STUD 100 Ref.[49641] Active ingredients: Lidocaine

Discontinue use if a rash or irritation develops.

If symptoms persist consult a doctor.

If you have liver or kidney failure, consult your doctor before using this product.

Keep medicines away from children.

Reports of interactions have been associated generally with systemic administration of lidocaine which results in high blood concentrations. The systemic uptake of lidocaine from STUD 100 is unlikely to be sufficient to produce interactions.

Interactions have been reported with antiarrhythmic agents, anticonvulsants, anticholinergic agents, antihypertensives, barbiturates, beta-blockers, muscle relaxants and sympathomimetic agents. Interactions with diagnostic tests for serum enzymes have also been reported.

STUD 100 is only indicated for use in males. However, possible transfer of lidocaine to the female partner could occur during intercourse.

Whilst there is no, or inadequate, evidence of safety of lidocaine in human pregnancy, it has been in widespread use without apparent adverse effects. Animal studies have shown no hazard. At the proposed male dose, the systemic availability of lidocaine to the female partner is unlikely to result in any adverse effects. Use of STUD 100 should be avoided if the female is pregnant.

The systemic uptake of lidocaine from STUD 100, applied topically, is unlikely to result in plasma concentrations sufficient to impair the ability to drive or operate machinery.

In extremely rare cases local anaesthetic preparations have been associated
with allergic reactions. Occasional local skin irritation may occur following
the use of STUD 100.

Systemic adverse reactions to lidocaine are usually the result of high plasma
concentrations due to high dosage, rapid absorption or may result from
hypersensitivity, idiosyncrasy or diminished tolerance on the part of the
patient. Such reactions involve excitatory and/or depressant actions on the
CNS characterised by nervousness, dizziness, convulsions, unconsciousness
and possible respiratory arrest. Cardiovascular reactions are depressant and
may include hypotension, myocardial depression, bradycardia and possibly
cardiac arrest.

The plasma lidocaine levels attained following application of STUD 100 at the
maximum recommended dose are extremely low at about 25 times lower than
the concentrations associated with systemic toxicity.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal
product 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 national reporting system (see details
below).

United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google, Play or Apple App Store

Malta: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

None known.