Medicinal Products

ADVILTAB COLD 200 mg / 30 mg

Generic drug of the therapeutic class: Otorhinolaryngology
active ingredients: Ibuprofen, Pseudoephedrine
laboratory: Pfizer Sante Familiale

Coated tablet
Box of 20
All forms

Indication

This medicine contains a nonsteroidal anti-inflammatory drug, ibuprofen, and a vasoconstrictor, pseudoephedrine.

It is indicated in the treatment during colds of the adult (from 15 years):

· Feeling of stuffy nose,

· Headache and / or fever.

Posology ADVILTAB RHUME 200 mg / 30 mg Coated tablet Box of 20

Administration mode

Oral way.

The tablets are swallowed as is with a large glass of water, preferably during meals.

Dosage

RESERVED FOR ADULTS (FROM 15 YEARS)

1 tablet per dose, repeat if necessary after 6 hours, not exceeding 4 tablets per day.

In case of more severe symptoms, take 2 tablets per dose, without exceeding 4 tablets per day.

The maximum duration of treatment is 5 days

Against indications

This medicine is contraindicated in the following situations:

· In children under 15,

· From the 6th month of pregnancy (see section on Pregnancy and lactation ),

· In the event of a history of allergy or asthma triggered by taking ibuprofen or substances of similar activity such as other NSAIDs, aspirin, or a history of allergy to the other constituents of the tablet,

· In case of evolving gastric ulcer disease,

· In case of severe hepatocellular insufficiency,

· In case of severe renal insufficiency,

· In case of severe or poorly balanced hypertension,

· In the event 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 coronary insufficiency,

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

· If there is a risk of urinary retention related to urethro-prostatic disorders,

· In case of a history of seizures,

· In case of systemic lupus erythematosus,

· in association:

o vasoconstrictor drugs such as bromocriptine, pergolide lisuride, cabergoline, ergotamine, dihydroergotamine or other nasal decongestants that are administered orally or nasally, (phenylpropanolamine, phenylephrine, ephedrine.), with methylphenidate,

o with non-selective MAOIs (iproniazide),

If breastfeeding (see section Pregnancy and breast-feeding ).

This medicine SHOULD NOT BE USED:

· Until the 5th month inclusive of pregnancy (see section on Pregnancy and lactation ),

· in association with:

o oral anticoagulants,

o other NSAIDs (including aspirin in high doses),

o heparins in curative doses or in the elderly,

o lithium,

o Methotrexate (used at doses greater than 15 mg / week).

Side effects Adviltab Cold

Linked to pseudoephedrine:

· Headache,

· Palpitations, tachycardia, hypertensive pressure,

· Sweats,

· Glaucoma crisis by closing the angle,

· Urinary disorders (dysuria, retention), especially in cases of urethral-prostatic disorders,

· Anxiety, insomnia,

· Dry mouth, nausea, vomiting.

Have been described, especially in children after administration of vasoconstrictors:

Convulsions,

· Hallucinations,

· Agitation, behavioral problems and insomnia.

A fever, an overdose, a drug combination likely to reduce the epileptogenic threshold or to contribute to an overdose have often been found and seem to predispose to the occurrence of these effects (see headings Contraindications, .4 4).

Exceptionally, hemorrhagic strokes have occurred in patients who have used specialties containing pseudoephedrine. These cerebrovascular accidents have occurred in the event of overdose, misuse and / or in patients with vascular risk factors.

Related to ibuprofen:

Gastrointestinal effects:

Gastrointestinal disorders such as nausea, vomiting, gastralgia, dyspepsia, transit disorders, occult or non-occult haemorrhage have usually been reported. These are all the more frequent as the dosage used is high and the duration of treatment extended.

· Hypersensitivity reactions:

o Dermatological: rashes, rash, pruritus, edema, worsening of chronic urticaria.

o Respiratory: the onset of asthma attacks in some subjects may be related to an allergy to aspirin or a nonsteroidal anti-inflammatory drug (see section 4.3 ).

o General: Quincke's edema.

Effects on the central nervous system:

Ibuprofen may exceptionally be responsible for vertigo and headache.

Other:

· Some rare cases of visual disturbances have been reported;

· Oliguria, renal failure;

· The discovery of aseptic meningitis with ibuprofen should result in systemic lupus erythematosus or connective tissue disease.

Some biological modifications could be observed:

· Hepatic: transient increase in transaminases, haematological: agranulocytosis, haemolytic anemia.

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