BREETHE FX Chewable Tablet 10's

Introduction About BREETHE FX CHEWABLE TABLET

BREETHE FX CHEWABLE TABLET is a combination of Fexofenadine and Montelukast which belongs to the group of medicines called Histamine H1 receptor blockers and Leukotriene receptor antagonists respectively. BREETHE FX CHEWABLE TABLET is indicated to manage symptoms of allergic rhinitis (such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes) in adults and in adolescents (aged 15 years of above).

Allergic rhinitis is a heterogeneous disorder caused by allergens such as pollens, dusts, mould or flakes of skin from certain animals. It can occur seasonally or year-round and often characterized by inflammation of the inner lining of nose accompanied by nasal decongestion, repeated sneezing or a red, watery and itchy eyes.

BREETHE FX CHEWABLE TABLET should not be used as an alternative to manage acute asthma attacks. Consult your doctor for advice. Before taking BREETHE FX CHEWABLE TABLET, inform your doctor if you have any lung, liver or kidney problems.

BREETHE FX CHEWABLE TABLET is not recommended for use in breast-feeding women and should be used during pregnancy only if it clearly advised by your doctor. BREETHE FX CHEWABLE TABLET is not recommended for use in children aged below 15 years due to lack of safety data.

The most common side effects of taking BREETHE FX CHEWABLE TABLET are dizziness, drowsiness, headache, nausea, vomiting and diarrhea. Consult your doctor if any of the symptom bothers you.

Uses Of BREETHE FX CHEWABLE TABLET

• Manage allergic rhinitis in adults and in adolescents (aged 15 years of above)

How BREETHE FX CHEWABLE TABLET Works

BREETHE FX CHEWABLE TABLET reduces the unpleasant symptoms of allergic rhinitis, where fexofenadine acts by antagonizing the effects of histamine (a substance that cause allergic reaction) on the surface of cells and montelukast acts by blocking the leukotriene receptor, thus leading to a relaxation in smooth muscle, which in turn decreases swelling and inflammation in the airways.

How to use BREETHE FX CHEWABLE TABLET

Take this medicine as advised by your physician. Chew the medicine in the mouth thoroughly until it dissolves and then swallow it. Do not stop taking BREETHE FX CHEWABLE TABLET without informing your doctor.

Side Effects Of BREETHE FX CHEWABLE TABLET

How To Manage Side Effects

Nausea and vomiting:

Take this medicine just after meals. Stick to simple meals and avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Diarrhea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own to manage diarrhea. Consult your doctor if the symptom did not improve.

Skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom did not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume too much of alcohol. Consult your doctor if the symptom did not improve.

Dizziness or Drowsiness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Warning & Precautions

Pregnancy

There is no proper information on the use of BREETHE FX CHEWABLE TABLET during pregnancy and it should be used during pregnancy only if considered clearly necessary. Consult your doctor before taking BREETHE FX CHEWABLE TABLET.

Breastfeeding

BREETHE FX CHEWABLE TABLET is not recommended for use in breast-feeding women. Consult your doctor before taking BREETHE FX CHEWABLE TABLET.

Driving and Using Machines

Do not drive or operate any machines if you experience dizziness or drowsiness after taking BREETHE FX CHEWABLE TABLET.

Alcohol

Avoid consumption of alcohol while taking BREETHE FX CHEWABLE TABLET because it can make you feel drowsier.

Kidney

BREETHE FX CHEWABLE TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking BREETHE FX CHEWABLE TABLET.

Liver

BREETHE FX CHEWABLE TABLET should be used with caution in patients with liver disease. Consult your doctor before taking BREETHE FX CHEWABLE TABLET.

Allergy

Do not take BREETHE FX CHEWABLE TABLET if you are allergic to Fexofenadine or Montelukast.

Lungs

BREETHE FX CHEWABLE TABLET should not be used as a substitute to manage acute asthma attacks. Patients should be advised to keep their usual appropriate rescue medication readily available and should seek immediate medical advice if required.

Heart Disease

BREETHE FX CHEWABLE TABLET should be used with caution in patients with history or recent heart disease since it may increase the risk of fast or irregular heartbeat. Consult your doctor before taking BREETHE FX CHEWABLE TABLET.

