Paralief Sinus Tablets Paracetamol 500 mg Pseudoephedrine hydrochloride 30 mg

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PSEUDOEPHEDRINE HYDROCHLORIDE; PARACETAMOL

Mevcut itibaren:

Chanelle Medical

ATC kodu:

N02BE; N02BE01; R01BA; R01BA02

INN (International Adı):

PSEUDOEPHEDRINE HYDROCHLORIDE; PARACETAMOL

Doz:

500/30 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product not subject to medical prescription

Terapötik alanı:

Anilides; paracetamol; Sympathomimetics; pseudoephedrine

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2017-01-27

Bilgilendirme broşürü

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 hyperthyroidism (an excessive secretion of thyroid
hormones).
• If you have glaucoma (increased pressure in the eye).
• If you have

Ürün özellikleri

Health Products Regulatory Authority
04 November 2020
CRN009X8F
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 filtr