Active ingredients: Cloperastine
PRIVITUSS 708 mg / 100 ml Oral suspension
Indications Why is Privituss used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Cough suppressant.
THERAPEUTIC INDICATIONS (WHEN THIS MEDICINE IS PRESCRIBED BY THE DOCTOR)
Cough suppressant.
Contraindications When Privituss should not be used
Hypersensitivity to one of the components of the product.
Due to the absence of studies in the age group between 0 and 2 years, the use of the drug in very early childhood is not recommended.
Generally contraindicated in pregnancy (see precautions for use)
Precautions for use What you need to know before taking Privituss
Although the toxicity studies carried out during pregnancy in animals have not shown teratogenic activity and fetal toxicity, it is a good prudent rule not to take the drug in the first months of pregnancy and in the further period only in case of actual need under the direct supervision of the doctor. .
Interactions Which drugs or foods may change the effect of Privituss
The drug can interact with both depressants and central nervous system stimulants.
It should be borne in mind the possibility of enhancing the effect of substances with antihistamine / antiserotonin action and, to a lesser extent, of papaverine-type muscle relaxants.
Warnings It is important to know that:
At therapeutic dosages the drug does not induce sedation and does not interfere with the ability to drive and use machines.
Additional Notes
It can cause allergic reactions, even delayed ones.
Dose, Method and Time of Administration How to use Privituss: Posology
Adults: 5 ml three times a day.
Children:
- between 2 and 4 years: 2 ml twice a day;
- between 4 and 7 years: 3 ml twice a day;
- between 7 and 15 years: 5 ml twice a day.
Shake well before use.
A 2-3-5 ml calibrated measuring cup is attached to the package.
Instructions for opening and closing the bottle
- Opening: Press the cap downwards by unscrewing it to the left.
- Closing: Screw the cap all the way to the right
Overdose What to do if you have taken too much Privituss
In the event of an overdose, it is advisable to carry out normal procedures (gastric lavage, activated charcoal, etc.) and to check for any signs of overexcitation.
Side Effects What are the side effects of Privituss
The results of clinical trials have reported rare cases of mild and transient gastrointestinal disturbances.
No signs or symptoms related to a central effect of a sedative or excitatory type were found at therapeutic dosages.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor.
It is important to inform the doctor or pharmacist of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The validity period is intended for the product in intact packaging, correctly stored.
Warning: do not use the product after the expiry date shown on the package.
This medicine does not require any special storage conditions.
Keep out of the reach and sight of children.
Deadline "> Other information
COMPOSITION
100 ml of suspension contain:
- Active ingredient: L-Cloperastine fendizoate 708 mg (equal to 400 mg cloperastine hydrochloride).
- Excipients: xanthan gum, polyoxyethylene stearate, xylitol, methyl p-hydroxybenzoate, propyl phydroxybenzoate, banana flavor, deionized water.
PHARMACEUTICAL FORM AND CONTENT
Oral suspension - 200 ml bottle
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
PRIVITUSS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml of suspension contain:
Active principle:
Cloperastine fendizoate 708 mg (equivalent to cloperastine hydrochloride 400 mg)
03.0 PHARMACEUTICAL FORM -
Suspension for oral use - 200 ml bottle
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Cough suppressant.
04.2 Posology and method of administration -
Adults: 5 ml three times a day.
Children: between 2 and 4 years: 2 ml twice a day;
between 4 and 7 years: 3 ml twice a day;
between 7 and 15 years: 5 ml twice a day.
A 2-3-5 ml calibrated measuring cup is attached to the package.
04.3 Contraindications -
Hypersensitivity to one of the components of the product.
Due to the absence of studies in the age group between 0 and 2 years, the use of the drug in very early childhood is not recommended.
Generally contraindicated in pregnancy.
04.4 Special warnings and appropriate precautions for use -
None.
04.5 Interactions with other medicinal products and other forms of interaction -
Although the central side effects of levocloperastine are significantly reduced, the drug may interact with both CNS depressants and stimulants.
It should be borne in mind the possibility of enhancing the effect of substances with antihistamine / antiserotonin action and, to a lesser extent, of papaverine-type muscle relaxants.
04.6 Pregnancy and breastfeeding -
Although the toxicity studies carried out during pregnancy in animals have not shown teratogenic activity and fetal toxicity, it is a good prudent rule not to take the drug in the first months of pregnancy and in the further period only in case of actual need under the direct supervision of the doctor. .
04.7 Effects on ability to drive and use machines -
At therapeutic dosages the drug does not induce sedation and does not interfere with the ability to drive and use machines.
04.8 Undesirable effects -
The results of clinical trials have reported only rare cases of gastrointestinal disturbances, of a mild, transient nature and of questionable attribution.
No signs or symptoms related to a central effect of a sedative or excitatory type were found at therapeutic dosages.
04.9 Overdose -
In the event of an overdose, it is advisable to carry out normal procedures (gastric lavage, activated charcoal, etc.) and to check for any signs of overexcitation.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
R05DB49 changed to 21
- Pharmacotherapeutic group:
Cough suppressant.
- Action mechanism:
Selective inhibitory action on the bulbar cough center.
Sedative action on peripheral stimuli that induce the tussigenous reflex, through inhibition of the mediators of the inflammatory process and an anti-bronchospastic effect.
05.2 "Pharmacokinetic properties -
The product is absorbed by the intestine and excreted mainly by the urinary route, mostly in a degraded form.
The maximum plasma peak is reached in 90-120 minutes, with subsequent wide distribution in the tissue districts, especially in the lungs.
05.3 Preclinical safety data -
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06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
100 ml of suspension contain:
Xanthan gum, Polyoxyethylene stearate, Xylitol, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Banana flavor, Deionized water.
Additional Notes:
It can cause hives. Generally it can cause delayed reactions such as contact dermatitis. Rarely immediate reactions with urticaria and bronchospasm.
06.2 Incompatibility "-
None.
06.3 Period of validity "-
5 years.
06.4 Special precautions for storage -
None.
06.5 Nature of the immediate packaging and contents of the package -
Yellow glass bottle with child-proof cap, fitted with a seal, containing a suspension with a fruity odor and sweet, pleasant taste.
06.6 Instructions for use and handling -
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07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
MITIM S.r.l. - Via Rodi, 27 - 25126 BRESCIA
08.0 MARKETING AUTHORIZATION NUMBER -
A.I.C. n ° 029134018
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Renewal date: June 2003
10.0 DATE OF REVISION OF THE TEXT -
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