What is paracetamol?

Paracetamol (Panadol, Calpol, Alvedon) is an analgesic and antipyretic drug that is used to temporarily relieve mild-to-moderate pain and fever. It is commonly included as an ingredient in cold and flu medications and is also used on its own.

Paracetamol is exactly the same drug as acetaminophen (Tylenol). Paracetamol is the drug’s name assigned using the International Nonproprietary Name (INN) generic name system. Paracetamol is the name used for the drug in places such as Europe, Australia, New Zealand and India. Acetaminophen is the generic name assigned using the United States Adopted Names (USAN) system. Acetaminophen is the name used in countries such as the US, Canada and Japan. Usually the INN and USAN generic names for a drug are the same and don’t differ between countries.

It is not clear exactly how paracetamol works. However, it is thought to work by blocking chemical messengers in the brain that let us know when we’re in pain and by affecting the chemical messengers that regulate our body temperature. The evidence suggests that paracetamol inhibits the production of prostaglandins, which are made by the body to deal with illness and injury. It’s also thought to act on the serotonergic, opioid, nitric oxide and cannabinoid pathways.

Paracetamol was first made in 1878, but only became more widely used in the 1950s. Today paracetamol is one of the most widely used painkillers in the world. Branded and generic versions of this drug are available.

What is paracetamol used for?

Paracetamol is available over-the-counter (OTC) and also as a prescription medication. It is used for the relief of:

• Headache
• Tension headache
• Migraine
• Backache
• Rheumatic and muscle pain
• Mild arthritis/osteoarthritis
• Toothache
• Period pain (dysmenorrhea)
• Colds and flu symptoms
• Sore throat
• Sinus pain
• Post-operative pain
• Fever (pyrexia)

Important information

Paracetamol (acetaminophen) is found in many different OTC cold and flu medications. Do not take paracetamol if you are taking any other prescription or non-prescription medications containing paracetamol or acetaminophen.

Who should not take paracetamol?

Do not take medications containing paracetamol if you are allergic to it or any of the other ingredients in the paracetamol product you are taking.

What should I tell my doctor before taking paracetamol?

Before you take paracetamol, tell your healthcare provider about all of your medical conditions, including:

• if you suffer from mild arthritis and need to take pain relief every day
• have liver or kidney problems
• are underweight or malnourished
• regularly drink alcohol. You may be more open to the side effects of paracetamol if you drink large amounts of alcohol.
• have a severe infection as this may increase you risk of metabolic acidosis. Signs of metabolic acidosis include:
  • deep, rapid, difficult breathing
  • feeling sick (nausea)
  • being sick (vomiting)
  • loss of appetite
    Contact your doctor immediately if you get a combination of these symptoms. You may need to avoid or limit paracetamol.
• have glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency)
• suffer from asthma and are sensitive to aspirin
• have hemolytic anemia (abnormal breakdown of red blood cells)

How should I take paracetamol?

• Always use exactly as your doctor or pharmacist tells you to
• Always read the instructions on your medication before taking it
• Do not take more than the recommended dose. Check the instructions for the paracetamol product you have. The strength and recommended dose among for different paracetamol-containing products.
• Paracetamol may be taken every 4 to 6 hours. Leave at least 4 hours between doses.
• Do not take more than four doses in 24 hours.
• Do not take for more than 3 days, unless your doctor tells you to
• Contact your healthcare professional if your symptoms get worse or do not improve

Paracetamol 500mg tablets and capsules

• Swallow tablets or capsules whole with a glass of water

Paracetamol 120 mg/5 ml, 250 mg/5 ml oral suspension

• Always use the oral syringe or measuring spoon that comes with your paracetamol suspension to make sure you are giving the correct dose. The recommended dose will depend on your child’s age and weight.
• Shake the bottle for 10 seconds then remove the cap
• Insert the syringe and draw up the recommended dose
• Place the syringe inside the child’s mouth against the inside of their cheek and press the plunger slowly to release the medicine
• Replace the cap on the paracetamol bottle and wash and dry the syringe

* Only for use of relief of fever after the 2 month immunizations in children weighing more than 4 kg who were born after 37 weeks. If your child still has a fever after 2 doses consult your doctor.

