Clabilla

Package leaflet: Information for the patient

Clabilla, 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, as you may need to read it again.
• If you have any questions, please 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 of the leaflet

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

1. What Clabilla is and what it is used for

Clabilla contains the active substance bilastine, which has antihistaminic properties.
Clabilla 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 Clabilla

When not to use Clabilla

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

Warnings and precautions
Before starting to use Clabilla, 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 especially if the patient is also taking other medicines (see “Clabilla and other medicines”).

Children
This medicine must not be given to children under 12 years of age.
Do not take a higher dose than recommended. If symptoms persist, consult a doctor.

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

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

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (a medicine used to reduce immune system activity, thereby preventing organ rejection after transplantation or reducing severity of diseases in which the immune system attacks the body's own organs, and allergic conditions such as psoriasis, atopic dermatitis, and rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic)

Clabilla with food, drink, and alcohol
Do not take the tablets together with food or grapefruit juice or other fruit juices, as this may reduce the effectiveness of bilastine. To avoid this, either:

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• wait two hours after eating or drinking fruit juice 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 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 or pharmacist before using this medicine.
Before taking 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, the patient should assess how this medicine affects them.

Clabilla 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 take Clabilla

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose for adults, including elderly people, and adolescents aged 12 years and older,
is 1 tablet (20 mg) per day.

• 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, "Clabilla with food, drink and alcohol").
• Swallow the tablet with a glass of water.
• The break line on the tablet is intended only to facilitate splitting the tablet if the patient has difficulty swallowing it whole. Regarding duration of treatment, your treating physician will determine the type of disease and decide how long Clabilla should be taken.

Use in children
Other formulations of this medicine – orally disintegrating tablets or oral solution – are intended for
children aged 6 to 11 years with body weight of at least 20 kg – please consult your doctor or
pharmacist.
Do not give this medicine to children under 6 years of age with body weight below 20 kg,
as there is insufficient data on use in this population.
Taking more Clabilla than recommended
If you or someone else takes more Clabilla than recommended, contact your doctor or pharmacist
immediately or go to the emergency department of the nearest hospital. Take the medicine
packaging or leaflet with you.
If you miss a dose of Clabilla
Do not take a double dose to make up for a missed dose.
If you forget to take a dose at the scheduled time, take it as soon as possible, 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 adverse reactions

Like any medicinal product, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences hypersensitivity reactions, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and (or) skin redness and swelling,
the medicine should be discontinued immediately and medical advice must 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 (electrocardiogram) findings
• blood test abnormalities indicating liver function disorders
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disturbances
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (sensation of dizziness or spinning)
• weakness
• increased thirst
• dyspnoea (difficulty breathing)
• dryness of the oral mucosa
• indigestion
• itching
• facial rash
• fever
• tinnitus (ringing in the ears)
• sleep disturbances
• blood test abnormalities indicating kidney function disorders
• elevated blood lipid levels

Frequency not known: cannot be estimated from the available data

• palpitations (awareness of heart beating)
• 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
• 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 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 contributes to the further enhancement of the safety profile of the medicinal product.

5. How to store the medicine Clabilla

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 the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required 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 Clabilla contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• Other ingredients are: microcrystalline cellulose 102, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Clabilla looks like and contents of the pack
Clabilla is a white to almost white, oval tablet with a break line on one side,
imprinted with the number “2” on one side of the break line and the number “0” on the other side of the break line,
smooth on the reverse side (length 10.1 mm, width 5.1 mm).
The break line on the tablet is intended only to facilitate breaking for easier swallowing and does not allow for division into equal doses.
The medicine is packed in blisters made of OPA/Aluminium/PVC/Aluminium foil.
Each blister contains 10 tablets. The blisters are placed in a cardboard box.
Available pack sizes:
30 tablets.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer/Importer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonińskiego 3 Street
00-728 Warsaw
Email: [email protected]
Tel. +48 22 35 12 500
This medicinal product is authorised in the European Economic Area countries under the following names:
Country name : Product name
Czech Republic : Bilastine Glenmark
Poland : Clabilla
Spain : ABISAX 20 mg tablets EFG