Brupro Cold & Flu 200 mg/30 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

متاح من:

Rowa Pharmaceuticals Limited

ATC رمز:

R05X

INN (الاسم الدولي):

Ibuprofen; PSEUDOEPHEDRINE HYDROCHLORIDE

جرعة:

200/30 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

OTHER COLD PREPARATIONS

الوضع إذن:

Marketed

تاريخ الترخيص:

2021-04-30

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRUPRO COLD & FLU 200 MG/30 MG FILM-COATED TABLETS
ibuprofen/pseudoephedrine hydrochloride
For adults and adolescents from 12 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 Brupro Cold & Flu is and what it is used for
2.
What you need to know before you take Brupro Cold & Flu
3.
How to take Brupro Cold & Flu
4.
Possible side effects
5.
How to store Brupro Cold & Flu
6.
Contents of the pack and other information
1.
WHAT BRUPRO COLD & FLU IS AND WHAT IT IS USED FOR
Brupro Cold & Flu 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.
Brupro Cold & Flu is used for the symptomatic relief of nasal/sinus
congestion with headache, fever and pain
associated with the common cold and flu, in adults and adolescents
aged 12 years and older.
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
doctor about using either ibuprofen or
pseudoephedrine by itself.
You must talk to a doct

خصائص المنتج

Health Products Regulatory Authority
23 December 2022
CRN00D7QP
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brupro Cold & Flu 200 mg/30 mg 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.
Yellow, round, film-coated tablets. Diameter: approx. 11 mm, height:
approx. 5 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of nasal/sinus congestion with headache,
fever and pain associated with the common cold and flu.
Brupro Cold & Flu is indicated in adults and adolescents aged 12 years
and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents aged 12 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 12 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 _
Brupro Cold & Flu is contraindicated in paediatric patients below 12
years of age (see section 4.3).
Method of administration
For oral use.
The tablets should be swal