Paroven Capsules 250mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paroven capsules 250 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Oxerutins 250 mg
3. PHARMACEUTICAL FORM
Capsules
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Relief of symptoms of oedema associated with chronic venous insufficiency.
4.2. Posology and Method of Administration
Adults and elderly: 2 capsules (500 mg) twice daily.
Children: not recommended for children under 12 years
4.3. Contra-Indications
Hypersensitivity to O-(beta-hydroxyethyl)-rutosides or to any of the excipients listed in section 6.1.
4.4. Special Warnings and Special Precautions For Use
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. If leg pain and swelling do not improve, or get worse, the patient should consult their doctor.
Paroven is not recommended for children under 12 years.
Interaction with other Medicinal products and other forms of Interaction
4.5.
None reported. Oxerutins have been shown not to interact with warfarin anticoagulants.
4.6 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 indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see section 5.3 Preclinical safety data).
Nevertheless, according to generally accepted safety recommendations, HR should not be used during the first three months of pregnancy.
Breastfeeding
In animal studies, traces of HR were found in the fetuses and in the milk of breastfeeding dams. These minor amounts of HR are of no clinical significance.
Fertility
Animal studies did not indicate effects on fertility following administration of O-(B-hydroxyethyl)-rutosides.
4.7. 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 not to drive or operate machines.
4.8 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. Very rare is the occurrence of dizziness, headache, flushing, fatigue or hypersensitivity reactions like anaphylactoid reactions.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be
estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness._
|
System Organ Class (SOC) Frequency |
Adverse Reaction |
|
Immune system disorders Very rare |
Anaphylactoid reactions Hypersensitivity reactions |
|
Nervous system disorders Very rare Very rare |
Dizziness Headache |
|
Vascular disorders Very rare |
Flushing |
|
Gastro-intestinal disorders Rare Rare Rare Rare Rare Rare |
Gastrointestinal disorder, Gastrointestinal disorder Flatulence Diarrhea Abdominal pain Stomach discomfort Dyspepsia |
|
Skin and subcutaneous tissue disorders Rare Rare Rare Very Rare Very Rare |
Rash Pruritus Urticaria Photosensitivity Alopecia |
|
General disorders and administration site conditions Very rare |
Fatigue |
|
Musculoskeletal, connective tissue and bone disorders Very Rare |
Arthralgia |
Since the new Human Regulations came into force in August 2012, there is a requirement to include specified wording to alert patients to report side effects found in schedule 27, part 1, paragraph 14. It states: The statement: “Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.”.
4.9 Overdose
No cases of overdosage with symptoms have been reported. No specific
antidotes are known.
5.1. 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 and in vivo studies. At the cellular level the capability of HR to protect the vascular wall from the oxidative attack of activated blood cells and its affinity to the endothelium of capillaries and venoles could be shown.
In studies in healthy individuals or in patients suffering from CVI the following pharmacodynamic effects of HR could be demonstrated:
- reduction of the capillary permeability
- restoration of the veno-arteriolar reflex
- increase of the venous refilling time
- increase of the transcutaneous oxygen tension.
All these effects are compatible with the primary effect of HR being on the microvascular endothelium, with a resultant diminution of oedema.
5.2. 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 14C-HR, peak plasma levels are detected after 2-9 hours. Distribution
The plasma level declines progressively until 40 hours, after which the decline is very slow. This observation and the results obtained after i.v. application, indicate that HR may be distributed to tissues (especially the endothelium of vessels), from which it is progressively and slowly released back into the circulation.
Plasma protein binding is 27-29%.
Biotransformation
The main metabolic pathway of HR after oral administration is hepatic O-glucuronidation.
Elimination
HR and its metabolites are excreted by both the biliar and the renal route. Excretion via the renal pathway is complete after 48 hours. The mean terminal half-life of the main constituent of HR, the tri-HR, is 18.3 hours with a range of 13.5 to 25.7 hours.
5.3. 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.
6.1 List of excipients
Polyethylene glycol Gelatin
Titanium dioxide E171 Yellow iron oxide E172 Black iron oxide E172 Shellac
6.2. Incompatibilities
None.
6.3. Shelf-Life
60 months.
6.4. Special Precautions for Storage
Protect from moisture.
6.5. Nature and Content 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.
6.6. Instructions for Use, Handling and Disposal
Medicines should be kept out of the reach of children.
7
MARKETING AUTHORISATION HOLDER
Novartis Consumer Health UK Limited Park View, Riverside Way,
Watchmoor Park, Camberley,
Surrey GU15 3YL
Trading as: Novartis Consumer Health
8. MARKETING AUTHORISATION NUMBERS
PL 0030/5002R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First authorisation: 19 July 1991 Date of renewal: 28 March 2011
10 DATE OF REVISION OF THE TEXT
19/06/2014