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TARGAXAN 550 mg film-coated tablets

Last Updated on eMC 21-Oct-2016 View document  | Norgine Limited Contact details

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 21-Oct-2016 and displayed until Current

Reasons for adding or updating:

  • 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

Date of revision of text on the SPC: 14-Oct-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 4.4 and 4.5: statement added with regards to warfarin

Updated on 04-Jan-2016 and displayed until 21-Oct-2016

Reasons for adding or updating:

  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.4       Special warnings and precautions for use

 

Due to the effects on the gut flora, the effectiveness of oral oestrogenic contraceptives could decrease after rifaximin administration.

However, such interactions have not been commonly reported. It is recommended to take additional contraceptives precautions, in particular if the oestrogen

Content of oral contraceptives is less than 50 µg (see also section 4.5).

 

Caution should be exercised when concomitant use of rifaximin and a P-glycoprotein inhibitor such as ciclosporin is needed (see section 4.5).

 

4.5       Interaction with other medicinal products and other forms of interaction

 

In healthy subjects, clinical drug interaction studies demonstrated that rifaximin did not significantly affect the pharmacokinetics of CYP3A4 substrates,

however, in hepatic impaired patients it cannot be excluded that rifaximin may decrease the exposure of concomitant CYP3A4 substrates administered

(e.g. warfarin, antiepileptics, antiarrhythmics, oral contraceptives), due to the higher systemic exposure with respect to healthy subjects.

 

In healthy subjects, co-administration of a single dose of ciclosporin (600 mg), a potent P-glycoprotein inhibitor, with a single dose of rifaximin (550 mg)

resulted in 83-fold and 124-fold increases in rifaximin mean Cmax and AUC∞. The clinical significance of this increase in systemic exposure is unknown.


4.8       Undesirable effects

 

Table 2 includes adverse reactions  observed in the placebo-controlled study RFHE3001, long term  study RFHE3002 and from post-marketing experience,

listed by MedDRA system organ class and frequency category.

 

Table 2: Adverse reactions listed by MedDRA system organ class and frequency category.

 

MedDRA System Organ Class

Common

Uncommon

Rare

Not known

Infections and infestations

 

Clostridial  infection, urinary tract infection, candidiasis

Pneumonia,

cellulitis, upper  respiratory tract infections, rhinitis

 

Blood and lymphatic system disorders

 

Anaemia

 

Thrombocytopenia

Immune system disorders

 

 

 

Anaphylactic reactions, angioedemas, hypersensitivity

Metabolism and nutrition disorders

 

Anorexia, hyperkalaemia

Dehydration

 

Psychiatric disorders

Depression

Confusional state, anxiety, hypersomnia, insomnia

 

 

Nervous system disorders

Dizziness, headache

 

Balance disorders amnesia, convulsion,

attention disorders

hypoesthesia, memory impairment

 

 

Vascular disorders

 

Hot flush

Hypertension, hypotension

Presyncope, syncope

Respiratory, thoracic, and mediastinal disorders

Dyspnoea

 

Pleural effusion

Chronic obstructive pulmonary disease

 

 

Gastrointestinal disorders

Abdominal pain upper,  abdominal distension, diarrhoea, nausea, vomiting, ascites

Abdominal pain,  oesophageal varices haemorrhage, dry mouth, stomach discomfort

Constipation

 

Hepatobiliary disorders

 

 

 

Liver function tests abnormalities

Skin and subcutaneous tissue disorders

Rashes, pruritus

 

 

 

Dermatitis, eczema

Musculoskeletal and connective tissue disorders

Muscle spasms, arthralgia

Myalgia 

Back pain

 

Renal and urinary disorders

 

Dysuria,

pollakiuria

Proteinuria,

 

 

General disorders and administration site conditions

Oedema peripheral

Oedema,  pyrexia

Asthenia

 

Investigations

 

 

 

International normalised ratio abnormalities

Injury, poisoning and procedural complications

 

Fall

 

Contusions, procedural pain

 

 

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

10      DATE OF REVISION OF THE TEXT

 

October 2015

Updated on 22-Feb-2013 and displayed until 04-Jan-2016

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

Norgine Limited

Company image
Address

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS

Fax

+44 (0)1895 825 865

Medical Information e-mail
Telephone

+44 (0)1895 826 600

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?

Active ingredients

rifaximin

Legal categories

POM - Prescription Only Medicine

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