TRIFLUSAL Hard capsule Ref.[8264] Active ingredients: Triflusal

Renal or hepatic impairment

Experience is limited. In patients with end stage renal disease on conventional haemodialysis, pre- and post-dialysis plasma levels of the main triflusal metabolite, HTB (2-hydroxy-4-(trifluoromethyl)benzoic acid), are similar (see section 4.2).

Bleeding risk

While triflusal has caused a low incidence of bleeding complications in clinical studies, it should be used with caution in patients at risk of bleeding due to trauma or other pathological conditions. Drugs that may induce bleeding, such as acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs), should also be used with caution in patients treated with triflusal (see section 4.5).

If elective surgery is planned in a patient, bleeding risk should be assessed and, if considered necessary, triflusal should be discontinued 7 days before surgery.

In vitro protein binding studies showed an increase in the free fraction of HTB (main active metabolite of triflusal) in the presence of NSAIDs. In addition, high HTB concentrations increase free fractions and may therefore increase the effect of NSAIDs, glisentide, and warfarin (see section 5.2). Dose adjustment of these drugs may be required if they are administered concomitantly with triflusal.

Safety of concomitant administration of triflusal with thrombolytic agents (rt-PA and streptokinase) was assessed in patients with acute myocardial infarction. Incidence of intracranial haemorrhage was lower than in patients treated with a combination of ASA and thrombolytic agents (0.1% vs. 1.1%, p=0.04) (see section 5.1).

Triflusal may potentiate the action of oral anti-diabetics. A dose adjustment of oral anti-diabetics may be required.

Pregnancy

For triflusal, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development. The benefit/risk should therefore be assessed when it is administered to pregnant women.

Breastfeeding

It is not known whether triflusal is excreted in human milk. The benefit/risk should therefore be assessed when it is administered during the lactation period.

Triflusal has no influence on the ability to drive and use machines.

The most commonly reported adverse reactions affect the gastrointestinal tract and usually resolve in a few days even while treatment is continued.

Adverse reactions ordered by system and frequency were as follows: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1.000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders: Uncommon: pruritus/skin rash.

Skin and subcutaneous tissue disorders

Uncommon: pruritus/skin rash.

Nervous system disorders

Common: headache

Uncommon: confusion/vertigo/dizziness/seizures

Ear and labyrinth disorders

Uncommon: tinnitus/hypoacusis

Other special sense disorders

Uncommon: taste disturbance

Gastrointestinal disorders

Very common: dyspepsia

Common: abdominal pain/nausea/constipation/vomiting/flatulence/anorexia

Uncommon: diarrhoea/gastrointestinal bleeding/melena/rectal bleeding

Vascular disorders

Uncommon: hypertension, cerebral haemorrhage

Cardiac disorders

Uncommon: transient ischaemic attack

Respiratory, thoracic and mediastinal disorders

Uncommon: dyspnoea/upper respiratory tract infection

Blood and lymphatic disorders

Uncommon: anaemia, epistaxis/haematoma/purpura/gingival bleeding

Renal and urinary disorders

Uncommon: haematuria/urinary tract infection

General disorders and administration site conditions

Uncommon: distended abdomen/fever/influenza symptoms

Some isolated photosensitivity reactions have been reported.

Not applicable.