Clabilla Gem

Package Leaflet: Information for the Patient

Clabilla Gem, 20 mg, Tablets

Bilastine

Read the package 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 package 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, ask 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, you should contact your doctor.

Table of Contents of the Leaflet

• 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 bilastine, which has antihistamine properties. Clabilla Gem 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. The medicine may also be used to treat itchy skin rashes (hives).

2. Important information before taking Clabilla Gem

When not to take Clabilla Gem

• 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 Gem, you should discuss it 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, and if you are also taking other medicines (see "Clabilla Gem 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 Gem with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as 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)
• cyclosporin (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, as well as allergic diseases 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 nottake the tablets with food or grapefruit juice or other fruit juices, as this reduces the effect of bilastine. To avoid this, 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 or breastfeeding women, as well as its effect on fertility. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist 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 vehicles in adults. However, the response to treatment may vary from patient to patient. Therefore, before driving or operating machinery, check how this medicine affects you.

Clabilla Gem contains sodium

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

3. How to take Clabilla Gem

This medicine should always be taken exactly as described in this package 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 and older is 1 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, "Clabilla Gem 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 you have difficulty swallowing it whole.

Duration of treatment

The duration of treatment depends on the type, duration, and course of the disease. Do not take this medicine without consulting your doctor for more than 10 days. If after 3 days there is no improvement or you feel worse, consult your doctor.

Use in children

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

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

Do not give these forms of bilastine 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 Gem

If you or someone else has taken a higher dose of Clabilla Gem than recommended, immediatelycontact your doctor or pharmacist or go to the emergency department of the nearest hospital. Take the medicine packaging or leaflet with you.

Missed dose of Clabilla Gem

Do nottake a double dose to make up for a missed dose. If you miss a dose, 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 Gem can cause side effects, although not everybody gets them. If you experience allergic reactions, 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 changes indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disorders
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis
• dizziness (feeling of spinning or rotation)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dryness of the mouth
• indigestion
• itching
• facial rash
• fever
• ringing in the ears (tinnitus)
• sleep disorders
• blood test changes 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

• rhinitis (nasal irritation)
• 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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 Clabilla Gem

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 "EXP" abbreviation. The expiry date refers to the last day of the month. There are no special storage instructions 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. 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 carboxymethylcellulose (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 "Y41" engraved on one side and a score line on the other side (length 10 mm, width 5 mm). The score line on the tablet is only to facilitate breaking the tablet, for easier swallowing, and not for dividing into equal doses. The medicine is packed in two types of blisters:

PVC/PVDC/Aluminum Blister:

A blister with PVC/PVDC film as the base layer and smooth aluminum foil as the covering layer, then packaged in a cardboard box.

Aluminum/Aluminum Blister:

A multi-layered blister with cold-formed aluminum, consisting of OPA and PVC film as the base layer and smooth aluminum foil as the covering layer, then packaged in a cardboard box. Available pack sizes: 10 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

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o., ul. Dziekońskiego 3, 00-728 Warsaw, tel. +48 22 35 12 500, e-mail: [email protected]

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

Date of last revision of the leaflet:March 2025