Paracetamol 60 mg, 125 mg and 250 mg suppositories

• Your child’s bowels need to be empty when you give them this medication. If they need to go to the toilet, make sure they do this before you give then a suppository.
• Position your child lying on their front or side on a bed to administer the suppositories. Or select another position that is comfortable for your child.
• Wash your hands and unwrap the suppository, taking care not to break it
• Gently push the pointed end of the suppository into your child’s rectum (back passage), then wash your hands
• Try and keep your child still for 1 to 2 minutes. Add a second suppository if another one is required. Wash your hands.
• Try and keep your child still for another 1 to 2 minutes after the full dose is administered

#Check with your doctor or pharmacist about the correct dose for your child, which will be based on their age and weight. Do not guess the dose.

*One dose can be given to babies who develop a fever after their immunizations at 2 months of age. Otherwise do not use in babies less than 3 months old unless your doctor tells you to.

Paracetamol 650 mg oral powder

• Check the sachet is not broken before use
• Empty the content of 1 sachet into a glass. Fill with freshly boiled water and stir under dissolved
• Allow the solution to cool and then drink it
• Adults and children aged 12 years and over can take 1 sachet every 4 hours if required. Do not take more than 4 sachets in 24 hours.
• Do not give to children under 12 years of age.

Paracetamol 250 mg orally disintegrating tablets

• Remove the orally disintegrating tablet from the foil using your fingernail, pressing along the dotted line before pressing it out
• Tablets can be sucked gently on the tongue until they melt into a paste which is easily swallowed
• Tablets can also be dissolved in water or milk if preferred

Paracetamol 500 mg effervescents tablets

• Place the paracetamol effervescent tablet(s) in a full glass of water and allow to dissolve completed before swallowing

* Do not give to children younger than 12 years old.

#Maximum 2 tablets per dose. Maximum 8 tablets in 24 hours.

Paracetamol 10 mg/ml solution for infusion

• This form of paracetamol comes in vials and is administered via intravenous (IV) infusion – an injection in your arm – over 15 minutes.
• The dose you need will depend on your age and weight and how well your kidneys work. Your healthcare provider will work out the dose you need.

What happens if I miss a dose?

If you miss a dose of paracetamol, give the next dose when needed as long as it’s been more than 4 hours since your last dose. Do not give a double dose or exceed the maximum daily dose.

What happens if I overdose?

If you or your child takes too much paracetamol, get medical help or contact a Poison Control Center right away (1-800 222-1222). Quick medical attention is critical for adults and children even if they seem well.

Paracetamol can caused delayed, serious liver damage. There may be no symptoms of overdose during the first 24 hours although paleness, nausea, sweating, vomiting, loss of appetite and abdominal pain may occur.

Dosing information

See “How should I take paracetamol?” above for information about paracetamol dosing. For further details read the full prescribing information.

What are the side effects of paracetamol?

Serious side effects of paracetamol include:

• Allergic reactions, which may be severe and include:
  • Skin rashes, itching or hives
  • Swelling of the throat, tongue or face
  • Shortness of breath or wheezing
• Skin rash or peeling, or mouth ulcers
• Breathing problems. This is more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
• Unexplained bruising or bleeding or becoming unusually tired. Getting more infections than usual.
• Liver problems. Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin can occur
  
  If you get any of the rare side effects listed above, stop taking the medicine and contact your doctor immediately.

Common side effect of paracetamol suppositories include:

• Redness or soreness in or around the rectum

Everyday, long-term use (several months or more) of paracetamol can cause liver or kidney damage. People taking this medication in the usual way for shorter periods of time have not had these problems.

These are not all of the possible side effects of this medication.

Call your doctor for medical advice about side effects.

