Paroven® capsules 250 mg

Active ingredient: Oxerutins 250 mg

Capsules

Relief of symptoms of oedema associated with chronic venous insufficiency.

Adults and elderly: 2 capsules (500 mg) twice daily.

Children: not recommended for children under 12 years

Hypersensitivity to any of the ingredients.

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.

None reported. Oxerutins have been shown not to interact with warfarin anticoagulants.

Clinical trials and animal studies have shown no increase in teratogenic (or other) hazard to the foetus if used in the recommended dosage during pregnancy. However, in keeping with current medical opinion, Paroven should not be used during the first trimester of pregnancy. In animal studies traces of oxerutins and/or their metabolites have been found in breast milk, but the levels are not considered to be of clinical relevance. The use of Paroven in lactating women is therefore at the physician's discretion.

None known.

The following adverse effects have been reported which disappear rapidly on stopping treatment.

Immune system disorders:

Very rare (<1/10,000): anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions

Nervous system disorders:

Very rare (<1/10,000): dizziness, headache

Vascular disorders :

Very rare (<1/10,000): flushing

Gastro-intestinal disorders:

Rare (>1/10,000,<1/1,000): gastrointestinal disorder, flatulence, diarrhea, abdominal pain, stomach discomfort, dyspepsia

Very rare (<1/10,000): nausea, vomiting

Skin and subcutaneous tissue disorders:

Rare (>1/10,000,<1/1,000): rash, pruritus, urticaria

Very rare (<1/10,000): photosensitivity, alopecia

Musculosceletal, connective tissue and bone disorders

Very rare (<1/10,000): arthralgia

General disorders and administration site conditions

Very rare (<1/10,000): fatigue

No cases of overdosage with symptoms have been reported. No specific antidotes are known.

Oxerutins has uniquely useful therapeutic actions in the microcirculation and particularly in the post-capillary venous segment. Oxerutins reduces capillary leakage and hence oedema formation.

Not all conventional pharmacokinetic parameters are available due to technical difficulties. Oxerutins is absorbed from the gastrointestinal tract of mammals. Its metabolism is, in part, determined by the degree of hydroxyethylation of the aromatic ring systems of the constituent rutoside derivatives. Biliary excretion plays a major role in elimination in the animal species studied. It is, however, not clear if this route of elimination is equally important in man since quantitative data in humans are not available.

The same applies to entero-hepatic recycling.

Not applicable.

Polyethylene glycol

Gelatin

Titanium dioxide E171

Yellow iron oxide E172

Black iron oxide E172

Shellac

None.

60 months.

Protect from moisture.

Blister pack composed of PVC blisters sealed with aluminium foil.

Pack sizes: 120 capsules.

Medicines should be kept out of the reach of children.

Novartis Consumer Health UK Ltd

Trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UK

PL 0030/5002R

15 October 1996

1 April 2009

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