Pacipayn 500 mg Tablets

Each PACIPAYN tablets contains the active substance paracetamol. Paracetamol belongs to analgesic and antipyretic; Paracetamol acts predominantly by inhibiting prostaglandin synthesis. PACIPAYN used to relieve mild to moderate pain and fever.

Do not take PACIPAYN

• if you are hypersensitive (allergic) to paracetamol or any of the other ingredients of PACIPAYN (listed in section 6).
• if you have severe renal (kidney) problems
• if you have severe liver problems.

Warnings and precautions

Take special care with PACIPAYN and tell you doctor:

• If you are suffering from liver or kidney disease.
• Do not use continuously for longer than ten (10 days) without consulting your doctor.
• DO NOT EXCEED THE RECOMMENDED DOSAGE. Dosages in excess of those recommended may cause sever liver damage. Consult your doctor if no relief is obtained with the recommended dosage.
• PACIPAYN contains FD & C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin sensitivity.
• Susceptibility to paracetamol toxicity is increased:
• in patients who have taken repeated high doses (greater than 5 - 10 g/day) of paracetamol for several days,
• in patients with chronic alcoholism,
• in patients with chronic liver disease,
• in patients with AIDs,
• in patients with malnutrition,
• in patients using medicine that induce liver microsomal oxidation (see “ Taking other medicine with PACIPAYN ”),
• PACIPAYN contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in patients receiving paracetamol. If you experience any signs of serious skin reactions such as swelling, itching, red severe rash, stop using PACIPAYN immediately and contact your doctor.

Other medicines and PACIPAYN

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Do not take PACIPAYN with any other medicine that contains paracetamol. Tell your doctor if you are taking:

• Metoclopramide or domperidone (medicines used for nausea and/or vomiting)
• Probenecid (medicine used for gout)
• Colestyramine (medicine used to reduce blood fat levels)
• Aspirin (medicine for pain, inflammation and fever)
• Warfarin and other anti-blood clotting medicine or anticoagulants (medicines for prevention of blood clots)
• Isoniazid (antibiotic medicine used to treat tuberculosis).

Pregnancy and breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking PACIPAYN.

Driving and using machines

PACIPAYN has no or negligible influence on the ability to drive and use machines.

Do not share medicines prescribed for you with any other person. Always take PACIPAYN 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. Do not exceed the recommended dose (see “Take special care with PACIPAYN Tablets”).

The usual adult dosage: One to two tablets (0,5 to 1 g) with a glass of water every 4 - 6 hours up to a maximum of 4 g daily (8 tablets)

Usual paediatric dose (children 6 - 12 years of age): 250 - 500 mg (half to one tablet) with a glass of water three to four times a day as required. Children under 6 years of age: Not suitable.

PACIPAYN is usually only used for short periods of time. Use PACIPAYN only when simple measures have failed to provide adequate relief. Don’t use for more than 10 (ten) days without consulting your doctor (see “ Taking special care with PACIPAYN ”).

If you take more PACIPAYN than you should

If you take more PACIPAYN than you should consult your doctor or pharmacist. If neither is available seek help at the nearest hospital or poison control centre. A delay in starting treatment may mean that an antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed. Symptoms of paracetamol overdosage in the first 24 hours include:

• paleness
• nausea
• anorexia (eating disorder - weight loss)
• possible abdominal pain.

Liver damage may become apparent 12 to 48 hours, or later after ingestion, and may lead to abnormal brain function (encephalopathy), coma and death.

Acute kidney failure with damage to the kidney tubular cells (acute tubular necrosis) may develop even in the absence of severe liver damage.

Abnormalities of glucose metabolism and too much acid in body fluids (metabolic acidosis) may occur.

Irregular heartbeat (cardiac arrhythmias) has been reported.

If you forget to take PACIPAYN: Take the missed dose as soon as you remember it. However, if it is almost time for your next regular dose, do not take your missed dose. If you miss two or more doses, consult your doctor or pharmacist. Do not take a double dose to make up for forgotten individual doses.

PACIPAYN can have side effects. Not all side effects reported for PACIPAYN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PACIPAYN, please consult your health care provider for advice.

If any of the following happens, stop taking PACIPAYN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• allergic reactions, including skin rashes

These are very serious side effects. If you have them, you may have had a serious reaction to PACIPAYN. You may need urgent medical attention or hospitalisation.

Less frequent side effects:

• feeling or being sick (nausea, vomiting), stomach pain or cramps, diarrhoea, loss of appetite.
• liver problems (toxicity and failure),
• gastrointestinal tract bleeding, inflammation of the pancreas (pancreatitis).
• convulsions, respiratory depression, cerebral swelling, coma.
• skin rashes and other allergic reactions. The skin rash is usually red or hives but it is sometimes more serious and may be accompanied by fever and mucosal lesions.
• blood disorders - changes in numbers and types of blood cells
• irregular heartbeat (cardiac arrhythmias).
• Acute kidney failure with acute damage to the kidney tubular cells (tubular necrosis).

Side effects with frequency unknown: The following adverse events have also been reported during postmarketing surveillance:

• Fixed drug eruptions (FDE), Drug-induced hypersensitivity syndrome (DIHS)).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 25 ºC. Store in the original package/container. Keep the container in the outer carton. Do not use after the expiry date stated on the carton/bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).