Sudafed Sinus Pressure & Pain 200mg/30mg film-coated tablets

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

थमां उपलब्ध:

McNeil Products Limited

ए.टी.सी कोड:

R05X

INN (इंटरनेशनल नाम):

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

फार्मास्यूटिकल फॉर्म:

FILM-COATED TABLET

रचना:

IBUPROFEN 200 milligram(s) ; PSEUDOEPHEDRINE HYDROCHLORIDE 30 milligram(s)

प्रिस्क्रिप्शन प्रकार:

OTC

चिकित्सीय क्षेत्र:

COUGH AND COLD PREPARATIONS

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2017-08-22

सूचना पत्रक

PAGE 1 OF 10
PACKAGE LEAFLET
PAGE 2 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUDAFED SINUS PRESSURE & PAIN
200 MG/30 MG FILM-
COATED TABLETS
Ibuprofen/Pseudoephedrine hydrochloride
FOR ADULTS AND ADOLESCENTS FROM 15 YEARS AND OLDER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has 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 symptoms worsen, or if this medicine is
required for more than 4 days
(adults) or 3 days (adolescents), respectively.
WHAT IS IN THIS LEAFLET
:
1. What Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets
is and what it is used for
2. What you need to know before you take Sudafed Sinus Pressure & Pain
200 mg/30 mg film-coated tablets
3. How to take Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated
tablets
4. Possible side effects
5. How to store Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated
tablets
6. Contents of the pack and other information
1.
WHAT SUDAFED SINUS PRESSURE & PAIN 200 MG/30 MG FILM-COATED TABLETS IS
AND WHAT IT IS USED FOR
Sudafed Sinus Pressure & Pain 200 mg/30 mg tablets contains two active
substances: ibuprofen and
pseudoephedrine hydrochloride.
Ibuprofen belongs to a group of medicines known as non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs
provide relief by reducing pain and high temperature.
Pseudoephedrine hydrochloride belongs to a group of active substances
called vasoconstrictors which act on the
blood vessels in the nose to relieve nasal congestion.
Sudafed Sinus Pressure & Pain 200 mg/30 mg film-coated tablets is used
for the symptomatic treatment of nasal
congestion in head colds together with head

उत्पाद विशेषताएं

PAGE 1 OF 18
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 18
1
.
NAME OF THE MEDICINAL PRODUCT
Sudafed Sinus Pressure & Pain 200mg/30mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen and 30 mg
pseudoephedrine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Yellow, round, film-coated tablets. Diameter: approx. 11 mm, height:
approx. 5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion associated with acute
rhinosinusitis suspected to be of viral
origin with headache and/or fever.
This product is indicated in adults and adolescents aged 15 years and
older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 15 years and older: _
1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine
hydrochloride) every 6 hours if
necessary.
For more intense symptoms, 2 tablets (equivalent to 400 mg ibuprofen
and 60 mg pseudoephedrine
hydrochloride) every 6 hours if necessary, to a maximum total daily
dose of 6 tablets (equivalent to 1200 mg
ibuprofen and 180 mg pseudoephedrine hydrochloride).
The maximum total daily dose of 6 tablets (equivalent to 1200 mg
ibuprofen and 180 mg pseudoephedrine
hydrochloride) must not be exceeded.
For short-term use.
THE PATIENT SHOULD CONSULT A DOCTOR IF SYMPTOMS WORSEN. THE MAXIMUM
DURATION OF TREATMENT IS 4
DAYS FOR ADULTS AND 3 DAYS FOR ADOLESCENTS AGED 15 YEARS AND OLDER.
In situations where the symptoms predominantly consist of either
pain/fever or nasal congestion,
administration of single entity products is to be preferred.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Paediatric population _
This product is contraindicated in paediatric patients below 15 years
of age (see section 4.3).
Method of administration
PAGE 3 OF 18
For oral use.
The tablets should be swallowed who