Clabilla

Package Leaflet: Information for the Patient

Clabilla, 20 mg, Tablets

Bilastine

Read the package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Clabilla and what is it 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 is Clabilla and what is it used for

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

2. Important information before taking Clabilla

When not to take Clabilla

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

Warnings and precautions

Before taking Clabilla, 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 heart conditions, and if you are also taking other medicines (see "Clabilla with other medicines").

Children

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

Do nottake a higher dose than recommended. If symptoms persist, consult your doctor.

Clabilla with other medicines

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

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

Clabilla with food, drink, and alcohol Do not take the tablets with food or with grapefruit juice, or other

fruit juices, as this reduces the effect of bilastine. To avoid this:

• swallow the tablet and wait one hour before eating or drinking fruit juice (see section 2, "Clabilla with food, drink, and alcohol").
• 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 or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Before taking any medicine, consult your 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 operating machinery, check how this medicine affects you.

Clabilla 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 Clabilla

Always take this medicine exactly as your 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 from 12 years of age is 1 tablet (20 mg) once daily.

• The tablet is for oral use.
• Take the tablet 1 hour before or 2 hours after food or fruit juice (see section 2, "Clabilla with food, drink, and alcohol").
• Swallow the tablet with a glass of water.
• The score line is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses. The duration of treatment will be determined by your doctor, depending on the type of disease and the response to treatment.

Use in children

Other forms of this medicine - orodispersible tablets or oral solution - are intended for children from 6 to 11 years of age 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 Clabilla

If you or someone else has taken more than the recommended dose of Clabilla, contact your doctor or pharmacist immediatelyor go to the emergency department of your nearest hospital. Take the package or leaflet with you.

Missed dose of Clabilla

Do nottake a double dose to make up for a forgotten dose.
If you forget to take a dose at the right time, take it as soon as possible, and then continue with your regular dosing schedule.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clabilla can cause side effects, although not everybody gets them.
If you experience 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, stop taking the medicine and consult your 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 electrocardiogram (ECG) readings
• blood test abnormalities indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disturbances
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis
• dizziness (dizziness or feeling of spinning)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial rash
• fever
• tinnitus (ringing in the ears)
• sleep disturbances
• blood test abnormalities indicating kidney problems
• increased lipid levels in the blood

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

• nasal congestion (runny nose)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 Clabilla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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.
• The other ingredients are: microcrystalline cellulose 102, sodium carboxymethylcellulose (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 score line on one side, with the number "2" embossed on one side of the score line and the number "0" on the other side, and smooth on the other side (length 10.1 mm, width 5.1 mm).
The score line is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
The tablets are packaged in a blister pack of OPA/Aluminum/PVC/Aluminum foil.
Each blister pack contains 10 tablets. The blister packs are packaged in a cardboard box.
Available pack sizes:
30 tablets.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvĕzdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic