Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Farco-Pharma GmbH, Gereonsmühlengasse 1‑11, 50670 Köln, Germany, Tel: ++49 221 594061, Fax: ++49 221 593614
Instillagel is contraindicated in children under 2 years (see section 4.2).
Instillagel must not be used in patients with known hypersensitivity to the active substances (amide-type anaesthetics, chlorhexidine and alkyl-hydroxy- benzoates) or to any of the excipients listed in section 6.1. Instillagel should not be used in patients who have damaged or bleeding mucous membranes because of the risk of systemic absorption of the lidocaine hydrochloride.
Products containing local anaesthetic should also be used with caution in patients with impaired cardiac conditions, hepatic insufficiency and in epileptics.
Oropharyngeal use of Instillagel may cause difficulty in swallowing and therefore an increased risk of aspiration due to its local anaesthetic effect. Numbness of the tongue and buccal mucosa may also increase the chance of biting trauma.
In case of systemic effects from absorption of lidocaine hydrochloride please see section 4.9 “Overdose”.
In the presence of severe damage to the urethra, an excessive hypersensive response may occur.
This medicinal product contains propylene glycol, which may cause skin irritation.
Lidocaine should be used with caution in patients receiving antiarrhythmic drugs.
During the first three months of pregnancy, lidocaine should be used only if absolutely necessary.
Since it is not known whether lidocaine passes into milk, breastfeeding should be suspended for 12 hours after administration.
Until now there exists no references that lidocaine interferes with fertility.
The ability to drive and operate machinery may be slightly impaired after the use of Instillagel. If affected, patients should be advised not to drive or use machinery.
Undesirable effects are listed below by frequency convention and system organ class database. Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
Possible undesirable effects:
Very rare: Allergic reactions (in severe cases, anaphylaxis) caused by a local anaesthetic of amide type and/or of chlorhexidine.
Very rare: Allergic reactions caused by methyl hydroxybenzoate and propyl hydroxybenzoate (possible delayed).
Not known: Caused by severe injury to the mucosa, absorption may occur. Possible systemic undesirable effects are anaphylaxis, fall in blood pressure, bradycardia or convulsions.
None.
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