Romilast L 5/2.5mg Tablet 10’S

INTRODUCTION

ROMILAST L 5/2.5MG TABLET is a combination of Levocetirizine and Montelukast which belongs to the group of medicines called H1 receptor antagonists and Leukotriene receptor antagonists respectively. ROMILAST L 5/2.5MG TABLET is indicated for the treatment and prevention of allergic rhinitis, chronic idiopathic urticaria (allergic skin reaction with red raised itchy bumps on the skin) and bronchial asthma in children aged between 6-14 years.

Allergic rhinitis (also known as hay fever) is a heterogeneous disorder characterized by inflammation of the inner lining of the nose accompanied by nasal decongestion, repeated sneezing, wheezing, or red, watery and itchy eyes.

It is usually caused by allergens such as pollens, dust, 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.

ROMILAST L 5/2.5MG TABLET is contraindicated for use in children having severe kidney impairment. Consult your child’s doctor before use.

ROMILAST L 5/2.5MG TABLET may cause certain unpleasant neuropsychiatric events (such as behaviour and mood-related changes: agitation including aggressive behaviour or hostility, depression) in some children. Consult your child’s doctor immediately if your child experiences any such events.

The most common side effects of taking ROMILAST L 5/2.5MG TABLET are upper respiratory tract infection, fever, cough, inflammation of the pharynx, dryness of mouth, headache and sleepiness. Consult your child’s doctor if any of the side effects worsen.

USES OF ROMILAST L 5/2.5MG TABLET
Treats and prevents allergic rhinitis, chronic idiopathic urticaria and bronchial asthma in children aged between 6-14 years
HOW ROMILAST L 5/2.5MG TABLET WORKS

ROMILAST L 5/2.5MG TABLET 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

Give ROMILAST L 5/2.5MG TABLET to your child as advised by the physician

For Tablet:

Tell your child to swallow ROMILAST L 5/2.5MG TABLET with a glass of water and not to crush or chew the medicine.

For Dispersible Tablet: Disperse ROMILAST L 5/2.5MG TABLET in the specified quantity of water as advised by the doctor. Tell your child to consume the mixture immediately after reconstitution.

Your child’s doctor will decide the correct dose and duration of ROMILAST L 5/2.5MG TABLET for your child depending upon the child’s age, body weight and disease condition.

SIDE EFFECTS OF ROMILAST L 5/2.5MG TABLET
COMMON
Upper respiratory infection
Cough, cold, fever or flu-like symptoms
Pharyngitis (inflammation of the pharynx)
Headache and tiredness
Dizziness, sleepiness
Nausea, vomiting, dry mouth, thirst, stomach pain, diarrhoea, indigestion
Otitis media (inflammation or infection of the ears)
Skin rash
Bleeding from the nose
Muscle pain, joint pain
UNCOMMON
Behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
Drowsiness, tingling, prickling and numbness sensation usually in hands or legs
Bruising, itching, hives
Muscle cramps
Bedwetting in children
Weakness, feeling unwell, swelling
RARE
Behaviour and mood-related changes: disturbance in attention, memory impairment
Uncontrolled muscle movements

Stop giving ROMILAST L 5/2.5MG TABLET to your child and contact the doctor immediately if your child experiences any of the following side effects:

Allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
Behaviour and mood-related changes: agitation including aggressive behaviour or hostility, depression
Seizure
Increased bleeding tendency
Tremor
Palpitations
HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Follow simple meal plan for your child while administering ROMILAST L 5/2.5MG TABLET. Avoid giving foods that are oily, fried or spicy foods. Do not let your child to lie down or sleep immediately after eating. Consult the child’s doctor if the symptom does not improve.

Diarrhoea:

Advise your child to drink plenty of water and stay hydrated. Avoid giving your child a high-fat diet or spicy foods. Try to avoid giving any medicine on your own to your child to treat diarrhoea. Consult the child’s doctor if the symptom gets worse.

Stomach pain:

Advise your child to rest and relax. Tell your child to eat and drink slowly or try to have lesser and more frequent meals. Keep a heating pad on the child’s stomach to relieve pain. Consult the child’s doctor if the symptom gets worse.

Headache:

Apply a hot or cold-water bag on your child’s head. Advise your child to take a rest in a quiet room. Massage the child’s scalp or head with mild pressure for relieving effect. Consult the child’s doctor if the symptom does not improve.

