Package leaflet: Information for the patient

Bilastina TecniGen 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 questions, 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bilastina TecniGen contains the active substance bilastine, which is an antihistamine. Bilastina TecniGen 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 may also be used for the treatment of itchy skin rashes (such as urticaria).

2. What you need to know before taking Bilastina TecniGen

Do not take Bilastina TecniGen
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 TecniGen if you have moderate or severe
renal impairment and are taking other medicines (see "Other medicines and Bilastina
TecniGen").
Children
Do not give this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Bilastina TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including medicines without 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 TecniGen 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 juices;
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 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 effects on fertility, are unavailable or limited.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding with breast milk, ask your doctor for advice before taking this medicine. Consult your doctor or pharmacist 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 the medicine affects you personally before driving or operating machinery.
Bilastina TecniGen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take Bilastina TecniGen

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) per day.

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 TecniGen with food, drink and alcohol”).
Swallow the tablet with a glass of water.
The score line on the tablet is intended to facilitate breaking the tablet if you have difficulty swallowing it whole.

Regarding the duration of treatment, your doctor will determine the type of illness you have and decide how long you should take Bilastina TecniGen.
Use in children
Other formulations of this medicine – orodispersible tablets of bilastina 10 mg or oral solution of bilastina 2.5 mg/mL – may be more suitable for children aged between 6 and 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 TecniGen than you should
If you or someone else has taken an excessive amount of Bilastina TecniGen, 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 TecniGen
Do not take a double dose to make up for the missed dose.
If you forget to take a dose at the scheduled time, 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.

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 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 from 1 to 10 in 1,000 people 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;
anxiety;
sensation of dryness or discomfort in the nose;
abdominal pain;
diarrhoea;
gastritis (inflammation of the stomach wall);
vertigo (a sensation of dizziness or spinning);
feeling of weakness;
thirst;
dyspnoea (difficulty breathing);
dry mouth;
indigestion;
itching sensation;
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 heart beat);
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 pain/upper abdomen pain).

Uncommon: may affect up to 1 in 100 people:

eye irritation;
dizziness;
loss of consciousness;
diarrhoea;
nausea;
swelling of the lips;
eczema;
urticaria;
fatigue.

Reporting of side effects
If you experience 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 the 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 Bilastina TecniGen

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 no longer required. This will help protect the environment.

6. Package contents and other information

What Bilastina TecniGen contains

The active substance is bilastina. Each tablet contains 20 mg of bilastina.
The other components are microcrystalline cellulose (grade 102), sodium starch glycolate
(type A), anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Bilastina TecniGen and contents of the pack
Bilastina TecniGen tablets are white to off-white, oval-shaped tablets with a break line,
imprinted with "2" on one side of the break line and "0" on the other side of the break line on one side, smooth on the other side.
Bilastina TecniGen tablets are available in blisters containing 10, 20, 30, 40, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Tecnigen srl
Via Galileo Galilei 40
20092 Cinisello Balsamo (Italy)

Manufacturer
Tecnimede – Sociedade Técnico-Medicinal SA
Quinta da Cerca, Caixaria
2565-187 Dois Portos, Portugal.
Atlantic Pharma - Produções Farmacêuticas s.a., Rua
Tapada Grande 2, 2710-089 Abrunheira, Sintra, Portugal.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy - Bilastina TecniGen
Portugal – Bilastina Verum Pharma