Uniplus - Package Leaflet
Active ingredients: Oxolamine (oxolamine citrate), Propifenazone
UNIPLUS Adults 250 mg + 350 mg Suppositories
UNIPLUS Children 125 mg + 150 mg Suppositories
UNIPLUS Early Childhood 60 mg + 50 mg Suppositories
Why is Uniplus used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY: Analgesic-antipyretic
THERAPEUTIC INDICATIONS: Therapy of inflammation of the upper airways (sinusitis, tonsillitis, pharyngitis, laryngitis, tracheobronchitis); otitis; pulpits; periodontitis; symptomatic therapy of influenza affections.
Contraindications When Uniplus should not be used
: Known hypersensitivity to one of the components; children under 2 months of age; granulocytopenia; acute intermittent porphyria; insufficiency of glucose-6-phosphate dehydrogenase.
Precautions for use What you need to know before taking Uniplus
Due to the presence of propiphenazone, the administration of high doses, or prolonged treatments with the product can cause haematological damage in hypersensitive subjects. Although "no teratogenic effects have been shown in animals, in pregnant women the product must only be administered in cases of actual need, under strict medical supervision. In breastfeeding women, the possibility that the active ingredients of the product are excreted with milk should be kept in mind.
Interactions Which drugs or foods can modify the effect of Uniplus
: No negative interactions have been reported with other drugs commonly used in therapy related to therapeutic indications
Warnings It is important to know that:
: During prolonged treatments, periodic checks of the blood count are recommended.
Keep the product out of the reach of children.
Dosage and method of use How to use Uniplus: Dosage
- Adult suppositories: 1 suppository 2-3 times a day according to the doctor's opinion.
- Suppositories children - children over 2 years: 1 suppository 2-3 times a day according to the doctor's opinion.
- Early childhood suppositories - children from 6 months to 2 years: 1 suppository 2-3 times a day according to age and doctor's opinion.
Side Effects What are the side effects of Uniplus
Rarely, allergic rashes may occur.
Report any undesirable effect not described in this leaflet to your doctor or pharmacist.
Expiry and Retention
ATTENTION do not use the medicine after the expiry date indicated on the package
Store at a temperature not exceeding 30 ° C.
- Adult suppositories - each suppository contains, active ingredients: oxolamine citrate 0.25 g; propiphenazone g 0.35
- Children suppositories - each suppository contains, active ingredients: oxolamine citrate 0.125 g; propiphenazone g 0.15
- Early childhood suppositories - each microsuppository contains, active ingredients: oxolamine citrate g 0.06; propiphenazone g 0.05 Excipients: semisynthetic glycerides.
- Adult suppositories: box of 10 suppositories
- Children suppositories: box of 10 suppositories
- Early childhood suppositories: box of 10 suppositories.
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
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains:
Adults: oxolamine citrate g 0.250; propiphenazone g 0.350;
Children: oxolamine citrate 0.125 g; propiphenazone g 0.150;
Early childhood: oxolamine citrate g 0.060; propiphenazone g 0.050.
03.0 PHARMACEUTICAL FORM
Adult suppositories; suppositories Children; suppositories Early childhood.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of inflammation of the upper airways (sinusitis, tonsillitis, pharyngitis, tracheobronchitis). Otitis. Rheumatic forms. Pulpits, periodontitis. Symptomatic therapy of influenza affections.
04.2 Posology and method of administration
Adults: 1 suppository two to three times a day, according to the doctor's opinion.
Children (over two years): 1 suppository two to three times a day according to the doctor's opinion.
Early childhood (Children aged 6 months to two years): 1 suppository two to three times a day, according to the age and the doctor's opinion.
Hypersensitivity already known to the components. Use in children under 2 months of age. Granulocytopenia, acute intermittent porphyria, glucose-6-phosphate dehydrogenase insufficiency.
04.4 Special warnings and appropriate precautions for use
Due to the presence of propiphenazone, high doses and prolonged treatments with the product can cause damage to the blood in hypersensitive subjects.
During prolonged treatments, periodic checks of the blood count are recommended. Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
The simultaneous use of other drugs did not show any negative interference with Uniplus.
04.6 Pregnancy and breastfeeding
Although no teratogenic effects have been shown in animals, in pregnant women the drug should be used only in case of real need and under strict medical supervision; in breastfeeding women, the possibility that the active ingredients contained in the product should be considered are excreted with milk.
04.7 Effects on ability to drive and use machines
Taking the drug does not affect the ability to drive or use other machinery.
04.8 Undesirable effects
In rare cases, allergic rashes may occur.
Acute intoxication manifests itself with anorexia, nausea and vomiting and, in the most severe cases, with deterioration of the general conditions. The measures include the use of cortisone, forced diuresis, hemodialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Mechanism of action: Uniplus positively modifies the components of inflammation of the bronchi and mucous membranes of the airways, fluidizing catarrhal secretions and preventing complications. This range of action is due to the original formulation of Uniplus which includes an antipyretic-analgesic (propiphenazone ) and an anti-inflammatory of the airways characterized by antitussive activity (oxolamine).
05.2 "Pharmacokinetic properties
Uniplus is easily absorbed both after oral and rectal administration. The component substances are distributed in the various tissues; Oxolamina, however, shows a specific tropism for the respiratory system. The components are largely eliminated in the urine after being extensively transformed in the body.
05.3 Preclinical safety data
Toxicology: The toxicological tests on various animal species have shown that the two substances making up Uniplus are well tolerated and have no teratogenic or mutagenic action. Activity: at therapeutic dosages Uniplus is able to perform antipyretic, anti-inflammatory and analgesic action.
06.0 PHARMACEUTICAL INFORMATION
Each suppository contains:
Adults: semisynthetic glycerides 2,100 g.
Children: semisynthetic glycerides 1,400 g.
Early childhood: semisynthetic glycerides g 0.690.
No incompatibility has been ascertained.
06.3 Period of validity
Suppositories are stable for 4 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Box of 10 suppositories Adults
Box of 10 suppositories Children
Box of 10 suppositories Early childhood
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
A.C.R. Angelini Francesco S.p.A. - Viale Amelia, 70 - 00181 ROME
08.0 MARKETING AUTHORIZATION NUMBER
suppositories Adults 020075040
suppositories Children 020075065
suppositories Early childhood 020075089
Date of first marketing: 1/12/1962
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
10.0 DATE OF REVISION OF THE TEXT