NUSSIDEX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE AS HYDROCHLORIDE

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

R01BA52

Pharmaceutical form:

TABLETS

Composition:

DEXCHLORPHENIRAMINE MALEATE 1 MG; PSEUDOEPHEDRINE AS HYDROCHLORIDE 25 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic area:

PSEUDOEPHEDRINE, COMBINATIONS

Therapeutic indications:

Symptomatic treatment of the common cold and allergic rhinitis (hay fever).

Authorization date:

2012-04-30

Patient Information leaflet

.תשפיחש המ תא ונאצמ אל
הנוכנ תנזהש תבותכה םא קודבל יאדכ
תבותכב עייסל חמשנ
[e-mail]
(
1
)

Summary of Product characteristics

1
This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked and approved on 11.09.2016
NUSSIDEX
®
TABLETS.
COMPOSITION
Each tablet contains:
_Active Ingredients _
Dexchlorpheniramine maleate
1 mg
Pseudoephedrine (as hydrochloride)
25 mg
_ _
_Other Ingredients _
Lactose monohydrate, microcrystalline cellulose, sodium starch
glycolate, povidone,
talc, magnesium stearate, colloidal silicon dioxide, hydroxypropyl
methylcellulose,
titanium dioxide, polyethylene glycol 400.
_Lactose content: 208 mg per tablet. _
_Sodium content: 0.31-0.47 mg per tablet. _
_ _
MECHANISM OF ACTION
Dexchlorpheniramine
is
an
alkylamine-type
antihistamine.
It
is
a
highly
active
histamine antagonist, and is effective in relatively low doses.
Pseudoephedrine is a sympathomimetic which acts predominantly on

-receptors and
has little effect on

-receptors. Therefore, it is an effective oral nasal decongestant
with minimal CNS stimulation.
Since Nussidex is a preparation intended for the symptomatic treatment
of allergic
conditions, it has been formulated to exclude coloring agents. The
possibility of
sensitization reactions is thus minimized.
INDICATIONS
Symptomatic treatment of the common cold and allergic rhinitis (hay
fever).
CONTRAINDICATIONS

Known hypersensitivity to either of the components of the preparation.

Pregnant women in third trimester.

Children under 6 years of age.

Because of the antihistamine component, Nussidex is contraindicated
in, closed-
angle glaucoma
, concomitant use with monoamine oxidase (MAO) inhibitor
therapy, or within 14 days of stoping MAO inhibitor treatment
(_also due to the _
_pseudoepehdrine _
_component_),
concomitant
use
with
sympathomimetic
decongestants, beta blockers .
Because of the pseudoephedrine component, Nussidex
is contraindicated in
severe hypertension and severe coronary artery disease,
phaeochromocytoma,
hyperthyroidism, diabetes mellitus, severe renal impairment.
WARNINGS
_Use in Pregnancy _
Use is contraindicated in_ _th