Ebal 10mg Tablet 10'S

INTRODUCTION

EBAL 10MG TABLET contains Ebastine which belongs to the group of medicines called Antihistamines. It is used in adults and children above 12 years of age for the treatment of seasonal and persistent allergic rhinitis (runny nose), with or without allergic conjunctivitis (inflammation of the eye). It is also used for the treatment of itching, and urticaria (hives) in adults over the age of 18 years.

Seasonal and perennial allergic rhinitis is an inflammatory condition of the nose that occurs when exposed to allergens. Symptoms include nasal congestion, sneezing, itching or runny nose.

EBAL 10MG TABLET should be used with caution in patients with severe liver disease, abnormal heart rhythm disorders, and low potassium levels in the blood. Contact your doctor before taking it.

EBAL 10MG TABLET should be used during pregnancy only if it is considered necessary and it is not recommended for use in breastfeeding women. Consult your doctor before taking this medicine.

EBAL 10MG TABLET is not recommended for use in children below 12 years of age. It is also not recommended for the treatment of urticaria (hives) in patients under the age of 18 years. Consult your doctor before taking it.

The most common side effects of taking EBAL 10MG TABLET are headache, drowsiness and dry mouth. Consult your doctor if any of these symptoms get worse.

USES OF EBAL 10MG TABLET

• Treat seasonal and persistent allergic rhinitis with or without allergic conjunctivitis in adults and children above 12 years of age
• Treat itching, and urticaria (hives) in adults over the age of 18 years

HOW EBAL 10MG TABLET WORKS

EBAL 10MG TABLET works by blocking the effect of histamine (a chemical messenger) which is responsible for allergic reactions in the body, thereby providing relief from allergic symptoms such as sneezing, runny nose, watery eyes and itchy skin rashes.

DIRECTIONS FOR USE

Take EBAL 10MG TABLET as advised by your physician. It can be taken with or without meals.

For Tablet: Swallow EBAL 10MG TABLET with a glass of water. Do not crush or chew the medicine.

For Dispersible Tablet: Disperse EBAL 10MG TABLET in the specified quantity of water as mentioned on the label. Consume the mixture immediately after reconstitution.

For Oral Disintegrating Tablet, Mouth Dissolving Tablet: Place EBAL 10MG TABLET inside your mouth and allow it to dissolve completely. Do not swallow or chew the medicine.

Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF EBAL 10MG TABLET

HOW TO MANAGE SIDE EFFECTS

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling drowsy. Do not consume alcohol, as it can aggravate your drowsiness. Contact your doctor if the drowsiness does not improve.

Dry Mouth

Try to drink plenty of cold water. Sip on cold, unsweetened drinks and use lip balm if your lips are dry. Try to brush your teeth twice a day and use mouthwash. Consult your doctor if the dry mouth gets worse.

Headache

Rest and relax. Drink plenty of fluids, such as water or ORS (Oral Rehydrating Solution), and apply a pain-relieving balm on the head if necessary. Contact your doctor if the headache does not improve.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

EBAL 10MG TABLET should be used during pregnancy only if it is considered necessary. Consult your doctor before taking EBAL 10MG TABLET.

BREASTFEEDING

Contraindicated

EBAL 10MG TABLET is not recommended for use in breastfeeding women as it is not known whether this medicine passes into breast milk. Consult your doctor before taking EBAL 10MG TABLET.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or operate any machines if you feel sleepiness, dizziness, tiredness and fainting after taking EBAL 10MG TABLET.

KIDNEY

Safe

EBAL 10MG TABLET can be used in patients with impaired kidney function with no dose adjustment. Contact your doctor before taking it.

LIVER

Consult your doctor

EBAL 10MG TABLET can be used in patients with mild to moderate impaired liver function with no dose adjustment. It should be used with caution in patients with severe liver disease. Contact your doctor before taking it.

ALLERGY

Contraindicated

EBAL 10MG TABLET is not recommended for use if you are allergic to Ebastine or any of the other ingredients of this medicine.

HEART DISEASE

Use with Caution

EBAL 10MG TABLET should be used with caution in patients with certain abnormal heart rhythm disorders such as prolongation of the QTc interval on the ECG. Consult your doctor before taking EBAL 10MG TABLET.

USE IN PEDIATRICS

Contraindicated

EBAL 10MG TABLET is not recommended for use in children below 12 years of age. It should not be used for the treatment of urticaria (hives) in patients under the age of 18 years as safety and efficacy have not been established. Consult your doctor before taking EBAL 10MG TABLET.

