Renal Impairment: This product should be used with caution and at reduced dosage in the presence
of impaired renal function.

Pacreatic/biliary Tract Disease: Opioids may cause spasms of the sphincter of Oddi and should be
used with caution in patients with biliary tract disease, including pancreatitis.

ADVERSE REACTIONS
The most frequently observed adverse reactions with dihydrocodeine include light-headedness,
dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation,
pruritis, and skin reactions. With the exception of constipation, tolerance develops to most of
these effects. Other reactions that have been observed with dihydrocodeine or opioids include
respiratory depression, orthostatic hypotension, cough suppression, confusion, diarrhea, miosis,
abdominal pain, dry mouth, indigestion, anorexia, spasm of biliary tract, and urinary retention.
Physical and psychological dependence are possibilities. Hypersensitivity reactions (include
anaphylactoid reactions), hallucinations, vivid dreams, granulomatous interstitial nephritis, severe
narcosis and acute renal failure have been reported rarely during dihydrocodeine administration.
Other reactions observed with the ingredients in this product include lassitude, nausea, giddiness,
dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement
(especially in children).

DRUG ABUSE AND DEPENDENCE
This combination product is subject to the provisions of the Controlled Substances Act and
has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine
type and therefore has the potential of being abused. Psychological dependence, physical
dependence, and tolerance may develop upon repeat administration of dihydrocodeine, and it
should be prescribed and administered with the same degree of caution appropriate to the use
of other opioid medications. Symptoms of dihydrocodeine withdrawal consist of irritability,
restlessness, insomnia, diaphoresis, anxiety, and palpitations.

OVERDOSAGE
An overdose of this product is a potentially lethal poly-drug overdose situation, and consultation
with a regional Poison Control Center is recommended. A listing of the Poison Control Centers
can be found in a standard reference such as the Physician's Desk Reference.

Signs and Symptoms:
Symptoms of an overdose include pinpoint pupils, respiratory depression, extreme somnolence
progressing to stupor, loss of consciousness or coma, skeletal muscle flaccidity, cold and clammy
skin and other symptoms common with narcotic overdosage. Convulsions, cardiovascular collapse,
and death may occur. A single case of acute rhabdomyolysis associated with an overdose of
dihydrocodeine has been reported.

Recommended Treatment:
Immediate treatment of an overdose of this product includes support of cardiovascular function and
measures to reduce further drug absorption. Vomiting should be induced with syrup of ipecac. If the
patients is alert and has adequate laryngeal reflexes, oral activated charcoal should follow. The first
dose should be accompanied by an appropriate cathartic. Gastric lavage may be necessary.
Hypotension is usually hypovole