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PARACETAMOL CODEINE PHOSPHATE AND CAFFEINE OMEGA 500MG/12.8/30 MG SOLUBLE TABLETS

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

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PACKAGE LEAFLET

Package leaflet: Information for the user
Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble
Tablets
Paracetamol, codeine phosphate hemihydrate, caffeine
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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 carefully before you start using 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
has 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 Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg
Soluble Tablets is and what it is used for
2. What you need to know before you take Paracetamol, Codeine Phosphate, and Caffeine
Omega 500 mg/30 mg/12.8 mg Soluble Tablets
3. How to take Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8
mg Soluble Tablets
4. Possible side effects
5. How to store Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8
mg Soluble Tablets
6. Contents of the pack and other information
1.

What Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8
mg Soluble Tablets is and what it is used for

Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble
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, neuralgia, strains and sprains, backache, pain in
bones and joints arising from arthritis and rheumatism, 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. The triple action of
the ingredients provides fast acting relief of moderate pain.
2.

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What you need to know before you take Paracetamol, Codeine Phosphate, and
Caffeine Omega 500 mg/30 mg/12.8 mg Soluble 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.

Do not take Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/ 30mg/12.8
mg Soluble Tablets:
- if you have ever had an allergic reaction to paracetamol, codeine, caffeine or to any of the
other ingredients (listed in Section 6)
- if you are taking other medicines containing paracetamol and codeine
- if you are under 12 years
- if you are breastfeeding
- if you have breathing difficulties
- if you suffer from chronic constipation
- 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
Talk to your doctor or pharmacist before you take this medicine:
- if you have liver or kidney disease, including alcoholic liver disease, or Gilbert’s
Syndrome (familial non-haemolytic jaundice) The dose must be reduced or the dosing
interval prolonged
- if you have bowel problems including blockage of the bowel
- if you have had an operation to remove your gall bladder
- if you have asthma and are sensitive to aspirin
- if you have hypotension, hypothyroidism, head injury or raised intracranial pressure
- if you are on a controlled sodium diet. Each tablet contains 427 mg of sodium
- if you have been told by your doctor that you have intolerance to some sugars, glucose-6phosphatedehyrogenase deficiency or glutathione deficiency
- if you have chronic alcoholism, malnutrition or dehydration
- if you are elderly, adult or adolescent weighting less than 50 kg
- elderly patients may require a reduced dose.
Ask your doctor or pharmacist for advice
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
Do not give this medicine to children under 12 years old.
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.
Other medicines and Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30
mg/12.8 mg Soluble Tablets
Tell your doctor or pharmacist if you are taking any other medicines; particularly:
metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]);
colestyramine (to lower blood cholesterol); monoamine oxidise 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 a blood thinning drugs (anticoagulants e.g. warfarin and coumarins) 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 Paracetamol, Codeine Phosphate, and Caffeine Omega
500 mg/30 mg/12.8 mg Soluble Tablets at the same time as anticoagulants.
If you are taking probenecid speak to your doctor as the dose of Paracetamol, Codeine
Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble Tablets may need to be
reduced.
If you are taking sedative, tranquilizers, and decongestants as Paracetamol, Codeine
Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble Tablets contains caffeine
which can interfere with or enhance their effects.
Pregnancy and breast-feeding
Do not take Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg
Soluble Tablets while you are breast-feeding. Codeine and morphine pass into breast milk.
Driving and using machines
Do not drive or operate machinery if taking Paracetamol, Codeine Phosphate, and Caffeine
Omega 500 mg/30 mg/12.8 mg Soluble Tablets causes dizziness or sedation.
Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble
Tablets contains sodium
This medicinal product contains 427 mg sodium per tablet. To be taken into consideration by
patients on a controlled sodium diet.
Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble
Tablets contains sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product
3.

