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

Logo TRIAZINE TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

TRIAZINE TABLETS

COMPOSITION:
Each tablet contains
Cyclizine hydrochloride 50 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.2 Anti-emetics and anti-vertigo preparations.

PHARMACOLOGICAL ACTION:
Cyclizine, a piperazine derivative, is a first generation H1-receptor antagonist. Cyclizine diminishes or abolishes the main action of histamine in the body by competitive, reversible blockade of histamine receptor sites on tissue. It possesses both anticholinergic and anti-emetic activity. The exact mechanism by which it suppresses nausea and vomiting is unknown. It increases lower oesophageal sphincter tone and reduces sensitivity of the labyrinthe apparatus. It may also inhibit part of the midbrain known as the emetic centre.
Cyclizine is well absorbed with peak plasma concentration achieved within 2 to 3 hours and a duration of action of 4 to 6 hours. It is widely distributed throughout the body including the central nervous system and is extensively metabolized mostly to the N-Demethylated derivative, Norcyclizine which has little (H1) antihistaminc activity and has a plasma elimination half-life of approximately 20 hours.

INDICATIONS:
Prophylaxis and treatment of motion sickness, accompanying air, sea or land travel. Triazine is also used for the symptomatic treatment of vertigo due to Ménières disease.

CONTRA-INDICATIONS:
- In patients who previously reacted adversely to cyclizine.
- Safety in pregnancy and lactation has not been established.
- During acute attacks of asthma, narrow angle glaucoma, urinary retention, prostatic hypertrophy, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, unless directed by a physican.
- Should be avoided in cases of cardiovascular disease, liver disease or epilepsy.

WARNING:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.
Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks, where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Cyclizine hydrochloride is given by mouth in a usual dose of 50 mg up to three times daily, although up to 200 mg may be given in 24 hours if necessary.
Motion Sickness
To prevent motion sickness, Triazine should be taken 30 minutes before travelling and may be repeated three times daily if necessary.
Tablets
Not recommended for children under the age of 6 years, since they may be especially sensitive to anticholinergic effects.
Adults and children over 12 years: 1 tablet (50 mg) three times a day, not to exceed 200 mg daily.
Children 6 to 12 years: ½ tablet (25 mg) three times a day, not to exceed 75 mg daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Triazine has central nervous system depression activity. The most common side-effects are sedation, varying from slight drowsiness to deep sleep, inability to concentrate, dizziness, lassitude, fatigue, blurred and double vision, euphoria, nervousness, insomnia and tremors. Effects like hypotension, tinnitus and headache have been reported less frequently.
Paradoxical central nervous system stimulation may occur especially in children, with insomnia, nervousness, euphoria, irritability, tremors and rarely nightmares, hallucinations, and convulsions.
In high doses, central nervous system stimulation may be attributed to antimuscarinic activity.
Antimuscarinic side-effects include dry mouth, thickened respiratory tract secretions and tightness of the chest; blurred vision; urinary difficulty and retention; a reduction in tone and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux; in high doses, transient bradycardia followed by tachycardia with palpitations and arrythmias.
In addition to constipation, gastro-intestinal disturbances such as nausea vomiting, diarrhoea, or epigastric pain have occurred with antihistamines. Hypersensitivity reactions, particularly of the skin and cross-sensitivity to related medicine may occur.
Blood disorders, including agranulocytosis, leucopenia, haemolytic anaemia, and thrombocytopenia, though less frequent, have been reported. Antihistamines may precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex. Antihistamines may suppress positive skin test results. Jaundice may be observed.
Special Precautions:
Triazine should not be given to premature infants or neonates, as this group of patients has an increased susceptibility to antimuscarinic effects. Elderly patients are also more susceptible to many adverse effects of Triazine; including antimuscarinic effects, sedation and hypotension. Patients should avoid alcoholic drink.

