Omnexel

  • Name:

    Omnexel

  • Company:
    info
  • Active Ingredients:

    Tamsulosin Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/07/15

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Summary of Product Characteristics last updated on medicines.ie: 21/7/2015
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Astellas Pharma Co. Ltd

Astellas Pharma Co

Company Products

Medicine NameActive Ingredients
Medicine Name Advagraf 0.5mg Prolonged-Release Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Advagraf 1mg Prolonged-Release Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Advagraf 3 mg prolonged-release hard capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Advagraf 5mg Prolonged-Release Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Betmiga 25mg and 50mg prolonged-release tablets Active Ingredients Mirabegron
Medicine Name DIFICLIR 200 mg film-coated tablets Active Ingredients Fidaxomicin
Medicine Name Eligard 22.5mg Active Ingredients Leuprorelin Acetate
Medicine Name Eligard 45mg Active Ingredients Leuprorelin Acetate
Medicine Name Eligard 7.5mg Active Ingredients Leuprorelin Acetate
Medicine Name Modigraf 0.2mg & 1mg granules for oral suspension Active Ingredients Tacrolimus Monohydrate
Medicine Name Mycamine 50 & 100 mg powder for solution for infusion Active Ingredients Micafungin sodium
Medicine Name Omnexel Active Ingredients Tamsulosin Hydrochloride
Medicine Name Prograf 0.5 mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf 1mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf 5mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf Concentrate for Infusion Active Ingredients Tacrolimus
Medicine Name Vesitirim 1 mg/ml oral suspension Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 10mg Film-coated Tablets Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 5mg Film-Coated tablets Active Ingredients Solifenacin succinate
Medicine Name Vesomni 6 mg/0.4 mg modified release tablets Active Ingredients Solifenacin succinate, Tamsulosin Hydrochloride
Medicine Name Xtandi 40 mg soft capsules Active Ingredients enzalutamide
Medicine Name Zepholin SR 100mg Prolonged Release Capsules Active Ingredients Theophylline
Medicine Name Zepholin SR 200mg Prolonged Release Capsules Active Ingredients Theophylline
1 - 0 of 23 items.Total: Infinity pages

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 21 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 July 2015 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The section regarding side effect reporting has been corrected to include the HPRA e-mail adress

Updated on 15 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 July 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 June 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 2 June 2015 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

HPRA contact details revised in section 4.8 regarding reporting of side-effects
Date of revision updated to May 2015

Updated on 24 April 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to reporting of AEs information, contact details in line IMB details 

Updated on 15 April 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.
  • Improved electronic presentation

Updated on 8 January 2014 PIL

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 2 January 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.8 Undesirable effects


Gastro-intestinal disorders
Not known (cannot be estimated from the available data): Dry mouth*


Reporting of  suspected reactions

Reporting of suspected adverse reactions after authorisation of the medicinal products 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 the online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed  manually and submitted to the IMB via ‘freepost’(see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

 

FREEPOST,

Pharmacovigilance Section,

Irish Medicines Board,

Kevin O’Malley House,

 Earlsfort Centre,

 Earlsfort Terrace,

Dublin 2,

Ireland.

Tel: +353 1 6764971,

 Fax: +353 1 6762517,

Website: www.imb.ie,

e-mail: imbpharmacovigilance@imb.ie.

Updated on 21 November 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 19 November 2013 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.6 Fertility, pregnancy and lactation

Omnexel is not indicated for use in women.

Omnexel

Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorization phase

Updated on 5 July 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 5 July 2013 SmPC

Reasons for updating

  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

improved version upload

Updated on 11 April 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company










4.4 Special warnings and precautions for use



The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during and after the operation.


Discontinuing tamsulosin hydrochloride 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit of treatment discontinuation has not yet been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to the surgery.

The initiation of therapy with tamsulosin hydrochloride in patients for whom cataract or glaucoma surgery is scheduled is not recommended. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.

4.8 Undesirable effects

During cataract and glaucoma surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (see also section 4.4).

