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INTRODUCTION
FEXOLIFE M 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. FEXOLIFE M TABLET is indicated to treat 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.
FEXOLIFE M TABLET should not be used as an alternative to treat acute asthma attacks. Consult your doctor for advice. Before taking FEXOLIFE M TABLET, inform your doctor if you have any lung, liver or kidney problems.
It is not recommended for use in breast-feeding women and should be used during pregnancy only if it clearly advised by your doctor. FEXOLIFE M 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 FEXOLIFE M TABLET are dizziness, drowsiness, headache, nausea, vomiting and diarrhea. Consult your doctor if any of the symptom bothers you.
USES OF FEXOLIFE M TABLET
- Treats allergic rhinitis in adults and in adolescents (aged 15 years of above)
HOW FEXOLIFE M TABLET WORKS
FEXOLIFE M 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.
DIRECTIONS FOR USE
Take FEXOLIFE M TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking FEXOLIFE M TABLET without informing your doctor.
SIDE EFFECTS OF FEXOLIFE M TABLET
COMMON
- headache
- drowsiness or dizziness
- nausea and vomiting
- diarrhea
- infections of upper respiratory tract
- skin rashes
- fever
UNCOMMON
- tiredness, sleepiness
- behavior and mood related changes (irritability, dream abnormalities, including nightmares, trouble sleeping, sleepwalking, anxious, restlessness)
- tingling, prickling or numbness sensation
- nosebleed
- indigestion, dry mouth
- bruising, itching
- muscle cramps, joint or muscle pain
- bedwetting in children
- weakness, feeling unwell, swelling
RARE
- attention disturbance, memory impairment and uncontrolled muscle movements
- palpitations
- angioedema (swelling of the areas under the skin)
Stop taking FEXOLIFE M TABLET and contact your doctor immediately if you experience any of the following side effects:
- severe allergic reactions (such as swelling of the face, lips, tongue and/or throat, difficulty in breathing or swallowing, mood changes, agitation, aggressive behavior or hostility, depression, seizure)
- increased bleeding tendency, tremor (shaking), palpitations (fast heartrate)
- flu-like symptoms, numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss Syndrome)
- decreased blood platelet count (signs include easy bleeding or bruising)
- inflammation (swelling) of the lungs
- neuropsychiatric changes (such as disorientation, hallucinations)
- thoughts of harming or killing yourself (suicidal ideation)
- erythema multiforme (a severe skin reactions)
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take this medicine with or just after meals. Stick to simple meals and avoid eating oil rich or spicy foods. Consult your doctor if the symptom did not improve.
Diarrhoea:
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own to treat 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 forehead 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 FEXOLIFE M TABLET during pregnancy and it should be used during pregnancy only if considered clearly necessary. Consult your doctor before taking FEXOLIFE M TABLET.
BREASTFEEDING
FEXOLIFE M TABLET is not recommended for use in breast-feeding women. Consult your doctor before taking FEXOLIFE M TABLET.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you experience dizziness or drowsiness after taking FEXOLIFE M TABLET.
ALCOHOL
Avoid consumption of alcohol while taking FEXOLIFE M TABLET because it can make you feel drowsier.
KIDNEY
FEXOLIFE M TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking FEXOLIFE M TABLET.
LIVER
FEXOLIFE M TABLET should be used with caution in patients with liver disease. Consult your doctor before taking FEXOLIFE M TABLET.
ALLERGY
Do not take FEXOLIFE M TABLET if you are allergic to Fexofenadine or Montelukast.
LUNGS
FEXOLIFE M TABLET should not be used as a substitute to treat 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
FEXOLIFE M 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 FEXOLIFE M TABLET.
OTHERS
Use in pediatrics:
FEXOLIFE M TABLET is not recommended for use in children and adolescents less than 15 years of age. Consult your child’s doctor for advice.
Use in geriatrics:
FEXOLIFE M TABLET should be used with caution in elderly patients (above 65 years of age). Your doctor may assess your kidney function regularly to properly adjust the dose and to prevent unwanted effects due to toxicity. Consult with your doctor for advice before taking FEXOLIFE M TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking FEXOLIFE M TABLET inform to your doctor, if you are taking any of these medicines:
- antacids (used to reduce stomach acids) Ex. aluminium or magnesium hydroxide
- phenytoin or phenobarbital (used to control seizure)
- rifampicin (used to treat tuberculosis)
- gemfibrozil (used to treat high cholesterol levels)
B. Drug-Food interactions:
While taking FEXOLIFE M 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 FEXOLIFE M TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage may cause undesirable effects such as stomach pain, sleepiness, thirst, headache, dizziness, tiredness, vomiting, hyperactivity and dry mouth.
SYNOPSIS
| Drug | : | Fexofenadine, Montelukast |
| Pharmacological Category | : | Histamine H1 receptor blocker, Leukotriene receptor antagonists |
| Therapeutic Indication | : | Allergic rhinitis |
| Dosage Forms | : | Tablet, Dispersible Tablet, Chewable tablet, Syrup, Suspension |
MORE INFORMATION
- Keep FEXOLIFE M TABLET out of reach of children
- Store at room temperature
FAQs ABOUT FEXOLIFE M TABLET
What is FEXOLIFE M TABLET used for?
FEXOLIFE M TABLET is indicated to treat 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 FEXOLIFE M TABLET?
Always take the dose that is prescribed by your physician. However, if you or anyone else accidentally take too much of FEXOLIFE M 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 FEXOLIFE M TABLET safe to use during pregnancy?
There is no proper information on the use of FEXOLIFE M TABLET during pregnancy and it should be used during pregnancy only if advised by the doctor. Consult your doctor before taking FEXOLIFE M TABLET if you are planning to get pregnant.
Can FEXOLIFE M TABLET be used in children?
No, FEXOLIFE M 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 FEXOLIFE M TABLET make you sleepy?
Yes, FEXOLIFE M 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] [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. Sanofi India Limited. Sanofi.in. [Revised in May 2020] [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-PI.pdf?la=en
10. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 23rd August 2021] https://www.medicines.org.uk/emc/files/pil.3487.pdf
11. 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
12. 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
USEFUL DIAGNOSTIC TESTS
- Complete blood count
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