PANADEINE TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CODEINE PHOSPHATE; Paracetamol

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CODEINE PHOSPHATE; Paracetamol

Unit dalam pakej:

200 Tablets

Dikeluarkan oleh:

Sanofi India Limited

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PANADEINE
® TABLET
_ _
Paracetamol / Codeine Phosphate (500mg / 8mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Panadeine is used for
2. How Panadeine works
3. Before you use Panadeine
4. How to use Panadeine
5. While you are using it
6. Side effects
7. Storage and Disposal of Panadeine
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT PANADEINE IS USED FOR
Panadeine is used for the temporary
relief of pain and discomfort such as:
• Headache
• Menstrual pain
• Musculoskeletal pain
• Muscle pain
• Nerve pain (neuralgia)
• Toothache
• Dental procedures
• Cold and flu symptoms
• Viral infections
• Fever
• Sore throat
This medicine 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.
HOW PANADEINE WORKS
Panadeine contains two different
medicines called codeine phosphate
and paracetamol. 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 painkillers
such as paracetamol.
BEFORE YOU USE PANADEINE
_-When you must not use it _
Do not take Panadeine if:
• You are allergic (hypersensitive) to
paracetamol, codeine phosphate or to
any of the other ingredients of this
medicine.
-Signs of an allergic reaction include a
rash or breathing problems. There can
also be swelling of the legs, arms, face,
throat or tongue.
• The person going to take the tablets is
under 12 years of age. Panadeine must
not be given to children under 12 years
of age.
•You are under 18 years of age and
have had your tonsils or adenoids
removed due to obstructive sleep
apnoea syndrome
• You have severe and/or acute
respiratory diseases
• You have acute breathing difficulties
such as bronchitis, unstable asthma,
emphysema (serious lung disease),
respiratory depression (shallow
breathing) or respiratory insufficiency
(difficu

Ciri produk

MY/PAN/0521/Australia SmPC 2020 10
_PANADEINE TABLET_
Analgesic-antipyretic
Paracetamol 500mg
Codeine Phosphate 8mg
FOR RELIEF OF MODERATE PAIN AND FEVER
DESCRIPTION
Each tablet contains 500mg paracetamol and 8mg codeine phosphate.
It is a round, white, flat, bevelled edge tablet with characteristic
marking.
INDICATIONS
Panadeine is indicated for the relief of painful disorders such as
headache, dysmenorrhea, conditions involving
musculoskeletal pain, myalgias and neuralgias. it is also indicated as
an analgesic and antipyretic in conditions
accompanied by discomfort and fever, such as the common cold and viral
infections. Panadeine is an effective
analgesic after dental work and tooth extractions.
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).
DOSAGE AND ADMINISTRATION
Adults and children over 12 years:
Two tablets, to be taken with a glass of water, not more frequently
than every 4 hours, do not exceed 8 tablets in any
24 hour period.
PAEDIATRIC POPULATION
Children aged less than 12 years: 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
codeine to morphine.
Panadeine is contraindicated in children below the age of 12 years for
the symptomatic treatment of cold.
Children aged 12 years to 18 years: Panadeine is not recommended for
use in children aged 12 years to 18 years with
compromised respiratory function for the symptomatic treatment of
colds.
_ _
CONTRAINDICATIONS
Panadeine must not be used in patients with known hypersensitivity to
paracetamol, codeine or any of the excipients
used in this product. It must not be used in patients with known
glucose-6-phosphate-dehydrogenase deficiency,
patients
with
severe
hepatocellular
insufficiency,
or
severe
respiratory
disease,
acute
respiratory
disease
and
respiratory depression, for example acute asthma, acu