Non-Drowsy Sudapro Head Cold 200mg/30mg film-coated tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

MAH:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC_code:

R05X

INN:

IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

pharmaceutical_form:

FILM-COATED TABLET

composition:

IBUPROFEN 200 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg

prescription_type:

OTC

therapeutic_area:

COUGH AND COLD PREPARATIONS

authorization_status:

Withdrawn

authorization_date:

2017-08-22

PIL

PAGE 1 OF 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NON-DROWSY SUDAPRO HEAD COLD 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 Non-Drowsy Sudapro Head Cold is and what it is used for
2. What you need to know before you take Non-Drowsy Sudapro Head Cold
3. How to take Non-Drowsy Sudapro Head Cold
4. Possible side effects
5. How to store Non-Drowsy Sudapro Head Cold
6. Contents of the pack and other information
1.
WHAT NON-DROWSY SUDAPRO HEAD COLD IS AND WHAT IT IS USED FOR
Non-Drowsy Sudapro Head Cold 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.
Non-Drowsy Sudapro Head Cold is used for the symptomatic treatment of
nasal congestion in head colds
together with headache and/or fever, in adults and adolescents aged 15
years and older.
PAGE 2 OF 11
You should only take this combination product if you have a blocked
nose with headache or fever. If you have
only one of these symptoms you should talk to your pharmacist or

SPC

PAGE 1 OF 18
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 18
1.
NAME OF THE MEDICINAL PRODUCT
Non-Drowsy Sudapro Head Cold 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 lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section
4.4).
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 _
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This product is contraindicated in paediatric patients b