Zyactin 4 mg Tablets.

ZYACTIN is used in the symptomatic treatment of seasonal and perennial rhinitis. ZYACTIN is also indicated for the symptomatic relief of pruritis.

For seasonal and perennial allergic rhinitis and pruritis. Posology:

Adults: The therapeutic range is from 4 mg to 20 mg per day. The majority of patients require 12 mg to 16 mg a day. It is suggested that the dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the weight and response of the patient.

Children (7 to 14 years): The usual dosage is 4 mg (1 tablet) 2 or 3 times a day. The dosage may be adjusted according to the weight and response of the child. Should an additional dose be required, it should preferably be taken at bedtime. The dosage must not exceed 16 mg per day.

Children (2 to 6 years): The suggested dosage is 2 mg (u00bd tablet) 2 or 3 times a day. The dosage may be adjusted according to the weight and response of the child. Should an additional dose be required, it should preferably be taken at bedtime. The daily dosage should not exceed 8 mg.

• Hypersensitivity to cyproheptadine or to any of the excipients (see section 6.1).
• In patients with closed angle glaucoma.
• In patients with bladder neck obstruction.
• In patients with symptomatic prostatic hypertrophy.
• In patients on monoamine oxidase inhibitor (MAOI) therapy.
• In patients with stenosing peptic ulcer.
• In pyloroduodenal obstruction.
• In the elderly or debilitated patient.

Paediatric use: Safety and efficacy in children below the age of two years have not been established.

Acute asthmatic attack: ZYACTIN should not be used for the treatment of an acute asthmatic attack.

Nursing mothers: Because of the higher risk of antihistamines for infants generally, and for newborns and babies born prematurely in particular, ZYACTIN is contraindicated in nursing mothers.

Dizziness, sedation and hypotension is more likely to occur in elderly patients. Prolonged therapy with ZYACTIN may cause blood dyscrasias. Due to the atropine-like action of ZYACTIN, it should be used with caution in patients with a history of bronchial asthma, hyperthyroidism, increased intra-ocular pressure, cardiovascular disease and hypertension.

Lactose monohydrate: ZYACTIN contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take ZYACTIN.

Monoamine oxidase inhibitors (MAOIs): MAOIs may prolong and intensify the anticholinergic effects of ZYACTIN.

Central nervous system (CNS) depressants: Cyproheptadine may have additive effects when combined with alcohol and other CNS depressants, e.g. hypnotics, sedatives, tranquillisers and anxiolytic medicines.

Antidepressants: Medicines with anti-serotonin activity, such as ZYACTIN, may interfere with serotonin-enhancing antidepressant medicines.

Drug screening: ZYACTIN may cause a false positive test result for tricyclic antidepressant medicines when evaluating a drug screen (e.g. urine, serum).

Safety in pregnancy has not been established.

ZYACTIN may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of other CNS depressant medicines or alcohol. Hence patients should not operate hazardous machinery or drive motor vehicles while on ZYACTIN.

Summary of the safety profile: The side effects that present frequently are drowsiness and somnolence. Many patients who complain initially of drowsiness may no longer do so after the first three of four days of continuous administration. Adverse reactions which have been reported with the use of cyproheptadine are as follows:

Blood and lymphatic system disorders: Less frequent: haemolytic anaemia, agranulocytosis, leucopenia, thrombocytopenia

Metabolism and nutrition disorders: Less frequent: increased appetite / weight gain

Psychiatric disorders: Frequency unknown: diminished mental alertness, excitability (especially in young children), confusion, hallucinations, restlessness, insomnia, irritability, nervousness, excitation, aggressive behaviour, euphoria

Nervous system disorders: Frequent: drowsiness and somnolence (the drowsiness effect may subside after the first three or four days of continuous administration) Less frequent: sedation, disturbed coordination, dizziness, confusion, restlessness, excitation, nervousness, irritability, aggressive behaviour, tremor, paraesthesia, insomnia, convulsions, euphoria, hallucinations, faintness, hysteria, neuritis, vertigo, headache

Eye disorders: Less frequent: blurred vision, diplopia

Ear and labyrinth disorders: Less frequent: tinnitus, acute labyrinthitis

Cardiac disorders: Less frequent: tachycardia, palpitations, extrasystoles

Vascular disorders: Less frequent: hypotension, anaphylactic shock

Respiratory, thoracic and mediastinal disorders: Less frequent: thickening of bronchial secretions, dryness of nose and throat, tightness of chest and wheezing, nasal stuffiness, epistaxis

Gastrointestinal disorders: Less frequent: dryness of the mouth, anorexia, epigastric distress, nausea, vomiting, diarrhoea, constipation

Hepatobiliary disorders: Less frequent: jaundice, cholestasis, hepatic failure, hepatitis, abnormal hepatic function

Skin and subcutaneous tissue disorders: Less frequent: allergic manifestations such as a rash and oedema, photosensitivity, excessive perspiration, urticaria

Renal and urinary disorders: Less frequent: frequency of micturition, difficult micturition, urinary retention

Reproductive system and breast disorders: Less frequent: early menses

General disorders and administration site conditions: Less frequent: fatigue, rigors, chills.

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of ZYACTIN is important. It allows continued monitoring of the benefit/risk balance of ZYACTIN. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Signs and symptoms of cyproheptadine overdosage may vary from hallucinations and CNS depression or stimulation, to convulsions and death, especially in infants and children. Atropine-like effects (dry mouth, fixed dilated pupils, flushing, etc) as well as gastrointestinal symptoms may occur.

If overdosage occurs, the patient should be monitored, and standard supportive treatment applied as required. If vomiting has not occurred spontaneously, vomiting should be induced if the patient is conscious. Stimulants should not be used. Hypotension may be treated with vasopressors.