FXSON M Tablet 10's

Introduction About FXSON M TABLET

FXSON 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. FXSON M 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
seasonally or year-round and often characterized by inflammation of the inner
lining of nose accomp
watery and itchy eyes. FXSON M TABLET should not be used as an alternative to
manage acute asthma attacks. Consult your doctor for advice. Before taking FXSON
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. FXSON 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 FXSON M TABLET are dizziness, drowsiness,
headache, nausea, vomiting and diarrhea. Consult your doctor if any of the
symptom bothers you.

Uses Of FXSON M TABLET

• Used to manage allergic rhinitis in adults and in adolescents (aged 15 years of above)

How FXSON M TABLET Works

FXSON 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.

How to use FXSON M TABLET

Take FXSON 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 FXSON M TABLET without informing your
doctor.

Side Effects Of FXSON M TABLET

Common

• Headache
• Drowsiness
• dizziness
• Nausea
• 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 FXSON 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

!### Diarrhea

Drink lot 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.

!### 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.

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.

!### 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

!### Skin rash Or Itching

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.

Warning & Precautions

!### Pregnancy

Consult your doctorThere is no proper information on the use of FXSON M TABLET during pregnancy and
it should be used during pregnancy only if considered clearly necessary. Consult
your doctor before taking FXSON M TABLET.

!### Breastfeeding

ContraindicatedFXSON M TABLET is not recommended for use in breast-feeding women. Consult your
doctor before taking FXSON M TABLET.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you experience dizziness or drowsiness
after taking FXSON M TABLET.

!### Alcohol

Consult your doctorAvoid consum
feel drowsier.

!### Kidney

Use with CautionFXSON M TABLET should be used with caution in patients with kidney problems.
Consult your doctor before taking FXSON M TABLET.

!### Liver

Use with CautionFXSON M TABLET should be used with caution in patients with liver disease.
Consult your doctor before taking FXSON M TABLET.

!### Allergy

ContraindicatedDo not take FXSON M TABLET if you are allergic to Fexofenadine or Montelukast.

!### Lungs

Consult your doctorFXSON M 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

Use with CautionFXSON 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 FXSON M TABLET.

!### Use In Pediatrics

ContraindicatedFXSON 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

Use with CautionFXSON 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 manage unwanted effects due to toxicity. Consult with
your doctor for advice before taking FXSON M TABLET.

Interactions

A. Drug-Drug interactions:

Before taking FXSON 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 manage tuberculosis)
• Gemfibrozil (used to manage high cholesterol levels)

B. Drug-Food interactions:

While taking FXSON 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 FXSON 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

Storage

• Keep FXSON M TABLET out of reach of children
• Store at room temperature

FAQs About FXSON M TABLET

Q: What is FXSON M TABLET used for?

A: FXSON M 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).

Q: What are the symptoms of overdose of FXSON M TABLET?

A: Always take the dose that is prescribed by your physician. However, if you or
anyone else accidentally take too much of FXSON 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.

Q: Is FXSON M TABLET safe to use during pregnancy?

A: There is no proper information on the use of FXSON M TABLET during pregnancy
and it should be used during pregnancy only if advised by the doctor. Consult
your doctor before taking FXSON M TABLET if you are planning to get pregnant.

Q: Can FXSON M TABLET be used in children?

A: No, FXSON 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.

Q: Can FXSON M TABLET make you sleepy?

A: Yes, FXSON 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.

Useful Diagnostic Tests

• Complete blood count