BILASTINE MEDREG

Package leaflet: Information for the user

Bilastine Medreg, 20 mg, tablets
Bilastinum
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 further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Bilastine Medreg is and what it is used for

Bilastine Medreg contains the active substance bilastine, which acts as an antihistamine.
Bilastine Medreg 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. It may also be used to treat itchy skin rashes (urticaria).

2. Important information before using Bilastine Medreg

When not to use Bilastine Medreg
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 Medreg, 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 the patient is taking other medicines (see "Bilastine
Medreg with 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 Medreg with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, 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 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 AIDS)
• Rifampicin (an antibiotic)

Bilastine Medreg with food, drink and alcohol
These tablets must not be taken with food or 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 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 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 on the use of bilastine in pregnant or breastfeeding women
and 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, the patient should assess how this medicine affects them.
Bilastine Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to take Bilastine Medreg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
ask 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, "Bilastine Medreg with food, drink and alcohol").
• Swallow the tablet with a glass of water.

Duration of treatment:
Your doctor will determine the type of illness and how long you should take Bilastine Medreg.

Use in children
Other dosage 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 weighing at least 20 kg. Please consult your
doctor or pharmacist.
Do not use these bilastine dosage forms in children under 6 years of age weighing less than 20 kg,
as there is insufficient data on their use.

Taking more Bilastine Medreg than recommended
If you take more tablets than recommended, contact your 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 Medreg
Do not take a double dose to make up for a forgotten 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient develops 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 immediately and medical advice must be sought urgently.
Other adverse reactions that may occur in adults and adolescents include:
Common: may occur in less than 1 in 10 patients

• headache
• somnolence (drowsiness)

Uncommon: may occur in less than 1 in 100 patients

• abnormal ECG (electrocardiogram)
• 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 problems
• changes in blood tests indicating kidney function abnormalities
• increased blood lipid levels

Frequency not known: frequency cannot be estimated from the available data

• palpitations (awareness of heart beat)
• tachycardia (rapid heartbeat)
• vomiting

Adverse reactions that may occur in children include:
Common: may occur in less than 1 in 10 patients

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

Uncommon: may occur in less than 1 in 100 patients

• 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 your doctor, pharmacist or nurse. Adverse reactions
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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bilastine Medreg

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after: EXP. The expiry date refers to the last day of the stated month.
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 pack and other information

What Bilastine Medreg contains

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

What Bilastine Medreg looks like and contents of the pack
Bilastine Medreg is white to almost white, round (7 mm in diameter), biconvex tablets.
The tablets are available in PVC/PVdC/Aluminium or OPA/Aluminium/PVC/Aluminium foil blisters containing 10, 20, 30, 50 or 100 tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Medreg 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 European Economic Area countries under the following names:
Sweden: Bilastine Medreg
Czech Republic: Bilastine Medreg
Poland: Bilastine Medreg
Italy: Bilastina Medreg
Romania: Bilastină Gemax Pharma 20 mg comprimate
Slovakia: Bilastine Medreg