Bilaxten 2.5mg /Ml 120 Ml Oral Solution

Product Description:

What Bilaxten is and what it is used for:

• Bilaxten contains the active substance bilastine which is an antihistamine.


• Bilaxten is used to relieve the symptoms of hay fever (sneezing, itchy, runny, blocked‐up nose and red and watery eyes) and other forms of allergic rhinitis.


• It may also be used to treat itchy skin rashes (hives or urticaria).


• Bilaxten 2.5 mg/ml oral solution is indicated in children aged 6 to 11 years with a body weight of at least 20 kg.

How To Use:

• Always use this medicine exactly as your doctor or pharmacist has told you.


• Check with your doctor or pharmacist if you are not sure.

Use in children:

• The recommended dose in children 6 to 11 years of age with a body weight of at least 20 kg is 10 mg bilastine (4ml of oral solution) once daily for the relief of symptoms of allergic rhinoconjunctivitis and urticaria.


• Do not give this medicine to children under 6 years of age with a body weight below 20 kg since no sufficient data are available.

Use in adults:

• For adults, including elderly and adolescents aged 12 years and over, the recommended dose is 20 mg bilastine once daily.


• For this patient population a more appropriate dosage form – tablet ‐ is available, ask your doctor or pharmacist.

The oral solution is for oral use.

• The bottle of oral solution is provided with a childproof cap and must be opened as follows:


• Press the plastic screw‐cap downwards and turn anticlockwise at the same time


• The oral solution is accompanied by a cup for dosage with a mark of 4 ml (= 10 mg bilastine per dosing),which will help you to dose the oral solution correctly


• Fill the cup with 4 ml of oral solution


• Administer directly from the cup


• Wash the cup after use


• You should give the oral solution to your child one hour before or two hours after your child has taken any food or fruit juice.


• As the duration of treatment depends on your child’s Underlying disease, your physician will determine for How long your child should take bilaxten.

Caution & Warnings:

Possible side effects

• Like all medicines, this medicine can cause side effects,although not everybody gets them.

Side effects that may be experienced in children are:

Common: may affect up to 1 in 10 people

• Rhinitis (nasal irritation)


• Allergic conjunctivitis (eye irritation)


• Headache


• Stomach pain (abdominal /upper abdominal pain)
  Uncommon: may affect up to 1 in 100 people


• Eye irritation


• Dizziness


• Loss of consciousness


• Diarrhea


• Nausea (the feeling of being sick)


• Lip swelling


• Eczema


• Urticaria (hives)


• Fatigue

Side effects that may be experienced 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 ECG heart tracing


• Blood tests which show changes in the way the liver is working


• Dizziness


• Stomach pain


• Tiredness


• Increased appetite


• Irregular heartbeat

Ingredients:

• Contents of the pack and other information

What Bilaxten contains:

• The active substance is bilastine.


• Each 1 ml contains 2.5 mg bilastine.

The other ingredients:

• betacyclodextrin,hydroxyethylcellulose, methyl parahydroxybenzoate,propyl parahydroxybenzoate, sucralose, liquid raspberryflavor, concentrated hydrochloric acid (37%) and sodiumhydroxide.

What Bilaxten looks like and contents of the pack:

• Bilaxten 2.5 mg/ml Oral Solution is a clear colorless slightly viscous aqueous solution without precipitate with raspberry flavor in amber glass bottles, not printed and without imperfections, sealed with a polypropylene.


• child‐proof cap, including a measuring cup in a cartonbox.


• Pack size: 1 Bottle (120 ml).