Kapake 30mg/500mg capsules

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Codeine phosphate; Paracetamol

Tersedia dari:

Galen Ltd

Kode ATC:

N02AJ06

INN (Nama Internasional):

Codeine phosphate; Paracetamol

Dosis:

30mg ; 500mg

Bentuk farmasi:

Oral capsule

Rute administrasi :

Oral

Kelas:

Schedule 5 (CD Inv)

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 04070100; GTIN: 5016298445107

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
KAPAKE 30MG/500MG CAPSULES
(Codeine Phosphate Hemihydrate and Paracetamol)
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, pharmacist or
nurse.
-
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.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Kapake 30mg/500mg Capsules are and what they are used for
2.
What you need to know before you take Kapake 30mg/500mg Capsules
3.
How to take Kapake 30mg/500mg Capsules
4.
Possible side effects
5.
How to store Kapake 30mg/500mg Capsules
6.
Contents of the pack and other information
1.
WHAT KAPAKE 30MG/500MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Kapake 30mg/500mg Capsules contain codeine, an opioid analgesic, in
combination with
paracetamol. Kapake 30mg/500mg Capsules are one of a group of
medicines called analgesics
or painkillers. They are used to relieve severe pain in adults.
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 KAPAKE 30MG/500MG CAPSULES
DO NOT TAKE KAPAKE 30MG/500MG CAPSULES:
-
if you are allergic to codeine phosphate hemihydrate, paracetamol or
any of the other
ingredients of this medicine (listed in section 6).
-
if you are suffering from increased pressure on the brain or a head
injury.
-
if you have been told by your doctor that you have a severe breathing
difficulty called
respiratory depression.
-
if you suffer from severe but usually short-lasting asthma attacks
(acute asthma).
-
if you consume excessive amounts of alcohol on a

Karakteristik produk

OBJECT 1
KAPAKE 30MG/500MG CAPSULES (CODEINE
PHOSPHATE HEMIHYDRATE AND PARACETAMOL)
Summary of Product Characteristics Updated 31-Oct-2017 | Galen Limited
1. Name of the medicinal product
Kapake 30mg/500mg Capsules / Co-Codamol 30mg/500mg Capsules
2. Qualitative and quantitative composition
per capsule
Paracetamol
500mg
Codeine Phosphate Hemihydrate
30mg
Excipients with known effect: Each capsule contains Cochineal Red A
(E124).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Hard gelatin capsule (size 0) with a red cap and a white body; both
are marked in black ink with “G
30/500”.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain in adults.
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
Posology
_Adults:_
One or two capsules every four hours as required.
Maximum of eight capsules daily.
_Paediatric population:_
CHILDREN AGED 12 AND OVER:
One capsule to be taken every six hours as required, up to a maximum
of four capsules in any 24-hour
period.
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 (see sections 4.3 and 4.4).
_Elderly: _
The adult dose is appropriate.
The duration of treatment should be limited to three days and if no
effective pain relief is achieved the
patients/carers should be advised to seek the views of a physician.
Method of administration
For oral use.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
This product is contraindicated in patients with raised intracranial
pressure or head injury, respiratory
depression, acute asthma, acute alcoholism.
Kapake/Co-Codamol 30mg/500mg Capsules are also contraind