What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL020417/063.


Boots Paracetamol Extra Effervescent Tablets 500 mg/65 mg

Information for the user

Boots Paracetamol Extra Effervescent Tablets 500 mg/65 mg

(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 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
  • You must talk to a doctor if you do not feel better or if you feel worse

What this medicine is for

This medicine contains paracetamol which belongs to a group of medicines called analgesics and antipyretics that relieve mild to moderate pain and reduce fever. Caffeine helps to increase the pain relief.

It can be used to relieve headache, migraine, toothache, period pain, backache, rheumatic aches and pains, sore throat and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

  • If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)
  • If you are pregnant or breastfeeding

Talk to your pharmacist or doctor:

  • If you have kidney or liver problems (including a disease caused by drinking alcohol)
  • If you have phenylketonuria (this medicine contains aspartame, a source of phenylalanine, which may be harmful to you)
  • If you are on a low salt (sodium) diet (each tablet contains 409 mg of sodium, which may be harmful to you)
  • If you need 1 or more tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

Other important information

This medicine contains caffeine, which is also found in tea, coffee, chocolate and some fizzy drinks such as cola. Taking too much caffeine can cause difficulty sleeping, shaking or a thumping sensation in the chest (palpitations).

You must not drink tea, coffee, chocolate or fizzy drinks if you need to take this medicine.

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

If you take other medicines

This medicine contains paracetamol.

Do not take with anything else containing paracetamol while taking this medicine.

Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

  • Domperidone or metoclopramide for feeling sick or being sick (may increase the pain relief effect of paracetamol)
  • Colestyramine for reducing blood fat levels (may reduce the pain relief effect of paracetamol)
  • Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that tablet. For oral use. Dissolve the tablets in at least half a glass of water before taking.

Adults, the elderly and children aged 16 to 18 years:

One to two tablets every 4 to 6 hours when necessary up to a maximum of 8 tablets in 24 hours.

(A reduced dose may be required in the elderly).

Children 12 to 15 years:

One tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.

Do not take more than the recommended dose.

Not recommended for children under 12 years of age.

If you do not get better, or your headache becomes persistent, talk to your doctor.

If you take too many tablets: 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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some:

If you get any of these serious side effects, stop taking the tablets.

See a doctor at once:

  • Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
  • Allergic skin reactions (which can sometimes be severe and include peeling, blistering and lesions of the skin)
  • Signs of caffeine sensitivity including
    • Difficult sleeping, dizziness, nervousness, restlessness, irritability, anxiety, palpitations
    • Headache, stomach upset

Breathing problems are more likely if you have asthma and have experiences them before when you have taken other medicines such as aspirin or ibuprofen (non-steroidal anti- inflammatory medicines).

If you get any of the following side effects see your doctor or pharmacist:

  • Other allergic reactions (e.g. skin rash)
  • Unusual bruising, or infections such as sore throats - this may be a sign of very rare changes in the blood
  • Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)

Reporting of side effects

If you get any side effects, talk to you 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.

How to store this medicine

Store in the original package and protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each effervescent tablet contains Caffeine 65 mg and Paracetamol 500 mg, which are the active ingredients.

As well as the active ingredients, the tablets also contain anhydrous citric acid (E330), povidone, saccharin sodium, sodium hydrogen carbonate (E500), anhydrous sodium carbonate, simeticone (E900), polysorbate 80 (E433), aspartame (E951).

The pack contains 24 round, white effervescent tablets.

Who makes this medicine

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by the manufacturer responsible for batch release

Kent pharmaceuticals Limited
Crowbridge Road
Ashford
Kent
TN24 0GR
UK

and

Kent Pharmaceuticals Limited
Repton Road
Measham
DE12 7DT
UK

UK Marketing Authorisation held by

Fannin (UK) Ltd DCC Vital
Westminster Industrial Estate
Repton Road
Measham
DE12 7DT
England

Leaflet prepared October 2019

If you would like any further information about this medicine, please contact

The Boots Company PLC
Nottingham
NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Paracetamol Extra Effervescent Tablets 500 mg/65 mg

Reference number: PL 20417/0063

This is a service provided by the Royal National Institute of Blind People.

Artwork number: TR1725612- WBAG400766