DYPRACET 30/500 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARACETAMOL, DIHYDROCODEINE BITARTRATE

Available from:

Auden Mckenzie (Pharma Division) Ltd

ATC code:

N02AJ01

INN (International Name):

PARACETAMOL, DIHYDROCODEINE BITARTRATE

Dosage:

30/500 Milligram

Pharmaceutical form:

Tablets

Prescription type:

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

Therapeutic area:

Dihydrocodeine and Paracetamol

Authorization status:

Transfer Pending

Authorization date:

2012-03-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DYPRACET 20MG/500MG TABLETS
DYPRACET 30MG/500MG TABLETS
Dihydrocodeine Tartrate Paracetamol 1. What are DYPRACET Tablets
AND WHAT ARE THEY USED FOR?
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- 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 only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours. 4.
- 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.
-
This medicine contains paracetamol.
-
Do not take any other paracetamol containing products.
-
Do not exceed the stated dose.
-
Immediate medical advice should be sought in the event of overdosage
because of the
risk of irreversible liver damage
What is in this leaflet:
1. WHAT DYPRACET TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DYPRACET TABLETS
3. HOW TO TAKE DYPRACET TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DYPRACET TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DYPRACET TABLETS ARE AND WHAT THEY ARE USED FOR
The name of this medicine is DYPRACET 20 mg/500 mg & DYPRACET 30
mg/500 mg
Tablets. These tablets have been prescribed for you to relieve severe
pain over a period of 4
to 6 hours. They contain the active ingredients dihydrocodeine
tartrate and paracetamol
which belong to a group of medicines called strong analgesics or
‘painkillers’. The other
ingredients are listed in section 6 of this leaflet. 2. B
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DYPRACET TABLETS
DO NOT TAKE DYPRACET TABLETS IF YOU:
-
Are allergic to dihydrocodeine, paracetamol or any of the other
ingredients of this
medicine (listed in section 6);
-
Have breathing problems, such as breathing more slowly or weakly than
expected, or
obstructive airways dise

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DYPRACET 30 mg/500 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
DYPRACET 30 mg/500 mg Tablets contain Paracetamol 500 mg and
Dihydrocodeine Tartrate 30 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
DYPRACET 30 mg/500 mg Tablets are oblong, white tablets, 19 mm x 7 mm
long with the marking P500 D30 on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DYPRACET 30 mg/500 mg Tablets: For the treatment of severe pain where
there is a higher analgesic requirement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults over 18 years_
1 or 2 tablets every four to six hours.
Do not exceed 8 tablets in any 24-hour period.
_Paediatric population_
_Adolescents 16-18 years_
1 or 2 tablets every six hours when necessary up to a maximum of 8
tablets in any 24 hour period.
_Children 12-15 years_
1 tablet every six hours when necessary up to a maximum of 4 tablets
in any 24 hour period.
_Children under 12 years_
Not recommended.
_Elderly_
1 tablet every –four to six hours increasing to two tablets every 4
- 6 hours if required and tolerated. Caution should be
exercised when increasing the dose in the elderly.
Method of administration
Oral.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_2_
_/_
_0_
_5_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_4_
_7_
_9_
_6_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
DYPRACET 30 mg\500 mg tablets should, if possib