Source: Medicines Authority (MT) Revision Year: 2020 Publisher: BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
Rinialer 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 with known effect:
Sucrose 300 mg/ml
Methyl Parahydroxybenzoate (E218) 1.00 mg/ml
Propylene glycol (E-1520) 200 mg/ml
For the 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 (E1520) |
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.
BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
MA004/00801
Date of first authorisation: 16/03/2012
Date of last renewal: 20/07/2016
| Drug | Countries | |
|---|---|---|
| RINIALER | Spain, Malta |
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