Actodryl contains a decongestant, antihistamine, analgesic and antipyretic, and is indicated for the management of upper respiratory tract conditions accompanied with headache and fever such as the common cold, hay fever, allergic and vasomotor rhinitis and aerotitis (otitis barotrauma).

Posology:
Adults and children 12 years and over: 10 ml three times daily.
Children 6 – 12 years: 5 ml three times daily. Maximum daily dose is 15 ml in 24 hours.
Leave at least 4 hours between doses.
Use for more than 5 consecutive days is not recommended. Should not be used for more than 5 days for children.
Not recommended for children under 6 years. 

Method of administration
For oral use only.
Use only the measuring cup provided.

Actodryl is contraindicated in: - Individuals with known hypersensitivity to the product or any of its components. Not to be used if the patient is allergic to paracetamol or any other ingredient in this product. - Patients under 6 years of age. - Patients with severe hypertension, severe coronary artery disease, thyrotoxicosis, glaucoma or urinary retention. - Patients who are currently receiving other sympathomimetic drugs. - Patients who are taking, or have taken, monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure or hypertensive crisis. The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of Actodryl and furazolidone, they should not be taken together.

Actodryl may cause drowsiness.
Caution should be exercised in the presence of renal or hepatic impairment.
Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, Actodryl should be used with caution in patients taking antihypertensive agents and tricyclic antidepressants.
The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.
Patients with the following conditions should be advised to consult a physician before using Actodryl: hypertension; coronary heart disease; diabetes; thyroid disease; difficulty in urination due to enlargement of the prostate; a respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma; or glaucoma.
Triprolidine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. While taking Actodryl, patients should be advised to consult a healthcare professional prior to taking with central nervous system depressants.
This product may act as a cerebral stimulant in children and occasionally adults giving rise to insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions. Care should be taken when used in epileptic patients.

Liver warning
This product contains paracetamol. Maximum daily dose is 15 ml for children 6 – 12 years in 24 hours. Severe or possibly fatal liver damage may occur if you take more than the recommended dose in 24 hours or with other drugs containing paracetamol.

Severe Skin reactions
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Actodryl should be discontinued and appropriate measures taken if needed.
Children 6 - 12 years: Not more than 3 doses should be given in any 24 hours.
Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Do not give with any other paracetamol-containing products. Do not use with other drugs containing paracetamol.
Consult a pharmacist or other healthcare professional before use in children under 12 years.
Each 5 ml dose of this medicine contains 750 mg of sugar. This should be taken into account in patients with diabetes mellitus.
The excipients sodium benzoate and Color FD&C yellow 6 may cause allergic reactions (possibly delayed).
As this product contains sugar and sorbitol, patients with rare hereditary problems of fructose intolerance, glucose – galactose malabsorption or sucrase – isomaltase insufficiency should not take the medicine.

Pseudoephedrine exerts its vasoconstricting properties by stimulating adrenergic receptors and displacing norepinephrine from neuronal storage sites. Since MAOIs (monoamine oxidase inhibitors) impede the metabolism of sympathomimetic amines and increase the store of releasable norepinephrine in adrenergic nervous tissue, MAOIs may potentiate the pressor effect of pseudoephedrine. Acute hypertensive crises have been reported in the medical literature with the concomitant use of MAOIs and sympathomimetic amines.
The effects of anticholinergics e.g., some psychotropic drugs and atropine, may be potentiated by this product giving rise to tachycardia, mouth dryness, gastrointestinal disturbances, e.g., colic, urinary retention and headache.
Concomitant use of Actodryl with tricyclic antidepressants, other sympathomimetic agents (such as decongestants, appetite suppressants and amphetaminelike psychostimulants) may occasionally cause a rise in blood pressure.
The effect of antihypertensive agents which interfere with sympathetic activity may be partially reversed by the pseudoephedrine in Actodryl, e.g. bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. 

There are no adequate and well controlled studies for pseudoephedrine and triprolidine in pregnant or breastfeeding women. But there is epidemiological evidence of the safety of paracetamol in human pregnancy.

