Clabilla gem

Patient Information Leaflet

Clabilla Gem, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement in your condition after 3 days, or if you feel worse, you should contact your doctor.

Table of Contents

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

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

Clabilla Gem contains the active substance bilastinum, which has antihistaminic properties.
Clabilla Gem is used to relieve symptoms of hay fever (sneezing, itching, runny nose, nasal congestion, red and 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 Gem

When not to use Clabilla Gem

• 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 Gem, consult a doctor or pharmacist if the patient has moderate or severe kidney function impairment, low blood potassium, magnesium or calcium levels, 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 also taking other medicines (see “Clabilla Gem 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 Gem and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription.
In particular, inform your doctor if the patient is taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary artery 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, as well as allergic conditions such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic)

Clabilla Gem 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 effect of bilastine. To avoid this:

• 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 during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Before using 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, individual response to treatment may vary among patients.
Therefore, before driving or operating machinery, patients should assess how this medicine affects them.

Clabilla Gem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Clabilla Gem

This medicine should always be taken exactly as described in this patient leaflet or as advised 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) 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, "Clabilla Gem 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.

Duration of treatment
The duration of treatment depends on the type, duration and course of the illness. This medicine should not be used for longer than 10 days without consulting a doctor. If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Use in children
Do not give this medicine to children under 12 years of age.
Other formulations of this medicine – orodispersible tablets or oral solution – are intended for children aged 6 to 11 years weighing at least 20 kg. Consult a doctor or pharmacist.
Do not give these formulations of bilastine to children under 6 years of age weighing less than 20 kg, as there is insufficient data on safety and use.

Taking more Clabilla Gem than recommended
If you or someone else takes more than the recommended dose of Clabilla Gem, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department.
Take the medicine pack or leaflet with you.

If you forget to take Clabilla Gem
Do not take a double dose to make up for a missed dose.
If you miss a dose, 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 swelling and redness,
the medicine should be discontinued and immediate medical advice must be sought.

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)
• 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 (dizziness or spinning sensation)
• 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
• increased blood lipid levels

Frequency unknown: 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 ache (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
• 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 of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 helps to provide more information on the safety of the medicine.

5. How to store Clabilla Gem

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 after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clabilla Gem contains

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

What Clabilla Gem looks like and contents of the pack
Clabilla Gem is a white to almost white, oval, biconvex tablet with the imprint “Y41” on one side and a score line* on the other side (length 10 mm, width 5 mm).
*The score line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dosing.
The medicine is packed in two types of blisters:
PVC/PVDC/Aluminium blister:
Blister made of PVC/PVDC as the base layer and smooth aluminium foil as the top layer, with the blister packed in a cardboard box.
Aluminium/Aluminium blister:
Multilayer cold-form aluminium blister consisting of OPA and PVC as the base layer and smooth aluminium foil as the top layer, with the blister packed in a cardboard box.
Pack sizes available:
10 tablets.
Marketing Authorisation 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
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego Street 3
00-728 Warsaw
Phone: +48 22 35 12 500
Email: [email protected]
This medicine is authorised in the Member States of the European Economic Area under the following names: