Package leaflet: Information for the user

Bilastine Dr. Max, 20 mg, tablets
Bilastinum
Please read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Table of contents:

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

1. What Bilastine Dr. Max is and what it is used for

Bilastine Dr. Max contains the active substance bilastine, which has antihistaminic activity.
Bilastine Dr. Max is used to relieve symptoms of seasonal allergic rhinitis (sneezing, itching, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (urticaria).
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Important information before using Bilastine Dr. Max

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

Warnings and precautions
Before starting treatment with Bilastine Dr. Max, 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 heart rate, 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 additionally is taking other medicines (see "Bilastine Dr. Max 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.

Bilastine Dr. Max and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

In particular, consult a doctor if the patient is taking any of the following medicines:

Ketoconazole (an antifungal medicine)
Erythromycin (an antibiotic)
Diltiazem (a medicine used to treat chest pain or tightness—angina)
Cyclosporine (a medicine used to reduce the activity of the immune system, thereby preventing transplant rejection or reducing the severity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
Ritonavir (a medicine used in the treatment of AIDS)
Rifampicin (an antibiotic)

Bilastine Dr. Max with food, drink, 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
After a meal or drinking fruit juice, wait 2 hours before taking the tablet.

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

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

Driving and operating machinery
It has been demonstrated that taking 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.

Bilastine Dr. Max 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 Bilastine Dr. Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose for adults, including elderly individuals 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 "Bilastine Dr. Max with food, drink and alcohol").
Swallow the tablet with a glass of water.

Duration of treatment:
The duration of treatment depends on the type, duration and course of the illness. This medicine 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, consult a doctor.

Use in children
Other pharmaceutical forms of this medicine—bilastine 10 mg orodispersible tablets or bilastine 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. Consult a doctor or pharmacist.
These forms of bilastine should not be used in children under 6 years of age or with body weight below 20 kg, as there is insufficient data on safety and efficacy.

Taking more Bilastine Dr. Max than recommended
If more tablets than recommended have been taken, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Take the medicine packaging or leaflet with you.

If you forget to take Bilastine Dr. Max
Do not take a double dose to make up for a missed dose.
If a dose is missed at the usual time, take the missed dose as soon as possible, then return to taking the medicine at the regular time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 must be sought.
Other adverse reactions that may occur in adults and adolescents include:
Common: may affect fewer than 1 in 10 people

headache
drowsiness

Uncommon: may affect fewer than 1 in 100 people

abnormal ECG (electrocardiogram) reading
blood test results indicating liver function abnormalities
dizziness
stomach pain
fatigue
increased appetite
irregular heartbeat
weight gain
nausea
anxiety
dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
vertigo (dizziness or sensation of spinning)
feeling of weakness
increased thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
cold sores (oral herpes)
fever
tinnitus (ringing in the ears)
sleep problems
changes in blood tests indicating kidney function abnormalities
elevated blood lipid levels
Frequency unknown: cannot be estimated from available data
palpitations (awareness of heartbeat)
tachycardia (rapid heartbeat)
vomiting

Adverse reactions that may occur in children include:
Common: may affect fewer than 1 in 10 people

rhinitis (nasal mucosal inflammation, nasal irritation)
allergic conjunctivitis (eye irritation)
headache
stomach pain (abdominal pain, epigastric pain)

Uncommon: may affect fewer than 1 in 100 people

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Bilastine Dr. Max

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the cardboard packaging
and blister pack following: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Doing so helps protect
the environment.

6. Contents of the package and other information

What Bilastine Dr. Max contains

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

What Bilastine Dr. Max looks like and contents of the pack
Bilastine Dr. Max is white to almost white, round (7 mm in diameter), biconvex tablets.
Bilastine Dr. Max is available in blister packs containing 10 tablets in a cardboard box.
Marketing Authorisation Holder:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199
Manufacturer/Importer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovakia
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Sweden: Bilasusa 20 mg tablett
Poland: Bilastine Dr. Max