Paracetamol BP 125mg/5ml Oral Suspension Taj Pharma

Name of the medicinal product

Paracetamol BP 120mg/5ml Oral Suspension Taj Pharma
Paracetamol BP 125mg/5ml Oral Suspension Taj Pharma

Qualitative and quantitative composition

a) Paracetamol BP 120mg/5ml Oral Suspension Taj Pharma
Each 5ml contains:
Paracetamol BP 120mg
Excipients: Q.S.

b) Paracetamol BP 125mg/5ml Oral Suspension Taj Pharma
Each 5ml contains:
Paracetamol BP 125mg
Excipients: Q.S.
For more excipients see 6.1

Pharmaceutical form

Oral Suspension.

Clinical particulars
- Therapeutic indications

For the treatment of mild to moderate pain and as an anti-pyretic. Used for the relief of pain and feverishness associated with teething, toothache, headache, colds, flu and post-immunisation pyrexia.

Posology and method of administration

Children aged 3 months – 12years :

Child’s Age	How Much	How often (in 24 hours)
3 – 6 months	2.5ml	4 times
6 – 24 months	5ml	4 times
2 – 4 years	7.5ml (5ml+ 2.5ml)	4 times
4 – 8 years	10ml (5ml+ 5ml)	4 times
8 – 10 years	15ml (5ml +5ml+5ml)	4 times
10 – 12 years	20ml(5ml+5ml +5ml+5ml)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist
Babies over 2 months in age For the relief of fever after vaccination at 2, 3 and 4 months 2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

` It is important to shake the bottle for at least 10 seconds before use.

Contraindications

Hypersensitivity to Paracetamol or any of the other constituents.

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.

The label should contain the following statements:

Contains paracetamol.
Do not give this medicine with any other paracetamol-containing product.
For oral use only.
Never give more medicine than shown in the table.
Do not overfill the spoon.
Always use the spoon supplied with the pack.
Do not give more than 4 doses in any 24 hour period.
Leave at least 4 hours between doses.
Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist.
If your baby still needs this medicine two days after receiving the vaccine talk to you doctor or pharmacist. (leaflet).
As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product.
Do not store above 25°C. Store in the original package.
Keep all medicines out of the sight and reach of children
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well (label).
Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage. (Leaflet)

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interaction with other medicinal products and other forms of interaction

Drugs which induce hepatic microsomal enzymes such as alcohol. Concomitant barbiturates and tricyclic antidepressants may increase the hepatoxicity of Paracetamol particularly after overdose. Anti-convulsant or oral steroid contraceptives have the ability to reduce serum levels of Paracetamol by liver enzyme induction. The speed of absorption of Paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anti-coagulant 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.

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 their doctor regarding its use. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

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

Effects on ability to drive and use machines
Undesirable effects

Very rare cases of serious skin reactions have been reported. Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causually related to Paracetamol. With prolonged use or overdosage, hepatic necrosis, acute pancreatitis and nephrotoxicity have been reported.

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. Overdose

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

Risk Factors

If the patient:

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 one 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. The effectiveness of the antidote declines sharply after this time. 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 h from ingestion should be discussed with the NPIS or a liver unit.

Pharmacological properties

Pharmacodynamic properties

Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependent on the inhibition of prostaglandin synthesis. This inhibition appears, however, to be on a selective basis.

Pharmacokinetic properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the half-life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no Paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

Pharmaceutical particulars

List of excipients

Ethanol 96%, Sorbitan Monooleate, Glycerol Magnesium Aluminium Silicate, Liquid Maltitol, Saccharin Sodium, Xanthan Gum, Cherry Flavour, Sodium Benzoate, Citric Acid (monohydrate), Polysorbate 80, Purified water

Incompatibilities

None known.

Shelf life

Amber glass bottles – 5 years
High density polyethylene – 5 years.

Special precautions for storage

Do not store above 25°C. Store in the original container. Keep container in the outer carton.

Nature and contents of container

Pack sizes: 70ml, 100ml, 150ml, 200ml and 500ml
High density polyethylene bottles with tamper evident plastic cap.

Pack sizes: 500ml and 1 Litre

Special precautions for disposal and other handling
As for all medicines
no special requirements.

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

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4
You must talk to your doctor if you do not feel better or if you feel worse after 3 days.

What is in this leaflet:

What Paracetamol Oral Suspension is and what it is used for
What you need to know before you use Paracetamol Oral Suspension
How to use Paracetamol Oral Suspension
Possible side effects
How to store Paracetamol Oral Suspension
Contents of the pack and other information
WHAT PARACETAMOL ORAL SUSPENSION IS AND WHAT IT IS USED FOR

Paracetamol 120mg/5ml Oral Suspension (“Paracetamol Oral Suspension”) contains paracetamol to relieve pain and reduce high temperatures. Paracetamol Oral Suspension can be used in babies and children for the treatment of pain and feverishness associated with teething, toothache, headache, colds and flu. It can also be used in babies who develop fever after vaccination.

