Solpadeine Plus soluble tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Codeine phosphate; Paracetamol; Caffeine

Dostopno od:

Omega Pharma Ltd

Koda artikla:

N02BE51

INN (mednarodno ime):

Codeine phosphate; Paracetamol; Caffeine

Odmerek:

8mg ; 500mg ; 30mg

Farmacevtska oblika:

Soluble tablet

Pot uporabe:

Oral

Razred:

Schedule 5 (CD Inv)

Tip zastaranja:

Never Valid To Prescribe As A VMP

Povzetek izdelek:

BNF: 04070100; GTIN: 5012616268007 5000347022920 5000347022906

Navodilo za uporabo

TRAILING EDGE
LEADING EDGE
BACK
150.0
12.0
12.0
8.2
120.0
80.0
TRAILING EDGE
LEADING EDGE
FRONT
150.0
12.0
12.0
8.2
8.2
• This medicine is for the short term
treatment of acute moderate pain
when other painkillers have not
worked.
• You should only take this product
for a MAXIMUM OF 3 DAYS at a time.
If you need to take it for longer
than 3 days you should SEE YOUR
DOCTOR OR PHARMACIST for advice.
• This medicine CONTAINS CODEINE
which can CAUSE ADDICTION if you
take it continuously for MORE THAN
3 DAYS. This can give you
WITHDRAWAL SYMPTOMS from the
medicine when you stop taking it.
• If you take this medicine for
headaches for MORE THAN 3 DAYS it
can MAKE THEM WORSE.
PLEASE READ RIGHT THROUGH THIS LEAFLET
BEFORE YOU START USING THIS MEDICINE.
This medicine is available without
prescription, but you still need to use
Solpadeine Plus Soluble
Tablets carefully to get the best results
from them.
• Keep this leaflet you may need to read
it again.
• If you have any questions, or if there is
anything you do not understand, ask
your pharmacist.
IN THIS LEAFLET:
1. What Solpadeine Plus Soluble Tablets
do
2. Check before you take Solpadeine Plus
Soluble Tablets
3. How to take Solpadeine Plus Soluble
Tablets
4. Possible side effects
5. How to store Solpadeine Plus Soluble
Tablets
6. Further information
1. What Solpadeine Plus Soluble
Tablets do
Solpadeine Plus Soluble Tablets can be
used in patients 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.
They can be used for migraine,
headache, dental pain, period pain,
strains & sprains, backache, rheumatic
pain and sciatica. The tablets contain
three active ingredients; paracetamol,
codeine and caffeine. Codeine belongs
to a group of medicines called opioid
analgesics which act to relieve
pain.Paracetamol is another analgesic to
relieve pain. Caffeine acts to further help
the effectiveness of paracetamol.
2. Check before you take
Solpadeine Plus Soluble Tablets
• This

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Solpadeine Plus Soluble Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
Paracetamol
Ph
Eur
500
mg,
Codeine
Phosphate
Hemihydrate Ph Eur
8 mg and Caffeine Ph Eur 30.0 mg.
Excipients with known effect
Each tablet contains:
Sorbitol (E420) 50mg
Sodium 427mg
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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
paracetamol or
ibuprofen alone.
Solpadeine Plus Soluble Tablets 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 tablets dissolved in at least half a tumbler of water every 4-6
hours up to
four times a day. The minimum dosing interval is 4 hours. No more than
4
doses (8 tablets) should be given in 24 hours.
Paediatric population:
Adolescents aged 16-18 years:
1-2 tablets every 6 hours up to 4 times a day. The minimum dosing
interval is 6 hours. No more than 4 doses (8 tablets) should be given
in
24 hours.
Adolescents aged 12 – 15 years:
1 tablet every 6 hours up to 4 times a day. The minimum dosing
interval is 6
hours. No more than 4 doses (4 tablets) 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 patien