacist.
If you stop taking BILATEC
Generally, no withdrawal effects occur when stopping treatment with BILATEC.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience symptoms of allergic reactions, which may include difficulty breathing,
dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or
skin swelling and redness, 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 indicating changes in liver function
  • dizziness
  • stomach pain
  • fatigue
  • increased appetite
  • irregular heartbeat
  • weight gain
  • nausea (feeling unwell)
  • anxiety
  • dryness or discomfort in the nose
  • abdominal pain
  • diarrhoea
  • gastritis (inflammation of the stomach lining)
  • vertigo (dizzy sensation)
  • feeling weak
  • thirst
  • dyspnoea (difficulty breathing)
  • dry mouth
  • indigestion
  • itching
  • cold sores (oral herpes)
  • fever
  • tinnitus (ringing in the ears)
  • difficulty sleeping
  • blood tests indicating changes in kidney function
  • increased blood lipids

Frequency not known: cannot be estimated based on available data

  • palpitations (awareness of 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 ache (abdominal pain/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 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 BILATEC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What BILATEC contains

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

Description of the appearance of BILATEC and the contents of the pack
BILATEC 20 mg orodispersible tablets are white to off-white, oval, biconvex tablets of approximately 10.3 x 5.5 mm, smooth to slightly mottled, with "20" engraved on one side and plain on the other.
The orodispersible tablets are supplied in blisters containing 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 European Economic Area Member States under the following names:
Sweden: Bilatec