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Orodispersible Tablet

Tinabil ODT 10 mg Orodispersible Tablet

Generic: Bilastine

Manufacturer: Incepta Pharmaceuticals Ltd.

Therapeutic class: Non-sedating (second-generation) antihistamine

What is Tinabil ODT used for?

Tinabil ODT (Orodispersible Tablet) contains Bilastine 10 mg and is made by Incepta Pharmaceuticals Ltd. Therapeutic class: Non-sedating (second-generation) antihistamine.

What is Tinabil ODT?

Tinabil ODT 10 mg is an orodispersible tablet containing bilastine, a second-generation non-sedating antihistamine from Incepta Pharmaceuticals Ltd. It is used to relieve symptoms of allergic rhinitis and urticaria, such as sneezing, runny nose, itching, and hives.

Tinabil ODT 10 mg orodispersible tablet by Incepta Pharmaceuticals Ltd. contains Bilastine, one of the newest non-sedating antihistamines. It is used to relieve allergic rhino-conjunctivitis — sneezing, runny and itchy nose, nasal blockage, red and watery eyes — and urticaria (hives) with skin itching. Bilastine hardly enters the brain, so at usual doses it causes essentially no drowsiness in most people.

During an allergic reaction the body releases histamine, which attaches to H1 receptors and produces sneezing, itching, swelling and watery discharge. Bilastine blocks these H1 receptors so histamine cannot act, calming the allergy symptoms. Because the medicine stays mainly outside the brain and is not broken down by the liver to any major extent, it works with minimal sedation and few drug interactions.

Indications

Tinabil ODT is used for:

  • Allergic rhino-conjunctivitis — seasonal or perennial allergy with sneezing, runny nose, nasal itching, blocked nose, and red, itchy or watery eyes
  • Urticaria (hives) — including chronic urticaria with itching and wheals
  • Other histamine-mediated allergic symptoms where the doctor finds it appropriate

It is approved for adults and adolescents from 12 years; for younger children, use only as directed by a doctor with the appropriate formulation.

Dosage & Administration

ChamberBD shows dosing only from the approved product label, with its source named, and no label is on file for Tinabil ODT 10 mg Orodispersible Tablet. Use the dose your doctor prescribed and the instructions in the pack leaflet.

Side Effects

Tinabil ODT is usually very well tolerated. Possible side effects include:

  • Headache
  • Drowsiness or tiredness in a small number of users
  • Dizziness
  • Stomach discomfort, nausea (uncommon)
  • Dry mouth (uncommon)
  • Rarely: palpitations or allergic reactions such as rash and swelling

Serious side effects are rare. If you develop widespread rash, facial swelling or breathing difficulty after taking Tinabil ODT, stop the medicine and seek immediate medical attention.

Precautions & Warnings

  • Always take Tinabil ODT on an empty stomach with water; food, fruit juice and grapefruit juice in particular reduce its absorption.
  • Tell your doctor if you have moderate or severe kidney problems — special caution is needed, especially with certain other medicines.
  • Although drowsiness is rare, check your own response before driving or operating machinery.
  • Avoid taking it together with ketoconazole, erythromycin or other interacting medicines unless your doctor approves.
  • Tell your doctor if you have a history of heart rhythm disorders.
  • Keep your doctor informed of all medicines and supplements you use.

Drug Interactions

Key interactions of Bilastine:

  • Food and fruit juices — significantly reduce absorption; keep a gap of at least 1 hour before and 2 hours after food, and avoid fruit juice within 1 hour.
  • Ketoconazole, erythromycin, diltiazem — can increase bilastine blood levels; use together only on medical advice.
  • P-glycoprotein inhibitors in patients with kidney impairment — combination should be avoided.
  • Alcohol — at the usual dose bilastine adds little sedation, but moderation is still sensible.

Tell your doctor or pharmacist about every medicine you take before starting Tinabil ODT.

Contraindications

  • Known hypersensitivity to Bilastine or any ingredient of the preparation
  • Not recommended below 12 years of age unless a child-appropriate formulation is prescribed by a doctor
  • In moderate-to-severe kidney impairment, avoid combining with ketoconazole, erythromycin, diltiazem or similar interacting drugs
  • Use in significant heart rhythm disorders only under medical supervision

Pregnancy & Lactation

There is limited experience with Bilastine in pregnant women, so it is preferably avoided during pregnancy unless the doctor judges it clearly necessary. Whether Bilastine passes into human breast milk is not well established; breastfeeding mothers should consult a doctor, who may select this medicine or a longer-studied alternative. Do not start Tinabil ODT in pregnancy or while breastfeeding without medical advice.

Storage Conditions

Store Tinabil ODT below 30°C in a dry place, protected from light and moisture. Keep the medicine in its original pack and out of the reach of children. Do not use after the expiry date printed on the packaging.

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