Solpadeine Capsules Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

CAFFEINE, PARACETAMOL, CODEINE PHOSPHATE, HEMIHYDRATE

Tillgänglig från:

Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland

ATC-kod:

N02AJ06

INN (International namn):

CAFFEINE 30 mg PARACETAMOL 500 mg CODEINE PHOSPHATE HEMIHYDRATE 8 mg

Läkemedelsform:

HARD CAPSULE

Sammansättning:

CAFFEINE 30 mg PARACETAMOL 500 mg CODEINE PHOSPHATE HEMIHYDRATE 8 mg

Receptbelagda typ:

OTC

Terapiområde:

ANALGESICS

Bemyndigande status:

Authorised

Tillstånd datum:

2006-09-22

Bipacksedel

Perrigo component code:
Artwork reference nr:
FOR APPROVAL • Approval needs to be given within AMS. Please verify
this proof carefully concerning lay-out, size, texts and bar code. For
the PMS colours please refer to the latest PMS coulour guide. After
your approval on the above we can proceed to the next stage of your
project.
Graphic Design
Solpadeine
Capsules
LF02111H
11027734
Ireland
148 x 420 mm
Capsules
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use 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 after 3 days.
WHAT IS IN THIS LEAFLET
1.
What this medicine is and what it is used for
2.
What you need to know before you take this
medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Solpadeine capsules contains the active
substances paracetamol 500 mg and codeine
phosphate hemihydrate 8 mg , which are both
pain-relieving drugs, and caffeine 30 mg, a
stimulant which acts to enhance the
pain-relieving effects of paracetamol.
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
pain killers such as paracetamol. Paracetamol also
helps to reduce temperature when you have a
fever. Codeine has some cough suppressant action.
Solpadeine capsules can be used in patie

Produktens egenskaper

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Solpadeine capsules
Paracetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains paracetamol 500 mg, codeine phosphate
hemihydrate 8 mg and caffeine 30 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Gelatin capsules with a red, opaque cap and a white, opaque body plain
on both halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Codeine-containing products are indicated in patients older than 12
years of age for the short-term
treatment of acute, moderate pain which is not relieved by other
analgesics such as paracetamol or
ibuprofen alone.
Solpadeine is indicated in the management of symptoms of headache,
including migraine, toothache,
backache, common cold, influenza, menstrual pain, musculoskeletal
pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
1-2 capsules up to four times daily as required to a 8 capsules in 24
hours.
The dose should not be repeated more frequently than every 4 hours.
_Adolescents aged 16 to 18 years of age _
1-2 capsules every 6 hours. Do not exceed 4 doses, equivalent to 8
capsules.
_Adolescents aged 12 years to 18 years: _
This medicine is not recommended for use in children aged 12 years to
18 years with compromised
respiratory function for the symptomatic treatment of cough and/or
cold (see section 4.4).
_Adolescents aged 12 to 15 years of age _
1 capsule every 6 hours. Do not exceed 4 doses, equivalent to 4
capsules.
_Paediatric population _
_ _
_Children aged less than 12 years: _
This medicine is contraindicated in children below the age of 12 years
for the symptomatic treatment
of cough and/or cold (see section 4.3).
Codeine should not be used in children below the age of 12 years
because of the risk of
Page 2 of 14
opioid toxicity due to the variable and unpredictable metabolism of
codeine to morphine (see sections
4.3 and 4.4).
_Elderly patients _
Experience