Exylin is indicated for the relief of cough and associated congestive symptoms.

For oral use
Adults and Children aged 12 years and over:
5 - 10 ml dose of syrup 4 times a day.
Maximum daily dose: 40 ml syrup.
Children 6 - 12 years:
5 ml 4 times daily.
Children under 6 years of age:
Exylin is contraindicated in children under the age of 6 years (see section 4.3).
The Elderly:

As for adults above (see Pharmacokinetics - The elderly).
Hepatic dysfunction
Caution should be exercised if moderate to severe hepatic dysfunction is present (see
Pharmacokinetics - Hepatic dysfunction).
Renal dysfunction
It may be prudent to increase the dosage interval in subjects with moderate to severe renal failure
(see Pharmacokinetics - Renal dysfunction).
Do not exceed the stated dose.
Keep out of the reach and sight of children.

Exylin is contraindicated in individuals with known hypersensitivity to the product or any of its constituents. Exylin is contraindicated in individuals with chronic or persistent cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by the physician. Exylin should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOI) or those patients who have received treatment with MAOIs within the last two weeks. This medication should not be used for the treatment of cough and cold symptoms in children under 6 years of age.

This product may cause drowsiness. If affected individuals should not drive or operate machinery.
Subjects with moderate to severe renal or hepatic dysfunction or urinary retention should exercise caution
when using this product (see Pharmacokinetics - Renal/Hepatic Dysfunction).
This product contains diphenhydramine and therefore should not be taken by individuals with narrow-angle
glaucoma or symptomatic prostatic hypertrophy.
Exylin should not be used with any other product containing diphenhydramine, even one used on skin.
Exylin should not be used to make the child sleepy.
A breathing problem such as chronic bronchitis.

Trouble urinating due to an enlarged prostate gland.
When using this product:
• Marked drowsiness may occur, therefore, patients are advised not to drive or operate machinery
when affected.
• Sedatives and tranquilizers may increase drowsiness.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase
insufficiency should not take this medicine

This product contains diphenhydramine and therefore may potentiate the effects of alcohol, codeine,
antihistamines and other CNS depressants.
As diphenhydramine possesses some anticholinergic activity, the effects of anticholinergics (eg, some
psychotropic drugs and atropine) may be potentiated by this product. This may result in tachycardia, dry
mouth, gastrointestinal disturbances (eg, colic), urinary retention and headache.

 

Although diphenhydramine has been in widespread use for many years without ill consequence, it is
known to cross the placenta and has been detected in breast milk. Exylin should therefore only be used
when the potential benefit of treatment to the mother exceeds any possible hazards to the developing
foetus or suckling infant.
The safety of this product during pregnancy has not been established, although there is no good
evidence of an association between first trimester exposure to either ammonium chloride or
diphenhydramine and foetal abnormalities.

This product may cause drowsiness. If affected, the patient should not drive or operate machinery.

Side effects associated with the use of Exylin are uncommon.
Diphenhydramine may cause drowsiness; dizziness; gastrointestinal disturbance; dry mouth; nose and
throat; difficulty in urination or blurred vision.
Less frequently it may cause palpitations, tremor, convulsions or parasthesia.

Hypersensitivity reactions have been reported, in particular, skin rashes, erythema, urticaria and
angiodema.
Adverse reactions to menthol at the low concentration present in Exylin are not anticipated.

To report any side effect(s): A The National Pharmacovigilance and Drug Safety Centre (NPC) o Fax: +966-11-205-7662 o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340. o Toll free phone: 8002490000 o E-mail: npc.drug@sfda.gov.sa o Website: www.sfda.gov.sa/npc

 

Symptoms and signs
The symptoms and signs of Exylin overdose may include drowsiness, hyperpyrexia and anticholinergic
effects. With higher doses, and particularly in children, symptoms of CNS excitation including
hallucinations and convulsions may appear; with massive doses, coma or cardiovascular collapse may
follow.
Treatment
Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying
(with Syrup of Ipecac-induced emesis or gastric lavage) and, in cases of acute poisoning, the use of
activated charcoal may be useful. Seizures may be controlled with Diazepam or Thiopental Sodium. The
intravenous use of Physostigmine may be efficacious in antagonising severe antichlolinergic symptoms.

Diphenhydramine possesses antitussive, antihistaminic and anticholinergic properties. Experiments have
shown that the antitussive effect (resulting from an action on the brainstem) is discrete from its
antihistaminic effect.
The duration of activity of diphenhydramine is between 4 and 8 hours.
Menthol has mild local anaesthetic and decongestant properties.

Ammonium chloride has an irritant effect on mucous membranes and is considered to have expectorant
properties.

Absorption
Diphenhydramine and menthol are well absorbed from the gut following oral administration. Peak serum
levels of diphenhydramine following a 50 mg oral dose are reached at between 2 and 2.5 hours.
Distribution
Diphenhydramine is widely distributed throughout the body, including the CNS. Following a 50 mg oral
dose of diphenhydramine, the volume of distribution is in the range 3.3 - 6.8 l/kg, and it is some 78%
bound to plasma proteins.
Metabolism and Elimination
Diphenhydramine undergoes extensive first pass metabolism. Two successive N-demethylations occur,
with the resultant amine being oxidised to a carboxylic acid. Values for plasma clearance of a 50 mg oral
dose of diphenhydramine lie in the range 600-1300 ml/min and the terminal elimination half-life lies in the
range 3.4 - 9.3 hours. Little unchanged drug is excreted in the urine. Menthol is hydroxylated in the liver by
microsomal enzymes to p-methane-3,8 diol. This is then conjugated with glucuronide and excreted both in
urine and bile as the Glucuronide.
The Elderly
Pharmacokinetic studies indicate no major differences in distribution or elimination of Diphenhydramine
compared to younger adults.
Renal Dysfunction
The results of a review on the use of Diphenhydramine in renal failure suggest that in moderate to severe
renal failure, the dose interval should be extended by a period dependent on Glomerular filtration rate
(GFR).
Hepatic Dysfunction
After intravenous administration of 0.8 mg/kg Diphenhydramine, a prolonged half-life was noted in
patients with chronic liver disease which correlated with the severity of the disease. However, the mean
plasma clearance and apparent volume of distribution were not significantly affected.

Mutagenicity
The results of a range of tests suggest that neither diphenhydramine nor menthol have mutagenic potential.
Carcinogenicity
There is insufficient information to determine the carcinogenic potential of diphenhydramine or menthol,
although such effects have not been associated with these drugs in animal studies.
Teratogenicity
The results of a number of studies suggest that the administration of either diphenhydramine or menthol
does not produce any statistically significant teratogenic effects in rats, rabbits and mice.
Fertility
There is insufficient information to determine whether diphenhydramine has the potential to impair
fertility, although a diminished fertility rate has been observed in mice in one study.

Methol BP
Raspberry Flavour
Caramel T12
Citric Acid Anhydrous
Saccharin Sodium
Sodium Citrate Anhydrous
Ponceau 4R (E 124)
Red Dye FD & C #40
Ammonium Chloride
Spray Dried Anhydrous
Ethanol 96%
Glycerol
Sucrose Granular
Purified Water q.s to (ml)

Not Applicable

36Months/3Years

• Do not store this product above 30ºC.
• This medicine will be expired after 30 days from the first opening.

14mg/5ml (100ml)
Amber Bottle with child resistant cap as container closure.

No Special Disposal