Co-dydramol 10mg/500mg tablets

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Paracetamol; Dihydrocodeine tartrate

থেকে পাওয়া:

Wockhardt UK Ltd

এটিসি কোড:

N02AJ01

INN (আন্তর্জাতিক নাম):

Paracetamol; Dihydrocodeine tartrate

ডোজ:

500mg ; 10mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

Schedule 5 (CD Inv)

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04070100; GTIN: 5012727906041 5012727906058

তথ্য লিফলেট

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
PRODUCT :
Co-dydramol 10/500mg Tablets - 100 Tabs (for UK)
CUSTOMER :
Wockhardt UK
PLANT LOCATION :
for UK alternative
DIMENSIONS :
(w)148 x (h)210mm
PHARMACODE No.:
645
TEXT FONT SIZE :
7pt. (10% condensed)
FILE NAME :
Co-dydramol_Leaflet_106995-3.ai
SOFTWARE :
Adobe Illustrator CS5
TYPEFACES :
Helvetica Medium / Bold
ARTWORK (DETAILS)
29th November & 5th December, 2016
RECEIVED ON :
PROOF REVISION :
R 1st PDF sent on
- 7TH DEC. 2016
WHAT IS IN THIS LEAFLET
1. What Co-dydramol Tablets are and what they are used for
2. What you need to know before you take Co-dydramol Tablets
3. How to take Co-dydramol Tablets
4. Possible side effects
5. How to store Co-dydramol Tablets
6. Contents of the pack and other information
1. WHAT CO-DYDRAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredients in Co-dydramol Tablets are paracetamol
and dihydrocodeine tartrate. They belong to a group of medicines
called analgesics, which act as painkillers. These tablets are
usually used for the treatment of mild to moderate pain in
muscles and joints (e.g. arthritic pain, sprains, strains etc.).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-DYDRAMOL
TABLETS
DO NOT TAKE CO-DYDRAMOL TABLETS IF YOU:
• are allergic to paracetamol, dihydrocodeine tartrate, or any of
the other ingredients of this medicine (listed in section 6).
• drink excessive amounts of alcohol.
• have severe asthma, bronchitis, breathing problems or if you
are having an asthma attack.
• have recently had a head injury or have increased pressure
within your head (raised intracranial pressure).
• are under 12 years of age.
• have an inflamed bowel or obstructive bowel disorder.
• have severe diarrhoea.
• are in a coma.
• have been told you have liver disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Co-dydramol
Tablets.
This product contains paracetamol.
• Do NOT take with any other par

পণ্য বৈশিষ্ট্য

OBJECT 1
CO-DYDRAMOL 10/500MG TABLETS
Summary of Product Characteristics Updated 25-May-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Co-dydramol 10/500mg Tablets
2. Qualitative and quantitative composition
Paracetamol 500.00mg
Dihydrocodeine Tartrate 10.00mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet for oral use
4. Clinical particulars
4.1 Therapeutic indications
Co-dydramol tablets are indicated for the relief of mild to moderate
pain in musculoskeletal conditions
(e.g. sciatica, osteoarthritis, chronic rheumatoid arthritis, sprains,
strains etc.)
4.2 Posology and method of administration
_ADULTS AND CHILDREN 16 YEARS AND OVER:_
_Analgesia: _
One to two tablets every four to six hours. Do not take more than 8
tablets in 24 hours.
_CHILDREN 12 – 15 YEARS:_ One tablet every 4-6 hours when necessary
to a maximum of 4 doses in any 24
hours.
_CHILDREN UNDER 12 YEARS OF AGE:_ Do not give to children under 12
years.
_Elderly:_
The initial dose should be reduced in the elderly and subsequently
adjusted according to response.
Hepatic impairment:
A reduction in dosage should be considered (see also 4.8 Undesirable
Effects)
Renal impairment:
The dosage should be reduced in moderate to severe renal impairment
(see also 4.8 Undesirable Effects)
For concomitant illnesses/conditions where dose reduction may be
appropriate, see 4.4 Special Warnings
and Precautions for Use.
Method of administration
For oral use.
4.3 Contraindications
Raised intercranial pressure or head injury (in addition to the risk
of respiratory depression and increased
intracranial pressure, may affect papillary and other responses vital
for neurological assessment). Known
hypersensitivity to paracetamol or dihydrocodeine tartrate, or to
other opioid analgesics or to any of the
excipients. Not to be given to children under twelve years. Severe
hepatic dysfunction. Acute respiratory
depression, obstructive airways disease. Acute alcoholism.
Dihydrocodeine is also contra-indicated where
there is a risk of pa