Syndol Film-coated Tablets Paracetamol 450 mg Codeine Phosphate Hemihydrate 10 mg Doxylamine succinate 5 mg Caffeine 30 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate; DOXYLAMINE SUCCINATE; Caffeine

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate; DOXYLAMINE SUCCINATE; Caffeine

Dosage:

450mg/10mg/5mg/30 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Authorization status:

Not marketed

Authorization date:

1975-09-03

Patient Information leaflet

SYNDOL FILM COATED TABLETS
paracetamol, 450mg
codeine phosphate hemihydrate, 10mg
doxylamine succinate, 5mg
caffeine, 30mg
PATIENT INFORMATION LEALET
- 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, please 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 signs of illness are the same as yourseIf you
get any
side effects, talk to your doctor or pharmacist. This includes any
side effects
not listed in this leaflet. See section 4.
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 TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SYNDOL TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SYNDOL IS AND WHAT IT IS USED FOR
The name of your medicine is Syndol Film Coated Tablets (called Syndol
throughout
this leaflet). Syndol contains four different medicines called
paracetamol, codeine,
doxylamine succinate and caffeine.
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.
This product contains codeine. Codeine belongs to a group of medicines
called
opioid analgesics which act to relieve pain. It can be used on its own
or in
combination with other pain killers such as paracetamol. Codeine can
be used in
children over 12 years of age for the short-term relief of moderate
pain that is not
relieved by other painkillers such as paracetamol or ibuprofen alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYNDOL
IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT 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 THIS MEDICINE FOR HEADACHES FOR MORE THAN THREE DAYS it
ca

Summary of Product characteristics

Health Products Regulatory Authority
23 April 2020
CRN0098KH
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Syndol Film-coated Tablets Paracetamol 450 mg Codeine Phosphate
Hemihydrate 10 mg Doxylamine succinate 5 mg Caffeine
30 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Paracetamol
450
mg
Codeine phosphate hemihydrate
10
mg
Doxylamine succinate
5
mg
Caffeine
30
mg
Excipients: contains lactose monohydrate and sunset yellow (E110).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
Yellow, capsule shaped tablet, embossed ‘SYNDOL’ on one side with
a single breakline on the 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 reliefof tension headache and other
pains of a similar tension state origin. For the
symptomatic relief of pain following surgical and dental operations
and procedures.
Syndol (which contains codeine) is indicated in patients older than 12
years of age for the treatment of acute moderate pain
which is not considered to be relieved by other analgesics such as
paracetamol or ibuprofen alone.
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.
Do not exceed 8 tablets per day.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the patients/carers should be
advised to seek the views of a physician.
Do not take for more than 3 days continuously without medical review.
The patient should consult a doctor if symptoms persist or worsen, or
if the product is required for more than 3 days.
CHILDREN UNDER 12 YEARS:
Syndol (which contains Codeine) should not be used in children below
the age of 12 years because of the risk of opioid toxicity
due to the variable and unpredictable metabolism of