TARGAXAN 550mg film-coated tablets
- Name:
TARGAXAN 550mg film-coated tablets
- Company:
Norgine Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/01/21

XPIL
Package Leaflet: Information for the user
Package Leaflet: Information for the user
1. What TARGAXAN is and what it is used for
1. What TARGAXAN is and what it is used for
2. What you need to know before you take TARGAXAN
2. What you need to know before you take TARGAXAN
3. How to take TARGAXAN
3. How to take TARGAXAN
4. Possible side effects
4. Possible side effects
5. How to store TARGAXAN
5. How to store TARGAXAN
6. Contents of the pack and other information
6. Contents of the pack and other information
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Norgine Limited

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 7 January 2021 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
4.8 Undesirable effects
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin2; Tel:+353 1 6764971; Fax:+353 1 6762517. Website: www.hpra.ie.; Email: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
10 DATE OF REVISION OF THE TEXT
06 January 2021
Updated on 7 January 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2. What you need to know before you take TARGAXAN
Targaxan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Section 4. Possible Side Effects
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. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin2; Tel:+353 1 6764971; Fax:+353 1 6762517. Website: www.hpra.ie.; Email: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
Section 6. Contents of the pack and other information
This leaflet was last revised in 01/2021.
Other sources of information
If you need the information on this leaflet in an alternative format, such as large print, please ring 00 44 1895 826 606.
Updated on 30 March 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
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.
United Kingdom: You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland: You can also report side effects directly 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.
By reporting side effects you can help provide more information on the safety of this medicine.
Marketing Authorisation Holder (UK):
Norgine Pharmaceuticals Limited
Norgine House, Widewater Place,
Moorhall Road, Harefield, Uxbridge,
UB9 6NS, UK
Marketing Authorisation Holder (IE):
Norgine B.V.
Antonio Vivaldistraat 150,
1083HP Amsterdam
Netherlands
This leaflet was last revised in 07/201903/2020
Updated on 15 October 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 15 October 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 5 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 5 April 2019 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 25 October 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 15 September 2017 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 21 October 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 October 2016 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 December 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 22 December 2015 SPC
Reasons for updating
- 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
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
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 contraceptive precautions, in particular if the oestrogen content of oral contraceptives is less than 50 mg (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
There is no experience regarding administration of rifaximin to subjects who are taking another rifamycin antibacterial agent to treat a systemic bacterial infection.
In vitro data show that rifaximin did not inhibit the major cytochrome P-450 (CYP) drug metabolizing enzymes (CYPs1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4). In in vitro induction studies, rifaximin did not induce CYP1A2 and CYP 2B6 but was a weak inducer of CYP3A4.
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.
An in vitro study suggested that rifaximin is a moderate substrate of P-glycoprotein(P-gp) and metabolized by CYP3A4. It is unknown whether concomitant drugs which inhibit P gp and/or CYP3A4 can increase the systemic exposure of rifaximin.
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.
The potential for drug-drug interactions to occur at the level of transporter systems has been evaluated in vitro and these studies suggest that a clinical interaction between rifaximin and other compounds that undergo efflux via P-gp and other transport proteins is unlikely ( MDR1, MRP2, MRP4, BCRP and BSEP).
4.8 Undesirable effects
Table 2 includes adverse reactions observed in the placebo-controlled study RFHE3001, and long term study RFHE3002 and from post-marketing experience, listed by MedDRA system organ class and frequency category.
Anaphylactic reactions, angioedemas, hypersensitivity have been moved form MeDRA System Organ Class 'Nervous system disorders' to 'Immune system disorders'.
.
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.
10 DATE OF REVISION OF THE TEXT
November 2015
Updated on 28 January 2014 SPC
Reasons for updating
- New SPC for new product
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 January 2014 PIL
Reasons for updating
- New PIL for new product
- New PIL for medicines.ie