1.         Name of the Medicinal Product

            Benylin Phlegm Cough Syrup

            Guaifenesin 100mg/5ml

            Levomenthol 1.1mg/5ml Syrup

6.5       Nature and contents of container

Amber glass bottles (pharmacopoeial grade III) with an aluminium ROPP cap with melinex-faced pulpboard wad or with a 3 piece plastic child resistant, tamper evident closure fitted with a PE-Alu-PET or polyethylene/ expanded polyethylene laminated wad or with a plastic HDPE cap fitted with a PE-Alu-PET wad..
Pack sizes: 30 ml, 125 ml, 150ml or 300 ml.

Not all pack sizes may be marketed.

10.       Date of revision

June 2016

Section 4.6 updated as follows:

Pregnancy

There are no or limited amounts of data from the use of Guaifenesin in pregnant women.  Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Non-Drowsy Chesty Coughs is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breastfeeding

Guaifenesin is excreted in breast milk in small amounts.  There is insufficient information on the effects of Guaifenesin in newborns/infants.  A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Benylin Non-Drowsy Chesty Coughs therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility

Section 4.8 updated as follows & HPRA details for AE reporting added:

Section 4.9 updated as follows:

Symptoms and signs

Guaifenesin

The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and somnolence. When taken in excess, Guaifenesin may cause renal calculi.

Menthol

Excessive use of menthol may lead to abdominal pain, vomiting, flushed face, dizziness, weakness, tachycardia, stupor, and ataxia