ACTIFEDDUO LP ALLERGIC RHINITIS contains cetirizine (second generation antihistamine) and pseudoephedrine (a nasal decongestant).
It is indicated in adults and adolescents over 15 years:
· In allergic manifestations with nasal congestion,
· In the treatment of symptoms of seasonal allergic rhinitis (hay fever) or not seasonal (animal dander, mold, dust mites ...) associated or not with allergic conjunctivitis: nasal congestion, clear nasal discharge, sneezing repeatedly, pruritus (itching) nasal and / or eye

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For warnings, the precautions and cons-indications, please see the instructions.


Film-coated tablet sustained release.
White to off-white, biconvex, round.
Cetirizine dihydrochloride ................................................................................................................... 5 mg
Pseudoephedrine HCl ...................................................................................................... 120 mg
Each tablet for extended release.
Excipient: lactose.
Excipients: Core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, croscarmellose sodium.
Coating: Opadry Y-1-7000 white (hypromellose, titanium dioxide, macrogol 400).
This medicine contains two active ingredients: cetirizine (antihistamine second generation) and pseudoephedrine (a nasal decongestant).
It is indicated for adults and adolescents over 15 years:
· In allergic manifestations with nasal congestion,
· The treatment of symptoms of seasonal allergic rhinitis (hay fever) or non-seasonal (animal dander, mold, dust mites ...) or not associated with allergic conjunctivitis: nasal congestion, clear nasal discharge, sneezing repeatedly, pruritus (itching) nasal and / or eye.
One tablet twice a day (morning and evening), with or without food.
The tablets should be swallowed whole with a little water and must not be chewed.
In patients with mild to moderate renal impairment, the dose should be reduced to one tablet per day.
In the absence of improvement after 5 days of treatment, it is necessary to seek medical advice.
Once the symptoms of allergic rhinitis relieved, take over the management of allergic conjunctivitis in a more appropriate treatment.
This medicine is indicated in against-the following situations:
Hypersensitivity to any component of the product.
· In children under 15 years.
· In patients with a history of stroke or risk factors that may increase the risk of stroke, due to the alpha vasoconstrictor sympathomimetic activity.
· In case of severe hypertension or poorly balanced treatment.
· In case of severe coronary insufficiency. · If risk of glaucoma angle closure.
· In case of risk of urinary retention related disorders urétroprostatiques. ·
With a history of seizures.
· In case of lactation (see section Fertility / pregnancy / lactation).
· In the case of impaired renal function due to the presence of cetirizine.
· In combination with non-selective MAOIs because of the risk of paroxysmal hypertension and hyperthermia can be fatal (see section Interactions).
· In association with sympathomimetic indirect action: vasoconstrictor for decongest the nose, whether administered orally or nasally [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine] and methylphenidate, because of the risk of vasoconstriction and / or outbreaks hypertensive (see section Interactions.).
· In association with alpha-sympathomimetic: vasoconstrictors for decongest the nose, whether administered orally or nasally [etilefrine, naphazoline, oxymetazoline, phenylephrine (aka neosynephrine), synephrine, tetryzoline, Tuaminoheptane, tymazoline] and midodrine, because of the risk of vasoconstriction and / or extensive hypertensive (see section Interactions.).
The combination of two decongestants is against-indicated, regardless of the route of administration (oral and / or nasal), such an association is useless and dangerous and is a misuse.
This medicine SHOULD NOT BE USED MAINLY during pregnancy (see section Fertility / pregnancy / lactation).
In case of high or persistent fever, signs of superinfection occurred or symptoms persist beyond five days, a reassessment of treatment should be made.
Special warnings
Due to the presence of pseudoephedrine
· It is imperative to adhere strictly to dosage, treatment duration of 5 days, the cons-indications (see Adverse Effects).
· Patients should be aware that the occurrence of hypertension, tachycardia, palpitations or cardiac arrhythmias, nausea or any neurological signs (such as the onset or increase of headache) should be discontinued treatment.
· It is advisable for patients to seek medical advice in case of hypertension, heart disease, hyperthyroidism, diabetes or psychosis.
Taking this medicine is not recommended because of the risk of vasoconstriction and / or hypertensive surges associated with its indirect sympathomimetic activity with the following medications (see section Interactions):
· MAO-A selective · Ergot alkaloids of rye dopaminergic (bromocriptine, cabergoline, lisuride or pergolide) or vasoconstrictor (dihydroergotamine, ergotamine, methylergonovine or methysergide).
