Clatra

Package Leaflet: Information for the Patient

Clatra, 2.5 mg/mL, Oral Solution

For Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg

Bilastine

Read the Package Leaflet Carefully Before Giving the Medicine to the Child, as it Contains Important Information for the Patient.

• Keep this Package 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 the Child Only. Do not Pass it on to Others. It may Harm them, even if their Symptoms are the Same as the Child's.
• If the Child Experiences any Side Effects, including any not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Clatra and What is it Used for
• 2. Important Information Before Taking Clatra
• 3. How to Take Clatra
• 4. Possible Side Effects
• 5. How to Store Clatra
• 6. Contents of the Package and Other Information

1. What is Clatra and What is it Used for

Clatra Contains the Active Substance Bilastine, which Acts as an Antihistamine.
Clatra is Used to Relieve the Symptoms of Hay Fever (Sneezing, Itching, Runny Nose, Nasal Congestion, and Red, Itchy, Watery Eyes) and Other Forms of Allergic Rhinitis.
Clatra may also be Used to Treat Itchy Skin Rashes (Hives or Urticaria).
Clatra, 2.5 mg/mL Oral Solution is Indicated for Use in Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg.

2. Important Information Before Taking Clatra

When Not to Take Clatra:

• If the Child is Allergic to Bilastine or any of the Other Ingredients of this Medicine (Listed in Section 6).

Warnings and Precautions

Before Starting to Take Clatra, Discuss this with the Doctor or Pharmacist if the Child has Moderate or Severe Kidney or Liver Problems, Low Potassium, Magnesium, or Calcium Levels in the Blood, if the Child has or has had Heart Rhythm Problems or a Very Slow Heart Rate, if the Child is Taking Medicines that may Affect the Heart Rhythm, if the Child has or has had an Abnormal Heart Rhythm (Known as a Prolonged QTc Interval on the Electrocardiogram), which may Occur in Certain Types of Heart Disease, or if the Child is Taking Other Medicines (See "Clatra with Other Medicines").

Children

Do not Give this Medicine to Children Under 2 Years of Age or with a Body Weight Below 15 kg, as there is Limited Data on the Use of this Medicine in this Age Group.

Clatra with Other Medicines

Tell the Doctor or Pharmacist About all Medicines the Child is Taking, Including those Bought Without a Prescription, and any the Child may Take in the Future.
Some Medicines Should not be Taken at the Same Time, and with Others, the Dose may Need to be Changed when Taken Together.
Always Inform the Doctor or Pharmacist if the Child is Taking any of the Following Medicines in Addition to Clatra:

• Ketoconazole (an Antifungal Medicine)
• Erythromycin (an Antibiotic)
• Diltiazem (a Medicine Used for Angina - Chest Pain or Discomfort)
• Cyclosporin (a Medicine that Reduces the Activity of the Immune System, Used to Prevent Transplant Rejection or Reduce the Severity of Diseases such as Psoriasis, Atopic Dermatitis, or Rheumatoid Arthritis)
• Ritonavir (Used to Treat HIV)
• Rifampicin (an Antibiotic)

Clatra with Food, Drink, and Alcohol Do not Take the Medicine with Food, Grapefruit Juice, or Other Fruit Juices

as thisReduces the Effect of Clatra. To Avoid Reducing the Effect of Clatra:

• Give the Child the Oral Solution and Wait for 1 Hour Before Giving the Child a Meal or Fruit Juice or
• If the Child has Eaten a Meal or Drunk Fruit Juice, Wait for 2 Hours Before Giving the Child the Oral Solution.

Bilastine at the Recommended Dose in Adults (20 mg) Does not Increase Drowsiness Caused by Alcohol Consumption.

Pregnancy, Breast-feeding, and Fertility

This Medicine is Intended for Use in Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg. However, the Following Information on the Safe Use of this Medicine Should be Considered. There are Limited Data on the Use of Bilastine in Pregnant or Breast-feeding Women, or on its Effects on Fertility.
If the Patient is Pregnant or Breast-feeding, or Plans to have a Child, She Should Consult the Doctor Before Taking this Medicine.
Before Taking any Medicine, Consult the 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 or Use Machines in Adults. However, the Response to Treatment may Vary from Patient to Patient.
Therefore, Check how this Medicine Affects the Child Before Allowing the Child to Ride a Bicycle, Drive Other Vehicles, or Use Machines.

