Panadol Original Tablets - Summary of Product Characteristics (SmPC) (2024)

This information is intended for use by health professionals

1. Name of the medicinal product

Panadol Original Tablets

2. Qualitative and quantitative composition

Each tablet contains Paracetamol Ph Eur 500.0 mg

3. Pharmaceutical form

Tablet

White, film-coated capsule shaped tablet with a triangular logo debossed on one side and a break line on the other.

4. Clinical particulars

4.1 Therapeutic indications

Panadol Original Tablets is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, aches and pains of colds and flu. Also recommended for the symptomatic relief of pain due to non-serious arthritis.

4.2 Posology and method of administration

Adults, the elderly, and children aged 16 years and over:

One or two tablets up to four times daily as required.

Children:

Aged 10 - 15 years: One tablet up to four times daily as required.

Not suitable for children under 10 years of age. Children should not be given Panadol Original Tablets for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every four hours nor should more than four doses be given in any 24 hour period.

Oral administration only.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special warnings and precautions for use

Contains paracetamol. Do not use with any other paracetamol-containing products.

Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.

Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis (refer also to section 4.9).

Use with caution in patients with glutathione depletion due to metabolic deficiencies.

If symptoms persist, medical advice must be sought.

Keep out of the sight and reach of children.

Pack Label:

Talk to a doctor at once if you take too much of this medicine even if you feel well. Do not take anything else containing paracetamol while taking this medicine.

Patient Information Leaflet:

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.

4.5 Interaction with other medicinal products and other forms of interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy and lactation

Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed, however, as with any medicine it should be used at the lowest effective dose for the shortest possible time.

Paracetamol is excreted in breast milk but not in a clinically significant amount in recommended dosages. Available published data do not contraindicate breastfeeding.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class and frequency.

The following convention has been utilised for the classification of the undesirable effects: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000), not known (cannot be estimated from available data).

Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.

Post marketing data

Body System

Undesirable effect

Frequency

Blood and lymphatic system disorders

Thrombocytopenia

Agranulocytosis

Very rare

Immune system disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including, among others, skin rashes and angioedema. Very rare cases of serious skin reactions have been reported.

Very rare

Respiratory, thoracic and mediastinal disorders

Bronchospasm*

Very rare

Hepatobiliary disorders

Hepatic dysfunction

Very rare

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App store.

4.9 Overdose

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or b, Regularly consumes ethanol in excess of recommended amounts.

Or c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.

5.2 Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1 - 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 - 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.

5.3 Preclinical safety data

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6. Pharmaceutical particulars

6.1 List of excipients

Maize starch, potassium sorbate, purified talc, stearic acid, polyvidone, starch pregelatinised, hypromellose, triacetin and carnauba wax.

6.2 Incompatibilities

None.

6.3 Shelf life

48 months.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

The tablets are packed into either:

PVC (250μm or 300μm) / aluminium foil 30μm blister strips

or

PVC (250μm or 300μm) / aluminium foil 20μm /8μm PET blister stripsin an outer cardboard cartons, containing 4, 6, 8, 12 or 16 tablets, or in a cardboard/PVC wallet containing 16 tablets.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0081

9. Date of first authorisation/renewal of the authorisation

29.05.84

10. Date of revision of the text

4th June 2020

Panadol Original Tablets - Summary of Product Characteristics (SmPC) (2024)

FAQs

What are the characteristics of paracetamol? ›

1.3. Chemical and physical properties of the pure substance
  • Description: White odourless crystalline powder; large monoclinic prisms from water.
  • Melting-point: 169–170.5 °C.

What do Panadol tablets contain? ›

Active ingredient: Each tablet contains Paracetamol 500 mg. Other ingredients: Maize starch, potassium sorbate (E 202), purified talc, stearic acid, povidone, starch pregelatinised, hypromellose, triacetin and carnauba wax.

What is the main ingredient in Panadol? ›

PANADOL Tablets contain 500 mg of paracetamol as the active ingredient. PANADOL Mini Caps contain 500 mg paracetamol as the active ingredient.

Where are Panadol tablets made? ›

GSK, one of the world's leading healthcare companies, employs 1,700 people across four locations in Ireland. GSK in Dungarvan, Co. Waterford, is the global home of Panadol: around 6.5 billion Panadol tablets are produced here each year.

What are the tablet characteristics? ›

A tablet computer, commonly shortened to tablet, is a mobile device, typically with a mobile operating system and touchscreen display processing circuitry, and a rechargeable battery in a single, thin and flat package.

