Paracetamol 500 mg Tablets TajP harma : Uses, Side Effects, I nteractions, Pi ctures, War nings, Para cetamol Dosag

e & Rx Info | Para cetamol Use s, Side Effects - Antipyretics, Paraceta mol : Indications, Side E ffe cts, War nings, Para cetamol - Drug I nformation - TajP harma, Paraceta mol dose Taj pharma ceuticals Paracetamol interactions, Taj P harma ceutical Para cetamol contraindi cations , Paraceta mol pri ce, ParacetamolTaj Phar ma Antipyretics Tablet s SmP C - TajP harma Stay conne cted to all updated on ParacetamolTaj Pharma ce uticals Taj pharma ceuticals Mumbai. Patient Infor mation Lea flets, SmP C.

Paracetamol Tablets BP 500mg 4.3 Contraindications

Hypersensitivity to paracetamol or any of the
constituents.
1. Name of the medicinal
product 4.4 Special warnings and precautions for use
Care is advised in the administration of
Paracetamol Tablets BP 500mg TajPharma paracetamol to patients with severe renal or
severe hepatic impairment. The hazards of
2. Qualitative and quantitative overdose are greater in those with non-cirrhotic
composition alcoholic liver disease.
Do not take more Paracetamol than the label
Each uncoated tablet contains:
tells you to. If you do not get better, talk to your
Paracetamol BP 500mg
doctor.
Excipients q.s.
Contains Paracetamol.
3. Pharmaceutical form
Do not take anything else containing
Tablet paracetamol while taking this Paracetamol.

4. Clinical particulars Talk to your doctor at once if you take too much
of this Paracetamol, even if you feel well. This is
4.1 Therapeutic indications because too much paracetamol can cause
For the treatment of mild to moderate pain delayed, serious liver damage.
including headache, migraine, neuralgia,
Patients should be advised that paracetamol may
toothache, sore throat, period pains, aches and
cause severe skin reactions. If a skin reaction
pains, symptomatic relief of rheumatic aches and
such as skin reddening, blisters, or rash occurs,
pains and of influenza, feverishness and feverish
they should stop use and seek medical assistance
colds.
right away.
4.2 Posology and method of administration
4.5 Interaction with other medicinal products
Adults, the elderly and young persons 16 years
and other forms of interaction
and over:
Cholestyramine: The speed of absorption of
2 tablets every 4 hours to a maximum of 8 paracetamol is reduced by cholestyramine.
tablets in 24 hours. Therefore, the cholestyramine should not be
taken within one hour if maximal analgesia is
Children 6 – 9 years: required.
½ tablet every 4 hours to a maximum of 4 doses Metoclopramide and Domperidone: The
in 24 hours. absorption of paracetamol is increased by
Children 10 – 11 years: metoclopramide and domperidone. However,
concurrent use need not be avoided.
1 tablet every 4 hours to a maximum of 4 doses
in 24 hours Warfarin: The anticoagulant effect of warfarin
and other coumarins may be enhanced by
Adolescents 12 – 15 years: prolonged regular use of paracetamol with
1 to 1 ½ tablets every 4 hours to a maximum of increased risk of bleeding; occasional doses
4 doses in 24 hours have no significant effect.

Do not give to children aged under 6 years of Chloramphenicol: Increased plasma

age. concentration of chloramphenicol.
 Paracetamol 500 mg Tablets TajP harma : Uses, Side Effects, I nteractions, Pi ctures, War nings, Para cetamol Dosag e & Rx Info | Para cetamol Use s, Side Effects - Antipyretics, Paraceta mol : Indications, Side E ffe cts, War nings, Para cetamol - Drug I nformation - TajP harma, Paraceta mol dose Taj pharma ceuticals Paracetamol interactions, Taj P harma ceutical Para cetamol contraindi cations , Paraceta mol pri ce, ParacetamolTaj Phar ma Antipyretics Tablet s SmP C - TajP harma Stay conne cted to all updated on ParacetamolTaj Pharma ce uticals Taj pharma ceuticals Mumbai. Patient Infor mation Lea flets, SmP C.

4.6 Pregnancy and lactation Or

Epidemiological studies in human pregnancy
have shown no ill effects due to paracetamol c) Is likely to be glutathione deplete e.g. eating
used in the recommended dosage, but patients disorders, cystic fibrosis, HIV infection,
starvation, cachexia.
should follow the advice of the doctor regarding
its use. Symptoms
Paracetamol is excreted in breast milk but not in Symptoms of paracetamoloverdosage in the first
a clinically significant amount. Available 24 hours are pallor, nausea, vomiting, anorexia
published data do not contraindicate breast and abdominal pain. Liver damage may become
feeding. apparent 12 to 48 hours after ingestion.
Abnormalities of glucose metabolism and
4.7 Effects on ability to drive and use
metabolic acidosis may occur. In severe
machines
None known. poisoning, hepatic failure may progress to
encephalopathy, haemorrhage, hypoglycaemia,
4.8 Undesirable effects cerebral oedema, and death. Acute renal failure
Adverse effects of paracetamol are rare. Very with acute tubular necrosis, strongly suggested
rare cases of serious skin reactions have been by loin pain, haematuria and proteinuria, may
reported. There have been reports of blood develop even in the absence of severe liver
dyscrasias including thrombocytopenia purpura, damage. Cardiac arrhythmias and pancreatitis
methaemoglobenaemia and agranulocytosis, but have been reported.
these were not necessarily causality related to
paracetamol. Management

