Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Taking this drug is contraindicated if you have rare hereditary diseases that can cause an incompatibility with one of the excipients (see section 4.4).
There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of ambroxol. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, ambroxol treatment should be discontinued immediately and medical advice should be sought.
In case of severe renal or liver impairment, ambroxol should be used only on medical advice.
In case of severe renal impairment, accumulation of metabolites of ambroxol formed in the liver is expected.
Medovent contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
There are no clinically relevant interactions reported with other drugs.
Ambroxol hydrochloride crosses the placenta. Animal studies do not indicate direct or indirect harmful effects with regard to pregnancy, embryonal/fetal development, parturition or postnatal development.
Clinical experience after the 28th week of pregnancy showed no harmful effects on the fetus.
However, usual precautionary measures must be applied during pregnancy drug administration.
Therefore, ambroxol hydrochloride is not recommended especially in the first trimester of pregnancy.
Ambroxol hydrochloride is excreted in human milk. Although occurrence of harm to breastfed infants is not expected, ambroxol hydrochloride is not recommended for nursing mothers.
Preclinical studies do not indicate direct or indirect harmful effects related to fertility.
There are no post-marketing data on an effect on the ability to drive or use machines. No studies on influence on the ability to drive or use machines have been performed.
Adverse reactions are classified using the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Common: nausea.
Uncommon: diarrhea, vomiting, dyspepsia, abdominal pain.
Rare: rash, urticarial.
Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Rare: hypersensitivity reactions.
Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
None known.
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