How to take Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30
mg/12.8 mg Soluble Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not sure.
Adults:
Take 1 to 2 tablets dissolved in at least half a tumbler of water (200 ml), every 4-6 hours as
needed.
- Do not take more frequently than every 4 hours.
- Do not take more than 8 tablets (equivalent to paracetamol 4g and 102.4 mg Codeine
phosphate hemihydrate and caffeine 240 mg) in 24 hours.
Elderly:
Elderly, frail and immobile patients may require a reduced dose
Renal Impairment:
It is recommended, when giving paracetamol to patients with renal failure, to reduce the
dose and to increase the minimum interval between each administration to at least 6 hours.
Adults:
Glomerular filtration rate
Dose
10-50 ml/min
500mg every 6 hours
<10ml/min
500mg every 8 hours
Hepatic Impairment:
In patients with impaired hepatic function or Gilbert’s Syndrome, the dose must be
reduced or the dosing interval prolonged.
Adolescents 16-18 years of age:
Take 1 to 2 tablets dissolved in at least half a tumbler of water (200 ml) every 6 hours as
required.
- Do not take more frequently than every 6 hours.
- Do not take more than 8 tablets (equivalent to paracetamol 4g and 102.4 mg Codeine
phosphate hemihydrate and caffeine 240 mg) in 24 hours.
Adolescents 12 -15 years of age:
Take 1 tablet dissolved in at least half a tumbler of water (200 ml), every 6 hours as needed.
- Do not take more frequently than every 6 hours.
- Do not take more than 4 tablets (equivalent to 2 g paracetamol and 51.2 mg codeine
phosphate hemihydrate and caffeine 120 mg) in 24 hours.
- Do not take more than the recommended dose.
The maximum daily dose of paracetamol should not exceed 2g/day unless your doctor gives a
different advice:
- If you are: elderly, adults or adolescents weighting less than 50kg
- If you suffer from mild to moderate liver or kidney problem
- If you have Gilbert’s syndrome (familial non-haemolytic jaundice)
- If you suffer from chronic alcoholism, malnutrition or dehydration
Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause
difficulty sleeping, shaking and uncomfortable feeling in the chest.

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.
Use in children and adolescents under 12 years of age
Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble
Tablets should not be used by patients under 12 years of age to risk of severe breathing
problems.
Possible withdrawal effects
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.
If your symptoms continue or your headache becomes persistent, see your doctor.
If you take more Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30
mg/12.8 mg Soluble Tablets than you should
Talk to your 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 you forget to take Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30
mg/12.8 mg Soluble Tablets
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and tell your doctor immediately if you experience:
• Dry mouth, nausea and vomiting if you have recently had your gall bladder removed
• Acute pancreatitis (inflammation of the pancreas) which may result in severe stomach
pain
• Allergic reactions which may be severe appearing as skin rash or mouth ulcers sometimes
with flu like symptoms, itching sometimes with swelling of the mouth/face or shortness of
breath, skin peeling
• 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, sudden weight loss, loss of appetite and yellowing of the eyes and skin
• Difficulty in urinating
• Cloudy urine
Other side effects:
• Nervousness and dizziness
• Constipation
How do I know if I am addicted?
If you take medicine according to the instructions on the pack, it is unlikely that 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 once you start
taking the medicine again.

Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. 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.
5.

How to store Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30
mg/12.8 mg Soluble Tablets

Keep this medicine out of the sight and reach of children.
Do not store above 25oC.
Store in the original package in order to protect the product from moisture.
Do not use this medicine after the expiry date which is stated on the blister and the carton
after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6.

Contents of the pack and other information

What Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg
Soluble Tablets contains
- The active substances are paracetamol, codeine phosphate hemihydrate and caffeine.
Each tablet contains 500 mg paracetamol, 12.8 mg codeine phosphate hemihydrate, 30
mg caffeine.
- The other ingredients are: Sorbitol (E420), sodium saccharin, sodium bicarbonate,
sodium laurilsulfate, citric acid, sodium carbonate, povidone k-25 and dimeticone 350.
What Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg
Soluble Tablets looks like and contents of the pack
Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg Soluble
Tablets white bevel-edged scored tablets, 25mm in diameter.
The score line is non-functional and not to divide the tablet into equal doses.
Pack sizes: 8, 10, 12, 16, 20, 24 or 32 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Omega Pharma Ltd.
1st floor,
32 Vauxhall Bridge Road
SW1V 2SA, London
United Kingdom
Manufacturer

GlaxoSmithKline Dungarvan Limited, Knockbrack, Dungarvan Co. Waterford, Ireland
or
Swiss Caps GmbH, Grassingerstraβe 9, 83043 Bad Aibling, Germany
This medicinal product is authorised in the Member States of the EEA under the
following
names:
UK
Romania
Poland
Ireland

Cyprus

Paracetamol, Codeine Phosphate, and Caffeine Omega 500 mg/30 mg/12.8 mg
Soluble Tablets
Solpadeine Forte 500 mg/12,8 mg/30 mg comprimate efervescente
Solpadeine MAX
Solpa-Plus with Caffeine Soluble Tablets
Paracetamol 500 mg, Codeine phosphate hemihydrate 12.8 mg, caffeine 30
mg
Solpadeine MAX Soluble Tablets

This leaflet was last revised in April 2017.

+ Expand Transcript

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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