Interactions

Tell your doctor or pharmacist about all the medicines you take, including prescription and OTC medicines, vitamins, and herbal supplements before taking this medication. Especially tell your doctor if you take:

• Blood thinning medications (anticoagulants) such as warfarin and you need to take a pain reliever daily. Occasional doses of paracetamol can be taken with anticoagulants
• Medications to help relieve nausea (metoclopramide or domperidone)
• Medications to treat high cholesterol (cholestyramine)
• Medications to treat epilepsy (lamotrigine)
• Medications to treat tuberculosis (isoniazide)
• Medication to treat fever or mild pain (aspirin, salicylamide)
• Barbiturate and tricyclic antidepressants to treat depression (amitriptyline)
• A medication to treat gout called probenecid
• A medication used to treat bacterial infections called chloramphenicol
• A medication used in HIV infections and AIDS called zidovudine
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment, and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.

Paracetamol may affect the results of laboratory tests for uric acid and blood sugar levels.

Paracetamol can be taken with oral contraceptives, but it may not work as well to lower your pain or fever.

Pregnancy and breastfeeding

Tell your healthcare provider if you are pregnant or plan to become pregnant. If necessary, paracetamol can be used during pregnancy. Paracetamol can be taken if you are breastfeeding. Small amounts of paracetamol pass into breast milk.

Use the lowest possible dose that reduces your pain and/or fever and use it for the shorted time possible. Contact your doctor or midwife if the pain and/or fever are not reduced or if you need to take this medicine more often.

Storage

• Keep out of sight and reach of children
• Do not use the medicine after the expiry date
• Store below 77°F (25°C) unless instructed otherwise
• Store paracetamol suppositories in a cool, dry place below 77°F (25°C) and out of direct sunlight
• Store paracetamol effervescent tablets below 86 7°F (30°C). Use within 1 month of first opening the tube. Do not use the effervescent tablets if you notice visible signs of deterioration, such as brown or black spots on the tablets, or bulging or discolored tablets.
• Store paracetamol solution for infusion below 86 7°F (30°C). Do not refrigerate or freeze. Store in the original package and protect from light.

What are the ingredients in paracetamol?

Active ingredient: paracetamol

Inactive ingredients:

Inactive ingredients will vary among the different brands and formulations. Check the product label for your formulation and strength of paracetamol for the list of inactive ingredients.

Zentiva paracetamol capsules: maize starch and magnesium stearate. The capsule is made of gelatine and sodium lauryl sulfate coloured with titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172) and indigo carmine (E132). The ink used to print on the capsules contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone and titanium dioxide.

Panadol original tablets: maize starch, potassium sorbate (E 202), purified talc, stearic acid, povidone, starch pregelatinised, hypromellose, triacetin and carnauba wax.

Effervescent tablets: anhydrous citric acid, Sodium hydrogen carbonate, Sorbitol E420, Sodium carbonate anhydrous, Povidone K25 (E1201), Simethicone, Saccharin sodium, Lemon flavour (containing maize maltodextrin, acacia gum (E 414), alpha-tocopherol (E 307), Macrogol 6000

Accord intravenous (IV) infusion: cysteine hydrochloride monohydrate, disodium phosphate dihydrate, hydrochloric acid (1M) (for pH-adjustment), sodium hydroxide (1M) (for pH-adjustment), mannitol, water for injections.

Calpol SixPlus Fastmelts orally disintegrating tablets: mannitol (E421), crospovidone, aspartame (E951), magnesium stearate, basic butylated methacrylate copolymer, polyacrylate dispersion 30% and colloidal anhydrous silica. The flavoring is strawberry (containing benzyl alcohol and glucose).

Boots Cold & Flu Relief Powders – Lemon flavor: sucrose, sodium citrate, citric acid, tartaric acid, sodium cyclamate, ascorbic acid, starch, natural colour (E100), spray dried lemon juice, lemon aroma

Calpol 120 mg/5 ml infant oral suspension: sucrose, sorbitol liquid (E420), glycerol, polysorbate 80, asulfame potassium, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethyl parahydroxybenzoate (E214), microcrystalline cellulose and carmellose sodium, xanthan gum and purified water. The flavoring is strawberry (containing propylene glycol (E1520)) and coloring is carmoisine (E122). Each 5 ml of this product contains 2.2 g of sucrose.

