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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 01/02/2012
SPC Orudis 50

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 01/02/2012 and displayed until Current
Reasons for adding or updating:
  • Removal of one or more presentations from joint SPC following discontinuation
Date of revision of text on the SPC:   11-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC retired by accident.
Updated on 24/06/2011 and displayed until 01/02/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
  • SPC Product / presentation discontinued
Date of revision of text on the SPC:   11-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3: Added the following:

Bronchospasm

Ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug.

Ketoprofen is also contraindicated in the third trimester of pregnancy.

History of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)

- haemorrhagic diathesis

 

Section 4.4: Added ‘Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine’ and ‘Patients with active or a past history of peptic ulcer.’

Updated warning on respiratory disorders to state ‘Patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have a higher risk of allergy to aspirin and/or NSAIDs than the rest of the population. Administration of this medicinal product can cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section 4.3).’

 

Other minor changes to wording

 

Section 4.5:

Amended section on lithium to state ‘Risk of elevation of lithium plasma levels, sometimes reaching toxic levels due to decreased lithium renal excretion. Where necessary, plasma lithium levels should be closely monitored and the lithium dosage levels adjusted during and after NSAIDs therapy.’

Amended section on antihypertensives to state ‘Antihypertensive agents (beta blockers, angiotensin converting enzyme inhibitors, diuretics): Risk of decreased antihypertensive potency (inhibition of vasodilator prostaglandins by NSAIDs)’

Added ‘particularly in elderly subjects’ to the ciclosporin and tacrolimus sections.

 

Sections 4.6 and 4.7 – Sections rewritten

 

Section 4.8 – rewritten to provide incidence classification

 

Section 4.9: Replaced existing paragraphs with the following information:

 

Cases of overdose have been reported with doses up to 2.5g of ketoprofen. In most instances, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain.

 

If renal failure is present, haemodialysis may be useful to remove circulating medicinal product.

 

There are no specific antidotes to ketoprofen overdosages. In cases of suspected massive overdosages, a gastric lavage is recommended and symptomatic and supportive treatment should be instituted to compensate for dehydration, to monitor urinary excretion and to correct acidosis, if present.
Updated on 22/09/2009 and displayed until 24/06/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   08-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.9

 

The following changes:

 

Symptoms

Like other propionic acid derivatives, ketoprofen is of low toxicity in overdosage. S; symptoms after acute ketoprofen intoxication are largely limited to drowsiness, abdominal pain and vomiting.  Headache, nausea, rarely diarrhoea, disorientation, excitation, coma, dizziness, tinnitus, fainting, occasionally convulsions may also occur.  A , but adverse effects seen after overdosage with propionic acid derivatives such as hypotension, bronchospasm and gastro-intestinal haemorrhage should be anticipated. 

 

In cases of significant poisoning, acute renal failure and liver damage are possible.

 

Therapeutic measures:

Gastric lavage and correction of severe electrolyte abnormalities may need to be considered.  Treatment is otherwise supportive and symptomatic.

Within one hour of ingestion, consideration should be given to administering activated charcoal. Alternatively, in adults, gastric lavage should be considered if the patient presents within 1 hour of ingesting a potentially toxic amount.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

Frequent or prolonged convulsions should be treated with intravenous diazepam.

The benefit of gastric decontamination is uncertain.

Other measures may be indicated by the patient’s clinical condition.

 

Section 4.2

 

Addition of: -

 

The maximum daily dose is 200mg.  The balance of risks and benefits should be carefully considered before commencing treatment with 200mg daily, and higher doses are not recommended (see also section 4.4).

 

Section 4.6

 

Following Changes: -

 

Pregnancy

No embryopathic effects have been demonstrated in animals. and there is epidemiological evidence of the safety of ketoprofen in human pregnancy. Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernable pattern. 

 

Nevertheless, iIt is recommended to avoid ketoprofen unless considered essential, in which case it should be discontinued within one week of expected confinement when NSAIDS might cause premature closure of the ductus arteriosus or persistent pulmonary hypertension in the neonate.  They may also delay labour. during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.


In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of premature closure of the ductus arteriosus), use in the last trimester of pregnancy is contra-indicated (see Section 4.3 - Contra-indications).  The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child.

 

Lactation
Trace amounts of ketoprofen are excreted in breast milk. In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. Avoid use of ketoprofen unless considered essential.

 

See Section 4.4 – Special warnings and precautions for use, regarding female fertility.

 

Section 4.7     

 

Following changes: -

 

CNS side effects have been observed in some patients (see section 4.8). Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected patients should not drive or operate machinery.

 

Section 4.8

 

Formatting changes

Updated on 28/04/2009 and displayed until 22/09/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3

Addition of the following contraindications; history of rhinitis, angioedema, urticaria, any other ingredients in this medicine. Contraindicated in active peptic ulcer or any history of gastrointestinal haemorrhage, ulceration or perforation.

Section 4.4

Sections added about nephrotoxicity, patients with abnormal liver function tests or with a history of liver disease, serious gastrointestinal toxicity, GI bleeding, ulceration or perforation and use with concomitant medications which could increase the risk of gastrotoxicity ulceration or bleeding.

Section 4.5

Section on Zidovudine added, anti-platelet agents added, use of 2 or more NSAIDs and Risk of reduced diuretic effect added.
Updated on 08/01/2009 and displayed until 28/04/2009
Reasons for adding or updating:
  • Joint SPC superseded by SPCs for individual presentations
Date of revision of text on the SPC:   01-Aug-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Joint SPC replaced by indivdual SPCs for the 2 strengths
Updated on 21/05/2008 and displayed until 08/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Aug-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 24/09/2007 and displayed until 21/05/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   08/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2 (Posology and method of administration): addition of the following paragraph:

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

 

Section 4.3 (Contraindications): Addition of the following text:

Severe heart failure

 

Section 4.4 (Special Warnings and precautions for use): addition of the following paragraphs:

Undesirable effects may be minimised by using the lowest effective dose for the shortest

duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks

below).

 

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

 

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen.

 

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

 

Section 4.8 (Undesirable effects): addition of the following paragraphs:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

 

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

 

Section 6.1 (List of excipients): change to ingredients listing:
Lactose

Magnesium stearate

 

Capsule shells:

Red Iron Oxide

Titanium Dioxide (E171)

Gelatin

 

Section 7 (Marketing Authorisation Holder): changed to sanofi-aventis

 
Updated on 23/09/2003 and displayed until 24/09/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 29/08/2001 and displayed until 23/09/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 29/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  ketoprofen