Medicinal Products

ACTIVEED LP ALLERGIC RHINITIS 5 mg / 120 mg

Generic drug of the therapeutic class: Otorhinolaryngology
Active ingredients: Cetirizine, Pseudoephedrine
Lab: Johnson & Johnson Sante Bea

Extended release film-coated tablet
Box of 10
All forms

Indication

This medicine contains two active ingredients: cetirizine (second-generation anti-histamine) and pseudoephedrine (nasal decongestant).

It is indicated in adults and adolescents over 15 years old:

· In allergic manifestations with nasal congestion,

· In the treatment of symptoms of seasonal allergic rhinitis (hay fever) or non-seasonal rhinitis (animal hair, mold, mites ...) associated or not with allergic conjunctivitis: nasal congestion, clear nasal discharge, repeated sneezing, nasal and / or ocular itching (itching).

Dosage ACTIFED LP RHINITE ALLERGIC 5 mg / 120 mg Extended-release film-coated tablet Box of 10

Oral way.

RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OLD.

One tablet twice daily (morning and evening), with or without food.

The tablets should be swallowed whole with a little water and should not be chewed.

In patients with mild to moderate renal impairment, the dosage will be reduced to one tablet per day.

In the absence of improvement after 5 days of treatment, it is necessary to take a medical opinion.

Once the symptoms of allergic rhinitis have been relieved, take over the management of allergic conjunctivitis by a more suitable treatment.

Against indications

This medicine is contraindicated in the following situations:

· Hypersensitivity to any of the constituents of the product.

· In children under 15 years old.

· In case of a history of stroke or risk factors that may lead to stroke, due to the sympathomimetic alpha activity of the vasoconstrictor.

· In case of severe or poorly balanced high blood pressure.

· In case of severe coronary insufficiency.

· If there is a risk of glaucoma by closing the angle.

· If there is a risk of urinary retention related to urethroprostatic disorders.

· In case of a history of convulsions.

· In case of breastfeeding (see section Pregnancy and breastfeeding ).

· In the event of impaired renal function due to the presence of cetirizine.

· In combination with non-selective MAOIs due to the risk of paroxysmal hypertension and potentially fatal hyperthermia (see section 4.5 ).

· In combination with indirect-acting sympathomimetics: vasoconstrictors to decongest the nose, whether administered orally or nasally [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine] as well as methylphenidate, due to the risk of vasoconstriction and / or hypertensive flare-ups (see section Interactions with other medicinal products and other forms of interaction ).

· In combination with alpha sympathomimetics: vasoconstrictors intended to decongest the nose, whether administered orally or nasally [etilefrine, naphazoline, oxymetazoline, phenylephrine (also known as neosynephrine), synephrine, tetryzoline, tuaminoheptane, tymazoline], as well as midodrine, because of the risk of vasoconstriction and / or hypertensive relapses (see section Interactions with other medicinal products and other forms of interaction ).

The combination of two decongestants is contraindicated, regardless of the route of administration (oral and / or nasal): such an association is useless and dangerous and corresponds to misuse.

This medicine SHOULD NOT BE USED during pregnancy (see section Pregnancy and breastfeeding ).

Adverse effects Actifed LP Allergic Rhinitis

Hypersensitivity reactions related to any of the components of this medicine.

Linked to the presence of pseudoephedrine

Cardiac disorders

· Palpitations.

· Tachycardia.

· Myocardial infarction.

Visual disorders

· Glaucoma crisis by closing the angle.

Gastrointestinal disorders

· Dry mouth.

· Nausea

· Vomiting.

Nervous system disorders

· Hemorrhagic strokes, exceptionally in patients who have used pseudoephedrine hydrochloride-based medicinal products : these strokes have occurred during overdose or misuse in patients with vascular risk factors.

· Ischemic vascular accidents.

· Headache.

· Convulsions.

Psychiatric disorders

· Anxiety.

· Agitation.

· Behavioral disorders.

· Hallucinations.

· Insomnia.

A fever, an overdose, a drug combination likely to reduce the epileptogenic threshold or to promote an overdose, have often been found and seem to predispose to the occurrence of such effects (see headings Contraindications and Warnings and precautions for use . ).

Urinary disorders

· Dysuria (especially in cases of urethroprostatic disorders).

· Urinary retention (especially in cases of urethroprostatic disorders).

Skin disorders

· Sweats.

· Exanthema.

· Pruritus.

· Urticaria.

Vascular disorders

· Hypertension (hypertensive thrust).

Linked to the presence of cetirizine

· Possibility of digestive disorders, dry mouth, vertigo,

· Exceptionally, cases of allergic reactions such as skin reactions and Quincke's edema have been reported,

· Rare cases of somnolence have been reported in some susceptible individuals, appearing from the start of treatment.

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