Solpa-Plus Tablets Paracetamol 500 mg Codeine Phosphate Hemihydrate 12.8 mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Chefaro Ireland DAC

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500 mg/12.8 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Authorization status:

Not marketed

Authorization date:

2017-03-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPA-PLUS TABLETS
paracetamol/codeine phosphate hemihydrate
-
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.
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE
IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Solpa-Plus Tablets is and what it is used for
2.
What you need to know before you take Solpa-Plus Tablets
3.
How to take Solpa-Plus Tablets
4.
Possible side effects
5.
How to store Solpa-Plus Tablets
6.
Contents of the pack and other information
1.
WHAT SOLPA-PLUS TABLETS IS AND WHAT IT IS USED FOR
Solpa-Plus Tablets
can be used in patients over 12 years of age for the short-term relief
of
moderate
pain
which
requires
stronger
relief
than
other
painkillers
such
as
paracetamol, ibuprofen or aspirin alone.
It can be used for headaches, migraine
with
or without
warning signs
(aura), dental
pain (including pain after extraction), period pain, backache, muscle
ache, neuralgia, pain
in bones and joints arising from arthritis and rheumatism, strains and
sprains, sciatica.
The tablets co

Summary of Product characteristics

Health℃Products℃Regulatory℃Authority
24℃May℃2023
CRN00D6QP
Page℃1℃of℃9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa-Plus℃Tablets℃Paracetamol℃500℃mg℃Codeine℃Phosphate℃Hemihydrate℃12.8℃mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each℃tablet℃contains℃500℃mg℃paracetamol℃and℃12.8℃mg℃codeine℃phosphate℃hemihydrate.
Excipients℃with℃known℃effect:℃5.9℃mg℃lactose℃monohydrate℃per℃tablet.℃
For℃full℃list℃of℃excipients,℃see℃section℃6.1.
3 PHARMACEUTICAL FORM
Film-coated℃tablet℃(tablets).
Red℃film℃coated℃capsule℃shaped℃tablets,℃15.8℃mm℃x℃8.4℃mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solpa-Plus℃Tablets℃are℃recommended℃for℃the℃relief℃of℃acute℃moderate℃pain℃which℃requires℃stronger℃analgesia℃than℃paracetamol℃
or℃ibuprofen℃or℃aspirin℃alone.℃For℃the℃treatment℃of:℃dental℃pain℃(including℃pain℃after℃extraction),℃headache,℃migraine℃(with℃and℃
without℃aura),℃dysmenorrhea,℃backache,℃pain℃in℃bones℃and℃joints℃arising℃from℃arthritis℃and℃rheumatism,℃neuralgia,℃strains℃and℃
sprains,℃sciatica.
The℃product℃is℃indicated
for℃use℃in℃patients℃aged℃12℃years℃and℃older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Oral℃administration℃only.
Adults:
Two℃tablets℃up℃to℃4℃times℃a℃day.℃This℃dose℃should℃not℃be℃repeated℃at℃more℃than℃4℃–℃6℃hours'℃intervals.
Adolescents 16 to 18 years of age:
Two℃tablets℃up℃to℃4℃times℃a℃day.℃This℃dose℃should℃not℃be℃repeated℃at℃more℃than℃6℃hours'℃intervals.
Not℃more℃than℃4℃doses℃(equivalent℃to℃Paracetamol℃4g℃and℃Codeine℃phosphate℃hemihydrate℃102.4℃mg)℃should℃be℃given℃in℃any℃
24-hour℃period.
Adolescents 12 to 15 years of age:
One℃tablet℃up℃to℃4℃times℃a℃day.℃This℃dose℃should℃not℃be℃repeated℃at