Updated on 26 November 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

MedDRA system organ class

Common
(>1/100, <1/10)

Uncommon
(>1/1,000, <1/100)

Rare
(>1/10,000, 

<1/1.000 1,000)

Very rare (<1/10,000)

Nervous systems disorders

Dizziness (1.3%)

Headache

Syncope

 

Cardiac disorders

 

Palpitations

 

 

Vascular disorders

 

Orthostatic hypotension

 

 

Respiratory, thoracic and mediastinal disorders

 

Rhinitis

 

 

Gastro-intestinal disorders

 

Constipation, diarrhoea, nausea, vomiting

 

 

Skin and subcutaneous tissue disorders

 

Rash, pruritus, urticaria

Angioedema

Stevens-Johnson syndrome

Reproductive system and breast disorders

Ejaculation disorders

 

 

Priapism

General disorders and administration site conditions

 

Asthenia

 

 

 

Updated on 17 August 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to MA holder contact details

Updated on 25 July 2012 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

7     Marketing authorisation holder

Astellas Pharma Co. Ltd.

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

Updated on 18 January 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 11 October 2011 SmPC

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
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

 

 

The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin hydrochloride. IFIS may lead to increased the risk of eye procedural complications during and after the operation. The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended. Discontinuing tamsulosin hydrochloride 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit of treatment discontinuation and duration of stopping of therapy prior to cataract surgery has not yet been established.  IFIS has also been reported in patients who had discontinued tamsulosin for a longer period prior to cataract surgery.

The initiation of therapy with tamsulosin hydrochloride in patients for whom cataract surgery is scheduled is not recommended. During pre-operative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.

Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.

 

Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4 (see section 4.5).

 

 It is possible that a remnant of the tablet is observed in the faeces.

4.5 Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults.

No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline.

Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, whereas furosemide a fall, but as levels remain within the normal range posology need not be adjusted.

In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450‑linked drug metabolising enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.

Concomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin hydrochloride. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and Cmax of tamsulosin hydrochloride by a factor of 2.8 and 2.2, respectively. Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype.

 

Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4.

Concomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of CYP2D6, resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively, but these increases are not considered clinically relevant.

 Concurrent administration of other α1‑adrenoceptor antagonists could lead to hypotensive effects.

4.8 Undesirable effects

MedDRA system organ class

Common
(>1/100, <1/10)

Uncommon
(>1/1.000, <1/100)

Rare
(>1/10.000, 

<1/1.000)

Very rare (<1/10.000)

Nervous systems disorders

Dizziness (1.3%)

Headache

Syncope

 

Cardiac disorders

 

Palpitations

 

 

Vascular disorders

 

OrthostaticPostural hypotension

 

 

Respiratory, thoracic and mediastinal disorders

 

Rhinitis

 

 

Gastro-intestinal disorders

 

Constipation, diarrhoea, nausea, vomiting

 

 

Skin and subcutaneous tissue disorders

 

Rash, pruritus, urticaria

Angioedema

Stevens-Johnson syndrome

Reproductive system and breast disorders

Ejaculation disorders

Abnormal ejaculation

 

Priapism

General disorders and administration site conditions

 

Asthenia

 

 

 

During cataract surgery a small pupil situation, known as Intraoperative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin during post-marketing surveillance (see also section 4.4).

Post-marketing experience: In addition to the adverse events listed above, atrial

fibrillation, arrhythmia, tachycardia and dyspnoea have been reported in

association with tamsulosin use. Because these spontaneously reported events are

from the worldwide post marketing experience, the frequency of events and the

role of tamsulosin in their causation cannot be reliably determined.

 

4.9 Overdose

Symptoms

Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects. Severe hypotensive effects have been observed at different levels of overdosing.

5. PHARMACOLOGICAL PROPERTIES

Absorption

Omnic Ocas 0,4 is a prolonged release tablet of the non‑ionic gel matrix type. The Ocas formulation provides consistent slow release of tamsulosin, resulting in an adequate exposure over 24 hours, with little fluctuation, over 24 hours.

