Bilastine Sandoz

Package leaflet: Information for the patient

Bilastina Sandoz 20 mg tablets

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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Bilastina Sandoz contains the active substance bilastine, which is an antihistamine.
Bilastina Sandoz is used to relieve symptoms of hay fever (sneezing, itching, runny nose,
nasal congestion, and red, watery eyes) 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 Sandoz

Do not take Bilastina Sandoz

• 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 Sandoz if you have moderate or severe renal impairment and are taking other medicines (see "Other medicines and Bilastina Sandoz").
Children
Bilastina Sandoz 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 Sandoz
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 (used to treat chest pain or tightness – angina pectoris)
• Cyclosporine (used 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 Sandoz with food, beverages 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, or
• 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 or breastfeeding women, as well as data on the effects of bilastine on fertility, are unavailable 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 for advice before taking any medicine.
Driving and using machines
It has been demonstrated 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 personally before driving or operating machinery.

3. How to take Bilastina Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, contact your doctor or pharmacist.
The recommended dose in adults, including elderly patients and adolescents aged 12 years and older, is 1
tablet (20 mg of bilastin) once 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 Sandoz with food, drinks 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 Sandoz.

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 Sandoz than you should
If you, or someone else, have taken an excessive amount of Bilastina Sandoz tablets, contact
immediately your doctor or pharmacist or go to the nearest hospital emergency department.
Remember to take the pack or the leaflet of this medicine with you.
If you forget to take Bilastina Sandoz
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 return to your regular dosing schedule.
If you stop taking Bilastina Sandoz
Generally, there will be no side effects when treatment with Bilastina Sandoz is
discontinued.
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.
The side effects that may occur in adults and adolescents are as follows:
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
• weight gain
• 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)
• 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 heart beat)
• tachycardia (fast heartbeat)
• allergic reactions, 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

The side effects that may occur in children are as follows:
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 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 get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
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 Sandoz

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 requires no special storage conditions.
Do not dispose of any medicine 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 Sandoz contains

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

Description of the appearance of Bilastina Sandoz and package contents
Bilastina Sandoz 20 mg tablets are white and round.
Each pack contains 10, 20, 30, 40, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
J. Uriach y Compañía S.A.
Av ingu da Camí Reial, 51-57
Palau Solità i Plegamans,
08184 Barcelona, Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana,
Slovenia