MEDISIP WITH DECONGESTANT POWDER FOR ORAL SOLUTION 500/12.2 Milligram Powder for Oral Solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

Saadav alates:

Actavis Group PTC ehf

ATC kood:

N02BE51

INN (Rahvusvaheline Nimetus):

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE

Annus:

500/12.2 Milligram

Ravimvorm:

Powder for Oral Solution

Retsepti tüüp:

Product not subject to medical prescription

Terapeutiline ala:

Analgesics and antipyretics

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-03-06

Infovoldik

Page 1/7 
V001 

MAY 2016 

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

MEDISIP WITH DECONGESTANT POWDER FOR ORAL SOLUTION PARACETAMOL
500 MG, 
PHENYLEPHRINE HYDROCHLORIDE 12.2 MG

(Paracetamol 500 mg, Phenylephrine Hydrochloride 12.2 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. 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 
Medisip with Decongestant Powder for Oral Solution 
is and what it is used for 
2. 
What you need to know before you take  
3. 
How to take 
 Medisip with Decongestant Powder for Oral Solution 
4. 
Possible side effects 
5. 
How to store 
 Medisip with Decongestant Powder for Oral Solution 
6. 
Contents of the pack and other information 

1. 
WHAT MEDISIP WITH DECONGESTANT POWDER FOR ORAL SOLUTION IS
AND WHAT IT IS USED FOR 

Medisip with Decongestant Powder for Oral Solution contains
paracetamol, an analgesic which 
relieves aches and reduces fever, and phenylephrine,
a decongestant to relieve a blocked up nose.  

Medisip with Decongestant Powder for Oral Solution is
used for the relief of the symptoms of colds 
and influenza, including the relief of aches, headache,
nasal congestion and lowering of temperature at 
adults and adolescents over 16 years of age. 

You must talk to a doctor if you do
not feel�

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medisip with Decongestant Powder for Oral Solution
Paracetamol 500mg
Phenylephrine hydrochloride 12.2mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_1 Sachet contains:_
Paracetamol
500 mg
Phenylephrine hydrochloride
12.2 mg
corresponding to phenylephrine
10.0 mg
_Excipients with known effects:_
Sucrose
1829.7 mg
Aspartame (E951)
17.5 mg
Sorbitol (E420)
1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution
Free flowing white powder.
The reconstituted solution is visually colourless, slightly
opalescent, free from particles and precipitates.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short term symptomatic treatment of colds and influenza (aches, fever)
when associated with nasal congestion.
Medisip with Decongestant Powder for Oral Solution is indicated in
adults and children over 16 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One sachet dissolved by stirring in half a mug of hot water (approx.
125 ml).
The dose may be repeated in 4-6 hours.
No more than four doses should be taken in 24 hours.
_Paediatric Population_
Children under 16 years of age:
Medisip with Decongestant Powder for Oral Solution is not recommended
for use in children below the age of 16.
Adolescents over 16 years of age:
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