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Paracetamol 1000 mg Tablets

Active Ingredient:
ATC code: 
N02BE01
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 19 May 2025

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 36722/0113.

Paracetamol 1000 mg Tablets

Package leaflet: Information for the patient

Paracetamol 1000 mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • 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.

What is in this leaflet

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

1. What Paracetamol Tablets is and what it is used for

Paracetamol Tablets contain paracetamol, which relieves pain (analgesic) and reduces the body temperature in fever (antipyretic). The tablets are recommended for use in treatment of mild to moderate pain and/or fever. This product contains high strength of Paracetamol.

Paracetamol Tablets are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve sore throat and the fever, aches and pains of colds and flu and are recommended for the relief of pain due to mild arthritis.

2. What you need to know before you take Paracetamol Tablets
Do not take Paracetamol Tablets:
  • if you have ever had an allergic reaction to paracetamol or to any of the other ingredients (listed in Section 6)
  • if you are taking other medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

Warnings and precautions

Talk to your doctor , pharmacist or nurse before taking Paracetamol Tablets

  • if you are suffering from kidney problems
  • if you are suffering from liver problems, including alcoholic liver disease
  • if you have Gilbert’s syndrome (mild jaundice)
  • if you have hemolytic anemia (abnormal breakdown of red blood cells)
  • if you are an asthmatic and sensitive to aspirin
  • if you are suffering from dehydration or chronic malnutrition
  • if you have fever after paracetamol therapy
  • if you suffer from glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency).
  • if you suffer from mild arthritis and need to take painkillers every day.
  • regularly drink alcohol
  • have a severe infection as this may increase the risk of metabolic acidosis.

Signs of metabolic acidosis include:

  • deep, rapid, difficult breathing
  • feeling sick (nausea), being sick (vomiting)
  • loss of appetite

Contact a doctor immediately if you get a combination of these symptoms. You may need to avoid using this product altogether or limit the amount of paracetamol that you take.

During treatment with Paracetamol Tablet, tell your doctor straight away if:

If 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).

Other medicines and Paracetamol Tablets

Talk to your doctor or pharmacist if you are taking any other medicines, including medicines obtained without a prescription.

Please inform your doctor or pharmacist if you are taking:

Tell your doctor before you take Paracetamol Tablets if you are taking;

  • flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2)
  • Drugs to thin the blood (anti-coagulant drugs e.g. warfarin) If you take blood thinning drugs (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol Tablets at the same time as anticoagulants.
  • Medicines used to relieve sickness (e.g. metoclopramide, domperidone)
  • Medicines used to treat high cholesterol (cholestyramine)
  • Probenecid (medicine used to treat high levels of uric acid in the blood stream i.e. gout)
  • Medicines to treat fever or mild pain (aspirin, salicylamide)
  • Drugs such as rifampicin (drug that helps to fight infection) and some antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone (drugs used to treat or cure convulsions)
  • Medicines used to treat epilepsy (lamotrigine)
  • Medicines to treat tuberculosis (isoniazid)
  • Medicines to treat HIV infections (zidovudine)

Effects of Paracetamol Tablets on laboratory tests

Uric acid and blood sugar tests may be affected.

Pregnancy and breast-feeding

If necessary, Paracetamol Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or fever and use it for the shortest time possible. Contact your doctor or midwife if your pain and/or fever are not reduced or if you need to take the medicine more often.

You can take this product whilst breast feeding.

Driving and using machines

Paracetamol Tablets have no effect on the ability to drive and use machines.

3. How to take Paracetamol Tablets

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

  • Take only one tablet every 4-6 hours as needed.
  • Do not take more than 4 tablets (4 grams) in 24 hours.

Not recommended for children under 16 years of age.

  • Do not take more frequently than every 4 hours.
  • Do not take more than the recommended dose.

If you take more Paracetamol Tablets than you should

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.

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

If you forget to take Paracetamol Tablets

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. The minimum time interval between two doses should be 4 to 6 hours. Never take a double dose to make up for the one you have missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking Paracetamol Tablets and see your doctor immediately if you experience symptoms like swelling in the face, tongue or throat, difficulty swallowing, red and itchy swellings on the skin and difficulty in breathing.

Rare (affects less than 1 in 1,000 patients):

  • Bleeding problems or clotting disorders (platelet disorders), decreased formation of cells, severe decrease in white blood cells which may lead to severe infections (agranulocytosis), frequent infections due to poorly functioning white blood cells or decrease in white blood cells (leucopenia), reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia), abnormal breakdown of red blood cells, which may cause weakness or pale skin (haemolytic anaemia), decrease in blood count (pancytopenia), reduced neutrophil count in blood (neutopenia).
  • Allergies (excluding swelling on the face, mouth and hands)
  • Depression, confusion, sensing unreal things
  • Tremor, headache
  • Abnormal vision
  • Abnormal accumulation of fluid under the skin (oedema)
  • Stomach pain, diarrhoea, nausea (feeling sick), vomiting, bleeding (haemorrhage)
  • Abnormal liver function, liver failure, death of liver cells (hepatic necrosis), jaundice
  • Dizziness, feeling of general discomfort or uneasiness (malaise), fever, drowsiness, drug interaction
  • Overdose and poisoning.

Very rare (affects less than 1 in 10,000 patients):

  • Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen and aspirin
  • Unexplained bruising or bleeding
  • Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
  • Damage caused to the liver (hepatotoxicity)
  • Immediate severe allergic reaction (hypersensitivity reaction requiring discontinuation of treatment)
  • Low levels of glucose in the blood (hypoglycemia)
  • Cloudy urine and kidney disorders
  • Life-threathening skin disease causing rash, skin peeling and sores (epidermal necrolysis) or mouth ulcers
  • Allergin reaction of the skin (erythema multiforme)
  • Severe life-threathening skin disease causing rash, skin peeling and sores (Stevens-Johnson syndrome)
  • Accumulation of fluid in the voice box (larynx)
  • Severe allergic reaction (anaphylactic shock)
  • Decrease in red blood cells (anemia)
  • Severe kidney impairment (renal alteration)
  • Kidney disorder (nephrite interstitial)
  • Blood in urine (haematuria)
  • Inability to urinate (anuresis)
  • Stomach ulcers and bleeding (gastrointestinal effects)
  • Uneasiness.

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)”

Reporting of side effects

If you get any side effects, talk to your doctor or 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Tablets

Keep this medicine out of the sight and reach of children.

Store in the original package in order to protect from light.

Do not use this medicine after expiry date which is stated on the carton, bottle or the blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Paracetamol Tablet contains
  • The active substance is paracetamol. Each tablet contains 1000 mg of paracetamol.
  • The other excipients are pregelatinised starch, povidone and magnesium stearate.

What Paracetamol Tablets looks like and contents of the pack

Paracetamol 1000 mg Tablets are white to off white, caplet shaped tablets, plain on both sides.

The tablets are supplied in blister packs of 20, 30, 40, 50 & 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
RxFarma
Colonial Way
Watford
Hertfordshire
WD24 4YR
United Kingdom

Manufacturer:
Rx Farma Limited
Unit 3
Colonial Way
Watford
Hertfordshire
WD24 4YR
United Kingdom

If you would like this leaflet in different format or want to report any side effects please contact marketing authorisation holder listed above.

This leaflet was last revised in April 2025.

Sigma Pharmaceuticals PLC (Special Concept Development / RxFarma)
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Address
HD House, Imperial Way, North Watford, Hertfordshire, WD24 4LQ, UK
Telephone
+44 (0)800 358 0163
Medical Information Direct Line
+44 (0)800 358 0163
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)800 358 0163
Stock Availability
[email protected]