· In association with linezolid.
· Neurological disorders such seizures, hallucinations, abnormal behavior, agitation, insomnia have been reported more frequently in children after administration of vasoconstrictors systemically, especially during episodes febrile or overdoses.
Therefore, it is particularly suitable:
· Not to prescribe this treatment in combination with drugs that lower the seizure threshold such as terpene derivatives, Clobutinol, antimuscarinic substances, local anesthetics ... or if convulsive history;
· To respect, in all cases, the recommended dosage, and to inform the patient of the risks of overdose when combined with other drugs containing vasoconstrictors.
Related to excipients
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or Lapp malabsorption of glucose or galactose (rare hereditary diseases).
The attention of athletes is drawn to the fact that pseudoephedrine could produce a positive reaction in doping tests controls.
Drug Interactions: Related to the presence of pseudoephedrine
Associations against-indicated
(See section 4.3 Contraindications)
+ Non-selective MAOIs
Paroxysmal hypertension, hyperthermia can be fatal. Because of the duration of action of MAO, this interaction is still possible 15 days after stopping the MAOI.
+ Other indirect sympathomimetic (ephedrine, methylphenidate, phenylephrine (aka neosynephrine), pseudoephedrine)
Risk of vasoconstriction and / or hypertensive crises.
+ Alpha sympathomimetic (oral and / or nasal) (etilefrine, midodrine, naphazoline, oxymetazoline, phenylephrine, synephrine, tetryzoline, Tuaminoheptane, tymazoline)
Risk of vasoconstriction and / or hypertensive surges.
Concomitant use not recommended
(See section 4.4 Special warnings)
+ Ergot alkaloids of rye dopaminergic (bromocriptine, cabergoline, lisuride, pergolide)
Risk of vasoconstriction and / or hypertensive surges.
+ Ergot alkaloids of rye vasoconstrictor (dihydroergotamine, ergotamine, methylergonovine, methysergide)
Risk of vasoconstriction and / or hypertensive surges.
+ Selective MAO-A (moclobemide toloxatone)
Risk of vasoconstriction and / or hypertensive surges.
Linezolid +
Risk of vasoconstriction and / or hypertensive surges.
Combinations requiring precautions for use
Halogenated volatile anesthetics +
Intraoperative hypertensive crisis.
For scheduled surgery, it is preferable to discontinue treatment a few days before surgery.
Given the available data, the use ACTIFED LP RHINITIS ALLERGIC is not recommended during pregnancy.
For pseudoephedrine
There are no reliable data teratogenicity in animals.
Clinical, epidemiological studies have not revealed any teratogenic effects associated with the use of pseudoephedrine.
However, as a precautionary measure and given the powerful vasoconstrictive properties of this drug, its use is not recommended during pregnancy.
For cetirizine
Studies in animals have shown no evidence of teratogenicity. In the absence of teratogenic effects in animals, a teratogen in humans is not expected. Indeed, to date, the substances responsible for malformations in humans have proven teratogenic in animals in studies conducted in two species well.
In clinical practice, the use of cetirizine in a limited number of pregnancies has apparently revealed no particular malformation or foetotoxic to date. However, additional studies are needed to assess the consequences of exposure during pregnancy.
Accordingly, the use of cetirizine should be considered during pregnancy if necessary.
Given the available data, the use of LP ACTIFED RHINITIS ALLERGIC is against-indicated during lactation.
Regarding pseudoephedrine
Pseudoephedrine passes into breast milk. Given the possible cardiovascular and neurological effects of vasoconstrictors, taking this medicine is against-indicated during lactation.
Regarding cetirizine
Because of a low pass into breast milk, use of cetirizine is not recommended during lactation.
Drive and use MACHINES
In some susceptible patients, cetirizine can cause drowsiness.
Although this effect is less frequently observed with cetirizine than with first-generation antihistamines, it is advisable for patients who need driving or operating dangerous machines do not exceed the recommended dosage, and assess their vigilance in treatment.
Hypersensitivity reactions related to any component of this medication.
Associated with the presence of pseudoephedrine
Cardiac Disorders
· Palpitations. · Tachycardia. · Myocardial infarction.
Visual disturbances
· Crisis closure glaucoma angle.
Gastrointestinal disorders
· Dry mouth. Nausea. · Vomiting.
