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PARACETAMOL & CAFFEINE 500 MG / 65 MG EFFERVESCENT TABLETS

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

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Package leaflet: Information for the patient
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 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,
pharmacist or nurse has told you.
 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Paracetamol & Caffeine Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information

Warnings and precautions
Take special care with Paracetamol & Caffeine Tablets
Talk to your doctor, pharmacist or nurse before taking Paracetamol & Caffeine Tablets:
- if you have severe kidney disease
- if you have severe liver disease including alcoholic liver disease
- if you have persistent headaches
- if you are on a controlled sodium diet
Other medicines and Paracetamol & Caffeine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
 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.
Paracetamol & Caffeine Tablets with food, drink and alcohol
Paracetamol & Caffeine Tablets should be dissolved in at least half a glass of water and can be
taken with or without a meal.
You should avoid drinking too much coffee, tea or some canned 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL &
CAFFEINE TABLETS

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
It is unlikely that Paracetamol & Caffeine Tablets will affect your ability to drive or operate
machines.
Paracetamol & Caffeine Tablets contain sodium and aspartame
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.

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Do not take Paracetamol & Caffeine Tablets:
• if you are allergic (hypersensitive) to paracetamol, caffeine, or to any of the other
ingredients of this medicine (listed in section 6)
• if you are taking any other paracetamol-containing products
• if you are under 12 years of age.
• if you are on low sodium diet
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New Cipla EU Fannin UK
Safety Variation

- Nervousness and dizziness: Difficulty in sleeping (insomnia), restlessness, anxiety,
irritability, headaches, gastrointestinal disturbances and Feeling your heartbeat
(palpitations).

3. HOW TO TAKE PARACETAMOL & CAFFEINE TABLETS
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist
or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Dosage
Adults and children aged 16 years and over
2 tablets every 4 hours as required.
Do not take more frequently than every 4 hours. Do not take more than 8 tablets in 24
hours.

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 & CAFFEINE TABLETS

Children aged 12 years to 15 years
- 1 tablet dissolved in a glass of water every 4 to 6 hours as needed.
- Do not take more than 4 tablets in 24 hours.
Do not take more than the recommended dose.

Keep this medicine 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.

Use in children:
Not recommended for children under 12 years of age.

Store in the original package and protect from moisture.

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 you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol and Caffeine Tablets can cause side effects although not
everybody gets them.
Stop taking the medicine and tell your doctor immediately if you experience:
- Allergic reactions which may be severe and life threatening such as skin rash and itching
sometimes with swelling of the face or throat or shortness of breath.
- Skin rash or blistering of the skin, mouth, and eyes or mouth ulcers.
- Difficulty in breathing or wheezing (bronchospasm). These are more likely if you have
experienced them before when taking other painkillers such as aspirin
- Reduction in blood platelets, which increases risk of bleeding or bruising.
- Disorders related to liver function.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how
to throw away medicine you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
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.

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Method of administration
For oral administration only. These tablets should be dissolved in at least half 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:
If you have accidentally taken more than the recommended dose, contact your nearest
hospital casualty emergency department or tell your doctor or pharmacist immediately.
Remember to take the pack and any remaining tablets with you.

Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom
Manufacturer
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom
This leaflet is available in formats suitable for the blind and partially-sighted upon request.
This leaflet was last revised in 12/2016.
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New Cipla EU Fannin UK
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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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