Reporting of suspected adverse reactions Immediate treatment is essential in the

management of paracetamol overdose. Despite a
Reporting suspected adverse reactions after lack of significant early symptoms, patients
authorisation of the medicinal product is should be referred to hospital urgently for
important. It allows continued monitoring of the immediate medical attention. Symptoms may be
benefit/risk balance of the medicinal product. limited to nausea or vomiting and may not
reflect the severity of overdose or the risk of
4.9 Overdose organ damage. Management should be in
Liver damage is possible in adults who have accordance with established treatment
taken 10g or more of paracetamol. Ingestion of guidelines, see BNF overdose section.
5g or more of paracetamol may lead to liver
damage if the patient has risk factors (see Treatment with activated charcoal should be
below). considered if the overdose has been taken within
1 hour. Plasma paracetamol concentration
Risk Factors
should be measured at 4 hours or later after
If the patient ingestion (earlier concentrations are unreliable).
a) Is on long term treatment with Treatment with N-acetylcysteine may be used up
carbamazepine, phenobarbitone, phenytoin, to 24 hours after ingestion of
primidone, rifampicin, St John's Wort or other paracetamolhowever, the maximum protective
drugs that induce liver enzymes. effect is obtained up to 8 hours post ingestion.
Or If required the patient should be given
intravenous-N-acetylcysteine, in line with the
b) Regularly consumes ethanol in excess of established dosage schedule. If vomiting is not a
recommended amounts. problem, oral methionine may be a suitable
alternative for remote areas, outside hospital.
 Paracetamol 500 mg Tablets TajP harma : Uses, Side Effects, I nteractions, Pi ctures, War nings, Para cetamol Dosag e & Rx Info | Para cetamol Use s, Side Effects - Antipyretics, Paraceta mol : Indications, Side E ffe cts, War nings, Para cetamol - Drug I nformation - TajP harma, Paraceta mol dose Taj pharma ceuticals Paracetamol interactions, Taj P harma ceutical Para cetamol contraindi cations , Paraceta mol pri ce, ParacetamolTaj Phar ma Antipyretics Tablet s SmP C - TajP harma Stay conne cted to all updated on ParacetamolTaj Pharma ce uticals Taj pharma ceuticals Mumbai. Patient Infor mation Lea flets, SmP C.

Management of patients who present with glutathione may accumulate following

serious hepatic dysfunction beyond 24 hours paracetamoloverdosage and cause liver damage.
from ingestion should be discussed with the
NPIS or a liver unit. 5.3 Preclinical safety data
None stated
5. Pharmacological properties 6. Pharmaceutical particulars
5.1 Pharmacodynamic properties
Mechanisms of Action/Effect 6.1 List of excipients
Croscarmellose Sodium, Povidone,
Analgesic – the mechanism of analgesic action Pregelatinised Maize Starch, Hydroxypropyl
has not been fully determined. Paracetamol may Methylcellulose
act predominantly by inhibiting prostaglandin
Polyethylene Glycol.
synthesis in the central nervous system (CNS)
and to a lesser extent, through a peripheral 6.2 Incompatibilities
action by blocking pain-impulse generation. None known.
The peripheral action may also be due to 6.3 Shelf life
inhibition of prostaglandin synthesis or to 3 years.
inhibition of the synthesis or actions of other
substances that sensitise pain receptors to 6.4 Special precautions for storage
mechanical or chemical stimulation. Do not store above 25°C.

Antipyretic – paracetamol probably produces 6.5 Nature and contents of container

antipyresis by acting centrally on the Aluminium Blister Pack.
hypothalamic heat-regulation centre to produce Pack size: 7, 14, 28, 30, 50, 90, 100 and 500
peripheral vasodilation resulting in increased tablets.
blood flow through the skin, sweating and heat
loss. The central action probably involves Not all packs may be marketed.
inhibition of prostaglandin synthesis in the 6.6 Special precautions for disposal and other
hypothalamus. handling
5.2 Pharmacokinetic properties Not applicable.
Absorption and Fate 7. Manufactured In India By:
Paracetamol is readily absorbed from the gastro- TAJ PHARMACEUTICALS LTD.
intestinal tract with peak plasma concentrations Mumbai, India
occurring about 30 minutes to 2 hours after Unit No. 214.Old Bake House,
ingestion. It is metabolised in the liver and Maharashtra chambers of Commerce Lane,
excreted in the urine mainly as the glucuronide
and sulfate conjugates. Less than 5% is excreted Fort, Mumbai - 400001
as unchanged paracetamol. The elimination half- at:Gujarat, INDIA.
life varies from about 1 to 4 hours. Plasma- Customer Service and Product Inquiries:
protein binding is negligible at usual therapeutic 1-800-TRY-FIRST (1-800-222-434 & 1-800-
concentrations but increases with increasing 222-825)
concentrations. Monday through Saturday 9:00 a.m. to 7:00 p.m.
A minor hydroxylated metabolite which is EST
usually produced in very small amounts by E-mail: tajgroup@tajpharma.com
mixed-function oxidases in the liver and which
is usually detoxified by conjugation with liver