Q: Who should NOT take Ambroxol?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Q: Can Ambroxol be used during pregnancy?

Pregnancy Preclinical studies, as well as extensive clinical experience after the 28th week of pregnancy, have revealed no evidence of harmful effects when administered during pregnancy. Nevertheless, the general principles governing the use of medicines during pregnancy should be observed, particularly during the first trimester. Breast-feeding Ambroxol hydrochloride is excreted into breast milk, but at therapeutic doses harm to the breast-fed infant is unlikely.

Q: What precautions should be taken with Ambroxol?

Reports of severe cutaneous reactions associated with the administration of ambroxol hydrochloride have been received, such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP). If symptoms or signs of a progressive skin rash (sometimes with blisters or mucosal lesions) appear, ambroxol hydrochloride must be discontinued immediately and medical advice sought. Excipients Sodium This medicinal product contain

Q: Who manufactures Ambroxol?

Aflofarm Farmacja Polska Sp. z o.o. (Polska)

Question 1

What is Ambroxol used for?

Accepted Answer

Ambrobene is indicated for acute and chronic bronchopulmonary disorders associated with impaired clearance of secretions; as prophylaxis during the pre- and postoperative period in surgery and traumatology; for pulmonary atelectasis; as supportive treatment of infant respiratory distress syndrome (IRDS); and as an alternative to glucocorticoids in the prevention of IRDS in threatened preterm labour.

Question 2

How does Ambroxol work?

Accepted Answer

Pharmacotherapeutic group: Expectorants, excluding combinations with cough suppressants; mucolytics.

Question 3

What is the active ingredient in Ambroxol?

Accepted Answer

Ambroxoli hydrochloridum (Ambroxoli hydrochloridum)

Question 4

What pharmaceutical form is Ambroxol available in?

Accepted Answer

Ambroxol: Syrop 15 mg/5 ml (doustna)

Question 5

Is Ambroxol OTC or prescription only?

Accepted Answer

Ambroxol is available over-the-counter (OTC) — no prescription required.

Question 6

What are the side effects of Ambroxol?

Accepted Answer

Adverse reactions are presented by MedDRA system organ class and by frequency of occurrence on the basis of post-marketing reports.
Frequencies are defined as follows: very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000; not known (cannot be estimated from the available data).
Immune system disorders Rare: hypersensitivity reactions
Not known: anaphylactic reactions, including anaphylactic shock, angioedema, and pru

Question 7

Who should NOT take Ambroxol?

Accepted Answer

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Question 8

Can Ambroxol be used during pregnancy?

Accepted Answer

Pregnancy
Preclinical studies, as well as extensive clinical experience after the 28th week of pregnancy, have revealed no evidence of harmful effects when administered during pregnancy. Nevertheless, the general principles governing the use of medicines during pregnancy should be observed, particularly during the first trimester.
Breast-feeding
Ambroxol hydrochloride is excreted into breast milk, but at therapeutic doses harm to the breast-fed infant is unlikely.

Question 9

What precautions should be taken with Ambroxol?

Accepted Answer

Reports of severe cutaneous reactions associated with the administration of ambroxol hydrochloride have been received, such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP). If symptoms or signs of a progressive skin rash (sometimes with blisters or mucosal lesions) appear, ambroxol hydrochloride must be discontinued immediately and medical advice sought.
Excipients
Sodium
This medicinal product contain

Question 10

Who manufactures Ambroxol?

Accepted Answer

Aflofarm Farmacja Polska Sp. z o.o. (Polska)

Question 11

What ATC class does Ambroxol belong to?

Accepted Answer

Ambroxol: ATC R05CB06. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Ambroxol

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