Clatra Contains Methyl Parahydroxybenzoate (E 218) and Propyl Parahydroxybenzoate

(E 216),which may Cause Allergic Reactions (Possible Delayed Reactions).

Clatra Contains Ethanol and Sodium

This Medicine Contains 0.44 mg of Alcohol (Ethanol) per Dose (4 mL), which is Equivalent to 11 mg/100 mL (0.011% w/v). The Amount of Alcohol in 4 mL of this Medicine is Equivalent to Less than 0.02 mL of Beer or 0.005 mL of Wine.
The Small Amount of Alcohol in this Medicine will not Produce any Notable Effects.
This Medicine Contains Less than 1 mmol (23 mg) of Sodium per 4 mL, which is Considered to be Essentially "Sodium-Free".

3. How to Take Clatra

This Medicine Should Always be Taken Exactly as Advised by the Doctor or Pharmacist. If You are Not Sure, Ask the Doctor or Pharmacist.

Use in Children

The Recommended Dose for Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg is 10 mg of Bilastine (4 mL of Oral Solution) Once a Day to Relieve the Symptoms of Allergic Rhinitis and Urticaria.
Do not Give this Medicine to Children Under 2 Years of Age or with a Body Weight Below 15 kg, as there is Limited Data on the Use of this Medicine in this Age Group.
For Adults, Including the Elderly and Adolescents Aged 12 Years and Above, the Recommended Dose of Bilastine is 20 mg Once a Day. For this Population of Patients, a More Suitable Form of the Medicine is Available - a Tablet; Consult the Doctor or Pharmacist.

• The Oral Solution is for Oral Use.
• The Oral Solution Bottle with a Child-Resistant Closure Should be Opened as Follows: Press the Plastic Cap Down and Turn it in the Opposite Direction to the Arrow.
• A Measuring Cup is Provided with the Oral Solution to Help Measure the Dose. The Measuring Cup has a Marking for 4 mL (= 10 mg Bilastine per Dose) to Ensure the Correct Amount of Oral Solution is Measured.
• Fill the Measuring Cup with 4 mL of Oral Solution.
• Give the Oral Solution Directly from the Measuring Cup.
• Wash the Measuring Cup After Use.
• Give the Oral Solution to the Child 1 Hour Before or 2 Hours After any Meal or Fruit Juice.

The Duration of Treatment Depends on the Type of Disease in the Child. The Doctor will Decide how Long the Child Should Take Clatra.

Overdose of Clatra

If the Child Takes More Clatra than they Should, or if Someone Else Takes the Child's Medicine, Contact the Doctor or Go to the Nearest Hospital Emergency Department Immediately. Take the Medicine Package or Package Leaflet with You.

Missed Dose of Clatra

If a Dose is Missed, Give it to the Child as Soon as Possible on the Same Day. Then, Give the Next Dose at the Usual Time on the Next Day as Advised by the Doctor.
Never Give a Double Dose to Make up for a Forgotten Dose.

Stopping Clatra Treatment

No Effects are Expected if Clatra Treatment is Stopped.
If You Have any Further Questions on the Use of this Medicine, Ask the Doctor or Pharmacist.

4. Possible Side Effects

Like all Medicines, Clatra can Cause Side Effects, although not Everybody Gets them.
If the Child Experiences 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 the Doctor Immediately.

Other Side Effects that may Occur in Children Include:

Common: May Affect up to 1 in 10 People

• Allergic Conjunctivitis (Eye Irritation)
• Headache

Uncommon: May Affect up to 1 in 100 People

• Eye Irritation
• Dizziness
• Loss of Consciousness
• Diarrhea
• Nausea
• Lip Swelling
• Rash
• Urticaria
• Fatigue
• Rhinitis (Nasal Irritation)
• Abdominal Pain (Stomach Pain, Abdominal Discomfort)

Side Effects that may Occur in Adults and Adolescents Include:

