“Relaxon™ exerts a fast pain relief and is indicated as an adjunct to rest, physical
therapy, and other measures for the relief of discomfort associated with acute, painful
musculoskeletal conditions.”

The usual adult dosage is two capsules to be taken 3 times daily. For oral administration and
short-term use only.
Do not take more than 14 capsules in 24 hours.
Do not take with any other Paracetamol-containing products. Do not give to children under 6
years of age.
Do not exceed the stated dose.

Warning:
Serious (including fatal) hepatocellular toxicity has been reported rarely in patientsreceiving
Chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable.
Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatoxicity such as fever, rash, anorexia, nausea,
vomiting, fatigue, right upper quadrant pain, dark urine or jaundice. Chloroxazone use should
be discontinued if a patient develops abnormal liver enzymes (e.g. AST, ALT, alkaline
phosphatase and bilirubin) 

Precautions:
Drowsiness can occur with the use of Chlorzoxazone and may be additive to drowsiness from
the concomitant use of central nervous system depressants or alcohol.
There are no evidence proving that the use of Chlorzoxazone during pregnancy is harmless.
Safety and effectiveness in children have not been established.
Patients suffering from liver or kidney disease should take this medicine under
medical supervision.
“Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic
impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
• Do not take more medicine than the label tells you to. If you do not get better, talk to your
doctor.
• Do not take anything else containing Paracetamol while taking this medicine.
• Talk to your doctor at once if you take too much of this medicine, even if you feel well. This
is because too much Paracetamol can cause delayed, serious liver damage.
• Patients should be advised that Paracetamol might cause severe skin reactions. If a skin
reaction such as skin reddening, blisters, or rash occurs, they should stop use and seek medical
assistance right away”.

The medicinal products that may interact with Chlorzoxazone include zolpidem, citalopram,
duloxetine, gapapentin, clonazepam, pregabalin, oxycodone, topirama, tramadol and alprazolam.
Alcohol and other CNS depressants: They cause drowsiness that may be additive to that
induced by Chlorzoxazone.

Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol
used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contra-indicate breast feeding.
“As for Chlorzoxazone, no data is available”

Relaxon™ should not be taken for drivers (as Chlorzoxazone causes drowsiness).

Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may
occur. There have been reports of rare blood dyscrasias including thrombocytopenia and
agranulocytosis, but these were not necessarily causally related to Paracetamol.
“Chlorzoxazone containing products are usually well tolerated. It is possible in rare
instances that Chlorzoxazone may have been associated with gastrointestinal bleeding.
Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an
occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop
during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is
no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration
of the urine resulting
from a phenolic metabolite of Chlorzoxazone. This finding is of no known clinical
significance”.
To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662.
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

Paracetamol
Liver damage is possible in adults who have taken 10g or more of Paracetamol. Ingestion of
5g or more of Paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin,
primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts. Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV
infection, starvation, cachexia.

Symptoms
Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting,
anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after
ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe
poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia,
cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly
suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe
liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management
Immediate treatment is essential in the management of Paracetamol overdose. Despite a lack of
significant early symptoms, patients should be referred to hospital urgently for
immediate medical attention. Symptoms may be limited to nausea or vomiting and may not
reflect the severity of overdose or the risk of organ damage. Management should be in
accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1
hour. Plasma Paracetamol concentration should be measured at 4 hours or later after ingestion
(earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to
24 hours after ingestion of Paracetamol; however, the maximum protective effect is obtained up
to 8 hours post-ingestion.

The effectiveness of the antidote declines sharply after this time. If required the patient should
be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting
is not a problem, oral methionine may be a suitable alternative for remote areas, outside
hospital. Management of patients who present with serious hepatic dysfunction beyond
24h from ingestion should be discussed with the NPIS or a liver unit.

“Chlorzoxazone
• Symptoms
Initially, gastrointestinal disturbances such as nausea, vomiting or diarrhea together with
drowsiness, dizziness, lightheadedness or headache may occur. Early in the course, there may
be malaise or sluggishness followed by marked loss of muscle tone, making voluntary
movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium
remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur
with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is
lowered, but shock has not been observed.

• Treatment
Gastric lavage or induction of emesis should be carried out, followed by administration of
activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed,
oxygen and artificial respiration should be employed and a patent airway assured by use of an
oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of
dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine.
Cholinergic drugs or analeptic drugs are of no value and should not be used.

Paracetamol:
Analgesic:
The mechanism of analgesic action has not been fully determined. Paracetamol may act
predominantly by inhibiting a prostaglandin synthesis in the central nervous system (CNS)
and to a lesser extent through a peripheral action by blocking painimpulse generation. The
peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the
synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical
stimulation.

Antipyretic:
Paracetamol probably produces antipyresis by acting centrally on the hypothalamic heatregulating
center to produce peripheral vasodilation resulting in increased blood flow through
the skin, sweating, and heat loss. The central action probably involves inhibition of
prostaglandin synthesis in the hypothalamus.

Chlorzoxazone:
“Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data
available from animal experiments as well as human study indicate that Chlorzoxazone acts
primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits
multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied
etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and
increased mobility of the involved muscles. Blood levels of Chlorzoxazone can be detected in
people during the first 30 minutes and peak levels may be reached, in the majority of the
subjects, in about 1 to 2 hours after oral administration of Chlorzoxazone. Chlorzoxazone is
rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the
glucuronide. Less than one percent of a dose of Chlorzoxazone is excreted unchanged in the
urine in 24 hours.”

Absorption and Fate
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations
occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and
excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is
excreted as unchanged Paracetamol. The elimination half-life varies from about 1 to 4 hours.
Plasma-protein binding is negligible at usual therapeutic concentrations but increases with
increasing concentrations.
A minor hydroxylated metabolite which is usually produced in very small amounts by mixedfunction
oxidases in the liver and which is usually detoxified by conjugation with liver
glutathione may accumulate following Paracetamol overdosage and cause liver damage.

There are no preclinical data of relevance to the prescriber additional to that already covered in
other sections of the SPC.

1. Sodium Lauryl Sulphate
2. Colloidal Silicon dioxide (Aerosil 200)
3. Magnesium Stearate
4. Crospovidone

None stated. 

Do not store above 30°C

30 capsules of Relaxon Capsules are packed in PVC-PVDC blister with Aluminum printed foil.

 Keep out of tile reach and sight of children
 Do not store above 30°C.
 Do not use Relaxon'" after the expiry date which is stated on the carton. Do not use
Relaxon'" if you notice change in medicine color or odour. Medicines should not be
disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required.
These measures will help to protect the environment