Paracetamol 1000 Mg Tablets
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PARACETAMOL 1000 MG TABLETS Paracetamol
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Paracetamol 1000 mg Tablets are and what they are used for
2. Before you take Paracetamol 1000 mg Tablets
3. How to take Paracetamol 1000 mg Tablets
4. Possible side effects
5. How to store Paracetamol 1000 mg Tablets
6. Further information
1. WHAT PARACETAMOL 1000 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Paracetamol 1000 mg Tablets contain paracetamol. Paracetamol belongs to a group of medicines called analgesics (painkillers) which also help to reduce your temperature when you have a fever. Paracetamol 1000 mg Tablets provide relief from pain (such as headaches, migraine, toothache, backache, muscle pain, rheumatic (joint) pain, sore throats and period pain). Paracetamol 1000 mg Tablets are also used to lower fever. Paracetamol 1000 mg Tablets should only be used by adults and adolescents aged 16 years and over, whose body weight is greater than 50 kg.
2. BEFORE YOU TAKE PARACETAMOL 1000 MG TABLETS Do not take Paracetamol 1000 mg Tablets if you:
• are allergic (hypersensitive) to paracetamol or any of the other ingredients of this medicine (listed in Section 6: Further information)
• are under 16 years old
• have a body weight of less than 50 Kg.
Do not take Paracetamol 1000 mg Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Paracetamol 1000 mg Tablets.
Take special care with Paracetamol 1000 mg Tablets
Talk to your doctor or pharmacist before taking Paracetamol 1000 mg Tablets if:
• you have moderate to severe kidney or liver problems, including acute hepatitis or liver problems caused by excessive alcohol consumption
• you have a condition called Gilbert’s syndrome which can cause yellowing of the skin or whites of the eyes (mild jaundice)
• you are taking other medicinal products which affect your liver
• you have a hereditary enzyme disorder called glucose-6-phosphate dehydrogenase deficiency
• you have a blood disorder called haemolytic anaemia which causes a reduced number of red blood cells, pale yellow skin and weakness or breathlessness
• you are suffering from dehydration or nutritional problems (chronic malnutrition)
• you have an addiction to alcohol
• you are already taking any other products that contain paracetamol. If this applies to you then do not take Paracetamol 1000 mg Tablets without first speaking to your doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular it is important to tell your doctor or pharmacist if you are taking any of the following medicines:
• medicines used to thin the blood such as warfarin as paracetamol may increase their effect
• medicines used to stop you feeling sick (nausea) or vomiting (e.g. metoclopramide or domperidone)
• products containing codeine (used to help suppress coughs and relieve pain)
• medicines used to treat high cholesterol (e.g. cholestyramine)
• the antibiotic chloramphenicol (used to treat infections)
• probenecid (a medicine used to treat high levels of uric acid in the blood stream i.e. gout)
• medicine used to treat fever or mild pain (e.g. salicylamide)
• any medicines that might affect your liver function. Examples of which include: cimetidine (used to treat stomach acid), isoniazid (used to treat tuberculosis), zidovudine (used to treat HIV), antiepileptic medicines used to treat convulsions (such as phenobarbital, carbamazepine, phenytoin, primidone and glutethimide), St John’s Wort (a herbal remedy) and rifampicin (used to treat infections). Always check the leaflet that comes with your other medicine.
Do not take Paracetamol 1000 mg Tablets if you are taking any other medicines containing paracetamol.
This includes some other painkillers, cough and cold remedies. This also includes a wide range of other medicines available on prescription and over the counter.
Taking Paracetamol 1000 mg Tablets with food and drink
You should not drink alcohol whilst taking these tablets. Taking Paracetamol 1000 mg Tablets with alcohol can increase your chances of getting side effects.
Paracetamol 1000 mg Tablets can be taken with or without food.
Pregnancy and breast-feeding
Although there is no evidence that paracetamol causes any ill effects, talk to your doctor or pharmacist before taking these tablets if:
• you are pregnant, think you may be pregnant or are planning to get pregnant
• you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Paracetamol 1000 mg Tablets have not been shown to affect your ability to drive or operate machinery.
