Adr19

South Africa: South African Medicines Control Council

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SIDE-EFFECTS AND SPECIAL PRECAUTIONS:http://home.intekom.com/pharm/hmr/tavanic.html

Gastro-intestinal symptoms may occur (gastric or abdominal symptoms, loss of appetite, nausea, vomiting, diarrhoea). The onset of diarrhoea, particularly if severe, persistent and / or bloody, during or after treatment with TAVANIC, may less frequently indicate the appearance of pseudomembranous colitis. Suspicion of pseudomembranous colitis requires immediate cessation of administration and treatment with appropriate specific antibiotic therapy. Products inhibiting peristalsis are contra-indicated in this clinical situation.

Disturbances of the nervous system, e.g. headaches, dizziness, sleep disturbances, unsteady gait and tremor (disturbances of muscular co-ordination), numbness and tingling in the limbs (parasthesiae; visual and auditory disturbances, disturbances of the senses of taste and smell, hallucinations, convulsions and psychotic reactions such as restlessness, agitation, anxiety, depression and confusion. In some cases, these reactions have occurred already after the first dose. In the event of such adverse reactions, TAVANIC must be discontinued immediately and the doctor informed.

Changes in the blood picture (leukopenia, eosinophilia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, haemolytic anaemia), hepatitis and transient increases in liver enzymes and/or bilirubin and in serum creatinine have been observed. Interstitial nephritis and acute kidney failure may also occur.

With the administration of TAVANIC I.V., local irritation, pain and reddening at the injection site, and phlebitis have been observed.

Allergic manifestation may occur, in particular hypersensitivity reactions of the skin such as pruritus, rash, urticaria and vasculitis. Isolated cases of severe bullous eruptions such as Stevens-Johnson syndrome. toxic epidermal necrolysis (Lyells syndrome) and erythema exsudativum multiforme have been reported. Photosensitivity reactions (skin reactions on exposure to strong sunlight and artificial UV rays) have been reported. There have been symptoms such as fever, allergic pneumonitis, angio-oedema, hypotension and anaphylactic-like shock. In the event of such reactions, TAVANIC should be discontinued immediately. Medical treatment (therapy for shock) is imperative.

Tendinitis (e.g. Achilles tendon) is less frequently observed with quinolones and if it is suspected, treatment with TAVANIC must be halted immediately and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon. Other musculoskeletal side effects such as arthralgia and myalgia have been less frequently observed and less frequent occurrences include:

* tendon rupture (Achilles tendon) - this undesirable effect may occur within 48 hours of starting treatment and may be bilateral.

* muscular weakness, which may be of special importance in patients with myasthenia gravis.

Isolated cases of rhabdomyolysis have been reported.

Hypoglycaemia, especially in diabetics, may occur

Asthenia, fungal overgrowth and proliferation of other resistant micro-organisms may occur

Fluoroquinolones are known to possibly trigger attacks of porphyria in patients suffering with porphyria

Interactions: If mineral-containing antacids or iron preparations are taken at the same time, absorption of TAVANIC tablets may be impaired. It is recommended that preparations containing divalent or trivalent cations such as iron salts, or magnesium- or aluminium-containing antacids should not be taken 2 hours before or after TAVANIC tablet administration.

The bioavailability of TAVANIC tablets is significantly reduced when administered together with sucralfate. If the patient is to receive both sucralfate and TAVANIC tablets, it is best to administer sucralfate two hours after the TAVANIC tablet administration.

No pharmacokinetic interactions of TAVANIC were found with theophylline in a clinical study. However there are indications of a pronounced lowering of the cerebral seizure threshold when quinolones are given concurrently with other drugs that lower the seizure threshold (e.g. theophylline ) or with fenbufen or similar non-steroidal anti-inflammatory drugs.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

According to studies in animals, the most important signs to be expected following acute overdosage of TAVANIC are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures.

Apart from symptomatic and supportive treatment, no specific therapeutic recommendation can be made in cases of overdosage.