Alvedon paracetamol suppositories: hard fat (Witepsol H12)

Panadol is marketed by GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. Calpol is marketed by McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK. Alvedon is marketed by Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berkshire, SL6 6PT, UK.

• Paracetamol is a medicine used to treat mild to moderate pain.
• Paracetamol can also be used to treat fever (high temperature).
• It’s dangerous to take more than the recommended dose of paracetamol.
• Paracetamol overdose can damage your liver and cause death.
• Always follow the directions on the packet when using paracetamol.

What is paracetamol?

Paracetamol is a medicine used for mild to moderate pain. It can be bought over the counter in pharmacies, supermarkets and other shops.

You can also take paracetamol for:

• fever (high temperature)
• stronger pain — used with other pain relievers such as codeine

Paracetamol doesn’t treat the cause of your pain, it just eases the feeling of pain.

Paracetamol can be used for:

• backache
• headache
• migraine
• muscle strains
• period pain
• toothache
• aches and pains due to colds and flu

How does paracetamol work?

Paracetamol has been in use for more than 70 years. The way it works to reduce pain and fever is not fully understood.

Paracetamol begins to ease pain and lower a high temperature about 30 minutes after a dose is taken. Its effects usually last for about 4 to 6 hours.

Types of paracetamol

Paracetamol comes in the following forms:

• tablets
• capsules
• suppositories
• soluble powders
• liquids

Paracetamol is made by lots of different companies and sold using different names. It’s also often combined with other medicines and found in:

• cold and flu medicines
• headache tablets

This makes it very easy to take too much paracetamol by mistake.

Modified release paracetamol

Modified release paracetamol has a higher dose of paracetamol than standard paracetamol tablets. This can also be called:

• controlled release paracetamol
• extended-release paracetamol
• slow-release paracetamol
• sustained release paracetamol

This type of paracetamol is often used to help manage pain associated with osteoarthritis.

Modified release paracetamol is released into your body more slowly than normal paracetamol products.

Modified release paracetamol is designed to be taken less often than normal paracetamol. You take a dose every 8 hours (3 times a day).

How much paracetamol can I take?

The suggested dose of paracetamol for adults and children 12 years and over is:

• no more than 1g every 4 to 6 hours
• a total of 4g daily

It’s dangerous to take more than the recommended dose of paracetamol. This may damage your liver, which can be fatal (cause death).

Paracetamol is sold under a variety of brand names. This can be confusing and lead to you taking more paracetamol than advised. Always check the packet before taking any medicine.

Children aged 1 month to 12 years

Dosing for children is 15 mg per kg. Paracetamol can be given every 4 to 6 hours as required, with no more than 4 doses in 24 hours.

The label on your liquid paracetamol product will have clear dosing instructions.

What should I do if I forget to take a dose of paracetamol?

If you forget to take your dose of paracetamol, you should:

• take the dose as soon as you remember
• unless it’s within 4 hours of your next dose — in which case you should skip that dose

Doses of paracetamol should be taken at least 4 hours apart.

Don’t take more than the recommended dose over a 24-hour period.

Check the directions on your medicine package. It should tell you what to do.

Can I take paracetamol with my other medicines?

DO NOT take paracetamol if you are also taking other medicines that contain paracetamol. These might be:

• paracetamol/ibuprofen combinations
• migraine preparations
• some cough and cold remedies
• medicines prescribed by your doctor

This is because of the risk of overdosing on paracetamol. This may damage your liver and can be fatal (cause death).

Paracetamol won’t interact with many other medicines if only taken for a few days for pain or fever. It’s also safe to take paracetamol if you are on antibiotics.

If you take other medicines, it is important to:

• check with your doctor or pharmacist that you can take your medicine with paracetamol
• read the information leaflet that comes with your medicine

Warfarin and paracetamol

Paracetamol is the suggested painkiller for people taking warfarin.

