NUSSIDEX

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE AS HYDROCHLORIDE

متاح من:

TEVA ISRAEL LTD

ATC رمز:

R01BA52

الشكل الصيدلاني:

TABLETS

تركيب:

DEXCHLORPHENIRAMINE MALEATE 1 MG; PSEUDOEPHEDRINE AS HYDROCHLORIDE 25 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

TEVA ISRAEL LTD, ISRAEL

المجال العلاجي:

PSEUDOEPHEDRINE, COMBINATIONS

الخصائص العلاجية:

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

تاريخ الترخيص:

2022-04-30

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed without a doctor’s prescription
Nussidex
®
Tablets
Composition
Each tablet contains:
Dexchlorpheniramine maleate 1 mg
Pseudoephedrine (as hydrochloride) 25 mg
For
information
regarding
inactive
ingredients
and
allergens, see section 2 – “Important information about
some of the ingredients of the medicine” and section 6 –
“Additional information”.
Read
the
entire
leaflet
carefully
before
using
the
medicine. This leaflet contains concise information about
the medicine. If you have additional questions, refer to the
doctor or the pharmacist.
Use the preparation according to the instructions in the
dosage section of this leaflet. Consult the pharmacist if you
need more information. Refer to the doctor if signs of the
ailment (symptoms) worsen or do not improve.
1. WHAT IS THE MEDICINE INTENDED FOR?
For
the
symptomatic
treatment
of
common
cold
and
allergic rhinitis.
Therapeutic class
Dexchlorpheniramine maleate is an antihistamine of the
polyamine class.
Pseudoephedrine
hydrochloride
is
an
alpha
agonist,
sympathomimetic decongestant.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
You are sensitive (allergic) to the active ingredients or
to any of the other ingredients this medicine contains
(see details in section 6). Some of the symptoms of
an allergic reaction may include: skin rash, breathing
difficulties or fainting.
•
The patient is a child under 6 years of age.
•
You suffer from a heart disease, including hypertension.
•
You have diabetes.
•
You suffer from a tumor of the adrenal gland
(pheochromocytoma).
•
You suffer from an overactive thyroid gland.
•
You suffer from severe kidney failure.
•
You suffer from closed-angle glaucoma.
•
You are at risk of developing respiratory failure – if
you have lung disease or breathing difficulties.
•
You
are
being
treated
with
medicines
from
the
monoamine oxidase inhibitors group (MAOI) or within
14 days of disc

خصائص المنتج

Nussidex- Tablets -SPC- KL-Notification 12-2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NUSSIDEX
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
_Active Ingredients _
Dexchlorpheniramine maleate
1 mg
Pseudoephedrine (as hydrochloride)
25 mg
_ _
Excipients with known effect
_: _
_Lactose content: 208 mg per tablet. _
_Sodium content: 0.31-0.47 mg per tablet. _
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets for oral use.
White, round biconvex film coated tablets.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Symptomatic treatment of the common cold and allergic rhinitis (hay
fever).
4.2
Posology and method of administration
_Adults _
1-2 tablets, twice a day, after/with meals.
_Children 6-12 Years of Age _
1 tablet once a day ,after/with meals.
4.3
Contraindications

Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.

Concomitant use of other sympathomimetic decongestants, beta-blockers
or monoamine
oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs. The
concomitant use
of MAOIs may cause a rise in blood pressure and/or hypertensive
crisis.

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Severe renal impairment
4.4
Special warnings and precautions for use
_Dexchlorpheniramine maleate _

Dexchlorpheniramine maleate may cause drowsiness and may add to the
effects of alcohol.
Drowsiness may continue the following day. Those affected should not
drive or operate
machinery; alcohol should be avoided.
Nussidex- Tablets -SPC- KL-Notification 12-2023

Dexchlorpheniramine maleate should be used with caution in patients
with:

narrow-angle glaucoma

stenosing peptic ulcer

prostatic hypertrophy

bladder neck obstruction

pyloroduodenal obstruction

cardiovascular disease including hypertension

increased intraocular pressure

hyperthyroidism

use wi