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Paroven Capsules 250mg

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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