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Romilast B-5 Tablet
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Romilast B-5 Tablet

Manufactured bySUN PHARMA LABORATORIES LTD
ContainsBambuterol (10 mg) + Montelukast (5 mg)
Description
Romilast B-5 Tablet is a combination medicine used for the treatment of chronic asthma, bronchospasm, and reversible airway obstruction. This medicine is not recommended for use if you are known allergic to it.
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Side effectsConcernsUsage

Side effects

Major & minor side effects for Romilast B-5 Tablet

  • Swelling of the face, arms, hands, lower legs, or feet
  • Severe skin rash and hives
  • Difficulty in breathing
  • Dizziness and fainting
  • Muscle pain and weakness
  • Increased thirst
  • Irregular heart beat
  • Shaking and trembling of arms and feet
  • Headache
  • Restlessness
  • Cramps and muscle spasm
  • Sleep disturbances
  • Nausea and Vomiting
  • Stomach pain
  • Chest tightness
  • Joint pain
  • Difficulty in swallowing
  • Pus in urine
  • Agitation and anxiety
  • Heart burn
  • Pain in the ears
  • Blurred vision
  • Suicidal thinking and behaviour

Uses of Romilast B-5 Tablet

What is it prescribed for?

  • Bronchospasm
  • chronic asth
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The effect of this medicine can be observed within 1 to 3 hours of administration of the dose.
  • How long do the effects of this medicine last?
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Is it safe to consume alcohol while taking this medicine?
    Consumption of alcohol is not recommended while receiving this medicine as it may increase the risk of side effects. Avoid performing activities that need high mental alertness like driving a vehicle or operating heavy machinery if alcohol and this medicine are used together.
  • Is this a habit forming medicine?
    No habit-forming tendencies were reported.
  • Can this medicine be taken during pregnancy?
    This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before using this medicine.
  • Can this medicine be taken while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless necessary. All the risks and benefits should be discussed with the doctor before using this medicine. If the medicine is used, the infant should be monitored closely for any undesirable side effects.

Allergy

This medicine is not recommended for use in patients with a known allergy to bambuterol, montelukast, or any other inactive ingredients present in the formulation.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before using this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless necessary. All the risks and benefits should be discussed with the doctor before using this medicine. If the medicine is used, the infant should be monitored closely for any undesirable side effects.
General warnings

Use in Children

This medicine is not recommended for use in patients below 15 years of age since the risk of adverse effects are significantly high. However, your doctor may prescribe this medicine if the benefits significantly outweigh the risks. In such a case, the patient should be monitored closely for any adverse effects.

Seizure disorder

This medicine should be used with caution in patients with a known history of seizure disorder due to the increased risk of recurrent seizures. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Glaucoma

This medicine should be used with caution in patients with pre-existing glaucoma due to the increased risk of worsening of the patient's condition. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Heart diseases

This medicine should be used with caution in patients with pre-existing heart diseases due to the increased risk of worsening of the patient's condition. Close monitoring of heart function, vital signs, or electrolyte levels may be necessary based on the clinical condition. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Hyperthyroidism

This medicine should be used with caution in patients with pre-existing hyperthyroidism due to the increased risk of worsening of the patient's condition. Close monitoring of thyroid hormone levels, appropriate dose adjustments, or replacement with a suitable alternative may be required based on the clinical condition.

Driving or Operating machinery

Use of this medicine may cause adverse effects such as drowsiness, dizziness, a shakiness of arms and legs, muscle stiffness, etc. in some patients. It is advised that you do not perform any activities such as driving a vehicle or operating machinery if you experience any of these symptoms during treatment with this medicine.

Other medicines

This combination medicine may interact with many other medicines and may cause severe adverse effects. Hence, it is advised that you report all your current medicines, including any herbs and supplements, to the doctor before beginning treatment with this medicine.

Acute asthma

This medicine is not recommended for use in patients having an acute and severe attack of asthma. Replacement with a suitable alternative should be considered under your doctor's supervision.

