Codeine 15mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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download PIL (PIL)
20-04-2020
download SPC (SPC)
07-06-2018
download PAR (PAR)
20-04-2020

active_ingredient:

Codeine phosphate

MAH:

Sun Pharma UK Ltd

ATC_code:

R05DA04

INN:

Codeine phosphate

dosage:

15mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

Schedule 5 (CD Inv)

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04070200; GTIN: 5015525033810

PIL

                                Patient Information Leaflet
SOVEREIGN
MEDICAL
CODEINE PHOSPHATE 15 mg, 30 mg and 60 mg Tablets
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE

Please 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 symptoms are the same as yours.

If any of the side effects becomes serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets are and what
they are used for
2. Before you take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
3. How to take Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
4. Possible side effects
5. How to store Codeine Phosphate 15 mg, 30 mg and 60 mg Tablets
6. Further information
1. WHAT CODEINE PHOSPHATE TABLETS 15 MG, 30 MG, AND 60 MG TABLETS ARE
AND
WHAT THEY ARE USED FOR
The name of your medicine is Codeine Phosphate 15mg, 30mg or 60mg
Tablets. The active
ingredient is codeine phosphate.
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 painkillers 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.
It can also be used to prevent coughs and to treat the symptoms of
chronic diarrhoea.
2. BEFORE YOU TAKE CODEINE PHOSPHATE 15 MG, 30 MG AND 60 MG TABLETS
DO NOT TAKE THIS MEDICATION:

if you have ever had an allergic reaction to any of the ingredients of
Codeine Phosphate 15
mg, 30 mg and 60 mg tablets or any other medicines that you may have
taken to relieve pain.
(allergic reactions include mild symptoms such as itching and/or rash.
More severe
symptoms include swelling of the face, lips, tongue an
                                
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SPC

                                OBJECT 1
CODEINE PHOSPHATE TABLETS BP 15MG
Summary of Product Characteristics Updated 25-Apr-2018 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
1. Name of the medicinal product
Codeine Phosphate Tablets BP 15mg
2. Qualitative and quantitative composition
Each tablet contains 15mg of codeine phosphate
Excipients with known effect:
Each tablet contains 28.85mg of lactose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White to off white circular normal biconvex tablets, embossed with
R114.
4. Clinical particulars
4.1 Therapeutic indications
Codeine is indicated in adults as an analgesic, an anti-tussive, and
for the symptomatic treatment of
chronic diarrhoea.
Codeine is indicated in patients older than 12 years 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:
As an analgesic:
Adults: 30-60mg every four hours, when necessary to a maximum 240mg
daily.
Elderly: Dosage should be reduced in the elderly where there is
impairment of hepatic or renal function.
As an anti-tussive:
Adults: 15-30mg three or four times daily.
Elderly: Dosage should be reduced in the elderly where there is
impairment of hepatic or renal function.
For the symptomatic treatment of chronic diarrhoea:
Adults: 15-60mg every four to six hours.
Elderly: Dosage should be reduced in the elderly where there is
impairment of hepatic or renal function.
Codeine should be used at the lowest effective dose for the shortest
period of time. This dose may be
taken up to 4 times a day at intervals of not less than 6 hours.
Maximum daily dose of codeine should not
exceed 240mg.
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.
Paediatric population
_Children over 12 years _
30-60mg every four hours, when necessary to a maximum 240mg daily.
_Children aged 12 years to 18 
                                
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