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PARACETAMOL AND CAFFEINE OMEGA 500MG/65MG SOLUBLE TABLETS

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

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Package leaflet: Information for the user
Paracetamol and Caffeine
Omega 500mg/65mg Soluble
Tablets
Paracetamol/ Caffeine
Read all of this leaflet carefully 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 after 3 days.

What is in this leaflet
1.
What Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets is and what it is
used for
2.
What you need to know before you take Paracetamol and Caffeine Omega 500mg/65mg
Soluble Tablets
3.
How to take Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets
4.
Possible side effects
5.
How to store Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets
6.
Contents of the pack and other information
1.

What Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets is and what it is
used for

Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets contain two active ingredients.
Paracetamol is a painkiller and also reduces your temperature when you have a fever.
Caffeine acts to further help the effectiveness of paracetamol. The dual action of the
ingredients provides fast and effective pain relief from headache and migraine with or
without warning signs (aura). They can also relieve backache p, muscle and joint pain,
toothache, period pain, neuralgia, sore throat and the fever, aches and pains of colds and flu.

2.

What you need to know before you take Paracetamol and Caffeine Omega
500mg/65mg Soluble Tablets

Do not take Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets:
If you have ever had an allergic reaction to paracetamol, caffeine or to any of the other
ingredients (listed in Section 6)
If you are taking other medicines containing paracetamol.
Warnings and precautions
Talk to your doctor or pharmacist before using Paracetamol and Caffeine Omega 500mg/65mg
Soluble Tablets.
If you have liver or kidney disease, including alcoholic liver disease
If you have asthma and are sensitive to acetylsalicylic acid

-

If you have Gilbert’s syndrome (familial non-haemolytic jaundice)
If you have been told by your doctor that you have intolerance to some sugars, glucose6-phosphatedehyrogenase deficiency or glutathione deficiency
If you have haemolytic anaemia, chronic malnutrition or dehydration
If you are an adult or adolescent weighting less than 50 kg
If you are on a controlled sodium diet. Each tablet contains 427 mg of sodium

Children and adolescents
Do not give this medicine to children below the age of 12 years.
Other medicines and Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines;
particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being
sick]) or cholestyramine (to lower blood cholesterol). If you take 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 and Caffeine Omega 500mg/65mg Soluble Tablets at the same time as
anticoagulants. If you are taking probenecid speak to your doctor as the dose of Paracetamol
and Caffeine Omega 500mg/65mg Soluble Tablets may need to be reduced. Tell your doctor
if you are taking sedative, tranquilizers and decongestants as Paracetamol and Caffeine Omega
500mg/65mg Soluble Tablets contains caffeine which can interfere with or enhance their
effects.
Pregnancy and breast-feeding
Due to the caffeine content of this product it should not be used if you are pregnant or breast
feeding.
Driving and using machines
Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets has no effect on your ability to
drive and use machines.
Paracetamol and Caffeine Omega 500mg/65mg 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 and Caffeine Omega 500mg/65mg 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 and Caffeine Omega 500mg/65mg 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 (including elderly) and Adolescents aged 16 years and over:
Take 1 to 2 tablets dissolved in a tumbler of water, every 4 to 6 hours as needed.
- Do not take more frequently than every 4 hours.
- Do not take more than 8 tablets in 24 hours.
The maximum daily dose of paracetamol should not exceed 2g/day unless your doctor gives you
different advice:
- If you suffer from liver or kidney problems
- If you have Gilbert’s syndrome
- If you suffer from chronic alcoholism, malnutrition or dehydration

- If you weigh less than 50 kg
In patients with impaired kidney or liver function and patients with Gilbert Syndrome, the dose
must be reduced or the dosing interval prolonged. Ask your doctor for advice.
Elderly: reduction of dose may be recommended if you are frail or immobile.
Adolescents 12-15 years of age:
Take 1 tablet dissolved in a tumbler of water, every 4 to 6 hours as needed.
- Do not take more frequently than every 4 hours.
- Do not take more than 4 tablets in 24 hours.
Do not take more than the recommended dose.
- Do not give to children under 12 years.
- Avoid too much caffeine in drinks like coffee and tea.
High caffeine intake can cause difficulty sleeping, shaking and uncomfortable feeling in the
chest.
Use in children and adolescents under 12 years of age
Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets is not recommended for
patients under 12 years of age.
If you take more Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets than you
should
Immediate medical advice should be sought in the event of an overdose, even if you feel well,
because of the risk of delayed, serious liver damage.
If your symptoms continue or your headache becomes persistent, see your doctor.
If you forget to take Paracetamol and Caffeine Omega 500mg/65mg 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.
A small number of people have had side effects.
Stop taking the medicine and tell your doctor immediately if you experience:
• 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
• Breathing problems. These are more likely if you have experienced them before when taking
other painkillers such as ibuprofen and acetylsalicylic acid
• Unexplained bruising or bleeding
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
• Cloudy urine
Other side effects:
• Nervousness and dizziness

• In very rare cases decrease in the number of white blood cells (neutropenia and leucopenia) may
occur.
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.
5.

How to store Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets

Keep this medicine out of the sight and reach of children.
Do not store above 250C
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 strip 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 and Caffeine Omega 500mg/65mg Soluble Tablets contains
The active substances are paracetamol and caffeine. Each tablet contains 500 mg
paracetamol and 65 mg caffeine.
The other ingredients are: sodium hydrogen carbonate, sorbitol (E420), saccharin
sodium, sodium laurilsulfate, citric acid anhydrous, sodium carbonate anhydrous,
povidone K25 and dimeticone 315/385.
What Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets looks like and
contents of the pack
Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets are white bevel-edged scored
effervescent tablets, (score line not intended for breaking the table into equal doses), in laminate
sachets.
Pack sizes: 4, 6, 12, 16, 18, 24, 30, 48 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road
London, SW1V 2SA,
United Kingdom
Manufacturer
Famar SA, Anthousis Av., 153 44, Pallini Attikis, Greece.

This medicinal product is authorised in the Member States of the EEA under the following names:

UK
Cyprus
Estonia
Greece
Ireland
Latvia
Lithuania
Poland
Romania

Paracetamol and Caffeine Omega 500mg/65mg Soluble Tablets
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Solpadeine Express
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SolpaExtra 500mg/65mg Soluble Tablet
Solpadeine Express
Solpadeine Express
Solapdine Control, 500 mg + 65 mg, tabletki musujące
Solpadeine PlusCaf 500mg/65 mg comprimate efervescente

This leaflet was last revised in November 2016.

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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