INTERACTIONS:
Patients are warned that Triazine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillizers.
The anticholinergic effect of medicine such as atropine and tricyclic antidepressants may be enhanced by concomitant administration of Triazine.
Monoamine oxidase inhibitors may enhance antimuscarinic effects of Triazine. Triazine may mask warning signs of damage by ototoxic medicine such as aminoglycoside antibiotics.
Triazine enhances the soporific effect of pethidine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage, consult your doctor or take the patient to the nearest hospital immediately.
Specialised treatment is essential as soon as possible. Overdosage may be fatal especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, facial flushing and hyperpyrexia.
A deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults the usual symptoms are drowsiness, coma and convulsions. Hypotension may also occur.
Treatment:
In severe overdose with Triazine the stomach should be emptied. Emetics may be tried if the patient is alert and there are no symptoms of toxicity, but may be ineffective due to the antiemetic activity of the antihistamine.
Activated charcoal has been given, as well as saline laxatives. Convulsions should be controlled by parenteral anticonvulsant therapy. Central stimulants may increase the risk of convulsions, and their avoidance is advisable.
Other treatment is supportive and symptomatic.

IDENTIFICATION:
White, shallow biconvex, tablet scored on one side and engraved with mortar and pestle on the other side.

PRESENTATION:
Blister packs of 20 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

REGISTRATION NUMBER:
N/5.7.2/168

APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27.7.1981
                        G307A

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS:
S2

THE PROPRIETARY NAME OF THE MEDICINE:

TRIAZINE TABLETS

COMPOSITION:
Cyclizine hydrochloride 50 mg
Lactose
Starch maize
Povidone K25
Sta-Rx 1500
Magnesium stearate

INDICATIONS:
Triazine is used in the prevention and treatment of motion sickness, accompanying air, sea or land travel. It may have some beneficial effect in the treatment of dizziness due to disease of the inner ear (usually associated with dizziness and ringing ears).

BEFORE TAKING THIS MEDICINE:
It is very important that you read and understand the following information. If it causes you any concern or if you have any questions ask your doctor, pharmacist or health care professional.
The following must be considered before taking this medicine:

ALLERGIES:
Tell your doctor, pharmacist or health care professional if you have ever had any unusual or allergic reaction to cyclizine hydrochloride or related substances or to any other substances, such as foods, preservatives, or dyes.

PREGNANCY:
Triazine should be avoided in pregnancy as the safety of Triazine has not been established. Birth defects, such as cleft palate can occur in doses many times the usual dose.

BREASTFEEDING:
Triazine should be avoided in breastfeeding, since these medicines tend to decrease the secretions of the body and it is possible that the flow of breast milk may be reduced in some patients.

CHILDREN:
Triazine is not recommended for children under the age of 6 years, since they may be especially sensitive to anticholinergic effects of these medicines.

OLDER ADULTS:
Elderly people may be more sensitive to the anticholinergic effects of these medicines.

INTERACTIONS WITH OTHER MEDICINES:
Tell your doctor or pharmacist if you are on any prescription or non-prescription medicine, as some medicines cannot be taken together and yet some medicines can only be taken together if their dosages are adjusted. By telling your doctor or pharmacist what medicine you are taking, you can be given the necessary advice.
Patients are warned that Triazine can slow down the activity of the nervous system if it is used together with alcohol, barbiturates, medicines which relieve pain, medicines that are used to treat nervousness, restlessness or sleeplessness, as these medicines may increase the side effects of either medicines. The anticholinergic effects of medicines like atropine and those used in the treatment of depression may be intensified by the use of Triazine and the monoamine oxidase inhibitors will intensify, the anticholinergic effects of Triazine. Effects include a dry mouth, nose and throat, blurred vision, difficulty and painful urination and tightness of the chest. Triazine may mask the warning signs of damage by medicines that have toxic effects on the nerve of the ear, such as the aminoglycosides. The sleeping effect of pethidine will be intensified by the use of Triazine.

