Rowa Cold & Flu 500 mg/30 mg Granules for Oral Suspension

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Acetylsalicylic acid; Pseudoephedrine hydrochloride

Boleh didapati daripada:

Rowex Ltd

Kod ATC:

N02BA; N02BA51

INN (Nama Antarabangsa):

Acetylsalicylic acid; Pseudoephedrine hydrochloride

Dos:

500/30 milligram(s)

Borang farmaseutikal:

Granules for oral suspension

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Salicylic acid and derivatives; acetylsalicylic acid, combinations excl. psycholeptics

Status kebenaran:

Not marketed

Tarikh kebenaran:

2012-08-31

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWA COLD & FLU 500 MG/30 MG GRANULES FOR ORAL SUSPENSION
Acetylsalicylic acid / pseudoephedrine hydrochloride
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 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 3 days.
WHAT IS IN THIS LEAFLET
1.
What Rowa Cold & Flu is and what it is used for
2.
What you need to know before you take Rowa Cold & Flu
3.
How to take Rowa Cold & Flu
4.
Possible side effects
5.
How to store Rowa Cold & Flu
6.
Contents of the pack and other information
1 WHAT ROWA COLD & FLU IS AND WHAT IT IS USED FOR
ROWA COLD & FLU IS USED TO TREAT
nasal congestion in
COLDS
associated with pain and fever
Rowa Cold & Flu should only be used when nasal congestion appears
together with pain and/or fever.
Take a medicine that contains only one of the active substances if you
have only one of the symptoms
above.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROWA COLD & FLU
DO NOT TAKE ROWA COLD & FLU IF YOU ARE/HAVE
•
ALLERGIC
to acetylsalicylic acid, salicylates (a medicine group used to treat
pain or inflammation,
and to which acetylsalicylic acid belongs), pseudoephedrine or any of
the other ingredients of this
medicine (listed in section 6)
•
had
ASTHMA
or
STOMACH AND BOWEL ULCER
due to use of salicylates or similar medicines used to
treat pain, fever or inflammation
•
stomach ulcers
•
active bleeding
•
an increased tendency to
BLEED
•
PREGNANT
or BREAST-FEEDING
•
severe reduced
LIVER
or KIDNEY

Ciri produk

Health Products Regulatory Authority
23 November 2018
CRN008L5Q
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowa Cold & Flu 500 mg/30 mg Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 500 mg acetylsalicylic acid (aspirin) and 30 mg
pseudoephedrine hydrochloride.
Excipient(s) with known effect
1869 mg sucrose per sachet.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granules, occasional yellowish agglomeration.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of nasal congestion associated with the common
cold and
cold-related pain and fever.
The fix combination should only be used when nasal congestion appears
together
with pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The use of Rowa Cold & Flu 500 mg/30 mg Granules for Oral Suspension
in children
and adolescents under 16 years is contraindicated. Due to the limited
experience
with Rowa Cold & Flu 500 mg/30 mg Granules for Oral Suspension there
are no
special dosage recommendations for pediatric patients. See also
section 4.4 (Reye’s
syndrome).
Monotherapy must be chosen when one of the symptoms predominates. Rowa
Cold
& Flu 500 mg/30 mg Granules for Oral Suspension must not be used for
more than 3
days. A physician should be consulted if the symptoms are still
existent after 3 days
of treatment.
Health Products Regulatory Authority
23 November 2018
CRN008L5Q
Page 2 of 12
Adults:
1-2 sachets as a single dose.
If necessary, there may be second administration of the single dose at
intervals of 4-8
hours. The maximum daily dose of 6 sachets must not be exceeded.
Elderly:
Elderly patients should carefully consider the warnings in section
4.4. and 4.5, as
many of them concern especially elderly persons.
Method of administration
_Oral use: _RowaCold & Flu 500 mg/30 mg Granules for Oral Suspension
has to be
dissolved in a glass of water prior to administration. After