Paracetamol Tablets 500mg
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL 500 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist 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.
- You must talk to a doctor if you do not feel
l better or if you feel worse after 3 days. j
1. What Paracetamol is and what it is used for
2. What you need to know before you take Paracetamol
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other information
Paracetamol belongs to groups of medicines known as analgesics and antipyretics. It works by relieving pain and reducing body temperature in cases of fever. Paracetamol Tablets are used to relieve mild to moderate pain including headache, migraine, toothache, backache, period pain and muscle and rheumatic pain.
They can also be used to relieve the symptoms of colds and flu (sore throat, fever, aches and pains), as well as relieve the pain due to mild arthritis.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol if you:
• have kidney problems
• have liver problems, particularly those due to drinking too much alcohol
• suffer from mild arthritis and need to take painkillers everyday
Other medicines and Paracetamol Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines bought without a prescription. This is because Paracetamol can affect the way some medicines work. Also, some medicines can affect the way Paracetamol works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• medicines to treat epilepsy such as phenobarbital
• doxorubicin, used in the treatment of cancer
• aspirin, used to treat pain, inflammation or fever
• metoclopramide or domperidone, for nausea (feeling sick) or vomiting (being sick)
• cholestyramine, to reduce blood cholesterol levels
• warfarin and other coumarins, used to thin the blood and prevent clots from forming
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Paracetamol.
Paracetamol with food and drink
You should avoid alcohol whilst taking Paracetamol, as it can increase the risk of the side effects.
Pregnancy and breast-feeding
Talk to you doctor or pharmacist before taking Paracetamol if you are pregnant. You can take this medicine whilst breast feeding.
Driving and using machines
This medicine should not affect your ability to drive or operate machines.
Do not take Paracetamol if you:
• are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6 of this leaflet)
• are taking other paracetamol-containing products If you are not sure, check with your doctor or pharmacist before taking Paracetamol.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
When taking this medicine
• Do not exceed the recommended dose
• Do not take with other paracetamol-containing products
• If your symptoms persist for more than three days, you should consult your doctor
• Swallow the tablets with a drink of water
The recommended dose is:
Adults (including the elderly):
Take 2 tablets up to 4 times a day, as required. Wait at least 4 hours between doses. Do not take more than 8 tablets in any 24 hour period.
Children aged 10 - 15 years:
One tablet to be taken every 4-6 hours, when necessary, up to a maximum of 4 tablets in any 24-hour period.
Children under 10 years:
Paracetamol 500 mg Tablets is not recommended for use in children under 10 years of age. A liquid form of this medicine may be more suitable for use in children of this age.
If you take more Paracetamol than you should
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Symptoms of an overdose may include paleness, nausea, vomiting, loss of appetite and abdominal pains. Consult a doctor or go to the nearest hospital casualty department straight away. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.
If you forget to take Paracetamol
Take the next dose when needed. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
• loss of appetite, abdominal discomfort, dark urine, or yellowing of the eyes and skin. These may be signs of changes to your liver.
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. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package, in a dry place and protect from light.
Do not use this medicine after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING this medicine and see a doctor or go to a hospital straight away if you notice any of the following side effects:
• an allergic reaction, the symptoms of which may include skin rash, itching, blistering or peeling of the skin, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, sudden wheezing or collapse.
If you get any of the following side effects, stop taking this medicine and talk to your doctor as soon as possible:
• unexplained bruising or bleeding, red-purple spots of discolouration on the skin, sore throats or infections. These may be signs of changes to your blood cells.
• skin rash or peeling, or mouth ulcers
• breathing problems. This is more likely if you suffer from asthma and have experienced similar problems before when taking painkillers such as aspirin or ibuprofen.
What Paracetamol tablets contain
The active ingredient in the tablets (the ingredient which makes this medicine work) is paracetamol. Each tablet contains 500 mg of paracetamol.
The tablets also contain povidone K30, pregelatinised starch (starch 1500), magnesium stearate and stearic acid.
What Paracetamol tablets look like and contents of the pack
Paracetamol tablets are capsule shaped, white, scored tablets, which come in blister packs of 28 and 32 tablets. The score line is not intended for breaking the tablet. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor,
Nicosia, P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 09/2016.
CL0088/P/PIL/CL6