Nervous System Disorders
· Stroke Hemorrhagic exceptionally in patients who used specialties pseudoephedrine hydrochloride: these strokes occurred in overdose or misuse in patients with risk factors for ischemic vascular · Strokes · Headache.. . · Convulsions.
Psychiatric Disorders
· Anxiety. · Agitation. · Behavioural Disorders. · Hallucinations. · Insomnia.
Fever, overdose, drug combination may lower the seizure threshold or promote an overdose, were often found and appear to predispose to the occurrence of such effects (see sections Contraindications and Warnings and precautions. ).
Urinary Disorders
Dysuria · (especially if urétroprostatiques disorders). · Urinary retention (particularly in the case of disorders urétroprostatiques).
Skin disorders
· Sweats. · Rash. · Itching. · Urticaria.
Vascular disorders
· Hypertension (hypertensive crisis).
Associated with the presence of cetirizine
· Possibility of digestive disorders, dry mouth, dizziness, unusually · have been described cases of allergic skin reactions such reactions and angioedema · rare cases of drowsiness have been reported in certain sensitive subjects, appearing at beginning treatment.
An acute overdose of cetirizine or pseudoephedrine may produce tachycardia, arrhythmia, hypertension, signs of depression (sedation, apnea, unconsciousness, cyanosis and cardiovascular collapse) or stimulation (insomnia, hallucinations, tremor, seizures epilepsy) CNS can be fatal.
The treatment, preferably in a hospital, to be symptomatic, taking into account the drugs ingested simultaneously. If vomiting does not spontaneously occur, it will be caused. Gastric lavage is also recommended.
There is no known antidote. Sympathomimetic amines should not be used. Hypertension is controlled by alpha-blocking agents, tachycardia with beta-blockers. Seizures may be treated with intravenous diazepam (or rectal diazepam in the case of children).
Cetirizine and pseudoephedrine are poorly removed by hemodialysis.
The pharmacodynamic activity of cetirizine and pseudoephedrine combination is directly related to an additive effect of the activity of each of these components.
Cetirizine is a potent and selective H1-receptor antagonist with additional antiallergic properties: This component inhibits the early phase of the allergic reaction associated with histamine and also reduces the migration of certain inflammatory cells and the release of certain mediators associated with the delayed allergic reaction; it inhibits the reactions caused by histamine or pollen in the nasal provocation tests.
Pseudoephedrine is a sympathomimetic amine orally active wherein the alpha-mimetic activity compared to the predominantly beta-mimetic activity; due to its vasoconstrictor action, it has a decongestant effect on the nasal mucosa.
After oral administration, cetirizine is rapidly and almost completely absorbed. Peak plasma concentrations are generally achieved in one hour in fasting conditions.
Cetirizine does not know first-pass metabolism.
After repeated oral administration, the daily urinary excretion of unchanged cetirizine is approximately equal to 65% of the dose.
The uptake and elimination of cetirizine are independent of dose. Variations inter-and intra-subject is low. The plasma half-life of cetirizine is about 9 hours. This value increases in patients with reduced kidney function. Cetirizine is highly bound to plasma proteins (93%). The volume of distribution is low and is about 0.5 l / kg.
Pseudoephedrine as cetirizine / pseudoephedrine extended-release reached peak plasma concentration between 3 and 5 hours after administration. It is primarily excreted unchanged in the urine. The urinary excretion rate is increased when the urine pH is reduced, and in case of reduced urine alkalinization. After repeated oral administration (every 12 hours), at steady state, the half-life is estimated apparent elimination nearly 9 hours.
A high fat meal did not highlight a change in the bioavailability of the two active substances, but it is nevertheless resulted in a peak plasma concentration of reduced and delayed cetirizine.
The onset of action of the combination is 30 minutes.
Preclinical safety
The chronic toxicity studies have identified doses without toxic effect of 30 mg / kg / day in rats and 40 mg / kg / day in cynomolgus monkeys. At these doses, exposure was higher in monkeys, but lower in rats than that measured in humans.
A battery of genotoxicity tests gave negative results for the combination cetirizine / pseudoephedrine.
Studies of reproductive toxicity in rats showed a slight increase in stillbirths and decreased body weight in males of the F1 generation of toxic doses to the mother. This dose (40 mg / kg / day) is similar to the therapeutic exposure in humans systemic exposure. The relevance of this information for safe use in humans during pregnancy and lactation is uncertain.
3 years.
No special precautions for storage.
No special requirements.
MA 3400937620703 (Plq/10)

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