Solpa-Sinus Film-coated Tablets Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Chefaro Ireland DAC

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

500 mg/30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

2003-11-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPA-SINUS FILM-COATED TABLETS
Paracetamol 500mg
Pseudoephedrine hydrochloride 30mg
POWERFUL RELIEF FROM SINUS PAIN & CONGESTION
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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Solpa-Sinus is used for the relief of nasal congestion when combined
with fever and/or pain such as
sore throat, sinus pain or headache in the common cold or flu in
adults and in .
This medicine contains the active substances Paracetamol 500mg, which
is a painkiller and reduces
your temperature when you have a fever and Pseudoephedrine
hydrochloride 30mg, which is a
decongestant which unblocks your nose and sinuses helping you breathe
more easily without
drowsiness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE SOLPA-SINUS:
•
if you are allergic to paracetamol, pseudoephedrine hydrochloride or
other sympathomimetics
(such as decongestants, appetite suppressants or stimulant drugs
called amphetamines), or any of
the other ingredients of this medicine (listed in Section 6);
•
if you have high blood pressure, overactive thyroid gland, enlarged
prostate, heart problems,
glaucoma (excessive pressure inside your eyes);
•
if you have diabetes;
•
i

Summary of Product characteristics

Health Products Regulatory Authority
14 June 2022
CRN00CY1M
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa-Sinus Film-coated Tablets Paracetamol 500mg Pseudoephedrine
Hydrochloride 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and pseudoephedrine
hydrochloride 30 mg.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
A bilayer (white/blue) film coated capsule shaped tablet. The tablet
is debossed with the number 2 in a circle on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solpa-Sinus is indicated in adults and in children and adolescents
aged 12 years and over for the symptomatic relief of nasal
congestion when combined with fever and/or pain such as, sore throat,
sinus pain or headache in the common cold or
influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, including the elderly, and children 16 years and over:
Two tablets up to three times daily as required for relief of
symptoms.
No more than 8 tablets should be taken in 24 hours
_Elderly patients_
Experience has indicated that normal adult dosage is usually
appropriate. However, in frail, immobile, elderly subjects or in
elderly patients with renal or hepatic impairment, a reduction in the
amount or frequency of dosing may be appropriate.
The maximum daily dose should not exceed 60mg/kg/day (up to a maximum
of 2g per day) in the following situations, unless
directed by a physician:

Weight less than 50kg

Chronic alcoholism

Dehydration

Chronic malnutrition _Paediatric population_ _Childrenaged 12 to 15
yearsold:_One tablet up to three times daily as
required for relief of symptoms.Not to be used in children under 12
years of age. The dose should not be repeated
more frequently than every four hours nor should more than three doses
be given in any 24-hour period. Do not
exceed the stated dose. Method of administration For oral use.The
tablets should be taken with water.Do not
exceed the recommen