Solpadeine Plus capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Caffeine; Paracetamol

Available from:

Omega Pharma Ltd

ATC code:

N02BE51

INN (International Name):

Codeine phosphate; Caffeine; Paracetamol

Dosage:

8mg ; 30mg ; 500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: ; GTIN: 5000347062681

Patient Information leaflet

children and adolescents after removal of their tonsils
or adenoids due to Obstructive Sleep Apnoea Syndrome.
Use in children with BREATHING PROBLEMS:
Codeine is not recommended in children with BREATHING
PROBLEMS, since the symptoms of morphine toxicity may
be worse in these children.
PREGNANCY AND BREAST FEEDING
TALK TO YOUR DOCTOR before taking Solpadeine Plus
Capsules if you are PREGNANT. DO NOT TAKE
Solpadeine Plus Capsules while you are BREAST-FEEDING.
Codeine and morphine passes into breast milk.
DRIVING AND USING MACHINES
This medicine can affect your ability to drive as it may
make you SLEEPY or DIZZY.
DO NOT DRIVE while taking this medicine UNTIL YOU KNOW
HOW IT AFFECTS YOU. It is an OFFENCE to drive if this
medicine affects your ability to drive.
However, you would NOT be committing an offence if:
• The medicine has been taken to treat a MEDICAL or
DENTAL problem and
• You have taken it ACCORDING TO THE INFORMATION
PROVIDED with the medicine and
• It was NOT AFFECTING your ability to drive safely.
TALK TO YOUR DOCTOR or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
Details regarding a NEW DRIVING OFFENCE concerning
driving after drugs have been taken IN THE UK may be
found here: www.gov.uk/drug-driving-law
3. How to take Solpadeine Plus Capsules
ADULTS:
SWALLOW 2 CAPSULES EVERY 4-6 HOURS AS NEEDED.
Do not take more than 8 CAPSULES IN 24 HOURS.
FOR THE ELDERLY A REDUCED DOSE MAY BE REQUIRED.
CHILDREN AGED 16 – 18 YEARS:
SWALLOW 1-2 CAPSULES EVERY 6 HOURS AS NEEDED.
CHILDREN AGED 12-15 YEARS:
SWALLOW 1 CAPSULE EVERY 6 HOURS AS NEEDED.
Do not take more than 4 CAPSULES IN 24 HOURS.
• Do not take MORE THAN THE RECOMMENDED DOSE
• AVOID TOO MUCH CAFFEINE IN DRINKS LIKE COFFEE AND TEA.
High caffeine intake can cause DIFFICULTY SLEEPING,
SHAKING and an UNCOMFORTABLE FEELING IN THE CHEST
• Solpadeine Plus Capsules should not be taken by
children BELOW THE AGE OF 12 YEARS, due to the risk of
severe breathing problems
• This medicine should not be ta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solpadeine Plus Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Paracetamol Ph Eur. 500 mg, Codeine Phosphate
Hemihydrate Ph Fur 8 mg and Caffeine Ph Eur 30.0 mg.
3.
PHARMACEUTICAL FORM
Hard gelatin capsules, size”0” with convex hemispherical ends.
Opaque red
cap and opaque
white
body,
plain
on
both
halves.
Capsules contain
white granular powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
Solpadeine
Plus
Capsules
are
recommended
for
the
relief
of
migraine,
headache, backache, rheumatic pain, period pains, dental pain, strains
&
sprains and sciatica.
4 CLINICAL PARTICULARS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults
2 capsules every 4-6 hours, up to four times a day. The minimum dosing
interval is
4 hours. No more than 4 doses (8 capsules) in 24 hours.
Paediatric population:
Adolescents aged 16-18 years:
1-2 capsules every 6 hours up to 4 times a day . The minimum dosing
interval is 6
hours. No more than 4 doses(8 capsules) should be given in 24 hours.
Adolescents aged 12 – 15 years:
1 capsule every 6 hours up to 4 times a day. The minimum dosing
interval is
6 hours. No more than 4 doses (4 capsules) should be given in 24
hours.
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 patients:
Elderly patients, especially those who are frail or immobile, may
require a reduced
dose or frequency of dosing.
Renal impairment:
Patients who have been diagnosed with kidney impairment must seek
medical
advice before taking this medication. It is recommended, when giving
paracetamol
to patients with renal failure, to reduce the