Package leaflet: Information for the patient

Bilastina Mylan 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 other people, even if their symptoms are the same as yours, because 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

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

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

Bilastina Mylan contains the active substance bilastine, which is an antihistamine.
Bilastina Mylan 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 (urticaria).

2. What you need to know before taking Bilastina Mylan

Do not take Bilastina Mylan:

if you are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before taking Bilastina Mylan if you have moderate or severe renal impairment and are taking other medicines (see "Other medicines and Bilastina Mylan").
Children
Bilastina Mylan 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 Mylan
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 Mylan with food, drinks and alcohol
The 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 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 or breastfeeding women, and data on the effects of bilastine on fertility, are limited or not available.
If you are pregnant, think you may be pregnant, planning to become pregnant, 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
Doses of 20 mg of bilastine have been shown not to 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 Mylan

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) daily.

The tablet is for oral use.
The tablet should be taken one hour before or two hours after eating food or drinking fruit juice (see section 2, “Bilastina Mylan 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 Mylan.

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 with a body weight below 20 kg, as sufficient data are not available.

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

If you forget to take Bilastina Mylan
Do not take a double dose to make up for the forgotten dose.
If you forget to take a dose, take it as soon as possible, then return to your regular dosing schedule.

If you stop taking Bilastina Mylan
Generally, there will be no adverse effects when treatment with Bilastina Mylan is stopped.
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 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)
Blood tests indicating changes in liver function
Dizziness
Stomach pain
Fatigue
Increased appetite
Irregular heartbeat
Increase in body weight
Nausea (feeling unwell)
Anxiety
Sensation of dryness or discomfort in the nose
Abdominal pain
Diarrhoea
Gastritis (inflammation of the stomach lining)
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
Increase in 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

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 ache (abdominal pain/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

Eye irritation
Dizziness
Loss of consciousness
Diarrhoea
Nausea (feeling unwell)
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 available 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 Mylan

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 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 Mylan contains:

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

Description of the appearance of Bilastina Mylan and pack contents
Bilastina Mylan 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
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
NOUCOR HEALTH, S.A,
Avda. Camí Reial 51-57, 08184
Palau-Solità i Plegamans,
Barcelona, Spain.

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Bilastin Viatris 20 mg Tabletten
Bulgaria: Bilastine Viatris 20 mg tablets
Spain: Bilastina Viatris 20 mg comprimidos EFG
France: Bilastine Viatris 20 mg, comprimé
Italy: Bilastina Mylan 20 mg compresse
Portugal: Bilastine Mylan 20 mg tablets