Non-Drowsy Sudafed Decongestant 60 mg Film-Coated Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

PSEUDOEPHEDRINE HYDROCHLORIDE

متاح من:

Johnson & Johnson (Ireland) Limited

ATC رمز:

R01BA; R01BA02

INN (الاسم الدولي):

PSEUDOEPHEDRINE HYDROCHLORIDE

جرعة:

60 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Sympathomimetics; pseudoephedrine

الوضع إذن:

Marketed

تاريخ الترخيص:

1979-04-01

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
NON DROWSY
SUDAFED
DECONGESTANT
60 MG FILM-COATED TABLETS
Pseudoephedrine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after 5 days
WHAT IS IN THIS LEAFLET
1. What Non-Drowsy Sudafed Decongestant Tablets is and what it is used
for
2. What you need to know before you use Non-Drowsy Sudafed
Decongestant Tablets
3. How to use Non-Drowsy Sudafed Decongestant Tablets
4. Possible side effects
5. How to store Non-Drowsy Sudafed Decongestant Tablets
6. Contents of the pack and other information
1. WHAT NON-DROWSY SUDAFED DECONGESTANT TABLETS IS AND WHAT IT IS USED
FOR
Non-Drowsy Sudafed Decongestant Tablets are a medicine used to provide
relief from cold, flu and
allergy
symptoms
such
as
blocked
sinuses,
stuffy
nose
and
catarrh.
The
tablets
contain
pseudoephedrine hydrochloride, which is a decongestant that relieves
nasal and sinus congestion.
This medicine is for use by adults and children aged 12 years and
over.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NON-DROWSY SUDAFED
DECONGESTANT TABLETS
This medicine is suitable for most people but a few people should not
use it. If you are in any doubt,
talk to your doctor or pharmacist.
X DO NOT USE THIS MEDICINE…
■ If you have ever had a BAD REACTION (ALLERGIC REACTION) to
PSEUDOEPHEDRINE or any of the other
ingredients (
_listed in section 6_
).
■ If you have SEVERE KIDNEY PROBLEMS.
■ If you have DIABETES.
■ If you have a PHAEOCHROMOCYTOMA (rare tumour which affects your
heart rate and blood pressu

خصائص المنتج

Health Products Regulatory Authority
08 January 2021
CRN00C1S7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sudafed Decongestant 60 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-Coated tablet contains Pseudoephedrine Hydrochloride 60.0
mg.
Excipients: Contains Lactose Monohydrate 112.0mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Reddish-brown, circular, biconvex, film coated tablets embossed
‘SUDAFED’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicine is a decongestant of the mucous membranes of the upper
respiratory tract, especially the nasal mucosa and
sinuses and is indicated for the symptomatic relief of nasal
congestion in conditions such as allergic rhinitis, vasomotor
rhinitis,
the common cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND CHILDREN AGED 12 YEARS AND OVER
The usual dose is 1 tablet (60 mg) every four to six hours, up to four
times a day.
Maximum daily dose: 240 mg pseudoephedrine
CHILDREN UNDER 12 YEARS
This medicine is contraindicated in children under the age of 12 years
(See Section 4.3)
USE IN THE ELDERLY
There have been no specific studies of this medicine in the elderly.
Experience has indicated that normal adult dosage is
appropriate.
HEPATIC DYSFUNCTION
Caution should be exercised when administering this medicine to
patients with severe hepatic impairment.
RENAL DYSFUNCTION
Caution should be exercised when administering this medicine to
patients with mild to moderate renal impairment.
DURATION OF USE:
Patients should be advised not to use this product for more than 5
days and to seek medical advice if symptoms persist.
METHOD OF ADMINISTRATION:
For oral use.
Health Products Regulatory Authority
08 January 2021
CRN00C1S7
Page 2 of 8
4.3 CONTRAINDICATIONS
This medicine is contra-indicated in individuals with known
hypersensitivity to pseudoephedrine or any of the excipients listed
in section 6.1.
This m