Bilastine Aurobindo

Package leaflet: Information for the user

Bilastina Aurobindo 20 mg tablets

Generic medicine
Please read all of 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bilastina Aurobindo contains the active substance bilastine, which is an antihistamine. Bilastina Aurobindo
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 Aurobindo

Do not take Bilastina Aurobindo:
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 Aurobindo if you have moderate or severe
renal impairment and are taking other medicines (see “Other medicines and Bilastina Aurobindo”).

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 Aurobindo
Tell 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);
• ciclosporin (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 Aurobindo with food, drinks and alcohol
The tablets must not be taken with food or with 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 alcohol-induced drowsiness.

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 lacking or limited.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine. Ask your doctor or pharmacist for advice 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 this medicine affects you before driving or operating machinery.

Bilastina Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Bilastina Aurobindo

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) 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 Aurobindo with food, drinks and alcohol”).
• Swallow the tablet with a glass of water.
• The score line is only intended to help you divide the tablet if you have difficulty swallowing it whole.

Regarding the duration of treatment, your doctor will assess your condition and decide how long you should take Bilastina Aurobindo.

Use in children
Other dosage forms of this medicine—bilastina 10 mg orodispersible tablets or bilastina 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 Aurobindo than you should
If you or someone else has taken an excessive amount of Bilastina Aurobindo, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.
Remember to bring the pack or the package leaflet of this medicine with you.

If you forget to take Bilastina Aurobindo
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, then return to 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 everyone experiences 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;
• increased body weight;
• nausea (feeling of sickness);
• 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;
• cold sores (oral herpes);
• fever;
• tinnitus (ringing in the ears);
• difficulty falling asleep;
• blood tests indicating changes in kidney function;
• increased blood fats.

Frequency not known: cannot be estimated from the available data

• palpitations (awareness of heartbeat);
• tachycardia (fast heartbeat);
• allergic reactions, the signs of 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. 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 ache (abdominal pain/upper abdominal 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 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 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 Aurobindo contains

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

Description of the appearance of Bilastina Aurobindo and package contents
Tablets.
Uncoated tablets, white to almost white, oval, biconvex, with ‘BN’ and ‘2’ imprinted on one side separated by a score line, and smooth on the other side.
The score line on the tablet is only intended to facilitate breaking and swallowing, and is not intended to divide the tablet into equal doses.
Bilastina Aurobindo 20 mg tablets are available in blister packs.
Pack sizes:
Blister packs: 10, 14, 20, 28, 30, 40, 50, 56, 60, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica SA
Rua João de Deus, 19,
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier,
69007 Lyon,
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Bilastine AB 20mg tabletten / comprimés / Tabletten
Denmark: Bilastin Aurobindo
France: Bilastine Arrow 20 mg, comprimé
Italy: Bilastina Aurobindo
Poland: Bellix
Portugal: Bilastina Generis
Romania: Bilastină Aurobindo 20 mg comprimate
Spain: Bilastina Aurovitas 20 mg comprimidos EFG