WARNING & PRECAUTIONS
PREGNANCY

ROMILAST L 5/2.5MG TABLET is not recommended for use in pregnant women as it is used only in children. Consult your doctor for advice.

BREASTFEEDING

ROMILAST L 5/2.5MG TABLET is not recommended for use in breast-feeding women as it is used only in children. Consult your doctor for advice.

DRIVING AND USING MACHINES

Do not let your child ride bicycles or drive other vehicles or operate any tools if your child experiences dizziness, headache or somnolence. Consult your child’s doctor for advice before administration of ROMILAST L 5/2.5MG TABLET to your child.

KIDNEY

ROMILAST L 5/2.5MG TABLET is not recommended for use in children with severe impairment of kidney function and should be used with caution in children with impaired kidney function. Consult your child’s doctor for advice before administration of ROMILAST L 5/2.5MG TABLET to your child.

LIVER

ROMILAST L 5/2.5MG TABLET should be taken with caution in children with liver disease. Consult your child’s doctor for advice before administration of ROMILAST L 5/2.5MG TABLET to your child.

ALLERGY

Talk to your child’s doctor if your child is allergic to Montelukast, Levocetirizine or Cetirizine or other ingredients of ROMILAST L 5/2.5MG TABLET.

LUNGS

ROMILAST L 5/2.5MG TABLET is not recommended for use in children with acute asthma attacks including status asthmaticus. Consult your child’s doctor for advice before administration of ROMILAST L 5/2.5MG TABLET to your child.

OTHERS

ROMILAST L 5/2.5MG TABLET is not recommended for use if your child:

Has galactose intolerance (an inherited condition in which the body cannot convert galactose to glucose)
Has Lapp lactase deficiency (deficiency of the enzyme lactase in the body)
Has glucose-galactose malabsorption
Has phenylketonuria (release of phenylalanine in urine)

Before giving ROMILAST L 5/2.5MG TABLET to your child, inform the child’s doctor if your child:

Has epilepsy
Has sensitivity to aspirin or other NSAIDs
Has schedule allergy skin tests
Has any predisposing factors of urinary retention (Ex. spinal cord lesion, prostatic hyperplasia)

Use in pediatrics:

ROMILAST L 5/2.5MG TABLET is strictly not recommended for use in children aged below 6 years. Consult your child’s doctor for advice before administration of ROMILAST L 5/2.5MG TABLET.

Use in geriatrics:

ROMILAST L 5/2.5MG TABLET is not recommended for use in elderly patients as it is used only in children. Consult your doctor for advice.

INTERACTIONS

A. Drug-Drug interactions:

Before giving ROMILAST L 5/2.5MG TABLET to your child, inform to child’s doctor if your child is taking or receiving any of the following medicines:

Gemfibrozil (used to control high blood cholesterol levels)
Phenytoin, phenobarbital (used to treat epilepsy)
Rifampicin (used to treat tuberculosis)
Ritonavir (a medicine used to treat viral infections)
Theophylline (a medicine used to treat asthma)

Overdosage:

If your child or anyone else accidentally takes too much of ROMILAST L 5/2.5MG TABLET, consult your child’s doctor immediately or visit the nearby hospital. Overdosage symptoms of ROMILAST L 5/2.5MG TABLET might include stomach pain, thirst, sleepiness, headache, vomiting, psychomotor hyperactivity, agitation and restlessness.

SYNOPSIS
Drug :   Levocetirizine, Montelukast
Pharmacological Category :   H1 receptor antagonist, Leukotriene receptor antagonist
Therapeutic Indication :   Allergic rhinitis, Bronchial asthma, Chronic idiopathic urticaria
Dosage Forms :   Tablet, Capsule, Dispersible Tablet, Oral Solution, Syrup, Suspension
MORE INFORMATION
Keep ROMILAST L 5/2.5MG TABLET out of reach of children
Store ROMILAST L 5/2.5MG TABLET at room temperature
FAQs ABOUT ROMILAST L 5/2.5MG TABLET

Can ROMILAST L 5/2.5MG TABLET be used to treat acute asthmatic attacks in children?

No, ROMILAST L 5/2.5MG TABLET is used only to prevent an asthma attack. ROMILAST L 5/2.5MG TABLET should not be used on an asthma attack that has been started already. Contact child’s doctor or go to the nearby hospital to avoid exacerbation of the attack.

Can ROMILAST L 5/2.5MG TABLET be used in infants?

