Lebia M Tablet 10’s

INTRODUCTION

LEBIA M is a combination of Levocetirizine and Montelukast which belongs to the group of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. LEBIA 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.

LEBIA M is not recommended for use in patients having severe kidney impairment. Consult your doctor before taking. Avoid consumption of alcohol while taking LEBIA M as it may reduce your alertness and cause impaired performance in activities requiring mental concentration. LEBIA 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.

LEBIA M should be taken during pregnancy only if clearly advised by your doctor and not recommended for use in breast-feeding women. LEBIA 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 LEBIA 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 LEBIA M

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

HOW LEBIA M WORKS

LEBIA 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 LEBIA M as advised by your physician. Swallow LEBIA 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 LEBIA M

COMMON

• Upper respiratory tract infection
• Cough, cold, fever or flu-like symptoms
• Headache and tiredness
• Sleepiness
• Nausea, vomiting, dry mouth, thirst, stomach pain, diarrhea
• Otitis media (inflammation or infection of the ears)
• Skin rash

UNCOMMON

• Changes in behavior and mood (anxiety, nightmares, irritability, sleepwalking)
• Dizziness, tingling and prickling sensation or numbness in the body
• Indigestion
• Bleeding in the nose
• Itching, bruising
• Joint or muscle pain
• Muscle cramps, weakness
• Urinary incontinence in children
• Swelling

RARE

• Attention disturbance, memory impairment, uncontrolled muscle movements

Stop taking LEBIA M 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
• Neuropsychiatric changes (such as disorientation, hallucinations)
• Thoughts of harming or killing yourself (suicidal ideation)
• Inflammation (swelling) of the lungs
• Erythema multiforme (a severe skin reactions)
• Hepatitis (inflammation of the liver)

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Try to take LEBIA 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

PREGNANCY

LEBIA M should be used during pregnancy only if considered clearly necessary. Consult your doctor before taking LEBIA M.

BREASTFEEDING

LEBIA M is not recommended for use in breastfeeding women. Consult your doctor before taking LEBIA M.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience drowsiness, tiredness, or sleepiness. Consult your doctor before taking LEBIA M.

ALCOHOL

Avoid consumption of alcohol while taking LEBIA M as it may reduce alertness and impairment of performance. Consult your doctor before taking LEBIA M.

KIDNEY

LEBIA M is not recommended for use in patients with severe kidney impairment. It should be taken with extreme caution in patients with mild to moderate kidney disease. Consult your doctor for before taking LEBIA M.

LIVER

LEBIA M should be taken with caution in patients with liver disease. Consult your doctor before taking LEBIA M.

ALLERGY

Do not take LEBIA M if you are allergic to Montelukast or Levocetirizine or Cetirizine.

OTHERS

LEBIA M is not recommended for use if you:

• Have galactose intolerance (inherited condition in which the body cannot convert galactose to glucose)
• Have Lapp lactase deficiency (deficiency of the enzyme lactase in the body)
• Have glucose-galactose malabsorption
• Have phenylketonuria (release of phenylalanine in urine)
• Have acute asthma attacks

Before taking LEBIA M, inform your physician if you:

• Have or at risk of having epilepsy
• Have sensitivity to aspirin or other NSAIDs
• Have any predisposing factors of urinary retention (Ex. spinal cord lesion, prostatic hyperplasia)
• Are scheduled for allergy testing

Use in pediatrics:

LEBIA M is strictly not recommended for use in children aged below 15 years. Consult your doctor before taking LEBIA M.

Use in geriatrics:

LEBIA M should be used with caution in elderly patients (aged 65 years or above). Proper dose titrations and careful monitoring of kidney functions are required in such patients. Consult your doctor before taking LEBIA M.

INTERACTIONS

1. Drug-Drug interactions:

Before taking LEBIA 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 LEBIA M, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of LEBIA M include stomach pain, thirst, sleepiness, drowsiness, headache, vomiting, psychomotor hyperactivity, agitation, and restlessness.

SYNOPSIS

MORE INFORMATION

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