Paracetamol Dispersible Tablets 650mg B.P. Taj Pharma

  1. Name of the medicinal product

Paracetamol Dispersible Tablets 500mg B.P. Taj Pharma
Paracetamol Dispersible Tablets 650mg B.P. Taj Pharma
Paracetamol Dispersible Tablets 1000mg B.P. Taj Pharma

  1. Qualitative and quantitative composition

a)Paracetamol Dispersible Tablets 500mg B.P. Taj Pharma
Each uncoated tablet contains:
Paracetamol B.P.                           500mg
Excipients                                       q.s.

b)Paracetamol Dispersible Tablets 650mg B.P. Taj Pharma
Each uncoated tablet contains:
Paracetamol B.P.                           650mg
Excipients                                       q.s.

c)Paracetamol Dispersible Tablets 1000mg B.P. Taj Pharma
Each uncoated tablet contains:
Paracetamol B.P.                           1000mg
Excipients                                       q.s.

See section 6.1 for Full Excipients:

  1. Pharmaceutical form
    Uncoated Tablet
  1. Clinical particulars

4.1 Therapeutic indications

For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, feverishness and feverish colds.

4.2 Posology and method of administration

Adults, the elderly and young persons 16 years and over:
2 tablets every 4 hours to a maximum of 8 tablets in 24 hours.
Children 6 – 9 years:
½ tablet every 4 hours to a maximum of 4 doses in 24 hours.
Children 10 – 11 years:
1 tablet every 4 hours to a maximum of 4 doses in 24 hours
Adolescents 12 – 15 years:
1 to 1 ½ tablets every 4 hours to a maximum of 4 doses in 24 hours
Do not give to children aged under 6 years of age.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the constituents.

4.4 Special warnings and precautions for use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Do not take more Paracetamol than the label tells you to. If you do not get better, talk to your doctor.
Contains Paracetamol.
Do not take anything else containing paracetamol while taking this Paracetamol.
Talk to your doctor at once if you take too much of this Paracetamol, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Patients should be advised that paracetamol may cause severe skin reactions. If a skin reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical assistance right away.

4.5 Interaction with other medicinal products and other forms of interaction

Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required.

Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.

Warfarin: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chloramphenicol: Increased plasma concentration of chloramphenicol.

4.6 Pregnancy and lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, but these were not necessarily causality related to paracetamol.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

  1. a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
    Or

b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).

Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol however, the maximum protective effect is obtained up to 8 hours post ingestion.

If required the patient should be given intravenous-N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital.

Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Mechanisms of Action/Effect

Analgesic – the mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation.

The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Antipyretic – paracetamol probably produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

5.2 Pharmacokinetic properties

Absorption and Fate

Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage.

5.3 Preclinical safety data
None stated

  1. Pharmaceutical particulars

6.1 List of excipients

Croscarmellose Sodium, Povidone, Pregelatinised Maize Starch, Hydroxypropyl Methylcellulose
Polyethylene Glycol.

6.2 Incompatibilities

None known.

6.3 Shelf life
3 years.

6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container

Aluminium Blister Pack.
8, 12, 16, 32 tablets.
Not all packs may be Marketed.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Manufactured By:
Taj Pharmaceuticals Ltd. (Mumbai, India)
Unit No. 214, Old Bake House,
Maharashtra Chambers of commerce Lane,Fort,
Mumbai-400001 at: Ahmedabad- Gujarat, INDIA.

Paracetamol Dispersible Tablets B.P. 500mg/650mg/1000mg Taj Pharma

Patient Information Leaflet.

Read this leaflet carefully because it contains important information for you.

This Paracetamol is available without a prescription, for you to treat a mild illness without a doctor’s help. Nevertheless, you still need to use your Paracetamol carefully to get the best results. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve.

If any of the side effects get serious,orifyou notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:

  1. What your Paracetamol is and what it is used for
  2. Before you take your Paracetamol
  3. How to take your Paracetamol
  4. Posible side effects
  5. How to store Paracetamol
  6. Furthe information

What your Paracetamol is and what it is used for

Each tablet contains: 500 mg of Paracetamol.

