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PARACETAMOL AND CAFFEINE 500 MG/65 MG EFFERVESCENT TABLETS

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

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PATIENT INFORMATION LEAFLET
PARACETAMOL & CAFFEINE 500 mg/65 mg EFFERVESCENT TABLETS
(paracetamol and caffeine)
The name of this medicine is Paracetamol & Caffeine 500 mg/65 mg Effervescent Tablets,
which will be referred to as Paracetamol & Caffeine Tablets throughout this leaflet.
Read all of this leaflet carefully because it contains important information for you.
• This medicine is available without prescription. However, you still need to use
Paracetamol & Caffeine Tablets carefully to get the best results from them.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

Take special care with Paracetamol & Caffeine Tablets
Before you take Paracetamol & Caffeine Tablets you should tell your doctor or pharmacist
if you:
• have severe kidney disease
• have severe liver disease, including alcoholic liver disease
• have persistent headaches.
Taking other medicines
Talk to your doctor or pharmacist before taking this medicine if you are taking any prescribed
medicine, in particular:
• metoclopramide or domperidone - for nausea (feeling sick) or vomiting (being sick)
• cholestyramine - used to treat high cholesterol.
If you take blood thinning medicines (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.
You may still be able to take Paracetamol & Caffeine Tablets but your doctor or
pharmacist will be able to advise you.

In this leaflet:
1. What Paracetamol & Caffeine Tablets are and what they are used for
2. Before you take Paracetamol & Caffeine Tablets
3. How to take Paracetamol & Caffeine Tablets
4. Possible side effects
5. How to store Paracetamol & Caffeine Tablets
6. Further Information

Taking your medicine with food and drink
Paracetamol & Caffeine Tablets should be dissolved in a glass of water and can be
taken with or without a meal.
You should avoid drinking too much coffee, tea or fizzy drinks when taking these tablets.

1. WHAT PARACETAMOL & CAFFEINE TABLETS ARE AND WHAT THEY
ARE USED FOR
The active ingredients in your tablets are paracetamol and caffeine. Paracetamol is an
analgesic and an antipyretic; it works by relieving pain and reducing body temperature
when you have a fever. Caffeine acts to further help the effectiveness of paracetamol.
Paracetamol & Caffeine Tablets are used to treat headache, migraine, backache,
rheumatic and muscle pain, toothache and period pain. They also relieve discomfort in
colds, influenza, sore throats and help reduce temperature.

2. BEFORE YOU TAKE PARACETAMOL & CAFFEINE TABLETS

Fertility, pregnancy and breast-feeding
Paracetamol-Caffeine is not recommended for use during pregnancy or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Paracetamol & Caffeine Tablets will affect your ability to drive or operate
machines.
Important information about some of the ingredients of Paracetamol & Caffeine
Tablets
Each of these tablets contains 409 mg of sodium. This may interfere if you are on a low
sodium diet.
This product also contains aspartame (a source of phenylalanine), which should not be
given to anyone with phenylketonuria.

Do not take Paracetamol & Caffeine Tablets if you:
• are allergic (hypersensitive) to paracetamol, caffeine, or to any of the other ingredients
(these are listed in section 6, Further Information)
• are taking any other paracetamol-containing products
• are under 12 years of age.
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Dosage
Adults and children aged 12 years and over 2 tablets dissolved in a glass of water
every 4 hours as required.
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.
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HC01 C

3. HOW TO TAKE PARACETAMOL & CAFFEINE TABLETS

5. HOW TO STORE PARACETAMOL & CAFFEINE TABLETS

Not recommended for children under 12 years of age.
Method of administration
For oral administration only. These tablets should be dissolved in a glass of water before
taking them. These tablets are meant to be dissolved first so don’t try to swallow them
whole.
If you take more Paracetamol & Caffeine Tablets than you should:
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.
Remember to take the pack and any remaining tablets with you. If you have any further
questions on the use of this product, ask your doctor or pharmacist.

Keep out of the sight and reach of children.
Do not take this medicine after the expiry date (EXP) stated. The expiry date refers to
the last day of that month.
Store in the original package and protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect
the environment.

6. FURTHER INFORMATION

Like all medicines, Paracetamol & Caffeine Tablets can cause side effects although
not everybody gets them. If you get any of the following symptoms after taking these
tablets you should stop taking them and contact you doctor or pharmacist immediately:
• any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids,
face, lips or throat
• skin rash
• Allergic skin reactions (which can sometimes be severe and include peeling,
blistering and lesions of the skin)
• Signs of caffeine sensitivity including
• Difficulty sleeping, dizziness, nervousness, restlessness, irritability, anxiety,
palpitations.
• Headache stomach upset
• Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may
be signs of liver problems)
Very rarely effects on the blood have been reported, resulting in:
• an increased tendency to bruise or bleed easily
• an increased susceptibility to infection.
Breathing problems are more likely if you have asthma and have experienced them before
when you have taken other medicines such as aspirin or ibuprofen (non-steroidal
anti-inflammatory medicines.
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.

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What Paracetamol & Caffeine Tablets contain:
The active ingredients are paracetamol and caffeine. Each tablet contains 500 mg of
paracetamol and 65 mg of caffeine.
Other ingredients are: citric acid (anhydrous) (E330), povidone, saccharin sodium, sodium
hydrogen carbonate (E500), sodium carbonate anhydrous, simeticone (E900),
Polysorbate 80 (E433) and aspartame (E951).
What Paracetamol & Caffeine Tablets look like and contents of the pack:
Paracetamol & Caffeine Tablets are white to off-white coloured circular flat bevelled tablets
plain on both sides. Your medicine is available in packs of 24 tablets.
Marketing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire,
NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
HC01 C

4. POSSIBLE SIDE EFFECTS

This information is available in alternative formats upon request.
This leaflet was last approved in: May 2015

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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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