What are the characteristics and uses of tablets? ›

A tablet must be strong and hard to withstand mechanical shock during manufacturing, packing, shipping, dispensing and use. The drug content of the tablet must be bioavailable that is, the tablet must be able to release its content in a predictable and reproducible manner.

What classification is Panadol? ›

Paracetamol belongs to the classes of analgesic and antipyretic drugs, commonly known as a pain reliever and fever reducer, respectively.

What is the purpose of using Panadol? ›

It's typically used to relieve mild or moderate pain, such as headaches, toothache or sprains, and reduce fevers caused by illnesses such as colds and flu. Paracetamol is often recommended as one of the first treatments for pain, as it's safe for most people to take and side effects are rare.

How many types of Panadol tablets are there? ›

Panadol 500mg Film Coated Tablets (paracetamol), Panadol Actifast Tablets 500mg (paracetamol), Panadol Extra 500mg/65mg Soluble Effervescent Tablets (paracetamol, caffeine), Panadol Night Tablets (paracetamol, diphenhydramine hydrochloride), Panadol Baby 120mg/5ml Oral Suspension (paracetamol).

What is the difference between Panadol and Panadol? ›

The difference is in how fast the tablet/caplet is absorbed: Panadol Rapid is absorbed twice as fast as regular Panadol tablets, whereas Panadol with Optizorb Formulation is absorbed 25% faster than regular Panadol tablets.

What is difference between Panadol and paracetamol? ›

Panadol – The GlaxoSmithKline brand name for 500g of Paracetamol . This 500g of Paracetamol is common among all of the panadol range and acts as an analgesic (pain relief) and anti-pyretic (decreases temperature). It contains no anti-inflammatory substances.

Is Panadol a brand name? ›

Common brand names include Panadol, Herron Paracetamol, Panamax, Chemist Own and Dymadon. Most pharmacy chains and supermarkets also have their own 'house brands'. Paracetamol is safe and effective when taken as directed on the label.

What is the origin of Panadol? ›

Harmon Northrop Morse synthesized paracetamol at Johns Hopkins University via the reduction of p-nitrophenol with tin in glacial acetic acid in 1877, but it was not until 1887 that clinical pharmacologist Joseph von Mering tried paracetamol on humans.

What is the name of the product Panadol? ›

Panadol is one of GlaxoSmithKline's trade names for paracetamol or acetaminophen.

When was Panadol first made? ›

First used clinically by von Mering in 1893, paracetamol did not appear commercially until 1950 in the United States and 1956 in Australia.

What are the classification of tablets? ›

Hence, tablets can be broadly classified as compressed tablets and moulded tablets. Compressed tablets can be further classified as directly compressible tablets, chewable tablets and tablet triturates etc.

What are tablets explain classification of tablets? ›

A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients.

What is the main advantage of tablet? ›

Because of their smaller screen sizes and less hardware, tablets have longer battery life. Tablets can also have more reliable batteries. Some tablet models boast battery life for up to 14 hours. Tablets are less expensive than laptops as they have fewer features.

What is the importance of the tablet? ›

Tablets in the classroom allow both students and trainers to be connected and in direct communication at any time. All notes, tasks or communications will be made and saved digitally, so it is difficult for them to get lost as can happen with hand-written notes.

What are benefits of a tablet? ›

Tablet pros and benefits
  • They're so light and portable. ...
  • You can get connectivity anywhere. ...
  • A tablet is more affordable than a laptop. ...
  • Tablets 'wake up' instantly. ...
  • They make excellent portable entertainment systems. ...
  • They're great for web browsing. ...
  • They're handy for giving presentations. ...
  • You can give one to your kids.

What is the contraindication of Panadol? ›

acute liver failure. liver problems. a condition where the body is unable to maintain adequate blood flow called shock. acetaminophen overdose.

Is Panadol good for pain relief? ›

Panadol Tablets provide fast, effective temporary relief from everyday pain and discomfort. Effective for: headache/tension headache, toothache, cold and flu symptoms, migraine headache, muscular aches, arthritis and osteoarthritis, period pain and fever.

Is Panadol a pharmaceutical? ›

What is paracetamol? Paracetamol is a pharmaceutical drug, which is use to treat a number of conditions including: mild pain. fever.

