Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 25mg/100mg/5mg hard capsules

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Paracetamol, Guaifenesin, Phenylephrine Hydrochloride

Available from:

Wrafton Laboratories Limited

ATC code:

N02BE51

INN (International Name):

Paracetamol, Guaifenesin, Phenylephrine Hydrochloride

Dosage:

250mg/100mg/5mg

Pharmaceutical form:

Capsule, hard

Administration route:

Oral use

Units in package:

Pack sizes: 8 and 16 capsules.

Prescription type:

GSL - General Sales List

Manufactured by:

Wrafton Laboratories Limited

Therapeutic group:

Other analgesics and antipyretics & other cold combination preparations

Therapeutic indications:

For the relief of symptoms associated with colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills, lowering of temperature, and to loosen stubborn mucous and provide relief from chesty coughs

Authorization status:

Authorised

Authorization date:

2015-04-14

Patient Information leaflet

Pack Copy 
Specification 
Galpharm Paracetamol, 
Guaifenesin, Phenylephrine 
Hydrochloride 250 mg / 100 
mg / 5 mg Capsules - Leaflet 
Marketing 
Authorisation number 
PL 12063/0125 
Version Number 
1 

Paracetamol, Guaifenesin, Phenylephrine  

PATIENT INFORMATION LEAFLET 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU TAKE THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION YOU NEED TO KNOW. 

This medicine is available without prescription, however, you
still need to use this product 
carefully to get the best results from it. Keep this leaflet
as you may need to read it again. Ask 
your pharmacist if you need more information or advice.  

1) WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?

THIS MEDICINE CONTAINS: 
•  PARACETAMOL which is a pain reliever (analgesic) and helps reduce your temperature when 
you have a fever 
•  GUAIFENESIN which is an expectorant to help loosen phlegm 
•  PHENYLEPHRINE which is a decongestant to
reduce swelling in the passages of the nose to 
help you breathe more easily. 

These capsules are used
for the relief of the symptoms of colds and
flu and the pain and 
congestion of sinusitis, including aches and pains, headache,
blocked nose and sore throat, 
chills and feverishness (high temperature). They can also loosen
stubborn mucus (phlegm) 
and provide relief from chesty coughs. 

2) IS THIS MEDICINE SUITABLE FOR YOU? 
DO NOT TAKE THIS MEDICINE IF YOU: 
•  are ALLERGIC to paracetamol, guaifenesin,
phenylephrine or any of the other ingredients 
•  have a serious heart condition
or cardiovascular disorder(s) 
•  have high blood pressure (hypertension) 
•  have diabetes 
•  have an overactive thyroid  
•  have glaucoma 
•  have difficulty passing urine, an
enlarged prostate or o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Galpharm Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250
mg/100 mg/5 
mg hard capsules  

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
ACTIVE 
INGREDIENT 

  MG/CAPSULE 

Paracetamol 

   250 

Guaifenesin 

   100 

Phenylephrine Hydrochloride        5  

For full list of excipients, see section 6.1.  

3 PHARMACEUTICAL 
FORM 
Capsule, hard (capsule).  

Light blue / purple hard gelatin capsules
containing the drug product, an off-white 
powder.  

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
For the relief of symptoms associated with colds and flu and the
pain and congestion 
of sinusitis, including aches and pains, headache, blocked nose
and sore throat, chills, 
lowering of temperature, and to loosen stubborn mucous and
provide relief from 
chesty coughs.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
For oral use. Swallow whole with water, do not chew.  

Adults, the elderly and children aged 12 years and over:  
Two capsules every four hours as required. Do not take more
than 8 capsules (4 
doses) in any 24 hour period.  

Do not give to children under 12 years old.  

4.3 CONTRAINDICATIONS 
Hypersensitivity to paracetamol, guaifenesin or phenylephrine
or any of the other 
ingredients.  
Hypertension (high blood pressure), hyperthyroidism, diabetes,
serious heart disease, 
cardiovascular disorders or those patients receiving or within
two weeks of stopping 
therapy with monoamine oxidase inhibitors (see Section 4.5).  

Those taking tricyclic anti-depressant drugs (see Section 4.5).  

Phaeochromocytoma  

Prostatic enlargement or urinary retention  

Use in patients with glaucoma, including closed angle glaucoma.  

Hepatic and renal impairment  

Use in patients who are currently receiving other sympathomimetic
drugs