Paracetamol 1000 mg Tablets

• 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.

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

• 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.

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).

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)

Uric acid and blood sugar tests may be affected.

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.

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

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 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.

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)”

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.

• The active substance is paracetamol. Each tablet contains 1000 mg of paracetamol.
• The other excipients are pregelatinised starch, povidone and magnesium stearate.

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.