Flu Relief Capsules with Decongestant

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

から入手可能:

Galpharm Healthcare Limited Wrafton, Braunton, North Devon, EX33 2DL, United Kingdom

ATCコード:

N02BE51

INN（国際名）:

PARACETAMOL 500 mg PHENYLEPHRINE HYDROCHLORIDE 12.18 mg

医薬品形態:

HARD CAPSULE

構図:

PARACETAMOL 500 mg PHENYLEPHRINE HYDROCHLORIDE 12.18 mg

処方タイプ:

OTC

治療領域:

ANALGESICS

認証ステータス:

Withdrawn

承認日:

2006-12-20

情報リーフレット

NUMARK FLU RELIEF CAPSULES WITH DECONGESTANT
PLEASE READ THIS LEAFLET CAREFULLY BEFORE USE
WHAT IS THE PRODUCT?
This pack contains 8/10/12/16/24/30/32/36 green & white capsules which
are printed "GH31"
(not all pack sizes may be marketed). The capsules contain Paracetamol
which relieves pain and
reduces fever; and Phenylephrine Hydrochloride which is a
decongestant, it shrinks the blood
vessels in the nose and sinuses which opens the airways helping you to
breathe more easily.
INGREDIENTS: Each capsule contains Paracetamol 500 mg and
 Phenylephrine Hydrochloride
12.18 mg as the active ingredients.
They also contain: Colloidal Anhydrous Silica, Sodium Starch
Glycollate, Magnesium Stearate. The
capsule shell contains Gelatin, Titanium Dioxide (E 171), Patent Blue
V (E 131) and Yellow Iron
Oxide (E 172).
Product Licence Holder               
Manufacturer
Galpharm Healthcare Ltd.,            
Cardinal Health Germany 405 GmbH
Hugh House,

Steinbeisstrasse 2
Upper Cliffe Road,                   
D-73614
Dodworth Business Park,              
Germany
Dodworth,

South Yorkshire, S75 3SP.           
WHAT IS IT USED FOR?
For the effective relief from the symptoms of colds and flu including
aches, pains and feverishness,
headache, nasal congestion and sinus pain.
WARNINGS
DO NOT TAKE IF:
- You are allergic to Paracetamol, Phenylephrine Hydrochloride or to
any of the ingredients detailed
above.
- You are pregnant.
- You are taking monoamine oxidase inhibitors (eg. tranylcypromine,
phenelzine) or within 14
days of stopping such treatment.
- You are taking tricyclic anti-depressant drugs (eg. amitriptyline).
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CHECK WITH YOUR DOCTOR BEFORE TAKING IF:
- You suffer from liver, kidney or heart disease; diabetes; glaucoma;
high blood pressure;
prostate trouble; or if you have an over active thyroid gland.
- You are breastfeeding.
- You are receiving a course of medical treatment as this medicine may
a

製品の特徴

Page 1 of 5 
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Flu Relief Capsules with Decongestant 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Paracetamol EP 500.0mg 
Phenylephrine Hydrochloride EP 12.18mg 

3. 
PHARMACEUTICAL FORM 

Hard Capsule 

CLINICAL PARTICULARS 

4.1. 
THERAPEUTIC INDICATIONS 

For  relief  of  symptoms  of  colds  and  influenza,  including  aches  and  pains,  headache,  nasal 
congestion sinus pain and feverishness. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral administration. 

Adults and children over 12 years of age: 1 capsule to be taken
every 4 hours. 
Maximum of 4 capsules in any 24 hours. 

Children under 12 years: Not recommended. 

4.3. 
CONTRA-INDICATIONS 

Patients  with  known  hypersensitivity  to  Paracetamol  or  Phenylephrine  or  any  of  the  other 
ingredients.  Also contra-indicated during pregnancy and in
those taking monoamine oxidase 
inhibitors or tricyclic anti-depressant drugs. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Paracetamol  should  be  used  with  care  in  patients  with  severe  renal  or  hepatic  impairment.

The hazard of overdose is greater in those with
non-cirrhotic alcoholic liver disease. 

Immediate  medical  advice  should  be  sought  in  the  event  of  an  overdose  even  if  you  feel 
well, because of the risk of delayed, serious liver damage. 
Page 2 of 5 
Do not to take with any other paracetamol-containing products. 

Phenylephrine  should  be  used  with  care  in  patients  with  hyperthyroidism,  cardiovascular 
disease, diabetes mellitus, closed angle glaucoma,
prostatic enlargement and hypertension. 

Do not exceed the stated dose. 
If symptoms persist consult your doctor. 
Keep out