VELTEX Capsule / Solution for injection Ref.[51198] Active ingredients: Diclofenac

Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with VELTEX therapy. In view of the VELTEX inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Caution is required in patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) and should only be treated with diclofenac after careful consideration.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs including VELTEX, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal. The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of VELTEX, in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving VELTEX, treatment with VELTEX should be stopped.

VELTEX should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolyis have been reported. VELTEX should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Regular use of NSAIDs such as VELTEX during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased. VELTEX must be given with care to patients with asthma or bronchospasm, bleeding disorders, patients with peptic ulceration or a history of such ulceration, and with cardiovascular disease.

Patients with gastrointestinal symptoms or with severe hepatic or renal damage should be kept under close surveillance during therapy.

In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Patients suffering from impaired hepatic, cardiac or renal functions should be carefully monitored. If peptic ulceration or gastrointestinal bleeding occurs while under treatment the medicine must be withdrawn.

VELTEX may mask the signs and symptoms of infection due to its pharmacodynamic properties. Injections of VELTEX may cause local pain and irritation; abscesses and local necrosis have been reported.

VELTEX capsules contain sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.

VELTEX ampoules contain benzyl alcohol.

Increased risk due to accumulation in young children.

High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).

Foetal Toxicity: Limit use of NSAIDs, including VELTEX, between 20 to 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus.

If NSAID treatment is necessary between 20 weeks and 30 weeks gestation, limit VELTEX use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if VELTEX treatment extends beyond 48 hours. Discontinue VELTEX if oligohydramnios occurs and follow up according to clinical practice (see section 4.3 and 4.6).

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as VELTEX. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis.

Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue VELTEX and evaluate the patient immediately.

VELTEX must be given with care to people who are receiving coumarin anticoagulants. Serious interactions have been reported after the use of high doses of methotrexate in combination with diclofenac. When given with preparations containing lithium or digoxin it may raise the plasma concentration of these compounds.

Acute allergic reactions have been reported. Because of the possibility of cross sensitivity due to structural relationships that exist among nonsteroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds. Plasma concentrations are significantly decreased by the concomitant administration of doses of aspirin.

Concomitant administration of glucocorticoids or other nonsteroidal anti-inflammatory agents may aggravate gastrointestinal side effects. Dosages may have to be reduced in the elderly.

NSAIDs: use of two or more NSAIDs concomitantly could result in an increase in side effects.

Anti-coagulants: VELTEX may enhance the effects of anti-coagulants such as warfarin.

Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

VELTEX should not be given to pregnant or lactating women.

Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn.

The onset of labour may be delayed and its duration increased.

Use of NSAIDs, including VELTEX, can cause premature closure of the foetal ductus arteriosus and foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, the use of VELTEX dose and duration between 20 and 30 weeks of gestation should be limited and avoided at around 30 weeks of gestation and later in pregnancy (see section 4.3 and 4.4).

Patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking or receiving VELTEX, should refrain from driving or using machines.

a) Summary of the safety profile

Gastrointestinal disturbances such as nausea, vomiting, abdominal discomfort and diarrhoea may occur. Peptic ulceration and gastrointestinal bleeding have been reported. Other side effects include nervousness, headache, dizziness, depression, drowsiness, insomnia, blurred vision and tinnitus. Oedema and skin reactions such as rashes, urticaria, pruritus and eczema have been reported. Abnormalities of liver function tests, impairment of renal functions, agranulocytosis, aplastic anaemia and thrombocytopenia have been observed. Sensitivity reactions such as bronchospasm or anaphylactoid reactions, jaundice, hepatitis, renal failure and nephrotic syndrome may occur. Other side effects that may occur are minor hearing disorders, irritability, agitation, palpitations, tiredness and increased serum transaminase levels.

Cardiac disorders: Oedema, hypertension and cardiac failure.

Gastrointestinal system disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis.

Skin and subcutaneous tissue disorders: Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug Reaction with Eosinophillia and Systemic Symptoms (DRESS) (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

Not applicable.