Bilastine amertil

Package leaflet: Information for the user

Bilastyna Amertil, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement within 3 days or if you feel worse, consult your doctor.

Contents of the leaflet:

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

1. What Bilastyna Amertil is and what it is used for

Bilastyna Amertil contains the active substance bilastinum, which has antihistaminic properties.
Bilastyna Amertil is used to relieve symptoms of seasonal allergic rhinitis (sneezing, itching, runny nose, nasal discharge, nasal congestion, red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (blisters or urticaria).
Bilastyna Amertil is indicated for use in adults and adolescents aged 12 years and older.

2. Important information before using Bilastyna Amertil

When not to use Bilastyna Amertil

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

Warnings and precautions
Before starting treatment with Bilastyna Amertil, consult a doctor or pharmacist if the patient has
moderate to severe kidney function impairment, low blood potassium, magnesium or calcium levels,
if the patient has or has had heart rhythm disorders or very slow heartbeat, if the patient is taking
medicines that may affect heart rhythm, or if the patient has or has had an abnormal heart tracing
(known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease
and when taking other medicines (see "Bilastyna Amertil and other medicines").

Children
This medicine must not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.

Bilastyna Amertil and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including
those obtained without a prescription, as well as any medicines the patient plans to take.

In particular, inform your doctor if you are taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (a medicine that reduces immune system activity, used in organ transplant patients or in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic)

Bilastyna Amertil with food, drink and alcohol
Do not take the medicine with food or with grapefruit juice or other fruit juices, as this may reduce
the effectiveness of Bilastyna Amertil. To avoid reduced effectiveness, do one of the following:

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• wait two hours after eating or drinking fruit juice before taking the tablet.

Bilastyna Amertil at the recommended dose (20 mg) does not increase alcohol-induced drowsiness.

Pregnancy, breastfeeding and fertility
There are no data or only limited data on the use of bilastine in pregnant or breastfeeding women,
or on its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor before using this medicine. Always consult a doctor or pharmacist before
taking any medicine.

Driving and using machines
It has been shown that bilastine at a dose of 20 mg does not affect the ability to drive in adults.
However, individual response to treatment may vary.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.

Medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take Bilastyna Amertil

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly individuals, and adolescents aged 12 years and older is: 1 tablet (20 mg) per day.

• Tablet for oral administration.
• The tablet should be taken one hour before or two hours after any meal or drinking fruit juice (see section 2, "Bilastyna Amertil with food, drink and alcohol").
• Swallow the tablet with a glass of water.
• The break line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.

Do not use Bilastyna Amertil for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.
The duration of treatment depends on the type of illness, its duration and course.

Use in children
This medicine should not be given to children under 12 years of age.

Taking more than the recommended dose of Bilastyna Amertil
If more than the recommended dose of Bilastyna Amertil has been taken, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department. Take the medicine package or leaflet with you.

Missed dose of Bilastyna Amertil
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible, then return to taking your regular dose at the usual time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences symptoms of hypersensitivity reactions, including: difficulty breathing,
dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) swelling
and redness of the skin, administration of the medicine should be discontinued and immediate
consultation with a doctor is required (frequency unknown).

Adverse reactions that may occur in adults and adolescents:
Common: occurring in less than 1 in 10 treated patients

• Headache
• Drowsiness

Uncommon: occurring in less than 1 in 100 treated patients

• Abnormal ECG recording
• Blood test abnormalities indicating liver function disorders
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Heart rhythm disturbances
• Weight gain
• Nausea
• Anxiety
• Feeling of dryness or discomfort in the nose
• Abdominal pain
• Diarrhoea
• Gastritis
• Dizziness (dizziness or sensation of spinning)
• Weakness
• Increased thirst
• Dyspnoea (difficulty breathing)
• Dry mouth
• Indigestion
• Itching
• Facial rash
• Fever
• Tinnitus (ringing in the ears)
• Sleep disturbances
• Blood test abnormalities indicating kidney function disorders
• Increased blood lipid levels

Frequency unknown: frequency cannot be estimated from the available data

• Palpitations (sensation of heart pounding)
• Tachycardia (rapid heartbeat)
• Vomiting

Adverse reactions that may occur in children:
Common: occurring in less than 1 in 10 treated patients

• Nasal mucositis (nasal irritation)
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 treated patients

• Eye irritation
• Dizziness
• Loss of consciousness
• Diarrhoea
• Nausea
• Swelling of the lips
• Rash
• Urticaria
• Fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bilastyna Amertil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of 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 Bilastyna Amertil contains

• The active substance is bilastyna. Each tablet contains 20 mg of bilastyna.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Bilastyna Amertil looks like and contents of the pack
Bilastyna Amertil tablets are white or almost white, elongated, biconvex, with an imprint
B20 and a score line on one side.
The tablets are packed in blisters made of Aluminium/Polyamide/Aluminium/PVC or
Aluminium/PVC/PE/PVDC, placed together with the patient leaflet in a cardboard box.
Pack sizes: 10 or 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]
Manufacturer
Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain