Patient leaflet - Paracetamol 500 mg film coated tablets

1. What Paracetamol 500 mg Film Coated Tablets are and what they are used for

Paracetamol 500 mg Film Coated Tablets are suitable for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve sore throat and fever, aches and pains of cold and ﬂu and are recommended for the relief of pain due to mild arthritis.

The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have a fever.

2. What you need to know before you take Paracetamol 500 mg Film Coated Tablets

Do not take Paracetamol 500 mg Film Coated Tablets

If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).
If you are taking any other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol 500 mg Film Coated Tablets:

If you suffer from mild arthritis and need to take painkillers every day.
If you have liver or kidney problems.
If you are underweight.
If you regularly drink alcohol.
If you have severe infection or 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), being sick (vomiting) and loss of appetite.

During treatment with Paracetamol 500 mg Film Coated Tablets, tell your doctor straight away 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.

Other medicines and Paracetamol 500 mg Film Coated Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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. You can still take occasional doses of Paracetamol 500 mg Film Coated 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 you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacists for advice before taking this medicine.

3. How to take Paracetamol 500 mg Film Coated Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults (including the elderly) and children 16 years and over

Swallow 1-2 tablets every 4 to 6 hours as needed.

Do not take more than 8 tablets in 24 hours.

Children aged 10 -15 years

Give 1 tablet every 4 to 6 hours as needed. Do not give more than 4 tablets in 24 hours.

Do not give for more than 3 days without consulting a doctor.

Do not take more frequently than every 4 hours.
Do not take more than the recommended dose.
Do not give to children under 10 years.

If you take more Paracetamol 500 mg Film Coated 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 500 mg Film Coated Tablets

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.

4. Possible side eﬀects

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

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, 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. 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 500 mg Film Coated Tablets

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the 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.

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6. Contents of the pack and other information

What Paracetamol 500 mg Film Coated Tablets contain

The active substance is paracetamol. Each tablet contains 500 mg paracetamol.
The other ingredients are pregelatinized starch, maize starch, talc, povidone and magnesium stearate.
The tablet coating contains hypromellose (E464), titanium dioxide (E171) and macrogol (E1521).

What Paracetamol 500 mg Film Coated Tablets look like and contents of the pack

White coloured, caplet shaped ﬁlm-coated tablets with 'K', bisect break line and '01' on one side and plain on the other side.

Paracetamol 500 mg Film Coated Tablets are available in blister packs of 32 & 100 tablets and HDPE bottles of 100, 300, 500 & 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited, 5 Sandridge Close,

Harrow, Middlesex, HA1 1XD, UK.

Manufacturer

Drugsrus Limited, 5 Sandridge Close,