OTHER MEDICAL PROBLEMS:
The action and dose of cyclizine can be affected if you have any of the following medical problems: enlarged prostate, acute attacks of asthma, narrow angle glaucoma (raised pressure in the eye), urinary retention, emphysema (destructive lung condition with loss of elasticity), chronic lung disease, shortness of breath, difficulty in breathing.
The use of cyclizine should be avoided in liver disease, epilepsy and in cardiovascular disease, as it may worsen the condition.
Make sure you tell your doctor, pharmacist or health care professional of these problems, so they can advise you on what to do.

REMEMBER THE FOLLOWING:
If you are taking other medicine on a regular basis concomitant use of this medicine may cause
undesirable interactions. Please consult your doctor or pharmacist.
ALSO:
If you are pregnant or breast feeding your baby before taking the medicine please contact your doctor, pharmacist or other health care professional for advice.

HOW TO TAKE THIS MEDICINE:
The following information includes only the average dose of Triazine. If your dose is different, do not change it, unless your doctor tells you to do so.
For the prevention and treatment of motion sickness, adults and children older than 12 years can take 50 mg (1 tablet) three times a day, thirty minutes before travel.
Adults and children over 12 years: 1 tablet (50 mg) three times per day, not to exceed 200 mg daily.
Children: The tablets is not recommended for children under the age of 6 years, since they may be more sensitive to side-effects. The dose is based on body weight and must be determined by your doctor.
Children 6 - 12: ½ tablet three times a day, not to exceed 75 mg daily.

REMEMBER:
Take the medicine exactly as directed for full course of treatment. Do not take more of it or take it more often than stated on the label or ordered by your doctor. This may increase the side-effects.
If you take this medicine regularly, do not miss doses. If you do, follow the next lot of instructions: Take the missed dose as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
DO NOT DOUBLE DOSE.

SIDE-EFFECTS AND PRECAUTIONS:
Not all side-effects reported for this medicine are included on this leaflet. If your general state of health worsens while taking medicine, please consult your doctor or pharmacist.
Check and tell the doctor in charge that you are taking this medicine, before you have any skin test for allergies, as the result may be affected by this medicine. Cyclizine will add to the effects of alcohol and other medicines that slow down the nervous system, possibly causing drowsiness. Check with your doctor before taking any medicines for hay fever, allergies, colds, medicine to induce sleep, prescription pain medicines, medicine for seizures, muscle relaxants, or anesthetics, including dental anesthetics.
This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous, if you are not alert.
Cyclizine may cause dryness of the mouth. For temporary relief use sugarless gum, candy, melt bits of ice in your mouth, or use a saliva substitute. If your mouth continues to feel dry for more than 2 weeks, check with your doctor or dentist, as continuing dryness of the mouth may increase the chance of dental disease.
Side-effects include, a calming effect, varying from slight drowsiness to deep sleep, inability to concentrate or to sleep, drowsiness, dizziness, lack of energy, fatigue and inco-ordination. Less common or rare effects are blurred and double vision, unrealistic feeling of well being, nervousness, shakiness, diarrhoea, constipation, nausea, vomiting, stomach distress, increase in appetite, or anorexia. Effects like dry nose and throat, difficulty and painful urination and tightness of the chest can occur.
Allergic reactions like inflammation of the skin, fever, sensitivity to light, hypersensitivity, disease of the liver with jaundice (yellow pigmentation of the skin and eyes) have been observed.
The following effects are rare: Hematological complications like: too few white blood cells, or a severe decrease in a particular type of white blood cell, a decrease in the number of red blood cells or too few platelets.
In the event of overdose, consult your doctor or take the patient to the nearest hospital immediately.

STORAGE AND DISPOSAL INFORMATION:
Store away from heat and direct light.
Do not store your medicine in the bathroom, near the kitchen sink, or in any other damp places as heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Consult your doctor or pharmacist on a proper method with which to dispose of such medicine, and be sure to keep discarded medicine out of the reach of children.
DO NOT SHARE MEDICINES PRESCRIBED FOR YOU WITH OTHERS.
STORE ALL MEDICINES OUT OF THE REACH OF CHILDREN.

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