PAROVEN

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 use Paroven because the effect of O-(beta- hydroxyethyl)-rutosides has not been shown in these indications.

Paediatric population The safety and efficacy of Paroven in children and adolescents aged less than 18 years has not yet been established. No data are available. Method of administration Oral use.

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) Adverse Reaction Frequency Immune system disorders Very rare Anaphylactoid reactions Hypersensitivity reactions Nervous system disorders Very rare Dizziness Very rare Headache Vascular disorders Very rare Flushing Gastro-intestinal disorders Rare Gastrointestinal disorder, Rare Flatulence Rare Diarrhea Rare Abdominal pain Rare Stomach discomfort Dyspepsia Skin and subcutaneous tissue disorders Rare Rash Rare Pruritus Rare Urticaria Very Rare Photosensitivity Very Rare Alopecia General disorders and administration site conditions Very rare Fatigue Musculoskeletal, connective tissue and bone disorders Very Rare Arthralgia Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medical product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. If leg pain and swelling do not improve, or get worse, the patient should consult their doctor.

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