Pizotifen malate

SECTION 2: Hazards identification

CHEMWATCH HAZARD RATINGS Min Max Flammability: 1 Toxicity: 2 Body Contact: 2 Min/Nil=0 Low=1 Reactivity: 1 Moderate=2 High=3 Chronic: 2 Extreme=4 CANADIAN WHMIS SYMBOLS EMERGENCY OVERVIEW RISK Harmful if swallowed. Possible risk of harm to the unborn child. Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Skin contact may produce health damage*. Cumulative effects may result following exposure*. Possible skin sensitiser*. * (limited evidence).

Potential Acute Health Effects

SWALLOWED ■ Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual. ■ Side effects of tricyclic antidepressants include dry mouth, sour or metallic taste, constipation, retention of urine, blurred vision and changes in focusing, palpitations, and fast heart beat. Gastrointestinal disturbances (including nausea and vomiting), drowsiness, tremor, low blood pressure when standing, dizziness, sweating, weakness and fatigue, inco-ordination, epilepsy-like seizures, and speech difficulties may occur. ■ Patients with Major Depressive Disorder may experience worsening of their depression and suicidal ideation even on medication until significant remission occurs. The association between the antidepressant drugs and worsening of symptoms are yet inconclusive. ■ Antihistamines have side effects such as sedation, stomach upset (nausea, vomiting, diarrhoea or constipation), blurred vision, ringing in the ears, mood changes, irritability, nightmares, loss of appetite, difficulty urinating, dry mouth, chest tightness and tingling, heaviness and weakness in the hands, nervousness, restlessness, irritability, feeling of well-being, disturbed eye movements, difficulties moving the face, "pins and needles", palpitations, faintness, increased heart rate, uncommonly irregular heart rhythms, lung swelling, and disturbed sleep and dreaming. Treatment may cause side effects within 15 minutes including a dry mouth and throat, blocked nose, wheeze, thick phlegm, fever, sweating, smell disturbances, skin flushing, double vision and dilated pupils. EYE ■ Although the material is not thought to be an irritant (as classified by EC Directives), direct contact with the eye may cause transient discomfort characterised by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. SKIN ■ The material is not thought to be a skin irritant (as classified by EC Directives using animal models). Abrasive damage however, may result from prolonged exposures. ■ Skin contact with the material may damage the health of the individual; systemic effects may result following absorption. ■ Open cuts, abraded or irritated skin should not be exposed to this material. ■ Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected. INHALED ■ The material is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation (as classified by EC Directives using animal models). Nevertheless, adverse systemic effects have been produced following exposure of animals by at least one other route and good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting. ■ Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled. If prior damage to the circulatory or nervous systems has occurred or if kidney damage has been sustained, proper screenings should be conducted on individuals who may be exposed to further risk if handling and use of the material result in excessive exposures.

Potential chronic health

■ Based on experience with animal studies, exposure to the material may result in toxic effects to the development of the foetus, at levels which do not cause significant toxic effects to the mother. Substance accumulation, in the human body, may occur and may cause some concern following repeated or long-term occupational exposure. There is limited evidence that, skin contact with this product is more likely to cause a sensitisation reaction in some persons compared to the general population. Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particles less than 0.5 micron penetrating and remaining in the lung. Prime symptom is breathlessness; lung shadows show on X-ray. Long-term use of antihistamines can cause sugar in the urine, obstructive jaundice, skin discolouration associated with loss of platelets, early periods, loss of milk production, breast development in males and decreased sex drive. Disturbances in the blood include anaemia, loss of white blood cells and platelets. Allergic reactions include fever, eczema, red wheal and blistering, a measles-like or scarlet-fever like rash, itching, sensitivity to light, swelling of the extremities, throat and other areas, asthma, lupus-like symptoms and anaphylactic shock. Prolonged use may cause difficulty in moving the muscles of the face. Withdrawing the drug generally improves these effects. Wide area external application of antihistamines can cause various side effects, including sensitisation and eczema.