3. HOW TO TAKE PARACETAMOL 1000 MG TABLETS
Always take Paracetamol 1000mg Tablets exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Do not take more than the recommended dose. If symptoms persist consult your doctor.
Adults and adolescents (16 years of age and over) weighing more than 50 kg
• One tablet to be taken 4 times a day as required.
• Swallow the tablets whole with a drink of water.
• Wait at least 4-6 hours before taking another dose.
• Do not take more than the maximum daily dose of 4 tablets in any 24-hour period.
Do not exceed the stated dose.
Children under 16 years of age
Paracetamol 1000 mg Tablets should not be given to children under 16 years of age.
Kidney problems
In moderate kidney problems: the usual dose is 500 mg (half a tablet) repeated every 6 hours.
In severe kidney problems: the usual dose is 500 mg (half a tablet) repeated every 8 hours.
Liver problems
In case of problems with your liver please consult your doctor. A dose of 2000 mg (2 tablets) per day should not be exceeded.
Paracetamol 1000 mg Tablets are suitable for patients with kidney and liver problems where a reduced dose is required, because the tablets can be divided into equal doses.
Reduced daily dose
A dose of 2000 mg (2 tablets) per day should not be exceeded in the following situations:
• if you have mild to moderate liver problems
• if you have a condition called Gilbert’s syndrome which can cause yellowing of the skin or whites of the eyes (mild jaundice)
• if you are dehydrated
• if you have nutrition problems (chronic malnutrition)
• if you are addicted to alcohol (chronic alcoholism).
If you take more Paracetamol 1000 mg Tablets than you should
Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver damage. It is important to contact your doctor even if you feel well.
Contact your nearest hospital emergency department or tell your doctor immediately and say exactly how much you have taken. Your doctor will advise you what to do.
Remember to take the pack and any remaining tablets with you. This is so the doctor knows what you have taken.
Symptoms of paracetamol overdose in the first 24 hours are paleness of the skin, feeling sick (nausea), vomiting, lack of appetite, and abdominal pain. Liver damage may become apparent 12 to 48 hours after taking paracetamol.
If you forget to take Paracetamol 1000 mg Tablets
If you forget to take a dose at the right time, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. You must allow at least 4-6 hours between doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol 1000 mg Tablets can cause side effects, although not everybody gets them. The frequency of these side effects is not known but experience indicates that side effects with paracetamol are rare and serious reactions are very rare.
Stop taking Paracetamol 1000 mg Tablets and see a doctor or go to a hospital straight away if:
• you experience a serious allergic reaction (anaphylaxis) such as swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
• you have serious illness with blistering of the skin, mouth, eyes and genitals or an itchy, lumpy skin rash.
The following side effects have also been reported. If you experience any of the following please tell your doctor or pharmacist:
• blood problems (such as agranulocytosis or thrombocytopenia), increased risk of bleeding, bruising more easily than usual or getting more infections than usual
• difficulty in breathing or wheezing (particularly if you have asthma and are allergic to aspirin or anti-inflammatory medicines (NSAIDs))
• liver problems.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PARACETAMOL 1000 MG TABLETS Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. FURTHER INFORMATION What Paracetamol 1000 mg Tablets contain
• The active substance of Paracetamol 1000 mg Tablets is paracetamol. Each tablet contains 1000 mg of paracetamol.
• The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, povidone K90, magnesium stearate and silicone dioxide.
What Paracetamol 1000 mg Tablets look like and contents of the pack
The tablets are white to slightly yellow, oblong with smooth surface and a central score line. The score line allows the tablet to be divided into equal doses.
Paracetamol 1000 mg Tablets come in blister-packs of 6, 8, 12 or 16 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A Viale Amelia 70 00181 Roma Italy
Manufacturer:
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona
Italy
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Paracetamol 1000 mg Tablets AT: Tachipirin 1000 mg Tabletten BG: Tachipirin 1000 mg TabneTKa CZ: Paracetamol Angelini 1000 mg, tablety EL: Noalga 1000 mg Sroria HU: Tachipirin 1000 mg Tabletta IE: Paracetamol Max 1000 mg Tablets PL: Codipar 1000
RO: Tachipirin 1000 mg Comprimate SK: Tachipirin 1000 mg Tablety