Fertility
There is no information on the effects of Actodryl on human fertility.

Pregnancy
This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus.

Breastfeeding
Pseudoephedrine distributes into and is concentrated in breast milk. Up to 0.7% of a single 60mg dose of pseudoephedrine may be distributed into breast milk over 24 hours. Pseudoephedrine concentrations in milk are from 2 to 3-fold higher than those in plasma. This milk/plasma drug concentration profile suggests low protein binding, although no protein plasma binding data in humans are available. Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breastfeeding mother.
Triprolidine is excreted in breast milk, it has been estimated that approximately 0.06 to 0.2% of a single 2.5 mg dose of triprolidine ingested by a nursing mother will be excreted in the breastmilk over 24 hours.
Paracetamol is excreted in breast milk. However, the level of paracetamol present is not considered to be harmful.
This product should not be used during lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the nursing infant.

Actodryl may cause drowsiness and impair performance in tests of auditory vigilance. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving a car or operating machinery, until they have established their own response to the drug.
It is recommended that patients are advised not to undertake tasks requiring mental alertness whilst under the influence of CNS depressants. Concomitant administration of Actodryl may, in some patients, produce additional impairment.

System organ class (SOC)	Adverse drug reaction (Preferred term)	Frequency
Immune system disorders	Hypersensitivity	Not known
	Anaphylaxis	Very rare
	Cutaneous hypersensitivity reactions	Very rare
	Angiodema	Very rare
	Stevens Johnson syndrome	Very rare
Psychiatric disorders	Insomnia	Common
	Nervousness	Common
	Anxiety	Not known
	Euphoric mood	Not known
	Hallucination	Not known
	Restlessness	Not known
Nervous system disorders	Dizziness	Common
	Epilepsy	Not known
	Headache	Not known
	Paraesthesia	Not known
	Psychomotor hyperactivity (in the paediatric population)	Not known
	Somnolence	Not known
	Tremor	Not known
Cardiac disorders	Arrhythmia	Not known
	Palpitations	Not known
	Tachycardia	Not known
Respiratory, thoracic and mediastinal disorders	Dry throat	Not known
	Epistaxis	Not known
	Nasal dryness	Not known
	Bronchospasm in patients sensitive to aspirin and other NSAIDs	Very rare
Gastrointestinal disorders	Dry mouth	Common
	Nausea	Common
	Abdominal discomfort	Not known
	Vomiting	Not known
Skin and subcutaneous tissue disorders	Pruritus	Not known
	Rash	Not known
	Urticaria	Not known
	Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)	Not known
Renal and urinary disorders	Dysuria	Not known
	Urinary Retention	Not known
General disorders and administration site conditions	Feeling jittery	Not known
	Fatigue	Not known
	Hyperpyrexia	Not known
Investigations	Blood pressure increased	Not known
Hepatobiliary disorders	Hepatic dysfunction	Very rare
Blood and lymphatic system disorders	Thrombocytopaenia	Very rare

To reports any side effect(s):
Saudi Arabia:
The National Pharmacovigilance Centre (NPC):

• SFDA Call Center: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa/

Other GCC States:
Please contact the relevant competent authority.

Symptoms
The effects of acute toxicity from Actodryl may include drowsiness, incoordination, weakness, irritability, palpitations, hypertension, convulsions and difficulty with micturition.

Pseudoephedrine
Overdosage may result in nausea, vomiting, sympathomimetic symptoms including central nervous system stimulation, insomnia, tremor, mydriasis, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension and reflex bradycardia. Other effects may include dysrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychoses, rhabdomyolysis, hypokalaemia, and ischemic bowel infarction. Drowsiness has been reported with overdose in children.
 

Triprolidine
Overdosage of an H1 receptor antagonist may result in CNS depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or dysrhythmias.
Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures.

