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SOLPADEINE PLUS TABLETS

Active substance: PARACETAMOL

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9409_ 1000003344_Solpadeine Plus Tabs 32 PIL UK V4

Item No.:

NA

OPI No.:
Last edit:

NA
20th February 2015
Solpadeine

Variant:

BACK

File title:

Brand:

FRONT

Note:
Main body font size 7pt/7.1

Plus Tabs 32

Component: Leaflet
Market/s:

UK

Dimensions: 140 x 210mm with 12mm borders
Printer:

In this leaflet:
1. What Solpadeine Plus Tablets do
2. Check before you take Solpadeine Plus Tablets
3. How to take Solpadeine Plus Tablets
4. Possible side effects
5. How to store Solpadeine Plus Tablets
6. Further information

1. What Solpadeine Plus Tablets do
Solpadeine Plus 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 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 Tablets
• 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.

If you are taking other medicines
Talk to your doctor or pharmacist before taking
these tablets if you are taking any prescribed
medicines; particularly metoclopramide or
domperidone (for nausea [feeling sick] and
vomiting [being sick]); cholestyramine (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
Tablets at the same time as anticoagulants.
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.
Pregnancy and breast feeding
Talk to your doctor before taking Solpadeine
Plus Tablets if you are pregnant. Do not take

3. How to take Solpadeine Plus Tablets
Adults and children aged 12 years and over:
Swallow 2 tablets every 4 hours as needed.
• Do not take more frequently than every 4
hours.
• Do not take more than 8 tablets 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 Tablets 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 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 vomiting if you have recently had your
gall bladder removed

TBA

EAN Code:

N/A

PharmaCode: 486
Replacement number: TBA
Manufacturing Site: Herrenberg
No. of colour: 1

Black
Cutter

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.

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

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.

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

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

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

5. How to store Solpadeine Plus
Tablets

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

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

6. Further information

Regulatory Approval:

Active ingredients Each tablet contains
Paracetamol 500 mg, Codeine Phosphate
Hemihydrate 8 mg and Caffeine 30 mg.
Other ingredients Maize starch, Starch
pregelatinised, potassium sorbate (E 202),
povidone, purified talc, magnesium stearate,
microcrystalline cellulose, stearic acid,
hypromellose, carmoisine (E 122).
Carmoisine may cause allergic reactions.

Sign:...............................................................................

Packs of Solpadeine Plus Tablets contain 16 or 32
tablets.
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 GlaxoSmithKline Dungarvan
Ltd., Co. Waterford, Ireland or Omega Pharma
Manufacturing GmbH & Co. KG,
Benzstraße 25, 71083, Herrenberg, Germany.
This leaflet was last revised in February 2015.

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

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

Ph Code 486

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 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.

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

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

TBA

Substrate:

• Nervousness, dizziness, irritability, drowsiness
or restlessness
• Allergic reactions which may be severe such as
skin rash and itching sometimes with swelling
of the mouth or face or shortness of breath
• 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 in urinating.

1000003344

• This medicine is for the short term treatment
of acute moderate pain when other painkillers
have not worked.
• You should only take this medicine 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.

Solpadeine Plus Tablets while you are
breast-feeding. Codeine and morphine passes
into breast milk.

1000003344

Paracetamol, Codeine,
Caffeine

Do not take Solpadeine Plus Tablets:
• 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
• 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.

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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