Patient leaflet - Paracetamol 500 mg capsules hard

1. What Paracetamol capsules are and what they are used for

The name of your medicine is Paracetamol 500 mg Capsules (called Paracetamol capsules throughout this leaflet). This medicine contains the active substance paracetamol. It belongs to a group of medicines called analgesics (painkillers) and is used for the treatment of headaches (including migraine and tension headaches), nerve pain, backache, muscle pain, joint pain, a sore throat and period pain. It is also used to lower a high temperature and relieve the symptoms of cold or flu.

2. What you need to know before you take Paracetamol capsules

Do not take Paracetamol capsules and tell your doctor

Ÿ If you are allergic to paracetamol or any of the other ingredients (listed in section 6). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue.

Children

Paracetamol 500 mg Capsules are not recommended for children under 12 years of age.

Do not take Paracetamol capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor before taking Paracetamol capsules

Ÿ if you have severe kidney or liver problems

Ÿ if you have a liver problem caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

During treatment with Paracetamol capsules, tell your doctor straight away:

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 capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because paracetamol can affect the way some other medicines work. Also, some other medicines can affect the way paracetamol works.

While taking Paracetamol capsules you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Please inform your doctor or pharmacist if you are taking:

Ÿ flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Tell your doctor if you are taking any other medicines:

Ÿ medicines used to thin the blood such as warfarin

Ÿ metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick (vomiting)

Ÿ colestyramine – for lowering blood cholesterol levels

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Paracetamol capsules.

Paracetamol capsules with alcohol

You should not drink alcohol whilst taking these capsules. Taking paracetamol with alcohol can increase your chances of getting side effects.

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 for advice before taking this medicine.

If necessary, Paracetamol capsules can be used during pregnancy however 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 or midwife if the pain and/or fever are not reduced or if you need to take the medicine more often.

Paracetamol capsules contain sodium

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

3. How to take Paracetamol capsules

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

Ÿ Do not take more than the recommended dose

Ÿ If you need to use this medicine for more than three days at a time, see your doctor.

Adults and children over 16 years

Ÿ The recommended dose is 2 capsules

Ÿ Swallow the capsules whole with a drink of water

Ÿ Wait at least 4 hours before taking another dose

Ÿ Do not take more than 4 doses in any 24-hour period

Use in children aged 12 to 15 years

Take one capsule every four to six hours when necessary up to a maximum of four capsules in 24 hours.

Use in children under 12 years

Paracetamol 500 mg Capsules should not be given to children under 12 years of age.

If you take more Paracetamol capsules than you should

Ÿ 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.

Ÿ Remember to take any remaining capsules and the pack with you. This is so the doctor knows what you have taken.

If you forget to take Paracetamol capsules

If you forget to take a dose at the right time, take it as soon as you remember. However, 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. The following side effects may happen with this medicine:

Stop taking Paracetamol capsules and see a doctor or go to a hospital straight away if:

Ÿ You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).

This may mean you are having an allergic reaction to paracetamol

Very rare cases of serious skin reactions have been reported.

Tell your doctor or pharmacist if any of the following side effects get serious or last longer than a few days:

Ÿ You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia). This side effect has only happened in a few people taking paracetamol.

Not known (frequency cannot be estimated from the available data) Ÿ 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 Website:

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 capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date which is stated on the pack. The expiry date refers to the last day of that month.

Store your medicine in the original packaging.

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 capsules contain

Ÿ The active substance is paracetamol. Each capsule contains 500 mg of paracetamol.

Ÿ The other ingredients are pregelatinised starch, magnesium stearate and sodium lauryl sulfate. The capsule shell is made of erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), gelatin and puriﬁed water.

What Paracetamol capsules look like and contents of the pack

Paracetamol capsules are red and white, hard, gelatin, size “0” capsules ﬁlled with a white to oﬀ-white blend.

Paracetamol capsules are available in child-resistant blister packs of 16 and 32 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, UK.

Manufacturer

Drugsrus Limited,