Interactions

A. Drug-Drug interactions:

Before taking BREETHE FX CHEWABLE TABLET inform to your doctor, if you are taking any of these medicines:

• antacids (used to reduce stomach acids) e.g., aluminium or magnesium hydroxide
• phenytoin or phenobarbital (used to control seizure)
• rifampicin (used to manage Tuberculosis)
• gemfibrozil (used to manage high cholesterol levels)

B. Drug-Food interactions:

While taking BREETHE FX CHEWABLE TABLET avoid taking it together with fruit juices such as grapefruit orange and apple as it may reduce the bioavailability and decrease the effect of this medicine

Overdosage:

If you or anyone else accidentally take too much of BREETHE FX CHEWABLE TABLET, consult your doctor immediately. Overdosage may cause undesirable effects such as stomach pain, sleepiness, thirst, headache, dizziness, tiredness, vomiting, hyperactivity and dry mouth.

Synopsis

More Information

• Keep BREETHE FX CHEWABLE TABLET out of reach of children
• Store at room temperature

FAQs About BREETHE FX CHEWABLE TABLET

What is BREETHE FX CHEWABLE TABLET used for?

BREETHE FX CHEWABLE TABLET is indicated to manage symptoms of allergic rhinitis (such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes) in adults and in adolescents (15 years of age and above).

What are the symptoms of overdose of BREETHE FX CHEWABLE TABLET?

Always take the dose that is prescribed by your physician. However, if you or anyone accidently take too much of BREETHE FX CHEWABLE TABLET, consult your doctor or seek immediate medical attention. Symptoms of overdose can include stomach pain, tiredness, thirst, headache, vomiting, dry mouth, dizziness and hyperactivity.

Is BREETHE FX CHEWABLE TABLET safe to use during pregnancy?

There is no proper information on the use of BREETHE FX CHEWABLE TABLET during pregnancy and it should be used during pregnancy only if considered clearly necessary. Consult your doctor before taking BREETHE FX CHEWABLE TABLET if you are planning to get pregnant.

Can BREETHE FX CHEWABLE TABLET be used in children?

No. BREETHE FX CHEWABLE TABLET is not recommended for use in children aged below 15 years due to lack of safety and effectiveness. Consult your child’s doctor for advice if your child experiences any symptoms of allergic rhinitis such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes.

Can BREETHE FX CHEWABLE TABLET make you sleepy?

Yes. BREETHE FX CHEWABLE TABLET may make you feel sleepy or drowsy. Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much of alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

References

1. KD. Tripathi. Autocoids and related drugs & Drugs for Cough and Bronchial Asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page – 166-169 & 228-229.

2. Randal A. Skidgel, Allen P. Kaplan and Ervin G. Erdos. Histamine, Bradykinin and their antagonists. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 920-924.

3. Gerald G. Briggs and Roger K. & M. Freeman. F. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 1555-1556 & 2629-2632.

4. Indira Gandhi Medical College, Shimla. Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in September 2015] [Accessed on 23rd August 2021] https://clinicaltrials.gov/ct2/show/NCT02551536

5. Sanofi. Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in January 2011 2015] [Accessed on 23rd August 2021] https://clinicaltrials.gov/ct2/show/NCT00638118

6. Mohini Sachin Mahatme, Ganesh Natthuji Dakhale, Kanchan Tadke, Sachin Keshaorao Hiware, S. D. Dudhgaonkar and Sumit Wankhede. Comparison of efficacy, safety and cost-effectiveness of montelukast-levocetirizine and montelukast-fexofenadine in patients of allergic rhinitis: A randomized, double-blind clinical trial. NCBI; PMC US National Library of Medicine, National Institute of Health. November – December 2016. [Accessed on 23rd August 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5155464

7. Cipla Ltd. Montair FX Tablets (Montelukast sodium + Fexofenadine hydrochloride). Ciplamed. [Revised in March 2016] [Accessed on 23rd August 2021] https://www.ciplamed.com/content/montair-fx-tablets

8. Sanofi India Limited. Allegra M Tablets. Sanofi.in. [Revised in February 2019] [Accessed on 23rd August 2021] https://www.sanofi.in/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-IN/Home/science-and-innovation/for-healthcare-professionals/product-information/Allegra-M---PI.pdf

9. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised on August 2018] [Accessed 23rd August 2021] https://www.medicines.org.uk/emc/files/pil.3487.pdf

10. Merck Sharp & Dohme Limited. Electronic Medicines Compendium (EMC). [Revised in May 2020] [Accessed on 23rd August 2021] https://www.medicines.org.uk/emc/files/pil.198.pdf

11. Merck & Co., Inc. U.S. Food & Drug Administration. [Revised in March 2012] [Accessed on 23rd August 2021] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021409s036lbl.pdf

Author Details

Written By Dr. R. Dinesh John Rajkumar - Pharm.D

Reviewed For Accuracy By Dr. M N Himaja - MBBS

Last updated on 22 Oct 2022 | 06:38 PM(IST)