Package leaflet: Information for the patient

BILASTINA EG 20 mg tablets

Generic medicine
Please read all of this leaflet carefully before you take 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Bilastina EG is and what it is used for

Bilastina EG contains the active substance bilastine, which is an antihistamine.
Bilastina EG 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 for the treatment of itchy skin rashes (such as urticaria).

2. What you need to know before taking Bilastina EG

Do not take Bilastina EG

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 EG if you have moderate or severe renal impairment and are taking other medicines (see "Other medicines and Bilastina EG").
Children
This medicine 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 EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:
ketoconazole (an antifungal medicine);
erythromycin (an antibiotic);
diltiazem (used to treat chest pain or tightness – 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).
Bilastina EG with food, drinks and alcohol
These tablets should 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 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 on the use of bilastine in pregnant women and during breastfeeding, as well as data on the effects of bilastine on fertility, are unavailable or limited in number.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding with breast milk, consult your doctor before taking this medicine.
Consult your doctor before taking any 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, it is important to assess how the medicine affects you personally before driving or operating machinery.

3. How to take Bilastina EG

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 the elderly, and adolescents aged 12 years and older, is 1 tablet (20 mg of bilastin) daily.
The tablet is for oral use.
The tablet should be taken one hour before or two hours after food or fruit juice (see section 2, “Bilastina EG with food, drink and alcohol”).
Swallow the tablet with a glass of water.
Regarding the duration of treatment, your doctor will assess your condition and decide how long you should take Bilastina EG.

Use in children
Other dosage forms of this medicine may be more suitable for children aged 6 to 11 years.
Do not administer this medicine to children under 6 years of age weighing less than 20 kg, as sufficient data are not available.

If you take more Bilastina EG than you should
If you or someone else has taken an excessive amount of Bilastina EG tablets, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine’s packaging or leaflet with you.

If you forget to take Bilastina EG
Do not take a double dose to make up for the missed dose.
If you forget a dose, take it as soon as possible and then continue with your regular dosing schedule.

If you stop taking Bilastina EG
Generally, no adverse effects are expected when stopping treatment with Bilastina EG.

If you have any questions about how to use 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 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)
abnormal blood tests indicating liver function abnormalities
dizziness
stomach pain
fatigue
increased appetite
irregular heartbeat
weight gain
nausea (feeling of sickness)
anxiety
nasal dryness or discomfort
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
vertigo (dizziness or spinning sensation)
feeling of weakness
thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
cold sore (oral herpes)
fever
tinnitus (ringing in the ears)
difficulty sleeping
blood tests indicating kidney function abnormalities
increase in blood lipids
Frequency not known: frequency cannot be estimated from the available data
palpitations (awareness of heart beat)
tachycardia (fast heartbeat)
allergic reactions, signs of which may include breathing difficulties, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and/or swelling and redness of the skin. If you notice any of these serious side effects, stop taking the medicine and contact your doctor immediately
vomiting
The side effects that may occur in children are the following:
Common: may affect up to 1 in 10 people
rhinitis (nasal irritation)
allergic conjunctivitis (allergic inflammation of the conjunctiva of the eye)
headache
stomach pain (abdominal pain/upper abdomen pain)
Uncommon: may affect up to 1 in 100 people
eye irritation
dizziness
loss of consciousness
diarrhoea
nausea (feeling of sickness)
swelling of the lips
eczema
urticaria
fatigue
Reporting of side effects
If you get any side effects, including ones 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 Bilastina EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or blister after the words “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 EG contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine (as monohydrate).
The other ingredients are microcrystalline cellulose, crospovidone (type A), magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Bilastina EG and contents of the pack

Bilastina EG 20 mg tablets are white and rounded in shape.
Each package contains 10, 20, 30, 40, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milan, Italy
Manufacturer
J. Uriach y Compañia S.A., Avinguda Cami Reial 51-57 Poligon Industrial Riera De Caldes
Palau-Solita I Plegamans 08184 Barcelona - Spain
This medicinal product is authorized in the European Economic Area (EEA) Member States
under the following names:
Germany Bilastin STADA Arzneimittel 20 mg Tabletten
Bulgaria Bilergia 20 mg tablets
Greece Bilastine/Stada
Spain Bilastina STADA 20 mg comprimidos EFG
France BILASTINE EG 20 mg, comprimé
Hungary Bilastine Stada 20 mg tabletta
Italy BILASTINA EG
Poland VERPYLLO
Portugal Bilastina Ciclum