Patient leaflet - Paracetamol 1000 mg tablets
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.
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.
This medicine is for adults and children aged 16 years and over only. For children under 16 years (weighing less than 50 kg), other presentations of paracetamol are available. Ask your doctor or pharmacist.
2. What you need to know before you take Paracetamol Tablets
Do not take Paracetamol Tablets:
- if you are taking other medicines containing paracetamol
- if you have ever had an allergic reaction to paracetamol or to any of the other ingredients (listed in Section 6)
Concomitant use of this medicinal product with other medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep. Should be avoided since high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without talking to your doctor.
Warnings and precautions
Talk to your doctor , pharmacist or nurse before taking Paracetamol Tablets
- if you have liver or kidney disease
if you suffer from alcoholism
- if you suffer from mild arthritis and need to take painkillers every day.
- 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; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or colestyramine (to lower blood cholesterol). 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.
Please inform your doctor or pharmacist 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).
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
Warning: each tablet contains 1000 mg of paracetamol. Do not take two simultaneously.
Adults, the elderly and children aged 16 years and over (weighing more than 50 kg):
- Take 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.
Do not give for more than 3 days at a time unless your doctor tells you to.
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 you have taken too much of this medicine, then stop the treatment immediately.
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. A small number of people have had side effects.
Stop taking the medicine and tell your doctor immediately if you experience:
- Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath
- Skin rash or peeling, or mouth ulcers
- 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.
- Very rare cases of serious skin reactions have been reported.
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 8 and 16 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.