PACKAGE LEAFLET: INFORMATION FOR

THE USER
Bilastina Pensa 20 mg
tablets
Bilastina
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any doubts, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BILASTINA PENSA is and what it is used for
What you need to know before taking BILASTINA PENSA
How to take BILASTINA PENSA
Possible side effects
How to store BILASTINA PENSA
Contents of the pack and other information

1. What BILASTINA PENSA is and what it is used for

BILASTINA PENSA contains the active substance bilastine, which is an antihistamine. BILASTINA PENSA is used to relieve symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, and eye redness and watering) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (such as urticaria).

2. What you need to know before taking BILASTINA PENSA

Do not take BILASTINA PENSA:

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 BILASTINA PENSA if you have moderate or severe renal impairment and are taking other medicines (see “Other medicines and BILASTINA PENSA”).
Children
BILASTINA PENSA must not be taken by children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and BILASTINA PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring 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 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)

BILASTINA PENSA with food, drinks and alcohol
The 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 the tablet and wait one hour before consuming food or fruit juice;
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 alcohol-induced drowsiness.
Pregnancy, breastfeeding and fertility
Data on the use of bilastine in pregnant and breastfeeding women, as well as data on the effects of bilastine on fertility, are unavailable or limited.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any 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 response to the medicine may vary. Therefore, it is important to assess how this medicine affects you personally before driving or operating machinery.

3. How to take BILASTINA PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults, including elderly patients and adolescents aged 12 years and older, is 1 tablet (20 mg) once daily.

The tablet is for oral use.
The tablet should be taken one hour before or two hours after eating food or drinking fruit juice (see section 2, “BILASTINA PENSA with food, drinks and alcohol”).
Swallow the tablet with a glass of water.

Regarding the duration of treatment, your doctor will determine the type of illness you have and decide how long you should take BILASTINA PENSA.
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.
If you take more BILASTINA PENSA than you should
If you or someone else has taken an excessive amount of BILASTINA PENSA, 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 BILASTINA PENSA
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 continue with your regular dosing schedule.
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.
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 indicating changes in liver function
dizziness
stomach pain
fatigue
increased appetite
irregular heartbeat
increase in body weight
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 dizziness)
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 indicating changes in kidney function
increase in blood lipids

Frequency not known: cannot be estimated from the available data

palpitations (awareness of heart beat)
tachycardia (fast heartbeat)
allergic reactions, the signs of which may include breathing difficulties, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or skin swelling and redness. If you notice any of these serious side effects, stop taking the medicine and contact your doctor immediately.
Vomiting

Side effects that may occur in children are the following:
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

Reporting of side effects
If you get 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:
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.

How to store BILASTINA PENSA

Keep this medicine out of the sight and reach of children.
Do not use BILASTINA PENSA after the expiry date which is 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 BILASTINA PENSA contains:
The active substance is bilastine. Each tablet contains 20 mg of bilastine (as monohydrate).
The excipients are microcrystalline cellulose grade 102, crospovidone type A, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of BILASTINA PENSA and package contents:
BILASTINA PENSA tablets are round and white in colour.
The tablets are supplied in blisters of 20 tablets.

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturer
J. URIACH y Compañía, S.A.
Avenida Camí Reial, 51-57
08184 – Palau-solità i Plegamans
Barcelona - Spain

This medicinal product is authorized in the European Economic Area countries under the following names:

Portugal: Bilastina Tolife 20 mg comprimido
Spain: Bilastina pensa 20 mg comprimidos EFG
Italy: Bilastina Pensa