Medicine induced bronchospams

This medicine is not recommended for use if the bronchospasm is due to a medicine being taken. Replacement with a suitable alternative should be considered under your doctor's supervision.

Liver disease

This medicine should be used with caution in patients with liver diseases due to the increased risk of adverse effects. Regular monitoring of liver function tests is necessary while receiving this medicine for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.

Behaviour and mood changes

Use of this medicine may cause changes in behavior and mood. Symptoms like agitation, irritability, anxiety, unusual dreams, suicidal thoughts should be reported to the doctor. Caution is advised while giving this medicine to people with pre-existing psychiatric disorders.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol is not recommended while receiving this medicine as it may increase the risk of side effects. Avoid performing activities that need high mental alertness like driving a vehicle or operating heavy machinery if alcohol and this medicine are used together.
Interaction with Medicine

Prednisolone

Propranolol

Phenobarbital

Furosemide

Fluconazole

Phenytoin

Carbamazepine

Clozapine

Carvedilol

Moxifloxacin

Disease interactions

Cardiovascular disease

This medicine should be used with caution in patients with a known history of cardiovascular diseases due to the increased risk of serious adverse effects. These side effects may include increased heart rate, alterations in blood pressure, palpitations, etc. Report any unusual symptoms to the doctor immediately. You may require a dose adjustment and more frequent clinical monitoring to safely use this medicine. Replacement with a suitable alternative may be necessary based on the clinical condition.

Diabetes

This medicine should be used with caution in patients with a known history of diabetes mellitus due to the increased risk of alterations in blood glucose levels. Close monitoring of blood glucose levels, appropriate dose adjustments, or replacement with a suitable alternative may be necessary in some cases based on the clinical condition.

Seizures

This medicine should be used with caution in patients with a known history of seizure disorder due to the increased risk of recurrent seizures. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition.

Hypokalemia

This medicine should be used with caution in patients suffering from electrolyte disturbances due to the increased risk of low potassium levels (hypokalemia). Report any symptoms such as shortness of breath, muscle weakness, changes in heart rate, etc. to the doctor immediately. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary based on the clinical condition.

Liver Disease

This medicine should be used with caution in patients with liver diseases due to the increased risk of adverse effects. Regular monitoring of liver function tests is necessary while receiving this medicine for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required in some cases based on the clinical condition.
Food interactions
Information not available.
Lab interactions
Information not available.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.
Take this medicine with or without food preferably in the evening, as directed by your doctor. Do not take in larger amounts than advised/prescribed. Consult the doctor if you experience any undesirable effects. Do not stop taking the medicine before completion of the course/without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works
Bambuterol works by relaxing and opening the blocked air passages leading to the lungs. This improves airflow into the lungs and makes breathing easier. Montelukast acts by blocking the response of certain specific chemicals that cause allergic responses in the body. Their combination is thus effective in treating chronic asthma.
Legal Status

Approved

Unknown

Unknown

Unknown

Classification

Category

Adrenergic bronchodilators, Leukotriene modifiers

Schedule

Schedule H

[Internet]. CiplaMed. 2019 [cited 11 January 2019]. Available from:

https://ciplamed.com/content/montair-plus-tablets-and-montair-plus-kid-dt

[Internet]. 2017 [cited 23 March 2017]. Available from:

https://www.medicines.org.uk/emc/medicine/28220

[Internet]. Medicines.org.uk. 2018 [cited 14 September 2018]. Available from:

https://www.medicines.org.uk/emc/files/pil.1652.pdf

Montelukast: MedlinePlus Drug Information [Internet]. Medlineplus.gov. 2017 [cited 23 March 2017]. Available from:

https://medlineplus.gov/druginfo/meds/a600014.html

Bambuterol - DrugBank [Internet]. Drugbank.ca. 2018 [cited 14 September 2018]. Available from:

https://www.drugbank.ca/drugs/DB01408
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Information on this page was last updated on 27 May 2019

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