BELLIX ALLERGY

Package leaflet: Information for the user

Bellix Allergy, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if you feel worse, contact your doctor.

Contents of the leaflet:

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

1. What Bellix Allergy is and what it is used for

Bellix Allergy contains the active substance bilastine, which has antihistaminic properties. Bellix Allergy is used to relieve symptoms of allergic rhinitis (sneezing, itching, runny or blocked nose, and red, watery eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (urticaria).

2. Important information before using Bellix Allergy

When not to use Bellix Allergy
If the patient is allergic to bilastine or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before starting treatment with Bellix Allergy, consult a doctor or pharmacist if the patient has
moderate or severe kidney function impairment, low blood levels of potassium, magnesium, or calcium,
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 rhythm pattern
(known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease,
and is also taking other medicines (see "Bellix Allergy 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.

Bellix Allergy and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
including those obtained without a prescription, as well as any medicines the patient plans to take.
In particular, consult a doctor if the patient is taking any of the following medicines:

• ketoconazole tablets (used in the treatment of Cushing's syndrome, when the body produces excess cortisol)
• erythromycin (an antibiotic)
• diltiazem (a medicine used to treat chest pain or pressure—angina pectoris)
• cyclosporine (a medicine used to reduce immune system activity, thereby preventing transplant rejection or reducing severity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (a medicine used in the treatment of HIV)
• rifampicin (an antibiotic)

Bellix Allergy with food, drinks, and alcohol
These tablets must not be taken with food or with grapefruit juice or other fruit juices, as this may reduce the effectiveness of bilastine. To avoid reduced effectiveness of the medicine:

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

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

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

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

Bellix Allergy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Bellix Allergy

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 people, and adolescents aged 12 years and older is 1 tablet (20 mg) once daily.

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

The duration of treatment depends on the type, duration and course of the illness.
Bellix Allergy should not be used for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Use in children
Bellix Allergy 20 mg tablets should not be used in children under 12 years of age.
Other forms of this medicine—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution—are more suitable for children aged 6 to 11 years weighing at least 20 kg—consult your doctor or pharmacist.
These forms of bilastine should not be given to children under 6 years of age weighing less than 20 kg, as there is insufficient data on their use.

Taking more Bellix Allergy than recommended
If you or someone else takes more Bellix Allergy than recommended, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Bring the medicine pack or leaflet with you.

If you forget to take Bellix Allergy
Do not take a double dose to make up for a missed dose.
If you miss a dose at the usual time, take the missed dose as soon as possible, then continue taking the medicine at your regular time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If the patient experiences symptoms of an allergic reaction, 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, the medicine should be discontinued and immediate medical advice sought.
Other adverse effects that may occur in adults and adolescents include:
Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• abnormal ECG (electrocardiogram) readings
• blood test results indicating liver function abnormalities
• 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 lining)
• vertigo (dizziness or sensation of spinning)
• feeling of weakness
• excessive thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores (oral herpes)
• fever
• tinnitus (ringing in the ears)
• sleep disturbances
• changes in blood tests indicating kidney function abnormalities
• increased blood lipid levels

Frequency not known: cannot be estimated from the available data
palpitations (awareness of heartbeat)
tachycardia (rapid heartbeat)
vomiting

Adverse effects that may occur in children include:
Common: may affect up to 1 in 10 people

• nasal mucositis (nasal irritation)
• allergic conjunctivitis of the eyes
• headache
• stomach pain (abdominal pain, epigastric pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea
• lip swelling
• rash
• urticaria (hives)
• fatigue

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, patients should inform their doctor, pharmacist or nurse. Adverse effects
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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Bellix Allergy

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 the stated month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Bellix Allergy contains

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

What Bellix Allergy looks like and contents of the pack
Tablet.
White to almost white, oval, biconvex, uncoated tablets, with engraved markings “BN” and “2” separated by a division line on one side and smooth on the other side.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.
Bellix Allergy 20 mg tablets are available in blisters (i.e. transparent blisters made of PVC/Aluminium foil) packed in a cardboard box.
Pack sizes: 6, 7, 10 and 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, unit 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany: Bilastin PUREN 20 mg Tabletten
Italy: ALYNE
Poland: Bellix Allergy
Portugal: Bilastina Aurovitas