Bilastine Msn

Leaflet attached to the packaging: patient information

Bilastine MSN, 20 mg, tablets

Bilastine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Bilastine MSN contains the active substance bilastine, which has antihistamine properties.
Bilastine MSN is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose, and red and itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (urticaria).

2. Important information before taking Bilastine MSN

When not to take Bilastine MSN

• if the patient is allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Bilastine MSN, the patient should discuss it with their doctor or pharmacist if they have moderate or severe kidney problems and are taking other medicines (see "Bilastine MSN and other medicines").

Children

Do not give this medicine to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, consult a doctor.

Bilastine MSN and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained 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 for angina)
• Cyclosporin (a medicine used to reduce the activity of the immune system, and thus prevent rejection of a transplant or reduce the severity of autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (a medicine used to treat AIDS)
• Rifampicin (an antibiotic).

Bilastine MSN with food, drink, and alcohol Do not take the medicine with food or grapefruit juice, or other fruit juices

asthey reduce the effect of bilastine. To avoid reducing the effect of the medicine, the patient should:

• swallow the tablet and wait one hour before eating or drinking fruit juice (see section 2 "Bilastine MSN with food, drink, and alcohol").
• after eating 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, or on fertility.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, the response to treatment may vary from person to person. Therefore, before driving or using machines, the patient should check how the medicine affects them.

Bilastine MSN contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Bilastine MSN

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents over 12 years of age is one tablet (20 mg) per day.

• The tablet is for oral use.
• Take the tablet one hour before or two hours after eating or drinking fruit juice (see section 2 "Bilastine MSN with food, drink, and alcohol").
• Swallow the tablet with a glass of water.
• The score line on the tablet is only to facilitate breaking the tablet, if the patient has difficulty swallowing it whole.

Regarding the duration of treatment, the doctor will determine the type of disease and decide how long to take Bilastine MSN.

Use in children

Other forms of this medicine - orally disintegrating tablets or oral solution - are more suitable for children aged 6 to 11 years with a body weight of at least 20 kg - ask your doctor or pharmacist.

Do not give this medicine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data on its use.

Overdose of Bilastine MSN

If the patient takes more tablets than recommended, they should immediatelycontact their doctor or pharmacist or go to the emergency department of the nearest hospital. They should take the packaging or leaflet with them.

Missed dose of Bilastine MSN

Do nottake a double dose to make up for a forgotten dose.
If a dose is missed at the usual time, take the missed dose as soon as possible, and then continue taking the medicine at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilastine MSN can cause side effects, although not everybody gets them.
If the patient experiences symptoms of an allergic reaction, including difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin, they should stop taking the medicine and consult their doctor immediately.

Other side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

• headache
• drowsiness.

Uncommon: may affect up to 1 in 100 people

• abnormal ECG
• blood test results indicating liver function changes
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (vomiting)
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (dizziness or feeling of spinning)
• feeling of weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sore (oral herpes)
• fever
• tinnitus (ringing in the ears)
• sleep problems
• blood test changes indicating kidney function disorders
• increased blood lipid levels.

Frequency not known: cannot be estimated from the available data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting.

Side effects that may occur in children are:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, epigastric pain).

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (vomiting)
• lip swelling
• rash
• hives
• fatigue.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Bilastine MSN

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.
There are no special precautions for storage.
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 MSN contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (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 "M" and "B" embossed on either side of the score line and smooth on the other side.
The score line on the tablet is only to facilitate breaking the tablet, for easier swallowing, and not to divide it into equal doses.
Bilastine MSN is available in cartons containing 10, 20, 30, 40, and 50 tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
info@pharmalab.pl

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal:
Bilastina MSN
Czech Republic:
Bilastine MSN
Hungary:
Bilastine MSN 20 mg tablet
Poland:
Bilastine MSN
Romania:
Arelasine 20 mg tablets
Slovakia:
Bilastine MSN 20 mg
Bulgaria:
Арелазин 20 mg tablets

Date of last revision of the leaflet: