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Description Bilastyna Hitaxa Junior contains the active substance bilastine, an antihistamine. It is used in children aged 6 to 11 years weighing at least 20 kg to relieve the symptoms of hay fever and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes. Composition The active substance is bilastine ( Bilastinum ) . Each orodispersible tablet contains 10 mg of bilastine. Excipients: Mannitol DC; Ethylcellulose; Crospovidone type A; Grape flavor (main ingredients: corn maltodextrin, gum arabic, flavoring substances); Magnesium stearate; Sucralose. Dosage Always use this medicine exactly as your doctor has told you. If you have any questions, ask your doctor or pharmacist. Children aged 6 to 11 years (weighing at least 20 kg): 1 tablet (10 mg) once daily. Adults and adolescents (12 years and over): The recommended dose is 20 mg daily, available in another form (standard tablets). The medicine should not be given to children under 6 years of age weighing less than 20 kg. The orodispersible tablet is intended for oral administration. Place the orodispersible tablet in your childs mouth. It will dissolve quickly in saliva and can then be easily swallowed. You can also dissolve the orodispersible tablet in a teaspoon of water before giving it to your child. Make sure there is no residue on the spoon. Use only water to dissolve the tablet; do not use grapefruit juice or other fruit juices. Give your child the orodispersible tablet one hour before or two hours after any meal or fruit juice. Action Bilastine Hitaxa Junior is an antihistamine drug. Bilastine is a non-sedating, long-acting histamine antagonist with selective affinity for peripheral H1 receptors. Indications Bilastyna Hitaxa Junior is indicated for the symptomatic treatment of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria. Bilastyna Hitaxa Junior is indicated for use in children aged 6 to 11 years with a body weight of at least 20 kg. Contraindications Do not use the medicine in case of hypersensitivity to any of the products ingredients. Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If your child experiences hypersensitivity reactions, including difficulty breathing, dizziness, collapse 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 a doctor or the nearest hospital emergency department immediately. Other side effects that may occur in children include: Common: occurring in less than 1 in 10 patients treated: rhinitis (nose irritation); allergic conjunctivitis (eye irritation); headache; stomach pain (abdominal pain, upper abdominal pain). Uncommon: occurring in less than 1 in 100 patients treated: eye irritation; dizziness; loss of consciousness; diarrhea; nausea; lip swelling; eczema; hives; fatigue. Side effects that may occur in adults and adolescents include: Common: occurring in less than 1 in 10 patients treated: headache; drowsiness. Uncommon: affecting less than 1 in 100 patients treated: abnormal ECG; changes in blood tests indicating liver problems; dizziness; stomach pain; tiredness; increased appetite; heart rhythm problems; weight gain; nausea; anxiety; dry or uncomfortable feeling in the nose; abdominal pain; diarrhea; gastritis (inflammation of the lining of the stomach); vertigo (dizziness or a spinning sensation); weakness; thirst; dyspnoea (difficulty breathing); dry mouth; indigestion; itching; oral herpes; fever; tinnitus (ringing in the ears); sleep disorders; changes in blood tests indicating kidney problems; increased levels of fat in the blood. Unknown frequency: cannot be estimated from the available data: palpitations (feeling of the heartbeat); tachycardia (rapid heartbeat); vomiting. Warnings and precautions Caution should be exercised especially in patients with: renal impairment, then concomitant administration of bilastine and P-glycoprotein inhibitors should be avoided. Taking the tablet simultaneously with grapefruit juice or food reduces the bioavailability of bilastine by 30%. Keep the medicine out of the sight and reach of children. Use of other medications Tell your doctor about all the medicines you are taking, have recently taken or are planning to take, including those obtained without a prescription. This information is especially important if you are taking: ketoconazole (an antifungal medicine), erythromycin and rifampicin (antibiotics), diltiazem (a medicine used to treat angina pectoris), cyclosporine (a medicine used to reduce the activity of the immune system, thus avoiding transplant rejection, or to reduce disease activity in autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis), ritonavir (a medicine used to treat AIDS). Pregnancy and breastfeeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The decision to use the drug during pregnancy or breastfeeding is made by the doctor. Use of the drug in children and adolescents Not to be used in children under 6 years of age weighing less than 20 kg. Driving and operating machinery This medicine does not affect your ability to drive or operate machinery.
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