You should take the lowest dose that helps your pain. If you’re still in pain after taking paracetamol for 3 or 4 days, speak with your doctor.

Long-term use of paracetamol may increase the effect of warfarin. This can increase your chance of bleeding. However, this is unlikely to happen if you take paracetamol occasionally.

When should I not take paracetamol?

DO NOT take paracetamol if you have:

• an allergy to paracetamol
• taken other medicines that contain paracetamol
• already taken the recommended dose within a 24-hour period

Check with your doctor or a pharmacist before taking paracetamol if you have:

• liver problems
• kidney problems
• drink more than the recommended amounts of alcohol
• you are very underweight

Paracetamol, food, alcohol and driving

Will paracetamol affect my driving?

Paracetamol is unlikely to affect your driving.

Is it okay to drink alcohol when I’m taking paracetamol?

Drinking a small amount of alcohol is unlikely to be harmful if you are taking paracetamol.

Are there any foods I should avoid?

You can eat normally when taking paracetamol.

What are the possible side effects of paracetamol?

Use of any medicine always carries some chance of unwanted side effects.

The most common side effects of paracetamol are:

• drowsiness and tiredness
• rashes and itching

People react differently to medicines. Just because a side effect is listed doesn’t mean you will get the side effect. It’s important to be careful when taking any medicine.

Can I use paracetamol often?

You should talk to your doctor about using paracetamol for a long time.

Long-term use of paracetamol can cause:

• tiredness
• breathlessness
• your fingers and lips to go blue
• anaemia (low red blood cell count)
• liver and kidney damage
• heart disease and stroke if you have high blood pressure

What happens if I take too much paracetamol?

for an ambulance — even if you have no symptoms.

Liver failure can happen if you take too much paracetamol and don’t get help. This can lead to death.

Symptoms of paracetamol overdose are:

• abdominal pain, nausea, vomiting
• liver problems
• seizures
• coma and death

These symptoms usually happen 24 hours after taking the drug.

You can be given an antidote if you get medical help soon after taking paracetamol.

How can I avoid taking too much paracetamol?

You can make sure that you don’t take too much paracetamol by:

• carefully following the directions for using paracetamol-containing medicines
• learning how to identify paracetamol as the active ingredient in medicines

Paracetamol and life stages

Can paracetamol be given to children?

You can give your child paracetamol if they have a high temperature, and this is making them uncomfortable. Get medical advice if the fever does not get better.

You can give paracetamol to your child after their vaccinations (shots) to treat pain and fever.

Don’t give paracetamol to babies younger than one month old.

How much paracetamol should I give my child?

Paracetamol comes in different strengths for different ages. It’s important to choose the right paracetamol product for your child’s age.

Make sure that you:

• always read the medicine label and packaging before use
• know your child’s weight — the recommended dose of paracetamol is based on their body weight

When giving your child paracetamol, never:

• give more than the maximum recommended dose
• give more doses than recommended in a 24-hour period

When giving your child medicines, you should:

• measure liquid medicines accurately using the syringe that comes with the medicine
• write down all the medicines your give them, and when you give them

Don’t give your child paracetamol for more than 48 hours unless told to do so by a doctor.

Always keep medicines in a safe place, out of the reach of children.

Can I take paracetamol if I’m pregnant?

Paracetamol is widely used during pregnancy. Paracetamol readily crosses the placenta, but doesn’t appear to raise the chance of birth differences or bad pregnancy outcomes.

As with any medicine taken during pregnancy, you should get medical advice before taking paracetamol.

If you take paracetamol when pregnant, make sure that you take it:

• at the lowest effective dose
• for the shortest possible time

Can I take paracetamol if I’m breastfeeding?

If you take paracetamol when breastfeeding, make sure you take the recommended dose, for the shortest possible time.

It appears in breast milk in very small amounts which are very unlikely to harm your baby.

Paracetamol is the first choice of painkiller if you are breastfeeding.