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PARACETAMOL EXTRA CAPLETS
Active substance(s): CAFFEINE ANHYDROUS / PARACETAMOL / CAFFEINE ANHYDROUS / PARACETAMOL / CAFFEINE ANHYDROUS / PARACETAMOL
Paracetamol EXTRA Caplets
File Prepared: 18.12.16
FILE VERSION : UTV17
Font used: HELVETICA Condensed (Med, Bold & Italic)
Font Size 8pt / spaced as 9.6
Document size 120 x 200 mm
Printed two sides in Back
Software: QUARK 9.5 presented as PDF Proof
Patient Information Leaflet for
PARACETAMOL EXTRA CAPLETS
Paracetamol and 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 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 after 3 days.
What is in this leaflet
1. What Paracetamol Extra Caplets are and what they are used for
2. What you need to know before you take Paracetamol Extra Caplets
3. How to take Paracetamol Extra Caplets
4. Possible side effects
5. How to store Paracetamol Extra Caplets
6. Contents of the pack and other information
1. WHAT PARACETAMOL EXTRA CAPLETS ARE
AND WHAT THEY ARE USED FOR
Paracetamol Extra Caplets contain paracetamol and caffeine and are used for the
relief of headache, migraine, backache, fever, dental pain, period pain, the
symptoms of cold and flu, sciatica and rheumatic and muscular aches and pains.
YOU NEED TO KNOW BEFORE YOU TAKE
PARACETAMOL EXTRA CAPLETS
Do not take these caplets if you:
Are allergic to Paracetamol, or any of the other ingredients listed in section 6
(See section 4 – Possible Side Effects)
Have a peptic ulcer or have had one in the past
Take special care and tell your doctor if you:
Suffer from liver or kidney problems
Have heart disease or high blood pressure
Suffer from G6PD deficiency
Suffer from alcohol dependency
Are pregnant or breast feeding
Are on a low sodium diet
Tell your doctor or pharmacist if you are already taking any of the following medicines:
Blood thinning medicines such as Warfarin
Metoclopramide, and Domperidone (for sickness and digestive disorders)
Colestyramine (to help control cholesterol levels)
Andrenocorticoids, anabolic steroids, androgens or ACTH
Oral tetracyclines (a type of antibiotic)
Any drugs that affect the liver
Any other anti inflammatory drugs e.g. aspirin
Antidepressants e.g. barbiturates, amitryptiline
3. HOW TO TAKE PARACETAMOL EXTRA CAPLETS
Dosage in adults and children over 16 years: Take one or two caplets every four to
six hours when necessary to a maximum of four doses in 24 hours.
Dosage in children 12-15 years: Take one caplet every four to six hours when necessary
to a maximum of four doses in 24 hours.
Swallow the caplets whole with a drink of water. Do not chew.
When taking this medicine, it is important to remember the following:
Do not give these caplets to children under 12 years of age unless told to by your doctor
Do not exceed the stated dose
Paracetamol Extra Caplets can cause side effects but not everybody gets them.
If you experience any of the following symptoms below after taking this
medicine go to the nearest hospital IMMEDIATELY.
Serious side effects
Pancreatitis or Hepatitis (symptoms include abdominal pain, tiredness, fever,
nausea, yellowing of skin or eyes)
Skin rashes and itching. Very rare cases of serious skin reactions have been reported.
Unusual bruising or bleeding, throat and mouth ulcers or bleeding gums
accompanied by tiredness and flu like symptoms
Other side effects
Pain in the lower back and groin
Nausea and vomiting
Restlessness and excitement
Blood disorders including aneamia
Changes in your urine
Irritability and anxiety
Rapid or irregular heartbeat
If you experience any of these or any other side effects and they get serious, contact
your doctor or pharmacist.
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 EXTRA CAPLETS
Keep medicines out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light
and moisture. Do not use this medicine after the expiry date printed on the packaging.
6. CONTENTS OF
THE PACK AND OTHER INFORMATION
The active ingredients in Paracetamol Extra Caplets are Paracetamol 500mg and
Caffeine Anhydrous 65mg. They are tablets with embossed ‘ap and x’ on
one face on either side of a break line. The other ingredients are starch, povidone K30, povidone K90, croscarmellose sodium, talc, stearic acid and magnesium stearate.
The Product Licence Holder and Manufacturer is Aspar Pharmaceuticals Ltd,
Capitol Way, Colindale, London NW9 0EQ.
PL 08977/0025 & PL 08977/0024
Paracetamol Extra Caplets are sold in blister packs of 8, 16, 24, 28 and 32.
Not all pack sizes may be marketed.
Text Revised November 2016
Do not drink alcohol or take other Paracetamol containing products whilst taking
Do not take excessive amounts of caffeine containing beverages.
If symptoms persist for more than 3 days consult your doctor.
If you take more Paracetamol Extra Caplets than you should.
Talk to a doctor at once if you take too much of this medicine, even if you feel
well because of the risk of delayed, serious liver damage. Take the container and
any remaining tablets with you. Symptoms of overdose include nausea,
diarrhoea, vomiting, and abdominal pain.
If you forget to take Paracetamol Extra Caplets.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or
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.