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Other brands with the same active ingredient
These brands contain the same active ingredient (Bilastine). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Tinabil is indicated for:
Pharmacology
Bilastine is a potent, long-acting histamine antagonist that doesn't cause sedation. It binds selectively and strongly to the H1 receptor, 3 times more strongly than Cetirizine and 5 times more strongly than Fexofenadine. Even at a high concentration, Bilastine shows no affinity for 30 other receptors, including the muscarinic, serotonergic, dopaminergic and noradrenergic receptors. It also doesn't bind to the other histamine receptor subtypes (H2, H3 and H4).
The safety profile is excellent, and the pharmacokinetic characteristics are very favourable. Bilastine doesn't need to be metabolised to become active. It leaves the body through feces (non-systemic) and urine (systemic), at approximately 66.35% and 28.31% respectively.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Adults and adolescents (12 years and over) take one 20 mg Bilastine tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet), and this should not be exceeded. If a dose is missed, take the next scheduled dose. Don't take an extra dose. Swallow the tablet with water on an empty stomach, so the body gets the best exposure to Bilastine.
Children between 6 and 11 years take a 10 mg mouth dissolving tablet for symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The mouth dissolving tablet is for oral use only. Place it in the mouth, where it disperses rapidly in saliva and can be swallowed easily. It can also be dispersed in a teaspoon of water before the child swallows it. The maximum recommended daily dose for children aged 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet), and this should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.
Children between 2 and 11 years: 4 ml once daily.
Side Effects
In clinical trials, the side effects most often reported with Bilastine were headache, dizziness, somnolence and fatigue. Patients who were given placebo had these same events at a similar rate.
Cautions & Contraindications
Warnings & Precautions
Bilastine does not affect driving performance. Still, patients should know that very rarely some people feel drowsy, and this may affect their ability to drive or use machines. In clinical trials, elderly patients (≥65 years) showed no difference in efficacy or safety compared with younger patients. In patients with severe renal impairment, the maximum plasma concentration of Bilastine after a 20 mg dose stays below the safety threshold for most common adverse effects and for cardiac and CNS safety. So no dose adjustment is needed in patients with renal impairment. Bilastine is not metabolized in humans. Most of it leaves the body through the kidneys, so biliary excretion is expected to play only a small part in its elimination. Changes in liver function are not expected to have a clinically relevant influence.
Contraindications
Don't give Bilastine to anyone who is hypersensitive to the active substance, or to any of the other ingredients (excipients) in the tablet.
Pregnancy & Breastfeeding
There is little or no data on the use of Bilastine in pregnant women. Animal studies don't show any direct or indirect harmful effects on reproductive toxicity, parturition or postnatal development. Even so, as a precaution, it is better to avoid Bilastine during pregnancy.
Whether Bilastine passes into breast milk has not been studied in humans. So the decision needs to weigh the benefit of breast-feeding for the child against the benefit of Bilastine therapy for the mother.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Bilastine has not been shown to be effective or safe in children under 2 years of age, and there is little clinical experience with it in children aged 2 to 5 years. For this reason, Bilastine should not be used in either of these age groups.
Overdose
In clinical trials, people were given Bilastine at 10 to 11 times the therapeutic dose, either 220 mg as a single dose or 200 mg/day for 7 days. Treatment-emergent adverse events happened two times more often than with placebo. The reactions reported most often were dizziness, headache and nausea. No serious adverse events were reported, and there was no significant prolongation in the QTc interval.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Bilastine below 30°C, away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Tinabil 20 mg
What is Tinabil 20 mg Tablet?
Tinabil 20 mg Tablet is a medicine that contains Bilastine. It is made by Incepta Pharmaceuticals Ltd. (Dhamrai Unit). It belongs to the Non-sedating antihistamines group of medicines.
What is Tinabil used for?
Tinabil is used for: Allergic Rhinitis, Fever, Urticaria, Conjunctivitis.
What are the side effects of Tinabil?
In clinical trials, the side effects most often reported with Bilastine were headache, dizziness, somnolence and fatigue. Patients who were given placebo had these same events at a similar rate.
Can I take Tinabil during pregnancy or while breastfeeding?
There is little or no data on the use of Bilastine in pregnant women. Animal studies don't show any direct or indirect harmful effects on reproductive toxicity, parturition or postnatal development. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Tinabil?
In clinical trials, people were given Bilastine at 10 to 11 times the therapeutic dose, either 220 mg as a single dose or 200 mg/day for 7 days. Treatment-emergent adverse events happened two times more often than with placebo. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Tinabil?
Store Bilastine below 30°C, away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Tinabil?
Some medicines can interact with Bilastine, for example: Cyclosporine, Erythromycin, Lorazepam, Ketoconazole, Diltiazem Hydrochloride. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Tinabil?
Tinabil is a prescription (Rx) medicine. Take it as your doctor advises.