USE IN GERIATRICS

Use with Caution

EBAL 10MG TABLET should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking EBAL 10MG TABLET, inform your doctor, if you are taking any of the following medicine:

• ketoconazole, itraconazole (medicines used to treat fungal infections)
• erythromycin, clarithromycin, josamycin (a medicine used to treat bacterial infections)
• rifampicin (used to treat tuberculosis)

Overdosage:

If you or anyone else accidentally takes too much of EBAL 10MG TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• keep the medicine out of reach of children
• Store EBAL 10MG TABLET at room temperature

FAQs ABOUT EBAL 10MG TABLET

Q: For what conditions is EBAL 10MG TABLET used?

A: EBAL 10MG TABLET is used in adults and children aged 12 years and older for the treatment of seasonal and persistent allergic rhinitis (runny nose), with or without allergic conjunctivitis (inflammation of the eye). It is also used for the treatment of itching and urticaria (hives) in adults over the age of 18 years. Consult your doctor before taking it.

Q: Does EBAL 10MG TABLET cause dry mouth?

A: Yes, EBAL 10MG TABLET can cause dry mouth. For long-term treatment, good oral hygiene should be maintained (teeth should be cleaned with fluoride toothpaste twice daily) to prevent the risk of caries.

Q: Is EBAL 10MG TABLET used for "cold"?

A: Yes, EBAL 10MG TABLET is also used for the treatment of cold urticaria, dermographic urticaria, atopic asthma, mosquito bites, and the common cold in combination with a medicine called pseudoephedrine. Consult your doctor before taking EBAL 10MG TABLET.

Q: Who should avoid taking EBAL 10MG TABLET?

A: EBAL 10MG TABLET is not recommended for use in patients with an allergic history to Ebastine, galactose intolerance (a condition marked by increased blood glucose levels), Lapp lactose deficiency (a rare hereditary disorder where the body is unable to digest lactose (a sugar found in dairy products), or glucose-galactose malabsorption (a rare hereditary disorder where the body is unable to absorb glucose and galactose). Consult your doctor before taking EBAL 10MG TABLET.

Q: Is EBAL 10MG TABLET safe?

A: Yes, EBAL 10MG TABLET is safe and effective in relieving symptoms of allergic rhinitis and chronic idiopathic urticaria and provides efficacy throughout the 24-hour dosing interval with once-daily administration, and clinical benefit is seen from the first day of treatment.

Q: What are the side effects of taking EBAL 10MG TABLET?

A: The most common side effects of taking EBAL 10MG TABLET are headache, drowsiness, and dry mouth. Consult your doctor if any of these symptoms get worse.

REFERENCES

1. KD. Tripathi. Histamine and Antihistaminics. Essentials of medical pharmacology. Seventh edition. 2013. Page -167.

2. Seoul National University Hospital. The Effect of Ebastine/Pseudoephedrine on Subacute Cough. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2014] [Accessed on 14th May 2022] https://clinicaltrials.gov/ct2/show/NCT02065440

3. L R Wiseman, D Faulds. Ebastine. a review of its pharmacological properties and clinical efficacy in the treatment of allergic disorders. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed.gov.  February 1996. [Accessed on 14th May 2022] https://pubmed.ncbi.nlm.nih.gov/8808167/

4. Giorgio Ciprandi. Clinical utility and patient adherence with ebastine for allergic rhinitis. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed Central. 2010 [Accessed on 14th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3003605/

5. S Rohatagi, M Gillen, M Aubeneau, C Jan, B Pandit, B K Jensen, G Rhodes. Effect of age and gender on the pharmacokinetics of ebastine after single and repeated dosing in healthy subjects. National Institute of Health NLM, National Centre for Biotechnology Information. PubMed.gov.  March 2001. [Accessed on 14th May 2022] https://pubmed.ncbi.nlm.nih.gov/11396753/

6. Ebastine. [Revised in November 2020] [Accessed on 14th May 2022] https://docetp.mpa.se/LMF/Ebastine%20Generics%20orodispersible%20tablet%20ENG%20PL_09001bee807a05ec.pdf

7. STADA Arzneimittel AG. Ebastine. [Revised in June 2021] [Accessed on 14th May 2022] https://www.geneesmiddeleninformatiebank.nl/bijsluiters/h115466_piluk.pdf

8. Industrias Farmacéuticas Almirall, S.A. Ebastine. [Revised in June 2021] [Accessed on 14th May 2022] https://www.ravimiregister.ee/en/Data/PIL_ENG/PIL_10430_ENG.pdf

9. Industrias Farmacéuticas Almirall, S.A. Ebastine. [Revised in May 2019] [Accessed on 14th May 2022] https://medicarcp.com/website/pdf/pils/484%20-%20en.pdf

USEFUL DIAGNOSTIC TESTS

• Percutaneous skin test
• Allergen-specific immunoglobulin E (IgE) antibody test

AUTHOR DETAILS

Written By Dr. Dhivakaran R, BDS
Last updated on 06 Apr 2023 | 03:18 PM(IST)