Bilastina Nasometin

Leaflet attached to the packaging: patient information

Bilastine Nasometin, 20 mg, tablets

For use in adults and adolescents 12 years of age and older

Bilastine

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

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

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

2. Important information before taking Bilastine Nasometin

When not to take Bilastine Nasometin

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

Warnings and precautions

Before taking Bilastine Nasometin, discuss with your doctor or pharmacist if you have moderate or severe kidney problems, low potassium, magnesium, or calcium levels in your blood, if you have or have had heart rhythm problems or very slow heart rate, if you are taking medicines that may affect your heart rhythm, if you have or have had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in certain types of heart disease, or if you are taking other medicines (see "Bilastine Nasometin and other medicines").
Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Children

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

Bilastine Nasometin and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take, including those obtained without a prescription.
In particular, always inform your doctor if you are taking any of the following medicines:

• ketokonazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina pectoris - pain or discomfort in the chest)
• cyclosporin (a medicine that reduces the activity of the immune system, used to prevent transplant rejection or reduce the severity of autoimmune diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (a medicine used to treat AIDS)
• rifampicin (an antibiotic)

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

becauseit reduces the effect of bilastine. To avoid reducing the effect of the medicine, you should:

• swallow the tablet and wait one hour before eating or drinking fruit juice or
• after eating or drinking fruit juice, wait 2 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 women, during breastfeeding, and on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

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

3. How to take Bilastine Nasometin

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents 12 years of age and older, is 1 tablet (20 mg) once daily.

• The tablet is intended for oral use.
• The tablet should be taken one hour before or two hours after eating or drinking fruit juice (see section 2 "Bilastine Nasometin with food, drink, and alcohol").
• The tablet should be swallowed with a glass of water.

The duration of treatment with Bilastine Nasometin depends on the type of allergy (seasonal or perennial). Consult your doctor or pharmacist.
It is not recommended to use Bilastine Nasometin for more than 10 days without consulting a doctor.

Use in children

Other forms of this medicine - bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution - are suitable for children aged 6 to 11 years with a body weight of at least 20 kg - consult your doctor or pharmacist.

Do not give these forms of bilastine to children under 6 years of age or with a body weight below

20 kg, as there are insufficient data.

Overdose of Bilastine Nasometin

In case of overdose of Bilastine Nasometin by a patient or another person, immediatelycontact a doctor or pharmacist or go to the emergency department of the nearest hospital. Bring the packaging or leaflet with you.

Missed dose of Bilastine Nasometin

Do nottake a double dose to make up for a missed dose.
If you miss a dose, take the missed dose as soon as possible, and then return to your regular dosing schedule.
If you have any further questions about the use of 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.
Stop taking the medicine and consult your doctor immediately if you experience allergic reactions, whose symptoms may include: difficulty breathing, dizziness, fainting or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin.

Side effects that may occur in adults and adolescents are:

Common: occurring in less than 1 in 10 people

• headache
• drowsiness

Uncommon: occurring in less than 1 in 100 people

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

Frequency not known: cannot be estimated from available data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• allergic reactions, whose symptoms may include: difficulty breathing, dizziness, fainting or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin. Stop taking the medicine and consult your doctor immediately if you experience these symptoms.
• vomiting.

Side effects that may occur in children are:

Common: occurring in less than 1 in 10 people

• nasal congestion (nasal irritation)
• allergic conjunctivitis (eye inflammation caused by an allergic reaction)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen)

Uncommon: occurring in less than 1 in 100 people

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bilastine Nasometin

Keep the medicine out of 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 the 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 Nasometin contains

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

What Bilastine Nasometin looks like and contents of the pack

Bilastine Nasometin, tablets, 20 mg are round, white tablets.
Each pack contains 10 tablets in an aluminum-aluminum blister pack in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Poland
tel. 22 209 70 00
Manufacturer
Noucor Health, S.A.
Avda. Camí Reial, 51-57 08184 Palau-solità i Plegamans,
Barcelona, Spain
Lek Pharmaceuticals d.d.
Verovskova ulica 57,
1526, Ljubljana, Slovenia

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

Germany: Lorano Bilastin 20 mg Tablets
Poland: Bilastyna Nasometin

Date of last revision of the leaflet:

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