Changee of MAH address

Change of MAH address

Film-coated tablet

White film coated capsule-shaped tablet with flat edges marked 'Hedex' on both sides and a break line on one side. The break line is only to facilitate breaking for ease of swallowing only and do not divide into equal doses.



6.1 List of excipients

10 Date of Revision of the text
April- August 2017

Update to the MAH address (section 7) to:
Chefaro Ireland DAC, Treasury Building

Lower Grand Canal Street Dublin 2,

Ireland

4.1  Posology and method of administration

 

Oral administration only.

Adults (including the elderly):

2 tablets repeated if necessary 3-4 times a day to a maximum of 8 tablets in any 24 hour period.

Paediatric population

Children 6-12 years:

The usual dose is 1 tablet repeated if necessary 3-4 times a day to maximum of 4 tablets in any 24 hour period. Hedex tablets are not suitable for children under 6 years of age.

These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period.

 

Maximum duration of continued use without medical advice: 3 days.

 

 

4.2  Contraindications

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use in children under 6 years of age.

 

4.3  Special warnings and precautions for use

 

Hepatic impairment

Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with renal or hepatic impairment should seek medical advice prior to treatment with paracetamol. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

 

Do not exceed the stated dose.

 

Patients should be advised not to take other paracetamol-containing products concurrently. If symptoms persist, consult your doctor.

 

Keep out of the sight and reach of children.

 

Consult your doctor if you are taking warfarin or have been diagnosed with liver or kidney disease.

 

4.4   Interaction with other medicinal products and other forms of interaction

 

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone.  The rate of paracetemol absorption may be reduced by colestyramine. Colestyramine should not be administered within one hour of taking paracetamol. 

 

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

 

In case of concomitant treatment with probenecid, the dose of paracetemol should be reduced because the probenecid reduces the clearance of paracetemol by 50% because it prevents the conjugation of paracetamol with glucuronic acid.

 

There is limited evidence to suggesting that paracetamol may affect cholaramphenicol pharmacokinetics but its validity has been criticised and evidence of a clinically relevant interaction appears to lack. Although no routine monitoring needed, it is important to bear in mind this potential interaction when these two medications are concomitantly administered, especially in malnourished patients.

 

 

4.5  Fertility, pregnancy and lactation

 

Pregnancy

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.

 

Breast-feeding

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

 

Fertility

There are no available data on the effect of paracetamol on fertility.

 

4.6  Effects on ability to drive and use machines

 

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

 

4.7  Undesirable effects

 

Adverse events associated with paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency. Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000),  not known (cannot be estimated from the available data).

 

Immune system disorders	Allergies (not including angioedema)	Rare
Skin and subcutaneous tissue disorders	Cutaneous hypersensitivity reactions, including skin rashes, pruritus, sweating, purpura, urticaria and angioedema.	Very rare
	TOXIC EPIDERMAL NECROLYSIS (TEN), DRUG-INDUCED DERMATITIS, Stevens Johnson syndrome. Anaphylaxis.	Very rare
Haematological system disorders	Thrombocytopaenia	Very rare
Respiratory system disorders	Aggravation of bronchospasm has been reported in asthmatic patients known to be sensitive to aspirin and other non-steroidal anti-inflammatory drugs	Very rare
Hepatobiliary disorders	Liver dysfunction	Very rare
Renal and urinary disorders	Sterile pyuria (cloudy urine)	Very rare

 

 

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

 

4.8  Overdose

 

Symptoms of paracetamol overdose 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 sever poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

 

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required.

General supportive measures must be available.

 

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

4.1  Special precautions for disposal

 

No special requirements.


10 DATE OF REVISION OF THE TEXT

 

November 2015

Chefaro Ireland Limited First Floor

Block A

The Crescent Building Northwood Office Park

Dublin 9 Ireland

Section 8 Marketing authoriastion number changed to PA 1186/009/001

Section 10 Revisions date changed to January 2013

Section 4.4                 

Caution is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. Underlying liver disease increases the risk of paracetamol-related liver damage. Patients with renal or hepatic impairment should seek medical advice prior to treatment with paracetamol. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

Patients should be advised not to take other paracetamol-containing products concurrently.

If symptoms persist consult your doctor.

Keep out of the reach and sight of children.

Consult your doctor if you are taking warfarin or have been diagnosed with liver or kidney disease.

Section 4.8

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

Adverse events associated with paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labeled dose and considered attributable are tabulated below by System Organ Class and frequency.  Frequencies are defined as: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports.

Immune system disorders

Very rare (< 1/10,000) Cutaneous hypersensitivity reactions, including skin rashes, angioedema and Stevens Johnson syndrome. Anaphylaxis.

Haematological system disorders

Very rare (<1/10,000) thrombocytopaenia

Respiratory system disorders

Very rare (<1/10,000) aggravation of bronchospasm has been reported in asthmatic patients known to be sensitive to aspirin and other non-steroidal anti-inflammatory drugs

Hepatobiliary disorders

Very rare (<1/10,000) Liver dysfunction

Section 5.1

ATC Code :  N02BE01

Paracetamol is an analgesic and antipyretic.  Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system

Section 1:         Hedex 500mg Film-coated Tablets

Section 2:         Each tablet contains paracetamol 500mg.

                         For a full list of excipients, see section 6.1.

Section 6.5:      Opaque PVC/aluminium foil blister strips packed into cardboard boxes                         containing 12, 16, 24 or 40 tablets.

                        Not all pack sizes may be marketed.

Section 9:         Date of last renewal: 20 August 2007

Section 10:       November 2008

Section 3 The first sentence was changed to say "Film-coated tablet".

Section 4.9 Changed to the following:

Symptoms of paracetamol overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required.      General supportive measures must be available.

Section 10 the date of revision of the text was changed to say January 2005.