PARAMOL 10/500 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL DIHYDROCODEINE BITARTRATE

Available from:

Galen Limited

INN (International Name):

PARACETAMOL DIHYDROCODEINE BITARTRATE

Dosage:

10/500 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

PARAMOL 10MG/500MG TABLETS 
(DIHYDROCODEINE HYDROGEN TARTRATE AND PARACETAMOL) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
-  Keep this leaflet. You may need to read it again. 
-  If you have any further questions, ask your doctor or
pharmacist. 
-  This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
-  If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1.  What Paramol 10mg/500mg Tablets are and what they are used for 
2.  Before you take Paramol 10mg/500mg Tablets 
3.  How to take Paramol 10mg/500mg Tablets 
4.  Possible side effects 
5.  How to store Paramol 10mg/500mg Tablets 
6.  Further information 

1.  WHAT PARAMOL 10MG/500MG TABLETS ARE AND WHAT THEY ARE USED 
FOR 

Paramol 10mg/500mg Tablets are one of a group of medicines known as
analgesics or 
painkillers.  They are used to relieve moderate pain.  They can
also be used in the treatment of a 
raised temperature and dry (non-productive) cough. 

2. 
BEFORE YOU TAKE PARAMOL 10MG/500MG TABLETS 

DO NOT TAKE PARAMOL 10MG/500MG TABLETS IF YOU

-  are allergic (hypersensitive) to paracetamol, dihydrocodeine, or
any of the other ingredients 
(see Section 6 for a full list of ingredients) 
-  have a condition where you breathe more slowly and weakly than
expected (respiratory 
depression) or where you have difficulty
breathing (obstructive airways disease) 
-  are pregnant, planning to become pregnant or breast-feeding 

CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING PARAMOL 10MG/500MG
TABLETS IF YOU 
-  suffer from asthma or other allergic (hypersensitive) disorders

-  are elderly and/or in poor health 
-  have an under active thyroid gland (hypothyroidism) 
-  have ki

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paramol 10mg/500mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Oval, white uncoated tablets marked ‘PARAMOL’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults and Children over 12 years:
Analgesic: The usual dose is one to two tablets every four hours or as directed by the doctor with a maximum of eight
tablets in twenty-four hours.
Antitussive and Antipyretic: The usual dose is one tablet every four hours.
PARAMOL IS NOT RECOMMENDED FOR CHILDREN UNDER 12 YEARS.
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity or idiosyncratic response to the active ingredients.
Use in respiratory depression or in obstructive airways disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product should be used with great caution in patients with allergic disorders or with a history of asthma, as
dihydrocodeine may cause the release of histamine.
Use with caution in patients with a previous history of opioid abuse. See section 4.5 for additional information.
Dosage should be reduced in the elderly, in hypothyroidism and in those with renal or hepatic dysfunction. Overdose
ACTIVE INGREDIENTS:
PER TABLET
Paracetamol
500.0 mg
Dihydrocodeine Hydrogen Tartrate 10.0 mg
As an analgesic in the relief of moderate pain. As an antipyretic and antitussive in the treatment of non-productive
cough.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/08/2014_
_CRN 2151426_
_page number: 1_
can cause hepatic necrosis.
Opioid analgesics should be avoided in patients