Uniplus - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Undesirable Effects Shelf Life and Storage

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.

COMPOSITION:

  • 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.

PHARMACEUTICAL FORM

  • 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.

Further information on Uniplus is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

UNIPLUS

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

Suppositories:

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.


04.3 Contraindications

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.


04.9 Overdose

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

06.1 Excipients

Each suppository contains:

Adults: semisynthetic glycerides 2,100 g.

Children: semisynthetic glycerides 1,400 g.

Early childhood: semisynthetic glycerides g 0.690.


06.2 Incompatibility

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

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07.0 MARKETING AUTHORIZATION HOLDER

A.C.R. Angelini Francesco S.p.A. - Viale Amelia, 70 - 00181 ROME

08.0 MARKETING AUTHORIZATION NUMBER

Code:

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

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10.0 DATE OF REVISION OF THE TEXT

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11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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