Patient Information Leaflet

Bilastina Mylan Generics 20 mg tablets

bilastine
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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

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

Do not take Bilastina Mylan Generics
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 Mylan Generics if you have moderate or severe
renal impairment, low levels of potassium, magnesium, or calcium in the blood, if you have or have had
heart rhythm problems, if your heart rate is very low, if you are taking medicines that could affect your
heart rhythm, if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on
electrocardiogram), which may occur in certain heart conditions and you are also taking other medicines
(see “Other medicines and Bilastina Mylan Generics”).
Children
This medicine is not intended for children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Bilastina Mylan Generics
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 Generics 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 eating food or drinking fruit juice;
if you have consumed food or fruit juice, 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
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.
Data on the use of bilastine in pregnant women and during breastfeeding, as well as data on the effects of bilastine on fertility, are unavailable or limited.
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 Mylan Generics contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Bilastina Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose in 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 Mylan Generics with food, drinks and alcohol”).
Swallow the tablet with a glass of water.

Duration of treatment:
Your doctor will determine the type of illness you have and decide for how long you should take Bilastina Mylan Generics.

Use in children
Other dosage forms of this medicine – bilastin 10 mg orodispersible tablets or bilastin 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.

Bilastina must not be used in 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 Generics than you should
If you or someone else has taken an excessive amount of Bilastina Mylan Generics, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the package or the package leaflet of this medicine with you.

If you forget to take Bilastina Mylan Generics
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 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 everybody 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 skin redness and swelling, stop taking the medicine and contact your doctor immediately.

Other 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
weight gain
nausea (feeling sick)
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 lipids

Not known: frequency cannot be estimated from the available data

palpitations (awareness of heartbeat)
tachycardia (fast heartbeat)
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 unwell)
swelling of the lips
eczema
urticaria
fatigue

Reporting of side effects
If you get any side effects, including those 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 the following website:
https://www.aifa.gov.it/en/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 Generics

Keep this medicine out of the sight and reach of children.
This medicine has no special storage requirements.
Do not use this medicine after the expiry date stated on the cardboard box and on the blister after Exp. The expiry date refers to the last day of that month.
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 Generics contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine.
The other components are: mannitol (E 421), microcrystalline cellulose, sodium starch glycolate, magnesium aluminium metasilicate, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Bilastina Mylan Generics and package contents
Bilastina Mylan Generics are biconvex, round tablets (7 mm in diameter), white to almost white in colour.
Bilastina Mylan Generics is available in blisters containing 10, 20, 30, 50 or 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer:
Saneca Pharmaceuticals a. s.
Nitrianska 100
Hlohovec
Trnava
920 27, Slovakia

This medicinal product is authorized in the European Economic Area Member States under the following names:
Sweden Bilastine Viatris 20 mg tablet
Spain Bilastina Viatris Pharmaceuticals 20 mg tablets
France Bilastine Viatris Santé 20 mg, comprimé
Italy Bilastina Mylan Generics
Portugal Bilastina Viatris 20 mg tablet