PAROVEN Capsule (2020)
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Περιεχόμενα
Name of the medicinal product
Paroven capsules 250 mg.
Qualitative and quantitative composition
<u>Active ingredient:</u> Oxerutins 250 mg.
Pharmaceutical form
Capsules.
Therapeutic indications
Relief of symptoms of oedema associated with chronic venous insufficiency.
Posology and method of administration
Posology Adults and elderly 2 capsules (500mg) twice daily. Patients with heart, renal or hepatic impairment Patients who have oedema of the lower limbs due to heart, kidney or liver disease should not ...
Contraindications
Hypersensitivity to O-(beta-hydroxyethyl)-rutosides or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Patients with heart, renal or hepatic impairment Treatment of leg oedema due to cardiac, renal or hepatic disease should be directed to the underlying cause; Paroven should not be used in these conditions. ...
Interaction with other medicinal products and other forms of interaction
None reported. Oxerutins have been shown not to interact with warfarin anticoagulants.
Fertility, pregnancy and lactation
Pregnancy Data on a limited number of exposed pregnancies indicate no adverse effects of O-(beta-hydroxyethyl)-rutosides on pregnancy or on the health of the fetus/new-born child. Animal studies do not ...
Effects on ability to drive and use machines
Paroven has no or negligible influence on the ability to drive and use machines. In rare instances tiredness and dizziness have been reported in patients using this product. If affected, patients are advised ...
Undesirable effects
Paroven may cause in rare cases gastrointestinal side effects or skin reactions like gastrointestinal disorder, flatulence, diarrhea, abdominal pain, stomach discomfort, dyspepsia, rash, pruritus or urticaria. ...
Overdose
No cases of overdosage with symptoms have been reported. No specific antidotes are known.
Pharmacodynamic properties
Pharmacotherapeutic group: Systemic vasoprotectors (bioflavonoid) ATC Code: C05CA51/rutoside combinations Mechanism of action The pharmacodynamic effects of HR have been demonstrated in different in vitro ...
Pharmacokinetic properties
The standardised mixture of HR consists of mono-HR, di-HR, tri-HR, and tetra-HR, which differ in the number of their hydroxyethyl substituents. Absorption After oral administration of <sup>14</sup>C-HR, ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of acute dose toxicity, repeated dose toxicity, genotoxicity and toxicity to reproduction.
List of excipients
Polyethylene glycol Gelatin Titanium dioxide E171 Yellow iron oxide E172 Black iron oxide E172 Shellac
Incompatibilities
None.
Shelf life
60 months.
Special precautions for storage
Protect from moisture.
Nature and contents of container
Blister pack composed of PVC blisters sealed with aluminium foil. Blister pack composed of PVC/PE/PVDC blisters sealed with aluminium foil. Pack sizes: 120 capsules.
Special precautions for disposal and other handling
Keep this medicine out of the sight and reach of children. No special requirements for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK
Marketing authorization number(s)
PL 00240/0550
Date of first authorization / renewal of the authorization
First Authorisation: 19 July 1991 Date of renewal: 28 March 2011
Date of revision of the text
02/11/2020
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