Moxonidine 400microgram tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Moxonidine

Disponible depuis:

Sandoz Ltd

Code ATC:

C02AC05

DCI (Dénomination commune internationale):

Moxonidine

Dosage:

400microgram

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 02050200; GTIN: 5015915947031

Résumé des caractéristiques du produit

OBJECT 1
MOXONIDINE 400 MICROGRAM FILM-COATED TABLETS
Summary of Product Characteristics Updated 21-Dec-2016 | Sandoz
Limited
1. Name of the medicinal product
Moxonidine 400 microgram film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 0.4 mg moxonidine.
Excipient: lactose monohydrate
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Appearance: All tablets are round, approximately 6 mm in diameter.
The tablet is dark pink
4. Clinical particulars
4.1 Therapeutic indications
Mild to moderate essential hypertension.
4.2 Posology and method of administration
Posology
Adults
Treatment must be instituted with the lowest dosage of Moxonidine.
This means a daily dose of 0.2 mg
moxonidine in the morning. If the therapeutic effect is insufficient,
the dose can be increased after three
weeks to 0.4 mg. This dose can be given as a single dose (to be taken
in the morning) or as a divided daily
dose (morning and evening). If the results are still insufficient
after a further three weeks treatment, the
dosage can be increased further to a maximum of 0.6 mg given divided
in the morning and evening. A
single dose of 0.4 mg Moxonidine and a daily dose of 0.6 mg Moxonidine
should not be exceeded.
_Paediatric population_
Moxonidine should not be given to children and adolescents under 16
years of age as insufficient
therapeutic data are available for this.
_Older people_
Provided that renal function is not impaired, dosage recommendation is
the same as for adults.
Renal impairment:
In patients with moderately impaired renal function (GFR > 30 ml/min
but < 60 ml/min), the single dose
should be not more than 0.2 mg and the daily dose not more than 0.4 mg
moxonidine.
Hepatic impairment:
No studies are available in patients with impaired hepatic function.
However, as moxonidine lacks
extensive hepatic metabolism no major influence on the
pharmacokinetics may be expected and dosage
recommendation is the same for patients with mild to moderate hepatic
impairment as