Medication info

Roxol C Tablets

Prescription medicationApproval withdrawn
Ingredient · strength
Ambroxol Hydrochloride›Strength being verifiedClenbuterol Hydrochloride›Strength being verified
Manufacturer / importer
삼아제약(주)
Appearance
Yellowish circular tablets
Packaging
1000 tablets (bottle)
Approval status
Approval withdrawn

MFDS item code 199100803 · Notified 1991.02.12

This product's status changed to Approval withdrawn on 2023.03.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of bronchial spasms and excessive mucus secretion
Who uses it
Adults · Children
Adult dosage
Adults: Take 1 tablet twice a day. After significant improvement of symptoms, dosage may be reduced to 1/2 tablet 2-3 times a day. Severe dyspnea patients may take 1 tablet three times a day for the first 2-3 days.
Children's dosage
Pediatric (12 years and older): Take 1 tablet twice a day.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

Improvement of bronchial spasms and excessive mucus secretion

  • Bronchial spasms
  • excessive mucus secretion
  • bronchial asthma
  • emphysema
  • bronchitis
View approved original text

In diseases such as bronchial asthma, emphysema, and bronchitis, bronchial spasms and excessive mucus secretion may make breathing difficult. This medication helps alleviate these abnormal bronchial symptoms and eases breathing, thereby improving symptoms.

Dosage and Administration

Adult dosage

Adults: Take 1 tablet twice a day. After significant improvement of symptoms, dosage may be reduced to 1/2 tablet 2-3 times a day. Severe dyspnea patients may take 1 tablet three times a day for the first 2-3 days.

Children's dosage

Pediatric (12 years and older): Take 1 tablet twice a day.

Precautions

This medication should not be used in patients with hypertrophic cardiomyopathy. This medication contains lactose, so patients with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with hyperthyroidism, hypertension, heart failure or arrhythmias, diabetes, and severe kidney disorders should use this medication with caution. This medication contains a dye called Yellow No. 5, and those allergic to this ingredient or who have exhibited hypersensitivity should be careful. During treatment, neurological symptoms such as headache, tremors, muscle rigidity, drowsiness, anxiety, dizziness, nervousness, insomnia, excitement, and numbness in the arms and legs may occur. Heart rate may increase or become irregular, and blood pressure may fluctuate or rise, so caution is advised. If symptoms of hypersensitivity such as rash, itching, angioedema, hives, bronchospasm, hypotension, and collapse occur, discontinue use immediately. Elevated liver function values, general malaise, and edema, as well as digestive disorders, can also occur as side effects. Excessive dosing may cause heart rhythm disturbances or heart attacks, so it is essential to adhere to the dosage instructions. If there is no effect, this medication may not be suitable, so it is advisable to stop taking it and consult a physician. Particularly, when administering to children, precise dosage instructions should be given, and their condition should be closely monitored. This medication may lower potassium levels in the blood, which can worsen conditions when taken with other medications; hence severe asthma patients should exercise caution. It should not be used in conjunction with sympathomimetics like epinephrine or isoproterenol, as this could lead to heart rhythm disturbances or the risk of myocardial infarction. Patients taking MAO inhibitors or tricyclic antidepressants should be cautious, as the vascular action of this medication may become stronger. It should not be taken with non-selective beta-blockers like propranolol. Patients taking a lot of other sympathomimetics should also be cautious when using this medication. In late pregnancy, animal tests have shown inhibited uterine contractions leading to delayed childbirth, and it can pass through the placenta and breast milk, so it should only be used when absolutely necessary during pregnancy, with extra caution especially in the first three months. Elderly patients may have reduced bodily functions, so they should use it carefully, possibly with a reduced dose. Symptoms of overdose usually resolve upon discontinuation of the medication, but a cardiac-selective beta-blocker can be used as an antidote, although caution is needed for patients with a history of bronchospasm. In rare cases, allergic rashes may occur if the dosage of ambroxol hydrochloride in this medication changes, and systemic allergic reactions may occur in some individuals with peculiar body types.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, bronchospasm → severe allergic reactions
  • Hypertension → severe edema or urinary abnormalities
  • Edema → severe edema or urinary abnormalities
  • Rash → severe allergic reactions

Mild side effects

  • Headache
  • tremors
  • muscle rigidity
  • drowsiness
  • anxiety
  • dizziness
  • nervousness
  • insomnia
  • excitement
  • numbness in extremities
Show 16 more
  • palpitations
  • tachycardia
  • blood pressure fluctuations
  • hypertension
  • arrhythmias
  • rash
  • itching
  • angioedema
  • bronchospasm
  • hypotension
  • collapse
  • ALT
  • AST elevation
  • general malaise
  • edema
  • gastrointestinal disturbances

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture access. The storage temperature should ideally be maintained between 1 to 30 degrees Celsius to safely retain the medication's efficacy.

Appearance and packaging

Appearance

Yellowish circular tablets

Package unit

1000 tablets (bottle)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.