Paracetamol
There may be no early symptoms following a life-threatening overdose. Ingestion of more than 12 g paracetamol or more than 150 mg paracetamol per kg bodyweight, whichever is the smaller, can cause severe liver damage. Liver damage (as demonstrated by a rise in plasma transaminase levels) may be apparent between 8 and 36 hours following overdose. Biochemical evidence of maximal damage, however, may not be attained until 72 - 96 hours after ingestion of the overdose.
Symptoms of paracetamol overdose in the first 24 hours may induce pallor, nausea, vomiting, anorexia, and abdominal pain. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death.
Liver damage results when excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrythmias and pancreatitis have been reported.

Management
The treatment of overdosage is likely to be symptomatic and supportive. Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated.
Catheterisation of the bladder may be necessary.
Alpha-adrenergic blockade may be required to treat hypertensive crises and beta-adrenergic blockade for the control of supra-ventricular dysrhythmias.
If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.
Intravenous N-acetylcysteine (NAC) is effective when initiated within 8 hours of the overdose of paracetamol. Efficacy declines progressively after this time, but NAC may provide some benefit up to and possibly beyond 24 hours. Oral methionine is also effective provided that it is given within 10 to 12 hours of the overdose of paracetamol. Activated charcoal should be considered if the dose of paracetamol ingested exceeds 12 g or 150 mg/kg, whichever is the smaller, and the procedure can be undertaken within 1 hour of the overdose.

Pharmacotherapeutic group: Sympathomimetics, pseudoephedrine, combinations.
ATC code: R01BA52.
Triprolidine provides symptomatic relief in conditions believed to depend wholly, or partly, upon the triggered release of histamine. Triprolidine is a potent, competitive H1receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.
Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant.
Pseudoephedrine is less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and is less potent in causing stimulation of the central nervous system.
After oral administration of a single dose of 2.5 mg triprolidine to adults the onset of action, as determined by the ability to antagonise histamine-induced weals and flares in the skin, is within 1 to 2 hours. Peak effects occur at about 3 hours, and although activity declines thereafter, significant inhibition of histamine-induced weals and flares still occurs 8 hours after dose. Pseudoephedrine produces its decongestant effect within 30 minutes persisting for at least 4 hours.
Paracetamol has analgesic and antipyretic actions.

Triprolidine concentration in plasma generally reaches a peak in 1.5 hours; plasma half-life is 3.2 hours.
Pseudoephedrine concentration in plasma generally reaches a peak in 1.5 hours after drug administration; plasma half-life is approximately 5.5 hours. The plasma half-life of pseudoephedrine is markedly decreased by acidification of urine and increased by alkalination.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma generally reaches a peak in 30 - 60 minutes; plasma half-life is 1 - 4 hours. It is metabolized in the liver and excreted in the urine, mainly as the glucuronide and sulfate conjugates.

Mutagenicity
There is insufficient information available to determine whether triprolidine, pseudoephedrine or paracetamol have mutagenic potential.

Carcinogenicity
There is insufficient information available to determine whether triprolidine, pseudoephedrine or paracetamol has carcinogenic potential.

Teratogenicity
In rats and rabbits, systemic administration of triprolidine up to 75 times the human daily dosage did not produce teratogenic effects. Systemic administration of pseudoephedrine up to 50 times the human daily dosage in rats, and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

Fertility
No studies have been conducted in animals to determine whether triprolidine, pseudoephedrine or paracetamol have potential to impair fertility. There is no information on the effect of Actodryl on human fertility.

Propylene glycol,
Glycerin,
Sorbitol 70% (non-crystalline),
Sugar,
Sodium benzoate,
Sodium saccharine,
Color FD&C yellow 6,
Orange flavor,
Purified water.

Not applicable.

The recommended shelf life of Actodryl is 24 months. Once opened, your medicine can be stored at a temperature below 30°C and must be used within 3 months.

Keep out of the reach and sight of children.
Do not store above 30°C.
Store in the original container.

Primary Packing Material - 120 ml USP type III amber glass bottle and the cap made from Polyethylene and polypropylene. The cap & bottle are mechanically sealed to prevent from any foreign contamination, measuring cup of 15 ml capacity provided.

No special requirements.