Optimum Medical optilube 1160 Mode D'emploi page 2

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GBR INSTRUCTIONS FOR USE
PRODUCT REF/CONTENTS
1160 OptiLube Active 6ml Prefilled Syringe
1161 OptiLube Active 11ml Prefilled Syringe
This is an OptiLube Active product information leaflet for the user.
OptiLube Active has been prescribed for you by a Healthcare Professional. Do not share
it with anyone else.
Read all of the product information leaflet prior to use and retain for your information.
If you are unsure about how to use this product, or whether it is suitable for you, please
seek medical advice.
PRODUCT DESCRIPTION
OptiLube Active (with Lidocaine and Chlorhexidine) is a sterile, single-use, pre-filled
syringe with water-soluble jelly available in 6ml and 11ml syringes.
INGREDIENTS
100g of OptiLube Active contains:
Active Ingredients
• 0.05g Chlorhexidine Gluconate; • 2g Lidocaine Hydrochloride.
Other Ingredients
• Purified Water; • Propylene Glycol; • Hydroxyethyl cellulose;
• Methyl Hydroxybenzoate; • Propyl Hydroxybenzoate.
INTENDED PURPOSE
OptiLube Active is a medical device that helps to prevent trauma being caused to the
patient during catheterisation procedures or other urethral procedures by effective
lubrication. Additionally, OptiLube Active contains the following ancillary medicinal
substances; antiseptic (Chlorhexidine) and local anaesthetic (Lidocaine) to help reduce
the risk of infection and pain for the patient.
INDICATION FOR USE
OptiLube Active is designed to lubricate the urethra prior to insertion of a urethral
catheter and other urological medical devices including cystoscopes.
CONTRAINDICATIONS
OptiLube Active must not be used in patients:
• With known allergies or hypersensitivity to any of the ingredients.
• Who have ever had a reaction to Lidocaine or Chlorhexidine.
• Who have damaged or bleeding mucous membranes because of the risk of systemic
absorption of the Lidocaine and Chlorhexidine.
Do not use in children below 2 years of age.
Do not use for intravenous (IV) or intramuscular (IM) injections.
Do not use orally. If swallowed, please seek medical advice.
Do not use in eyes. If it comes into contact with the eyes, please seek medical advice.
WARNINGS AND PRECAUTIONS
OptiLube Active must only be used under the supervision of Healthcare Professionals in
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accordance with local guidelines, policies and procedures.
OptiLube Active is not suitable if a patient:
• Has a damaged or bleeding urethra.
Care should be taken when using the jelly with patients who:
• Have heart problems or taking medication for treating irregular heartbeat;
• Have liver problems;
• Are epileptic.
OptiLube Active must not be used at the same time as other medical devices or
medicines containing Lidocaine or other local anaesthetic.
Patients may experience a slight stinging on application of the jelly, but this usually
stops once the anaesthetic starts to work. Encourage patients to report any reaction to
the jelly.
Keep out of reach of children.
Ensure OptiLube Active is suitable for the intended use and compatible with other
medical devices to be used in conjunction with it.
This is a single-use device. Re-use of this device may result in patient infection/
cross-contamination.
Re/sterilisation, reprocessing, cleaning and disinfection may also compromise the
product characteristics, resulting in trauma or infection to the patient.
OptiLube Active is latex free.
PREGNANCY AND LACTATION
Only use during pregnancy and breast feeding under the direction of a doctor.
Always ask the patient if they are pregnant prior to using the jelly.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINERY
The ability to drive and operate machinery may be slightly impaired after the use of
lubricant jelly with Lidocaine. If affected, patients should be advised not to drive or use
machinery.
INTERACTIONS OF MEDICINAL SUBSTANCES
AND SUBSTANCES THAT ARE ABSORBED
Depending on the absorption of Lidocaine, these interactions can be seen when used
with the following medications:
Propranolol: Reduction in plasma clearance of Lidocaine;
Cimetidine: Reduction in plasma clearance of Lidocaine;
Antiarrhythmic products: Increase in the toxicity of Lidocaine;
Phenytoin or barbiturates: Reduction in plasma levels of Lidocaine.
Specified interactions can be seen in the long-term use and repeated high doses.
When administered as recommended, there is no clinically significant interactions
reported.
UNDESIRABLE SIDE EFFECTS
Like any medication, OptiLube Active may cause side effects in some people. Side
effects to this product must be documented in patient records.
In rare cases local hypersensitivity reactions may occur, such as redness, stinging,
blistering or itching and/or systemic reactions to Lidocaine and/or Chlorhexidine.
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