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SOLPADEINE PLUS CAPSULES

Active substance(s): CAFFEINE / CODEINE PHOSPHATE / PARACETAMOL

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File title:

9408_LF03513C_11017638_Solpadeine Plus Capsules PIL UK v5

Item No.:

11017638

OPI No.:

LF03513C

Last edit:

6th Nov 2015

Brand:

Solpadeine

Variant:

Plus Capsules 32

Component: Leaflet
Market/s:

UK

Dimensions: 150 x 200mm

Solpadeine Plus Capsules 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 capsules contain
three active ingredients; paracetamol, codeine and
caffeine. Codeine and paracetamol are both
painkillers. 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. Caffeine acts to further help the
effectiveness of paracetamol.

2. Check before you take Solpadeine Plus
Capsules
• 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 a painkiller for headaches for more
than 3 days it can make them worse.

Warnings and precautions
Codeine is transformed to morphine in the liver by
an enzyme. Morphine is the substance that produces
pain relief. Some people have a variation of this
enzyme and this can affect people in different ways.
In some people, morphine is not produced or
produced in very small quantities, and it will not
provide enough pain relief. Other people are more
likely to get serious side effects because a very high
amount of morphine is produced. If you notice any
of the following side effects, you must stop taking
this medicine and seek immediate medical advice:
slow or shallow breathing, confusion, sleepiness,
small pupils, feeling or being sick, constipation, lack
of appetite.
Children and adolescents
Use in children and adolescents after surgery:
Codeine should not be used for pain relief in
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.

3. How to take Solpadeine Plus Capsules
Adults and children aged 12 years and over:
Swallow 2 capsules every 4 hours as needed.
• Do not take more frequently than every 4 hours
• Do not take more than 8 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 taken for more than 3
days. If the pain does not improve after 3 days,
talk to your doctor for advice.
Possible withdrawal effect
This medicine contains codeine and can cause
addiction if you take it continuously for more than 3
days. When you stop taking it you may get
withdrawal symptoms. You should talk to your
doctor or pharmacist if you think you are suffering
from withdrawal symptoms.
Talk to a doctor at once if you take too much of this
medicine, even if you feel well. This is because too
much paracetamol can cause delayed, serious liver
damage. If your symptoms continue or your
headache becomes persistent, see your doctor.

4. Possible side effects
Some people may have side effects when using this
medicine. If you have any unwanted side effects you
should seek advice from your doctor, pharmacist or
other healthcare professional.
When using this product you may experience:
• Constipation
Stop taking this medicine and tell your doctor
immediately if you experience:
• Severe abdominal pain, dry mouth, nausea and

Cutter guide: CG148_L607D008
TSS file:
Printer:
Substrate:

TSS SOLP 32CAP_PLUS_UK_AEN-v2
N/A
Uncoated paper, white, 60g/m2

EAN Code:

N/A

PharmaCode: 10931
Replacement number: 11016706
Manufacturing Site: Aenova
No. of colour: 1
Black

120mm

Cutter

81 Rivington Street
Shoreditch
London EC2A 3AY
United Kingdom
awk contact:
Phil Hinckley
phil@oneagency.co
+44 (0)7710 521027
+44 (0)203 008 6041

Marketing Approval:
Sign:...............................................................................

Date:...............................

5. How to store Solpadeine Plus Capsules

Name (please print):....................................................................................................

Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date shown
on the pack.
Store below 25°C.

Contact email:................................................................................................................

6. Further information
Active ingredients Each capsule contains
Paracetamol 500 mg, Codeine Phosphate
Hemihydrate 8 mg and Caffeine 30 mg.
Other ingredients Maize starch, magnesium stearate,
titanium dioxide (E 171), erythrosine (E 127), patent
blue V (E 131), quinoline yellow (E 104), gelatin,
shellac, propylene glycol (E 1520), iron oxide black (E
172) and ammonium hydroxide (E 527).
Packs of Solpadeine Plus Capsules contain 16 or 32
capsules, they have an opaque red cap and opaque
white body, with "solpadeine" printed in black on
both halves or plain on both halves.
The marketing authorisation holder is Omega
Pharma Ltd., 32 Vauxhall Bridge Road, London,
SW1V 2SA, United Kingdom and all enquiries
should be sent to this address.
The manufacturer is SmithKline Beecham S.A.,
Carretera de Ajalvir, Km 2500, 28806 Alcala De
Henares, Madrid, Spain or
Swiss Caps GmbH Grassingerstraβe 9
83043 Bad Aibling, Germany (Aenova Group).
This leaflet was last revised in October 2015.

11017638

1. What Solpadeine Plus Capsules do

If you are taking other medicines
Talk to your doctor or pharmacist before taking
these capsules if you are taking any prescribed
medicines; particularly metoclopramide or
domperidone (for nausea [feeling sick] or vomiting
[being sick]); colestyramine (to lower blood
cholesterol); monoamine oxidase inhibitors (MAOIs)
prescribed for depression in the last 2 weeks or
substances that make you drowsy (e.g. sedatives,
antidepressants or alcohol). If you take blood
thinning drugs (anticoagulants e.g. warfarin) and
you need to take a pain reliever on a daily basis, talk
to your doctor because of the risk of bleeding. But
you can still take occasional doses of Solpadeine Plus
Capsules at the same time as anticoagulants.

80mm

• 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 Capsules
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 Capsules do
2. Check before you take Solpadeine Plus Capsules
3. How to take Solpadeine Plus Capsules
4. Possible side effects
5. How to store Solpadeine Plus Capsules
6. Further information

If you are under 12 years:
• For pain relief in children and adolescents (0-18
years of age) after removal of their tonsils or
adenoids due to obstructive sleep apnoea
syndrome
• If you know that you metabolise very rapidly
codeine into morphine
If you are breastfeeding.
Ask your doctor before you take this medicine:
• If you have liver or kidney disease, including
alcoholic liver disease
• If you have bowel problems including blockage of
your bowel
• If you have had an operation to remove your gall
bladder.

LF03513C 11017638

Paracetamol, Codeine,
Caffeine

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

vomiting if you have recently had your gall bladder
removed
• Nervousness, dizziness, irritability, drowsiness or
restlessness
• Allergic reactions which may be severe such as skin
rash and itching
• Skin rash or peeling or mouth ulcers; itching or
sweating
• Breathing problems. These are more likely if you
have experienced them before when taking other
painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding
• Nausea, upset stomach, sudden weight loss, loss of
appetite and yellowing of the eyes and skin
• Difficulty urinating.
Reporting of side effects: If you get any side effects,
talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this
leaflet. You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
How do I know if I am addicted?
If you take this medicine according to the
instructions on the pack, it is unlikely you will
become addicted to the medicine. However, if the
following apply to you it is important that you talk
to your doctor:
• You need to take the medicine for longer periods
of time.
• You need to take more than the recommended
dose.
• When you stop taking the medicine you feel very
unwell but you feel better if you start taking the
medicine again.

LF03513C

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.

Do not take Solpadeine Plus Capsules:
• If you have ever had an allergic reaction to
paracetamol, caffeine, codeine, other opioid
painkillers or to any of the other ingredients (listed
in Section 6)
• If you are taking other medicines containing
paracetamol or codeine

Regulatory Approval:
Sign:...............................................................................

Date:...............................

Name (please print):....................................................................................................

Contact email:................................................................................................................

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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