Loratadine 5mg5ml oral solution

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Loratadine

Commercializzato da:

Mylan

Codice ATC:

R06AX13

INN (Nome Internazionale):

Loratadine

Dosaggio:

1mg/1ml

Forma farmaceutica:

Oral solution

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 03040100; GTIN: 5016695001135

Scheda tecnica

OBJECT 1
LORATADINE 5 MG/ 5 ML SYRUP
Summary of Product Characteristics Updated 05-Jun-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Loratadine 5 mg/ 5 ml syrup
2. Qualitative and quantitative composition
Each ml of syrup contains 1 mg of loratadine.
Excipients with known effect:
Loratadine syrup contains 600 mg of sucrose per ml, methyl
hydroxybenzoate and propyl
hydroxybenzoate.
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Syrup
Clear, slightly viscous solution.
4. Clinical particulars
4.1 Therapeutic indications
Loratadine syrup is indicated for the symptomatic treatment of
allergic rhinitis and chronic idiopathic
urticaria in adults and children over the age of 2 years.
4.2 Posology and method of administration
Posology
Adults and children and adolescents over 12 years of age
10 ml (10 mg) of the syrup once daily.
_Paediatric population (under 12 years of age)_
Children 2 to 12 years of age ARE DOSED BY WEIGHT:
Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily.
Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily.
The safety and efficacy of loratadine syrup in children under 2 years
of age has not been established. No
data are available.
_Patients with hepatic impairment_
Patients with severe liver impairment should be administered a lower
initial dose because they may have
reduced clearance of loratadine. An initial dose of 10 mg every other
day is recommended for adults and
children weighing more than 30 kg and for children weighing 30 kg or
less, 5 ml (5 mg) every other day
is recommended.
_Patients with renal impairment_
No dosage adjustments are required in patients with renal
insufficiency.
_Elderly_
No dosage adjustments are required in the elderly.
Method of administration
For oral use.
The syrup may be taken without regard to mealtime.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
Loratadine syrup should be administered