Panadol 500 mg Soft Capsule

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. This medicine is available without prescription, but you still need to use Panadol 500 mg capsules carefully to get the best results from them.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist or doctor if you need more information or advice.
• 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.
• If pain lasts for longer than 5 days or fever lasts for longer than 3 days or if these symptoms become worse a doctor must be consulted.

1. What Panadol 500 mg capsules are and what it is used for
2. Check before you take Panadol 500 mg capsules
3. How to take Panadol 500 mg capsules
4. Possible side effects
5. How to store Panadol 500 mg capsules
6. Contents of the pack and other information

Panadol 500 mg capsules belong to a group of medicines named analgesics (painkillers).

Panadol 500 mg capsules are used for symptomatic treatment of mild to moderate pain and/or fever.

Panadol 500 mg capsules can be used for headache including migraine and tension headaches, toothache rheumatic pain, back pain, muscle pain, period pain, sore throat, fever, aches and pains of colds and flu, pain due to mild arthritis.

• if you have ever had an allergic reaction to paracetamol or to any of the other ingredients of this medicine (listed in section 6);
• if you are already taking other medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

• if you suffer from mild arthritis and need to take painkillers every day
• if you have liver or kidney problems
• if you are underweight or malnourished
• if you regularly drink alcohol
• if you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), suffer from malnutrition, chronic alcoholism or if you are taking flucloxacillin (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 is taken together with flucloxacillin. Symptoms 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. Long-term or frequent use is not advised. Do not exceed the recommended dose. You should use the lowest possible dose and use it for the shortest time possible.

Long-term use of every analgesic to treat headache can worsen the headache. If this occurs, stop taking this product and consult your doctor.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to medicines which you are able to obtain on prescription.

Contact your doctor or pharmacist before you take paracetamol, if you are taking any of the following medicines: metoclopramide or domperidone (for nausea or vomiting) or cholestyramine (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 Panadol 500 mg capsules at the same time as anticoagulants. If you take flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

You can eat and drink normally while taking paracetamol. Do not drink alcohol whilst taking Panadol 500 mg capsules. With chronic alcohol abuse, the dose of paracetamol may not be higher than 2 grams (4 capsules) a day.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Panadol 500 mg capsules can be used during pregnancy if necessary. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Breast-feeding

Although paracetamol is excreted in small quantities in the maternal milk, it does not have any adverse effect on children who are breastfed. Paracetamol can be used in the recommended dose for a short time by women who breastfeed.

As far as is known, paracetamol does not have any effect on the ability to drive or use machines.

This medicine contains 108 mg sorbitol liquid in each soft capsule. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

This medicine contains 20 mg propylene glycol in each soft capsule.

The capsules should be swallowed whole with a glass of water.

You should take the lowest possible dose and take it for the shortest time possible.

• Do not take more frequently than every 4 hours.
• Do not exceed the recommended dose. This could lead to damage to the liver (see section 4).
• Do not use in combination with other paracetamol-containing products.
• If the symptoms of pain and/or fever recur, administration can be repeated on the basis of the stated dosage regimen.
• If pain lasts for longer than 5 days or fever lasts for longer than 3 days or these symptoms become worse a doctor must be consulted.

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, talk to your doctor.

Do not take a double dose to make up for a forgotten dose. Continue your regular dosing schedule.

If you suddenly stop taking Panadol 500 mg capsules, nothing in particular will occur.

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.

The active substance is paracetamol. One capsule contains 500 mg paracetamol.

The other ingredients are macrogol 400, purified water, propylene glycol and silica (colloidal anhydrous).

Capsule shell: Gelatin, sorbitol (liquid, partially dehydrated), purified water, titanium dioxide (E171).

Panadol 500 mg capsules are white, oval shape soft gelatin capsules.

Panadol 500 mg capsules are supplied in a PVDC/PVC-Alu/PET blister in a carton box. Each pack contains 8, 10, 12 or 16 capsules.

Not all pack sizes may be marketed.

The marketing authorisation holder is

and all enquiries should be sent to this address.

The manufacturer is