Paracetamol works by relieving pain and reducing high temperature and fever. Your Paracetamol is for effective relief from: mild to moderate pain including headache, migraine, sharp nerve pain (neuralgia), toothache, sore throat, period pains, aches and pain, symptomatic relief of rheumatic aches and pains, influenza symptoms, feverishness and feverish colds.

  1. Before you take your Paracetamol

Please read the following information. Do not give to children under 6 years.
Do not take if you:

  • are taking any other products that contain paracetamol
  • are allergic to paracetamol or any of the other ingredients

Take special care and talk to a pharmacist or your doctor before taking this Paracetamol if you are:

  • suffering from liver or kidney disease (including alcoholic liver disease) or G-6-PD deficiency (an hereditary condition leading to low red blood cell counts).

Taking other Paracetamols

Do not use this Paracetamol if you are taking Paracetamols that reduce the clotting of the blood (e.g. warfarin).

Talk to your doctor or a pharmacist if you are taking some antibiotics (chloramphenicol), anti-sickness treatments (metoclopramide, domperidone), some treatments for diarrhoea caused by gall bladder disease, or lipid lowering drugs (cholestyramine).

  1. How to take your Paracetamol

For oral administration and short term use only

Dosage: Adults, the elderly and young persons aged 16 or over:

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. Take 2 tablets up to 4 times a day, as required. The tablets should be taken with water. Take only as much as you need to relieve your symptoms and leave at least 4 hours between each dose.

Do not take more than 8 tablets in 24 hours.
For children 6 to 9 years of age:
Give ½ a tablet with a drink of water, every 4 hours as required.
For children 10 to 11 years of age:
Give 1 tablet with a drink of water, every 4 hours as required.
For adolescents 12 to 15 years of age:
Give 1 to 1 ½ a tablet with a drink of water, every 4 hours as required.
For all children’s dosing, give only as much as you need to relieve symptoms and leave at least 4 hours between each dose.

Do not give more than 4 doses in 24 hours

  1. How to take your Paracetamol (continued)

Do not take with any other paracetamol-containing products.
Do not give to children under 6 years of age.
Do not exceed the stated dose.

If you take more tablets than you should:
Talk to a doctor at once if you take too much of this Paracetamol, even if you feel well.
This is because too much paracetamol can cause delayed, serious liver damage.
Bring any remaining Paracetamol with you to show the doctor.

  1. Possible Side effects:

If you experience any of the following serious effects STOP taking this Paracetamol immediately and contact your doctor or pharmacist:

  • Severe allergic reactions: difficulty breathing, skin rash, swollen facial features or a runny nose.
  • Very rare cases of serious skin reactions have been reported. Symptoms could include skin reddening, blisters or rash.

Other possible side effects

If any of the following side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist:

  • Occasionally the blood does not clot well, which may result in easy bruising or bleeding.
  • Rarely, a severe reduction in the number of white blood cells, which makes infections

more likely

  • Other rare side effects like shortness of breath.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

  1. How to store your Paracetamol
  • Do not use this Paracetamol after the expiry date shown on the end of the carton.
  • Do not store above 25ºC.
  • Keep out of sight and reach of children
  1. Further Information

What does this Paracetamol contain?

a)Paracetamol Dispersible Tablets 500mg B.P. Taj Pharma
Each uncoated tablet contains:
Paracetamol B.P.                           500mg
Excipients                                       q.s.

b)Paracetamol Dispersible Tablets 650mg B.P. Taj Pharma
Each uncoated tablet contains:
Paracetamol B.P.                           650mg
Excipients                                       q.s.

c)Paracetamol Dispersible Tablets 1000mg B.P. Taj Pharma
Each uncoated tablet contains:
Paracetamol B.P.                           1000mg
Excipients                                       q.s.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

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