Paralief Sinus Tablets Paracetamol 500 mg Pseudoephedrine hydrochloride 30 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

Clonmel Healthcare Ltd

ATC code:

N02BE; N02BE01; R01BA; R01BA02

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE

Dosage:

500/30 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Anilides; paracetamol; Sympathomimetics; pseudoephedrine

Authorization status:

Marketed

Authorization date:

2017-01-27

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARALIEF SINUS TABLETS
Paracetamol 500 mg / Pseudoephedrine Hydrochloride 30 mg
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 or
nurse. 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.
THE NAME OF THIS MEDICINE IS
Paralief Sinus Tablets.
WHAT IS IN THIS LEAFLET
1.
What Paralief Sinus Tablets are and what they are used for
2.
What you need to know before you take Paralief Sinus Tablets
3.
How to take Paralief Sinus Tablets
4.
Possible side effects
5.
How to store Paralief Sinus Tablets
6.
Contents of the pack and other information
1.
WHAT PARALIEF SINUS TABLETS ARE AND WHAT THEY ARE USED FOR
Paralief Sinus Tablets relieves the symptoms of colds and flu
including aches, pains, fever, nasal and
sinus congestion.
The tablets contain paracetamol, an analgesic and antipyretic to
relieve pain and fever, and
pseudoephedrine, a decongestant to clear nasal congestion and blocked
sinuses.
This medicine is for use in adults and adolescents aged 15 years and
over
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARALIEF SINUS TABLETS
DO NOT TAKE THIS MEDICINE:

If you are allergic to paracetamol or pseudoephedrine or any of the
other ingredients of this
medicine (listed in section 6).

If you have
HIGH BLOOD PRESSURE
or
HEART DISEASE

If you are taking any other
PARACETAMOL
containing products

If you are taking, or have taken in the last two weeks,
DRUGS FOR DEPRESSION
known as Monoamine
Oxidase Inhibitors (MAOIs)

If you are taking tricyclic antidepressants.

If you have
H

Summary of Product characteristics

Health Products Regulatory Authority
09 September 2022
CRN00C33V
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paralief Sinus Tablets Paracetamol 500 mg Pseudoephedrine
hydrochloride 30 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of paracetamol and 30 mg of
pseudoephedrine hydrochloride
Excipient(s) with known effect
Each tablet contains no more than 0,882 mg of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Approximately 18 mm plain, white to off-white, capsule shaped tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paralief Sinus Tablets are indicated for the short term symptomatic
treatment of nasal and sinus congestion associated with the
symptoms of cold and flu, such as mild pain, headache and/or fever.
Paralief Sinus Tablets are indicated in adults and
adolescents aged 15 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS AGED 15 YEARS AND OVER:
Oral. One to two tablets, every four to six hours, two to three times
a day. Maximum daily dose: 6 tablets (i.e. 180 mg
pseudoephedrine hydrochloride, 3 g paracetamol).
CHILDREN AND ADOLESCENTS AGED UNDER 15 YEARS:
Paralief Sinus Tablets are not recommended in children and adolescents
aged under 15 years.
THE ELDERLY:
Experience has indicated that normal adult dosage is appropriate.
However in frail, immobile, elderly patients, a reduction in
the amount or frequency of dosing may be appropriate.
HEPATIC DYSFUNCTION
In patients with impaired hepatic function or Gilbert’s Syndrome,
the dose must be reduced or the dosing interval prolonged.
RENAL DYSFUNCTION:
Caution should be exercised when administering Paralief Sinus Tablets
to patients with moderate to severe renal impairment,
particularly if accompanied by cardiovascular disease. It is
recommended, when giving paracetamol to patients with renal
failure, to reduce the dose and to increase the minimum interval
between each administration to at least 6 hours.
Glomerular filt