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.

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)

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.