No, ROMILAST L 5/2.5MG TABLET is only meant to be used in children aged between 6-14 years. ROMILAST L 5/2.5MG TABLET  is strictly not recommended for use in children aged below 6 years without consulting your child’s doctor.

Can ROMILAST L 5/2.5MG TABLET make my child feel sleepy?

Yes, ROMILAST L 5/2.5MG TABLET can cause sleepiness or drowsiness in some children, although not everybody gets them. This is quite normal and does not need to worry about. Avoid unnecessary distractions in children and try to make them stay relaxed. Avoid taking them outdoors unnecessarily. Avoid giving them concomitant medicines that can make them drowsier like cough syrups or sedatives. If the symptom does not improve or worsens contact your child’s doctor.

Can ROMILAST L 5/2.5MG TABLET make my child hyperactive?

Yes, ROMILAST L 5/2.5MG TABLET can cause certain neuropsychiatric events like behaviour and mood-related changes: agitation including aggressive behaviour or hostility, depression in some children, although not everybody gets them. Consult your child’s doctor immediately if you notice any unusual behaviour in your child during treatment with ROMILAST L 5/2.5MG TABLET.

Is ROMILAST L 5/2.5MG TABLET safe to use in children with kidney problems?

ROMILAST L 5/2.5MG TABLET is not recommended for use in children with severe impairment of kidney function and should be used with caution in children with impaired kidney function. Consult your child’s doctor for advice before administration of ROMILAST L 5/2.5MG TABLET to your child.

REFERENCES

1. KD. Tripathi. Histamines and Antihistamines & Drugs for cough and bronchial asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page – 166-168 & 228-229.

2. Peter J. Barnes. Pulmonary pharmacology. 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 – 918-923 & 1052-1054.

3. B Knorr, P Larson, H H Nguyen, S Holland, T F Reiss, P Chervinsky, K Blake, C H van Nispen, G Noonan, A Freeman, R Haesen, N Michiels, J D Rogers, R D Amin, J Zhao, X Xu, B C Seidenberg, B J Gertz, S Spielberg. Montelukast dose selection in 6- to 14-year-olds: comparison of single-dose pharmacokinetics in children and adults. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. August 1999. [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/10434229/

4. Gary M Doherty. Is montelukast effective and well tolerated in the management of asthma in young children? Part A: Evidence-based answer and summary. NCBI; PMC US National Library of Medicine, National Institute of Health. April 2007. [Accessed on 13th October 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2528689/

5. Maciej Ciebiada, Malgorzata Górska-Ciebiada, Lawrence M DuBuske, Pawel Górski. Montelukast with desloratadine or levocetirizine for the treatment of persistent allergic rhinitis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. November 2006. [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/17165277/

6. Montelukast for asthma. Medicines for Children. November 2014. [Accessed on 13th October 2021] https://www.medicinesforchildren.org.uk/montelukast-asthma

7. A N Pampura, N G Papadopoulos, V Spicák, R Kurzawa. Evidence for clinical safety, efficacy, and parent and physician perceptions of levocetirizine for the treatment of children with allergic disease. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. 2011. [Accessed on 13th October 2021] https://pubmed.ncbi.nlm.nih.gov/21346367/

8. F Estelle R Simons. Early Prevention of Asthma in Atopic Children (EPAAC) Study Group. Safety of levocetirizine treatment in young atopic children: an 18-month study. ResearchGate. October 2007. [Accessed on 13th October 2021] https://www.researchgate.net/publication/6274909_Early_Prevention_of_Asthma_in_Atopic_Children_EPAAC_Study_Group_Safety_of_levocetirizine_treatment_in_young_atopic_children_an_18-month_study

9. Fourrts. L Montus Kid Forte. Fourrts.com. [Accessed on 13th October 2021] https://www.fourrts.com/l-montus-2/

10. Merck Sharp & Dohme Limited. Electronic Medicines Compendium (EMC). [Revised in May 2020] [Accessed on 13th October 2021] https://www.medicines.org.uk/emc/files/pil.197.pdf

USEFUL DIAGNOSTIC TESTS
Complete Blood Count
VIDEOS
Levocetirizine Montelukast TABLET – Drug Information

Levocetirizine Montelukast TABLET : Therapeutic Uses, Warning and Precautions, Interactions, Directions for Use, Side Effects and Storage

PRODUCT DETAILS
Net Qty
1 N
Item Weight
17.5 g
Ingredient
LEVOCETIRIZINE 2.5MG MONTELUKAST 5MG
Hsn Code
30049031
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