INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CIPLA-ACTIN Tablets

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CIPLA-ACTIN Tablets

COMPOSITION:
Each tablet contains
cyproheptadine hydrochloride 4 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics.

PHARMACOLOGICAL ACTION:
Cyproheptadine hydrochloride, a piperidine derivative, is a sedating antihistamine with antimuscarinic, serotonin-antagonist and calcium-channel blocking actions.

INDICATIONS:
CIPLA-ACTIN is used in the symptomatic treatment of seasonal and perennial rhinitis. CIPLA-ACTIN is also indicated for the symptomatic relief of pruritis.

CONTRA-INDICATIONS:
Cyproheptadine is contra-indicated in patients hypersensitive to cyproheptadine and other medicines of similar chemical structure; in closed angle glaucoma; in bladder neck obstruction; in symptomatic prostatic hypertrophy; in patients on monoamine oxidase inhibitor therapy; in stenosing peptic ulcer; in pyloroduodenal obstruction; and in the elderly, debilitated patient.
Paediatric use:
Safety and efficacy in children below the age of two years have not been established.
Acute asthmatic attack:
Cyproheptadine should not be used for the treatment of an acute asthmatic attack.       
Pregnancy and lactation:
Safety in pregnancy and lactation has not been established.

WARNINGS:
Activities requiring mental alertness:
Cyproheptadine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of other CNS depressant agents or alcohol. Hence patients should not operate hazardous machinery or drive motor vehicles on this medication.
Drug interactions:
Monoamine oxidase (MAO) inhibitors may prolong and intensify the anticholinergic effects of cyproheptadine.
CNS depressants:
Cyproheptadine may have additive effects when combined with alcohol and other CNS depressants, e.g. hypnotics, sedatives, tranquillizers and anxiolytic agents.

DOSAGE AND DIRECTIONS FOR USE:
For seasonal and perennial allergic rhinitis and pruritis.
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 size 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 (1/2 tablet) 2 or 3 times a day. The dosage may be adjusted according to size 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The side-effects that present frequently are drowsiness and somnolence. The drowsiness effect may subside after the first three or four days of continuous administration.
The following adverse reactions have been reported with the use of cyproheptadine:
Neurological: Sedation, sleepiness (often transient), disturbed coordination, dizziness, confusion, restlessness, excitation, nervousness, irritability, tremor, paraesthesiae, insomnia, convulsions, euphoria, hallucinations, faintness, hysteria and neuritis.
Dermatological: Allergic manifestations such as a rash and oedema, photosensitivity, excessive perspiration and urticaria.
Special senses: Blurred vision, tinnitus, diplopia, acute labyrinthitis and vertigo.
Cardiovascular: Tachycardia, palpitations, hypotension, extrasystoles and anaphylactic shock.
Haematological: Heamolytic anaemia, agranulocytosis, leukopenia and thrombocytopenia.
Gastro-intestinal:Dryness of the mouth, anorexia, epigastric distress, nausea and vomiting, diarrhoea, jaundice and constipation.
Genito-urinary: Frequency of micturition, difficult micturition, urinary retention and early menses.
Respiratory: Thickening of bronchial secretions, dryness of nose and throat, tightness of chest and wheezing, nasal stuffiness.
Mental alertness: Cyproheptadine may diminish mental alertness (see "Warnings"); conversely, it may occasionally produce excitation, particularly in the young child.
Other: Fatigue, rigors, headache and increased appetite/weight gain.
Special precautions:
Dizziness, sedation and hypotension is more likely to occur in elderly patients.
Prolonged therapy with cyproheptadine may cause blood dyscrasias.
Due to the atropine-like action of cyproheptadine, it should be used with caution in patients with a history of bronchial asthma, hyperthyroidism, increased intra-ocular pressure, cardiovascular disease and hypertension.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of cyproheptadine overdosage may vary from hallucinations and central nervous system 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 gastro-intestinal 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 or the patient should be subjected to gastric lavage. Stimulants should not be used. Hypotension may be treated with vasopressors.

IDENTIFICATION:
White circular tablets with flat faces with 'CTN' engraved on one side and a central break-line on the other.

PRESENTATION:
Each carton contains colourless, transparent PVC and aluminium foil combipak blister strips of 10 tablets, in packs of 30.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C, protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
36/5.7.1/0072

NAME AND BUSINESS ADDRESS OF APPLICANT:
Cipla Life Sciences (Pty) Ltd.
Rosen Heights, Rosen Park,
Bellville, 7530, RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 2003

® CIPLA LIFE SCIENCES (PTY) LTD 2003

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New addition to this site: January 2005
Source: Community Pharmacy

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