SYNDOL Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

PARACETAMOL BP CODEINE PHOSPHATE BP DOXYLAMINE SUCCINATE NF CAFFEINE BP

Dostopno od:

Imbat Limited

INN (mednarodno ime):

PARACETAMOL BP CODEINE PHOSPHATE BP DOXYLAMINE SUCCINATE NF CAFFEINE BP

Farmacevtska oblika:

Tablets

Tip zastaranja:

Product not subject to medical prescription

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2014-08-15

Navodilo za uporabo

 
PATIENT INFORMATION LEAFLET 

Read all of this leaflet carefully before you start taking this 
medicine because it contains important information for you. 
ƒ 
Keep this leaflet, you may wish to read it again. 
ƒ 
Ask your doctor or pharmacist if you need more information 
or advice. 
ƒ 
If you get any side-effects, talk to your doctor or 
pharmacist. This includes any possible side-effects not listed 
in this leaflet. 
ƒ 
You must talk to a doctor if you do not feel better or
if you 
feel worse. 

WHAT IS IN THIS LEAFLET 
1. 
WHAT SYNDOL IS AND WHAT IT IS USED FOR 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYNDOL 
3. 
HOW TO TAKE SYNDOL  
4. 
POSSIBLE SIDE-EFFECTS 
5. 
HOW TO STORE SYNDOL  
6. 
CONTENTS OF THE PACK AND OTHER INFORMATION 

1.  WHAT SYNDOL IS AND WHAT IT IS USED FOR 

Syndol is indicated for the short-term relief of
tension headache 
and other pains of a similar tension state origin, or pain
following 
surgery or a dental procedure. You should only take the product 
for a maximum of three days at a time. If you need to
take it for 
longer than three days, you should see your doctor or pharmacist 
for advice.  

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
SYNDOL 

THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION if 
you take it continuously for more than three days. This can
give 
you withdrawal symptoms from the medicine when you stop using 
it. IF YOU TAKE A PAINKILLER FOR HEADACHES FOR MORE THAN 
THREE DAYS IT CAN MAKE THEM WORSE.

DO NOT TAKE: 
ƒ 
If you are allergic to paracetamol, codeine phosphate 
hemihydrate, doxylamine succinate or caffeine or to any of 
the ingredients in this product, or opiod analgesics. See 
section 6 - ‘Contents of the pack and other information’ for 
the full list of ingredients. 
ƒ 
At the same time as taking other medicines containing 
paracetamol, codeine or Monoamin

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Syndol Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Excipients-Contains Lactose Monohydrate and Sunset Yellow Aluminium Lake (E110)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from _the UK:
Yellow, capsule shaped tablet, embossed ‘SYNDOL’ on one side with a single breakline on reverse
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic relief of tension headache and other pains of a similar tension state origin. For the
symptomatic relief of pain following surgical and dental operations and procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
ADULTS AND CHILDREN OVER 12 YEARS:
Take 1 or 2 tablets every four or six hours as needed for relief.
Not recommended for children under 12 years.
Do not exceed 8 tablets per day.
Do not take for more than 3 days continuously without medical review.
ELDERLY
Dosage as for Adults
Codeine should be used with caution in elderly and debilitated patients, as they may be more susceptible to the
respiratory depressant effects.
RENAL AND HEPATIC IMPAIRMENT
Care is advised in the administration of paracetamol-containing product to patients with severe renal or severe hepatic
impairment and in those with non-cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with
alcoholic liver disease. Patients suffering from liver or kidney disease should take paracetamol under medical
supervision. The dosage in renal and hepatic impairment must be reduced.
Paracetamol
450mg
Codeine Phosphate Hemihydrate 10mg
Doxylamine Succinate
5mg
Caffeine
30mg
IRISH M