Paracetamol 500 mg Capsules (PL 43461/0086) (POM)

• 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.
• You must talk to a doctor if you do not feel better or you feel worse after 3 days.

1. What Paracetamol Capsules are and what they are used for
2. What you need to know before you take Paracetamol Capsules
3. How to take Paracetamol Capsules
4. Possible side effects
5. How to store Paracetamol Capsules
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 any other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

Talk to your doctor or pharmacist before taking Paracetamol Capsules if you-

• suffer from mild arthritis and need to take painkillers every day.
• suffer from liver or kidney problems
• are underweight or malnourished
• regularly drink alcohol
• have a severe infection as this may increase the risk of metabolic acidosis.

During treatment with Paracetamol, 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).

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.

Do not give to children under 10 years.

Talk to your doctor or pharmacist before taking these capsules if you are taking any prescribed 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 Capsules 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).

Talk to your health care professional before taking Paracetamol Capsules if you are pregnant. If necessary, Paracetamol Capsules can be used during pregnancy. Consider taking the lowest effective dose for the shortest period of time. You can take this product whilst breastfeeding.

If you are suffering from a headache and it becomes persistent, consult your doctor.

Paracetamol has no influence on the ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodium-free'.

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

Do not take more than 8 capsules in 24 hours.

Give 1 capsule every 4 to 6 hours as needed.

Do not give more than 4 capsules in 24 hours.

Do not give for more than 3 days at a time unless your doctor tells you to.

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.

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 your capsules(s), take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

Remember to leave at least 4 hours between doses.

If you get any side effects, talk to your doctor, 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 Google Play Store or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Each capsule contains 500mg of the active ingredient, paracetamol. The other ingredients are sodium starch glycolate (Type-A), pregelatinised starch, colloidal anhydrous silica and magnesium stearate. The capsule shells are made of gelatin, water, titanium dioxide (E171) and ferric oxide red (E172).

The capsules are hard gelatin capsule, with red cap and white base containing a white powder.

The capsules are available in blister packs as below:

Paracetamol Capsules are available in blister packs of 36, 40, 48, 56, 60, 84, 96 or 100 capsules.

Not all pack sizes may be marketed.