WHAT YOU NEED TO KNOW BEFORE YOU USE PARACETAMOL ORAL SUSPENSION

DO NOT give Paracetamol Oral Suspension if your child is taking any other paracetamol-containing products, other flu, cold, cough or decongestant products.

DO NOT give Paracetamol Oral Suspension to your child if he/she:

is allergic (hypersensitive) to paracetamol, or any of the other ingredients of Paracetamol Oral Suspension (see Section 6 and end of Section 2).
has kidney or liver problems

If you are not sure about any of the above, please consult your doctor.

Warnings and precautions

If your child does not get better, talk to your doctor.

Other medicines and Paracetamol Oral Suspension

Tell your doctor or pharmacist if your child is taking, or has recently taken, any other medicine, even those obtained without a prescription, but especially medicines which:

are to treat ‘flu’ or a cold, containing paracetamol and/or a decongestant
thin the blood (e.g. warfarin)
control nausea and vomiting (e.g. domperidone or metoclopramide)
reduce levels of cholesterol and other fats in the blood (e.g. colestyramine)
treat epilepsy (e.g. anti-convulsants)
have been prescribed by your doctor to improve sleep (e.g. barbiturates), or for anxiety or depression (e.g. tricyclic antidepressants).

The effects of alcohol may be increased whilst taking Paracetamol Oral Suspension.

Avoid alcohol while taking this medicine.

Pregnancy and breast-feeding

This medicine is intended for use in children. If necessary, Paracetamol Oral Suspension can be used during pregnancy. Ask your doctor or pharmacist for advice before taking any medicines during pregnancy or breast-feeding. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Driving and using machines

This medicine is intended for use in children. However, it should be noted that Paracetamol Oral Suspension is not expected to affect ability to drive or operate machinery.

Important information about some of the ingredients of Paracetamol Oral Suspension

Paracetamol Suspension contains:

Ethanol: This medicinal product contains small quantities of ethanol (alcohol), less than 100mg per 5ml. (It contains up to 0.08 g of ethanol (alcohol) per 5ml dose, equivalent to less than 2ml beer or 1ml wine per 5ml dose).
Liquid Maltitol Syrup: if your child has an intolerance to some sugars including fructose, contact your doctor before giving this medicine.

HOW TO USE PARACETAMOL ORAL SUSPENSION

Check the tables overleaf to see how much of the medicine to use

For oral use only
It is important to shake the bottle for at least 10 seconds before use
Never give more medicine than shown in the table
Do not overfill the spoon
Always use the spoon supplied with the pack
Do not give anything else containing paracetamol while giving this medicine

For the relief of fever after vaccination at 2, 3 and 4 months 2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.

Children aged 3 months – 12 years:

Child’s Age	How Much	How often (in 24 hours)
3 – 6 months	2.5ml	4 times
6 – 24 months	5ml	4 times
2 – 4 years	7.5ml (5ml + 2.5ml)	4 times
4 – 8 years	10ml (5ml + 5ml)	4 times
8 – 10 years	15ml (5ml + 5ml + 5ml)	4 times
10 – 12 years	20ml (5ml + 5ml + 5ml + 5ml)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without • speaking to your doctor or pharmacist • • If you do not get better, talk to your doctor.

If your child takes more of this medicine than they should:
Talk to a doctor at once if your child takes too much of this medicine even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage.

If you forget to give this medicine:

If you miss a dose give it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the missed dose.

POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol Oral Suspension can cause side effects although not everybody gets them. You or your child may notice the following:

Rash, itchy skin, swelling of the lips, eyes, tongue, or difficulty in breathing, which may be signs of an allergic reaction. STOP giving Paracetamol Oral Suspension to your child immediately.
blood disorders

Very rare cases of serious skin reactions have been reported.

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. By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE PARACETAMOL ORAL SUSPENSION

Keep this medicine out of sight and reach of children.

Do not store above 25˚C. Store in the original container. Keep the container in the outer carton. Do not use this medicine after the expiry date which is stated on the label and/or carton. 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Paracetamol Oral Suspension contains

Each 5ml of Paracetamol Oral Suspension contains:

The active ingredient: paracetamol 120mg.
The other ingredients are: ethanol, sorbitan monooleate, glycerol, magnesium aluminium silicate, liquid maltitol syrup, saccharin sodium, xanthan gum, cherry flavour, sodium benzoate, citric acid monohydrate, polysorbate 80 and purified water (see end of Section 2 for further information).

What Paracetamol Oral Suspension looks like and contents of the pack:

Paracetamol Oral Suspension is presented in 70ml, 100ml, 150ml and 200ml. A 2.5ml/5ml measuring spoon is provided. This medicinal product is a colour free and sugar free product.

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