INTRODUCTION

LEVOLER M is a combination of Levocetirizine and Montelukast which belongs to the group of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. LEVOLER M is indicated for the treatment and prevention of allergic rhinitis, chronic idiopathic urticaria (allergic skin reaction with red raised itchy bumps on skin) and bronchial asthma in adults and in adolescents (aged 15 years or above).

Allergic rhinitis (also known as hay fever) is a heterogeneous disorder characterized by inflammation of the inner lining of nose accompanied by nasal decongestion, repeated sneezing, wheezing, or a red, watery, and itchy eyes. It is usually caused by allergens such as pollens, dusts, mould, or flakes of skin from certain animals and can occur seasonally or year-round. Bronchial asthma is a long-term medical condition in which the path of the airways becomes inflamed, narrow, and swollen. Symptoms include coughing, wheezing, and chest tightness.

Levocetirizine is a H1 receptor antagonist that antagonizes the effects of histamine (a substance that cause allergic reaction) on the surface of the cells and montelukast is a leukotriene receptor antagonist that blocks the actions of leukotrienes responsible for causing narrowing and inflammation of the airways, thus leading to relaxation of smooth muscles in the lungs and reduction in swelling and/or inflammation of the airways.

LEVOLER M is not recommended for use in patients having severe kidney impairment. Consult your doctor before taking. Avoid consumption of alcohol while taking LEVOLER M as it may reduce your alertness and cause impaired performance in activities requiring mental concentration. LEVOLER M may cause certain unpleasant neuropsychiatric events (such as anxiety, depression, nightmares, hallucinations, or even suicidal thoughts) in some individuals. Contact your doctor immediately if you or anyone else experience such events.

LEVOLER M should be taken during pregnancy only if clearly advised by your doctor and not recommended for use in breast-feeding women. LEVOLER M should be used with caution in elderly patients (above 65 years of age) and not recommended for use in children and adolescents (less than 15 years of age). The most common side effects of taking LEVOLER M are upper respiratory tract infection, fever, cough, inflammation of the pharynx, dryness of mouth, headache, and somnolence. Consult your doctor if any of the symptoms worsen.

USES OF LEVOLER M

• To treat and prevent allergic rhinitis, chronic idiopathic urticaria and bronchial asthma in adults and in adolescents (aged 15 years or above)

HOW LEVOLER M WORKS

LEVOLER M provides relief from the symptoms of allergic rhinitis, asthma and urticaria where levocetirizine acts by blocking the actions of histamines (a substance that cause allergic reaction), at the H1 receptors present on the surface of cells and montelukast acts by blocking the action of leukotrienes D4 (an inflammatory molecule causing narrowing and swelling of the airways) in the lungs, thus causing relaxation of smooth muscle, reduction in swelling and/or inflammation of the airways and a marked decrease in the onset of allergic reactions.

DIRECTIONS FOR USE

Take LEVOLER M as advised by your physician. Swallow LEVOLER M 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.

SIDE EFFECTS OF LEVOLER M

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take LEVOLER M with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom did not improve.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. 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:

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.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking LEVOLER M inform to your doctor, if you are taking any of these medicines:

• gemfibrozil (used to control high blood cholesterol levels)
• other CNS depressants such as phenobarbital or phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis)
• ritonavir (used to treat viral infections)
• theophylline (used to treat asthma)

Overdosage:

If you or anyone else take too much of LEVOLER M, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of LEVOLER M include stomach pain, thirst, sleepiness, drowsiness, headache, vomiting, psychomotor hyperactivity, agitation, and restlessness.

SYNOPSIS

MORE INFORMATION

• Keep LEVOLER M out of reach of children
• Store LEVOLER M at room temperature

FAQs ABOUT LEVOLER M

How long does it take for LEVOLER M to provide relief from symptoms?

Following oral administration of LEVOLER M, it is believed to provide relief from the symptoms of allergy and asthma within 30 minutes to an hour. Please note that the onset of action varies from product to product and consult your doctor if you have any queries.

Can LEVOLER M be used to treat acute asthma attacks?

No. LEVOLER M is used only to prevent asthma attack. It should not be used on an asthma attack that has been started already. Contact your doctor or go to the nearby hospital to avoid exacerbation of the attack.   

Can LEVOLER M be used in infants?

No. LEVOLER M is only meant to be used in adults and in adolescents (aged 15 years or above). LEVOLER M is strictly not recommended for use in children aged between 6 months to 11 years of age without consulting your doctor.   

Can LEVOLER M make you feel sleepy?

Yes. LEVOLER M 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 sleepy. Avoid alcohol intake, as it could aggravate your existing condition. Consult your doctor if the symptom did not improve.

Can I drink alcohol while taking LEVOLER M?

Avoid consumption of alcohol while taking LEVOLER M as it may reduce your alertness and cause impaired performance in activities requiring mental concentration. Consult your doctor before taking LEVOLER M if you are alcoholic.

What to do If I forget to take LEVOLER M?

You should take LEVOLER M immediately when you remember. If it is time for your next dose skip the dose and follow your regular dose schedule. Do not double the dose of LEVOLER M to match up your missed dose.

REFERENCES

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USEFUL DIAGNOSTIC TESTS

• Absolute Eosinophil Count
• Complete Blood Count