What is a stronger version of Panadol? ›

For stronger pain, you can take paracetamol and ibuprofen combined in the same medicine (brand names: Nuromol, Maxigesic). Taking these active ingredients over a long period of time, or in amounts higher than suggested can be dangerous.

What is the difference between paracetamol brands? ›

What's the difference between branded and generic medicine? When it comes to paracetamol and ibuprofen, there's no difference in quality between branded and generic. Whether you pay three cents or 26c a tablet, the same dosage of paracetamol will work in exactly the same way.

Is Panadol a brand of paracetamol? ›

Paracetamol is known as acetaminophen in the USA. Acetaminophen relieves mild-to-moderate pain, headache and fever. It is available as brand names such as Tylenol, Mapap or Panadol, and also as generics and store-specific brands.

Is Panadol just paracetamol? ›

Paracetamol for adults Brand names: Disprol, Hedex, Medinol, Panadol.

How many types of paracetamol are there? ›

Paracetamol Calpol, Disprol, Hedex, Panadol.

Is Panadol a branded generic? ›

Generic and branded medication can essentially be the same where they have the same active ingredient. For example, Panadol is a brand name with an active ingredient named paracetamol, which is also available in a generic form.

What is a paracetamol product? ›

Paracetamol has analgesic and antipyretic actions similar to those of aspirin and hence is a suitable alternative for patients sensitive to aspirin. For the relief of mild to moderate pain and febrile conditions, eg headache, toothache, colds, influenza, rheumatic pain and dysmenorrhoea.

How do I know original paracetamol? ›

The foil pattern is also different while its print color is darker. The fake paracetamol tablet's color is also darker than the authentic one.

What is the classification of paracetamol? ›

Paracetamol belongs to the classes of analgesic and antipyretic drugs, commonly known as a pain reliever and fever reducer, respectively.

What is the principle of paracetamol? ›

Paracetamol has a central analgesic effect that is mediated through activation of descending serotonergic pathways. Debate exists about its primary site of action, which may be inhibition of prostaglandin (PG) synthesis or through an active metabolite influencing cannabinoid receptors.

Did you know facts about paracetamol? ›

Key facts. Paracetamol can take up to an hour to work. The usual dose of paracetamol is one or two 500mg tablets at a time up to 4 times in 24 hours with a maximum of 8 tablets in 24 hours. Do not take paracetamol with other medicines containing paracetamol because there is a risk of overdose.

What is the structure of paracetamol? ›

What is the difference between Panadol and paracetamol? ›

Panadol – The GlaxoSmithKline brand name for 500g of Paracetamol . This 500g of Paracetamol is common among all of the panadol range and acts as an analgesic (pain relief) and anti-pyretic (decreases temperature). It contains no anti-inflammatory substances.

Is paracetamol and Panadol same? ›

Paracetamol is used for pain relief. Find out how to take it safely and possible side effects. Paracetamol is commonly called Panadol.

What Panadol is used for? ›

Panadol Advance 500 mg Tablets are a mild analgesic and antipyretic, and are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever, ...

What is the manufacturing process of paracetamol? ›

The starting material for the commercial manufacture of paracetamol is phenol, which is nitrated to give a mixture of the ortho and para-nitrotoluene. The o-isomer is removed by steam distillation, and the p-nitro group reduced to a p-amino group. This is then acetylated to give paracetamol.

What is the brand name of paracetamol? ›

Other names
Generic nameBrand names
ParacetamolDymadon®, Lemsip®, Panadol®, Panamax®, Tylenol®
Paracetamol and codeinePanadeine Forte®, Panamax Co®
Paracetamol, codeine and doxylamineMersyndol® and Mersyndol Forte®, Panalgesic®
2 Dec 2021

How long is Panadol effective? ›

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.

Why is paracetamol so effective? ›

Paracetamol reduces fever by affecting an area of the brain that regulates our body temperature (the hypothalamic heat-regulating center). Paracetamol is about as effective as aspirin and ibuprofen at relieving mild to moderate pain and reducing fever, but unlike these it doesn't reduce inflammation.

Why paracetamol is widely used? ›

It has a broad tolerability and is of particular value in the treatment of patients in whom nonsteroidal anti-inflammatory drugs are contraindicated such as aspirin-sensitive asthmatics and people at risk of gastrointestinal complications.

What functional group is formed in the product paracetamol? ›

Paracetamol contains three functional groups: the hydroxyl group (OH), the amide group (HN-CO-R), and the aromatic group (benzene ring), as shown in Fig. ...

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