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: PL 12063/0007.


Boots Paracetamol Extra 500mg/65mg Tablets

Information for the user

Boots Paracetamol Extra 500mg/65mg Tablets

(Caffeine, Paracetamol)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

  • Keep this leaflet, you may need to read it again
  • Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Paracetamol, which belongs to a group of medicines called analgesics, which act to relieve pain and reduce fever. Caffeine helps to increase the pain relief.

It can be used to treat mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, relief of the symptoms of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. It can also be used to relieve the symptoms of colds and flu and reduce a fever.

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 under 12 years old
  • If you are allergic to any of the ingredients (see “What is in this medicine”)
  • If you have high blood pressure or an irregular heart beat
  • If you have an anxiety disorder
  • If you take any of these medicines:
    • Medicines for high blood pressure
    • Medicines for depression, including monoamine oxidase inhibitors, or stimulant medicines
    • Medicines for anxiety, or medicines that make you feel sleepy
    • Disulfiram (for alcoholism)
    • Decongestants containing ephedrine
    • Theophylline (for breathing problems)
    • Thyroxine (for thyroid problems)
  • If you are pregnant or breastfeeding

Talk to your pharmacist or doctor:

  • If you have severe kidney or liver problems (including alcoholic liver disease)

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 containing caffeine if you need to take this medicine.

Do not drink alcohol (wine, beers, spirits) whilst taking this medicine.

If you need to have tests for your heart, stop taking this medicine 24 hours before the test. It may affect the results.

If you take other medicines

This medicine contains paracetamol.

Do not take with any other paracetamol-containing products.

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:

  • Other medicines containing caffeine
  • Phenytoin (for epilepsy)
  • Methoxsalen (for psoriasis)
  • Pipemidic acid (for infections)
  • Domperidone or metoclopramide (for feeling sick or being sick)
  • Colestyramine (for reducing blood fat levels)
  • Warfarin or other blood thinners – 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.

Adults and children of 16 years and over: take two tablets every 4 to 6 hours, if you need to.

Don’t take more than 4 doses (8 tablets) in 24 hours.

Children aged between 12 and 15 years: take one tablet Every 4 to 6 hours, if you need to.

Don’t take more than 4 doses (4 tablets) in 24 hours.

Do not take more often than every 4 hours.

Swallow each tablet with water.

Do not give to children under 12 years.

Do not take more medicine than the label tells you to

Do not continue to take for longer than 3 days, unless instructed by your doctor.

If you do not get better, talk to your doctor.

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 side effects, stop taking this medicine. 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
    • Tremor, difficulty sleeping, dizziness, nervousness, restlessness, irritability, anxiety
    • Headache, ringing in the ears
    • Fast or irregular heartbeat, rapid breathing
    • Frequent need to pass urine, stomach upset

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

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

  • Other allergic reactions (e.g. skin rash)
  • Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)
  • Unusual bruising, or infections such as sore throats – this may be a sign of very rare changes in the blood
    If you have taken this medicine for a long time you may get a headache, feel tired, or feel sleepy for up to a week after you stop taking the tablets.
  • Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin.

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.

How to store this medicine

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. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

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

As well as the active ingredients, the tablets also contain maize starch, methylcellulose, povidone, purified water, talc, calcium stearate.

The pack contains 16 or 32 tablets.

Who makes this medicine

Manufactured for

The Boots Company PLC
Nottingham
NG2 3AA

by the Marketing Authorisation holder

Wrafton Laboratories Limited
Braunton
Devon
EX33 2DL

Leaflet prepared August 2018

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 500mg/65mg Tablets

Reference number: 12063/0007

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

Artwork reference: WBAG329863