Toilax micro enema suspension

  • Name:

    Toilax micro enema suspension

  • Company:
    info
  • Active Ingredients:

    Bisacodyl

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/01/21

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Summary of Product Characteristics last updated on medicines.ie: 7/1/2021

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Orion Pharma (Ireland) Ltd

Orion Pharma (Ireland) Ltd

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Medicine Name Bufomix Easyhaler 80 micrograms/4.5 micrograms Active Ingredients Budesonide, Formoterol fumarate dihydrate
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Medicine Name Indivina 2 mg/5 mg tablets Active Ingredients Estradiol valerate, Medroxyprogesterone Acetate
Medicine Name Methotrexate Orion 10 mg tablets Active Ingredients Methotrexate disodium
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Medicine Name Stalevo 100 mg/25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 200 mg/50 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 50 mg/12.5 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Stalevo 75 mg/18.75 mg/200 mg film-coated tablets Active Ingredients Carbidopa, Entacapone, Levodopa
Medicine Name Toilax micro enema suspension Active Ingredients Bisacodyl
Medicine Name Veramil 120 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
Medicine Name Veramil 80 mg Film-coated Tablets Active Ingredients verapamil hydrochloride
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 7 January 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 6.6 - Special precautions for disposal and other handling

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The following changes have been made to the Summary of Product Characteristics:

Section 4.4 - addition of information/updated wording:

  • Excessive and prolonged use is dangerous and may result in diarrhoea leading to electrolyte depletion, hypokalaemia, dehydration, electrolyte imbalance such as hypokalaemia, malabsorption and protein losing
  • Dizziness and/or Ssyncope has been reported during the use of bisacodylToilax

Section 4.7 updates:

No studies on the effects of bisacodyl on the ability to drive and use machines have been performed. 

However, patients should be advised that due to a vasovagal response (e.g. to abdominal spasm) they may experience dizziness and / or syncope. If patients experience abdominal spasm they should avoid potentially hazardous tasks such as driving or operating machinery.

Section 4.8 updates:

Rare cases of colitis including ischaemic colitis have been reported, has been added (frequency not known)

Dizziness has been added (frequency not known)

Section 4.9 updates:

Wording updated to state 'electrolyte imbalances such as hypokalaemia with muscular weakness and ECG alterations may develop'.

Section 6.6 updates/added text:

Any unused medicinal product or waste material should immediately be disposed of in accordance with local requirements.

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 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 2 of the leaflet has been updated to include:

Driving and using machines
Toilax can cause dizziness and fainting. Do not drive or use machinery if you experience dizziness while taking this medicine.
Excipients
This medicine contains less than 1 mmol (23 mg) sodium per 5ml Rectal Suspension, that is to say essentially ‘sodium- free’.

Patients are also asked to consult their doctor or pharmacist if they experience dizziness.

Section 4 of the leaflet has been updated to include:

Frequency Not known:
 - Dizziness and/or loss of consciousness or fainting (syncope)
 - Colitis (inflammation of the inner lining of the colon)

Updated on 15 March 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 18 January 2019 PIL

Reasons for updating

  • Change to section 3 - use in children/adolescents

Updated on 18 January 2019 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The SPC has been updated to clarify the dosing information for use in children.

Special warnings and precaustions for use have been updated to include the following statement: Haematochezia may be seen but is usually mild and self-limiting; more severe bloody diarrhoea may be associated with colonic mucosal ischaemia.

Undesirable effects has been updated haematochezia and syncope.

Updated on 14 August 2018 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 6 January 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 January 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 16 December 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 24 March 2010 PIL

Reasons for updating

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

Updated on 23 October 2009 PIL

Reasons for updating

  • New PIL for medicines.ie