Common: May Affect up to 1 in 10 People

• Headache
• Drowsiness

Uncommon: May Affect up to 1 in 100 People

• Abnormal Electrocardiogram (ECG) Reading
• Changes in Blood Tests Indicating Liver Problems
• Dizziness
• Abdominal Pain
• Fatigue
• Increased Appetite
• Heart Rhythm Problems
• Weight Gain
• Nausea
• Anxiety
• Nose Dryness or Discomfort
• Abdominal Pain
• Diarrhea
• Gastritis (Inflammation of the Stomach Lining)
• Dizziness (Feeling of Spinning or Rotating)
• Weakness
• Increased Thirst
• Shortness of Breath (Difficulty Breathing)
• Dry Mouth
• Indigestion
• Itching
• Oral Thrush
• Fever
• Tinnitus (Ringing in the Ears)
• Sleep Disorders
• Changes in Blood Tests Indicating Kidney Problems
• High Levels of Lipids in the Blood

Frequency Not Known: Cannot be Estimated from the Available Data

• Palpitations (Feeling of Heartbeats)
• Tachycardia (Fast Heart Rate)
• Vomiting.

Reporting Side Effects

If the Child Experiences any Side Effects, including any not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Drug Safety, Ministry of Health, via the Online Reporting System at [insert website URL].
Side Effects can also be Reported to the Marketing Authorization Holder.

5. How to Store Clatra

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 Bottle after "EXP".
The Expiry Date Refers to the Last Day of that Month.
Do not Store Above 30°C.
The Shelf-Life After First Opening is 6 Months.
Do not Use this Medicine if the Patient Notices any Visible Particles.
Medicines Should not be Disposed of via Wastewater or Household Waste. Ask the Pharmacist how to Dispose of Medicines no Longer Required. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Clatra Contains

• The Active Substance is Bilastine. 1 mL of Oral Solution Contains 2.5 mg of Bilastine.
• The Other Ingredients are: Betadex (E 459), Hydroxyethylcellulose, Methyl Parahydroxybenzoate (E 218), Propyl Parahydroxybenzoate (E 216), Sucralose (E 955), Raspberry Flavor (Main Components are: Ethanol, Triacetin, Water, Ethyl Acetate, Linalool Acetate), Hydrochloric Acid 37% or 10% (for pH Adjustment), Sodium Hydroxide (for pH Adjustment), Purified Water.

What Clatra Looks Like and Contents of the Package

Clatra is a Clear, Colorless, Slightly Viscous Aqueous Solution with a pH of 3.0-4.0 and no Sediment.
Clatra, 2.5 mg/mL Oral Solution, is Available in a Brown Glass Bottle with a Child-Resistant Closure, Together with a Measuring Cup with a 4 mL Marking. Each Bottle Contains 120 mL of Oral Solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Faes Farma, S.A.
Màximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

This Medicine is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the Following Names:

Austria:
Nasitop 2,5 mg/ml Lösung zum Einnehmen
Belgium:
Bellozal 2,5 mg oral solution
Bulgaria:
Фортекал за деца, 2.5 mg/ml перорален разтвор
Cyprus:
Bilaz 2.5 mg/mL πόσιμο διάλυμα
Czech Republic:
Xados
Denmark:
Revitelle, oral opløsning 2,5 mg/ml
Estonia:
Opexa
Finland:
Revitelle
France:
Bilaska 2.5 mg/ ml solution buvable
Germany:
Bilaxten 2,5 mg/ml Lösung zum Einnehmen
Greece:
Bilaz 2.5 mg/mL πόσιμο διάλυμα
Hungary:
Lendin
Iceland:
Bilaxten 2,5 mg/ml mixtúra, lausn
Ireland:
Drynol
Latvia:
Opexa 2,5 mg/ml šķīdums iekšķīgai lietošanai
Lithuania:
Opexa
Luxembourg: Bellozal 2,5 mg oral solution
Malta:
Gosall 2.5 mg/ml oral solution
Norway:
Zilas 2,5 mg/ml mikstur, oppløsning
Poland:
Clatra
Portugal:
Lergonix 2,5 mg/ml solução oral
Romania:
Borenar 2,5 mg/ml soluţie orală
Slovakia:
Omarit 2,5 mg/ml perorálny roztok
Slovenia:
Bilador 2,5 mg peroralna raztopina
Spain:
Ibis 2,5 mg/ml solución oral
Sweden:
Bilaxten
United Kingdom (Northern Ireland): Ilaxten
To Obtain More Detailed Information on this Medicine, Contact the Local Representative of the Marketing Authorization Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of Last Revision of the Package Leaflet:03/2025