PAROVEN Capsule Ref.[8610] Active ingredients: Rutoside Troxerutin

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.

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

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-(beta-hydroxyethyl)-rutosides.

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.

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.

Immune system disorders

Very rare: Anaphylactoid reactions, Hypersensitivity reactions

Nervous system disorders

Very rare: Dizziness, Headache

Vascular disorders

Very rare: Flushing

Gastro-intestinal disorders

Rare: Gastrointestinal disorder, Flatulence, Diarrhea, Abdominal pain, Stomach discomfort, Dyspepsia

Skin and subcutaneous tissue disorders

Rare: Rash, Pruritus, Urticaria

Very Rare: Photosensitivity, 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None.