Bilastine msn

Patient Information Leaflet

Bilastine MSN, 20 mg, tablets
Bilastinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with 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 or pharmacist. See section 4.

Table of Contents:

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

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

Bilastine MSN contains the active substance bilastine, which acts as an antihistamine.
Bilastine MSN 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).

2. Important information before using Bilastine MSN

When not to use Bilastine MSN

• 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 to use Bilastine MSN, 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 heartbeat, 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 MSN 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 MSN and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including those available without 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 for 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 MSN with food, drink, and alcohol
Do not take the medicine together with food or grapefruit juice or other fruit juices, as this may reduce the effect 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 consumption.
Pregnancy, breastfeeding, and fertility
There are no data or limited data on the use of bilastine in pregnant or breastfeeding women and its effect on 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.
Driving and using machines
It has been demonstrated that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, individual response to treatment may vary. Therefore, before driving or operating machinery, patients should assess how this medicine affects them.
Bilastine MSN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Bilastine MSN

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for adults, including elderly patients, and adolescents aged 12 years and older, is 1 tablet (20 mg) once daily.

• This is an oral tablet.
• The tablet should be taken one hour before or two hours after a meal or drinking fruit juice (see section 2 “Bilastine MSN with food, drink and alcohol”).
• Swallow the tablet with a glass of water.
• The break line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.

Regarding duration of treatment, your doctor will determine the type of illness and decide how long you should take
Bilastine MSN.
Use in children
Other formulations of this medicine—such as orally disintegrating tablets or oral solution—are more suitable
for children aged 6 to 11 years weighing at least 20 kg—please consult your doctor or pharmacist.
This medicine should not be given to children under 6 years of age weighing less than 20 kg,
as there is insufficient data on its use.
Taking more Bilastine MSN than recommended
If you take more tablets of Bilastine MSN than recommended, you must immediately
contact your doctor or pharmacist or go to the emergency department of your nearest
hospital. Take the medicine pack or leaflet with you.
If you miss a dose of Bilastine MSN
Do not take a double dose to make up for a missed dose.
If you miss a dose at the usual time, take the missed dose as soon as possible, then return to 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 experiences them.
If the patient experiences symptoms of an allergic reaction, including: 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 should be sought without delay.
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 recording
• blood test results indicating changes in liver function
• 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
• excessive thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores (oral herpes)
• fever
• tinnitus (ringing in the ears)
• sleep disturbances
• changes in blood tests indicating kidney function disorders
• increased blood lipid levels.

Frequency not known: cannot be estimated from the 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 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
• swelling of the lips
• rash
• urticaria
• fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. 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
By reporting adverse reactions, more information on the safety of this medicine can be collected.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Bilastine MSN

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

6. Contents of the pack and other information

What Bilastine MSN contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylstarch (type A), colloidal anhydrous silica, magnesium stearate.

What Bilastine MSN looks like and contents of the pack
Bilastine MSN 20 mg is a white or almost white, oval, biconvex, uncoated tablet, with the letters "M" and "B" embossed on either side of the break line and smooth on the other side.
The break line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Bilastine MSN tablets are available in cardboard boxes containing 10, 20, 30, 40, or 50 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
[email protected]

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Bilastina MSN
Czech Republic: Cluzin
Hungary: Bilastine MSN 20 mg tabletta
Poland: Bilastine MSN
Romania: Arelasine 20 mg comprimate
Slovakia: Cluzin 20 mg
Bulgaria: Arelasine 20 mg tablets