Tamsulosin hydrochloride administered as Omnic Ocas 0,4 mgprolonged release tablets is absorbed from the intestine. Under fasting conditions approximately 57% Oof the administered dose, approximately 57%  is estimated to be absorbed.

The rate and extent of absorption of tamsulosin hydrochloride administered as Omnic Ocas 0,4prolonged release tablets are not affected by fooda low fat meal. The extent of absorption is increased by 64% and 149% (AUC and Cmax respectively) by a high-fat meal compared to fasted.

Biotransformation

In vitro results suggest that CYP3A4 and also CYP2D6 are involved in metabolism, with possible minor contributions to tamsulosin hydrochloride metabolism by other CYP isozymes. Inhibition of CYP3A4 and CYP2D6 drug metabolizing enzymes may lead to

increased exposure to tamsulosin hydrochloride (see section 4.4 and 4.5).

 

10. Date of revision of the text

August 2011

Updated on 21 April 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

400 micrograms tamsulosin hydrochloride changed to 0.4 mg tamsulosin hydrochloride

 

 

6.3     Shelf life

 

Increased from 2 years to 3 years

 

 

10.     DATE OF REVISION OF THE TEXT

 

Changed from October 2006 to May 2009

Updated on 13 February 2009 PIL

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 8 November 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Omnexel SPC Changes

(October 2005 v October 2006)

 

Section 2 Qualitative and Quantitative Composition

Insertion of a reference to the excipients in section 6.1.

 

Section 4.2 Posology and method of administration

Insertion of the following new text:
 

“Oral Use.”

 

“No dose adjustment is warranted in renal impairment.

No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency (see also 4.3., Contraindications).

There is no relevant indication for use of Omnexel®, 400 micrograms, in children.”

 

Section 4.3 Contraindications

Insertion of new text (highlighted in red below) to the end of the following sentence:

“Hypersensitivity to tamsulosin hydrochloride or to any of the excipients, including drug-induced angioedema.”

 

Section 4.4 Special warnings and precautions for use

Insertion of the following new text:

The 'Intra-operative Floppy Iris Syndrome' (IFIS), a variant of small pupil syndrome has been observed during cataract surgery in some patients on or previously treated with tamsulosin.  IFIS may lead to increased procedural complications during the operation.  The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended. Discontinuing tamsulosin 1-2 weeks prior to cataract surgery is anecdotally considered helpful, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established.

During preoperative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.

It is possible that a remnant of the tablet is observed in the faeces.”

 

Section 4.5 Interaction with other medicinal products and other forms of interaction

Insertion of the following new text: “Interaction studies have only been performed in adults”

 

Section 4.8      Undesirable effects

Description of the frequency of the undesirable effects changed from percentages to fractions.

 

Insertion of the following new text:

“During cataract surgery, a small pupil situation, known as Intra-operative Floppy Iris Syndrome (IFIS), has been associated with therapy of tamsulosin  during post-marketing surveillance (See also section 4.4). “

 

 

Section 4.9      Overdose

Insertion of the following new text:

“Acute overdose with 5 mg of tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day. “

 

Section 5.2      Pharmacokinetic properties

The heading “Metabolism” has been changed to “Biotransformation”

Deletion of the following text:

“No dose adjustment is warranted in hepatic insufficiency”

“No dose adjustment is warranted in renal impairment”.

 

Section 6.5      Nature and contents of container

Insertion of two new pack sizes: “..18,..45,..”

 

Section 9 Date of First Authorisation/Renewal of the Authorisation

Updated to: 18th March 2005/12th July 2006

 

Section 10 Date of Revision of the Text

Updated to: October 2006

Updated on 7 November 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet
  • Change of special precautions for disposal

Updated on 28 June 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd

 

Section 8: Marketing Authorisation Number changed to 1241/6/1

 

Section 10: Date of Revision of the Text changed to October 2005

Updated on 27 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 May 2005 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)