Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: J. Uriach y Compañia, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain), Telephone: +34 93 864 96 92, Fax: +34 93 864 66 06
Rupatadine 1 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear yellow solution. |
Each ml of oral solution contains: 1 mg of rupatadine (as fumarate).
Excipients:
Sucrose 300 mg/ml
Methyl Parahydroxybenzoate (E218) 1.00 mg/ml
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rupatadine |
Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor antagonist activity. Some of the metabolites (desloratadine and its hydroxylated metabolites) retain an antihistaminic activity and may partially contribute to the overall efficacy of the drug. |
| List of Excipients |
|---|
|
Propylene glycol |
120 ml amber polyethylene terephthalate (PET) bottle with low density polyethylene (LDPE) perforated stopper closed with yellow high density polyethylene (HDPE) child-resistant closure in a cardboard box also containing 5 ml oral syringe (polypropylene, polyethylene) graduated at 0.25 ml.
J. Uriach y Compañia, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain), Telephone: +34 93 864 96 92, Fax: +34 93 864 66 06
PL11906/0009
27/03/2012
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