Boots Paracetamol & Caffeine 500mg/65mg Tablets

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.

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever
• caffeine which helps to increase the pain relief from paracetamol and makes you more alert.

These tablets are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, flu, feverishness and feverish colds.

• are allergic to paracetamol, caffeine or any of the other ingredients of this medicine (listed in section 6)
• have high blood pressure or are taking any medication for high blood pressure, such as beta blockers
• your heart beat is too fast, too slow or irregular
• are recovering from alcoholism and are taking the medicine disulfiram
• are taking any medication to treat anxiety, this includes antidepressants (e.g. lithium carbonate or monoamine oxidase inhibitors), anxiolytics (including clozapine) or sedatives (e.g. diazepam)
• have an anxiety disorder
• are currently taking the medicine ephedrine (a decongestant) or theophylline, which is used to treat asthma.

Talk to your doctor or pharmacist before taking this medicine if you:

• suffer from hepatocellular insufficiency
• suffer from renal failure
• have Gilbert's Syndrome (familial non-haemolytic jaundice)
• are taking other medicines that can affect the liver
• your body is missing or doesn't have enough of the enzyme glucose-6-phosphate dehydrogenase
• you suffer from abnormal breakdown of red blood cells, which may cause weakness or pale skin
• have glutathione deficiency
• are dehydrated
• are malnourished
• weigh less than 50kg
• suffer from kidney or liver problems, including alcoholic liver disease
• have asthma or are sensitive to aspirin.

Talk to your doctor if you have frequent or daily headaches despite (or because of) the regular use of analgesics.

Do not take other paracetamol containing products together with this medicine.

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.

• you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, like:

• medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as cholestyramine
• medicines to control feeling sick or being sick such as metoclopramide or domperidone
• medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis
• medicines used during hospital test for heart conditions such as adenosine and dipyridamole
• medicines used to treat the skin condition psoriasis, such as methoxsalen
• medicines to treat epilepsy, such as phenytoin
• medicines used to treat thyroid conditions, such as levothyroxine
• medicines used to treat infections, such as pipemidic acid
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2)
• probenecid to treat gout
• the antibiotic chloramphenicol
• sedatives or tranquilizers
• decongestants (e.g. ephedrine)
• the antipsychotic clozapine
• medicines to lower the blood pressure such as atenolol, metoprolol, oxprenolol, propranolol
• disulfiram to treat alcoholism
• antidepressants such as monoamine oxidase inhibitors and lithium carbonate
• theophylline to treat asthma.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Each tablet contains 65 mg of caffeine and up to 8 tablets (or 520 mg of caffeine) may be taken per day. If you are also consuming other medicines or food that contains caffeine (coffee, tea, cola drinks, chocolate) you may have a high caffeine intake and might have difficulty sleeping, start shaking and/or have an uncomfortable feeling in the chest. You should avoid too much caffeine in drinks like coffee and tea.

Although the amount of caffeine in a drink of coffee and tea depends on how they are made, you can use the information below as a guide to the amount of caffeine contained within certain foods and drinks:

• Filter coffee – 100 ml contains 50 - 100 mg of caffeine
• Instant coffee – 100 ml contains 20 - 73 mg of caffeine
• Tea – 100 ml contains 20 - 73 mg of caffeine
• Cola drink – 100 ml contains up to 20 mg of caffeine
• Chocolate – 100 g contains 5 - 20 mg of caffeine
• Your medicine – 1 tablet contains 65 mg of caffeine.

*100 ml is a small cup/glass.

Maximum recommended caffeine intake per day: 520 mg

Adults, the elderly and children over 16 years:

2 tablets to be taken every 4 to 6 hours, as required. Do not take more than 4 doses (8 tablets) in any 24 hour period.

Children aged 12 to 15 years:

1 tablet to be taken every 4 to 6 hours, as required. Do not take more than 4 doses (4 tablets) in any 24 hour period.

Do not give to children under 12 years.

Do not take more often than every 4 hours.

Do not continue to take for longer than 3 days, unless instructed by your doctor. Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

If pain or fever persist for more than 3 days or gets worse, or if any other symptoms occur, stop taking this medicine and consult 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.

Do not take a double dose to make up for a forgotten dose.

If your symptoms continue or your headache becomes persistent, see your doctor.

• sudden, severe allergic reaction with breathing difficulty, swelling, lightheadedness, fast heartbeat, sweating and loss of consciousness
• reduction in blood platelets, which increases the risk of bleeding or bruising
• severe decrease in white blood cells which may lead to severe infections
• shortness of breath, this is more likely if you have experienced this before when taking other painkillers such as aspirin or ibuprofen (non-steroidal anti-inflammatories)
• swelling of skin or mucous membrane, face, tongue and throat causing breathing difficulties
• life-threatening reaction with flu-like effects and blistering in the skin, mouth, eyes and genitals
• life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals
• sudden blisters in large skin areas
• drug-induced inflammation of the skin
• very rare cases of skin reactions have been reported.

Paracetamol side effects

Very rare side effects (may affect up to 1 in 10,000 people):

• allergic reactions
• liver problems
• allergic skin reactions including:
  • skin rashes
  • itching
  • sweating
  • rash of raised red or purple spots, the spots look like small bruises or blood spots
  • hives.
• cloudy urine.

Frequency not known (frequency cannot be estimated from the available data): A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Caffeine side effects

If you do not take more than the recommended 520 mg of caffeine per day side effects are unlikely, but you must remember to take into account caffeine from coffee, tea, other medicines, etc. Some people are more sensitive to caffeine and can get side effects at lower doses, especially if they have never had caffeine before or have not had caffeine for some time.

Not known (frequency cannot be estimated based on available data):

• dizziness
• tremor
• insomnia
• nervousness
• irritability
• anxiety
• headache
• tinnitus (ringing in the ears)
• stomach complaints (e.g. nausea, vomiting and diarrhoea)
• abnormal or irregular heartbeat, rapid heartbeat, an increased need to pass water, and rapid breathing.

If you experience any caffeine-related side effects, stop taking all medicines containing caffeine, including this medicine and stop consuming food that contains caffeine (coffee, tea, cola drinks, and chocolate).

There are some people who may experience unwanted side effects when they stop taking tablets or foods containing caffeine after regular use. The most common effect is headache but also tiredness and feeling less alert can occur. These effects are temporary and may last up to a week but to minimize these effects it is best to gradually reduce caffeine intake.

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.

Each tablet contains the active ingredients: paracetamol 500 mg and caffeine 65 mg.

The other ingredients are: povidone, maize starch, methylcellulose, talc and calcium stearate.

White capsule shaped tablets with no marks and plain on both sides.

This product is available in pack sizes of 16 and 32 tablets. Not all pack sizes are available.

The Marketing Authorisation holder and manufacturer is