TRIHEXYPHENIDYL HYDROCHLORIDE

Posology Adults and Elderly:

Initial dose 2mg. Subsequent doses up to 20mg as recommended by a physician.

Children:

Not recommended. Method of administration For oral administration

Modern clinical data required to determine the frequency of undesirable effects are lacking for trihexyphenidyl. Minor side effects such as dryness of mouth, constipation, blurring of vision, dizziness, mild nausea or nervousness will be experienced by 30-50% of all patients.

These reactions tend to become less pronounced as treatment continues. Patients should be allowed to develop a tolerance using the smaller initial dose until an effective level is reached.

Immune system disorders:

Hypersensitivity.

Psychiatric disorders:

Nervousness, restlessness, confusional states, agitation, delusions, hallucinations, insomnia, especially in the elderly and patients with arteriosclerosis. The development of psychiatric disturbances may necessitate discontinuation of treatment.

Euphoria may occur. There have been reports of abuse of trihexyphenidyl due to its euphoric and hallucinogenic properties.

Nervous system disorders:

Dizziness. Impairment of immediate and short-term memory function has been reported. 4). 4).

Cardiac disorders:

Tachycardia.

Respiratory, thoracic and mediastinal disorders:

Decreased bronchial secretions.

Gastrointestinal disorders:

Dry mouth with difficulty swallowing, constipation, nausea, vomiting.

Skin and subcutaneous tissue disorders:

Flushing and dryness of skin, skin rashes.

Renal and urinary disorders:

Urinary retention, difficulty in micturition.

General disorders:

Thirst, pyrexia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Precautions:

Since the use of trihexyphenidyl may, in some cases, continue indefinitely, the patient should be under careful observation over the long term. It should be administered with care to avoid allergic or other untoward reactions. Except in the case of vital complications, abrupt discontinuation of the drug should be avoided.

Incipient glaucoma may be precipitated by para-sympatholytic drugs such as trihexyphenidyl. Hypertension, cardiac, liver or kidney disorders are not contraindicated, but such patients should be followed closely. As trihexyphenidyl may provoke or exacerbate tardive dyskinesia, it is not recommended for use in patients with this condition.

Trihexyphenidyl should be used with caution in patients with glaucoma, obstructive disease of the gastro-intestinal or genito-urinary tracts, and in elderly males with possible prostatic hypertrophy. Since trihexyphenidyl has been associated with clinical worsening of myasthenia gravis, the drug should be avoided or used with great caution in patients with this condition.

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Warnings:

Trihexyphenidyl may be the subject of abuse (on the basis of hallucinogenic and euphoriant properties, common to all anti-cholinergic drugs) if given in sufficient amounts. 6g per 5ml. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.

1634 mg/ml. The amount in 5ml of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects. 27mg per 5ml. Co- administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.

While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.

Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.

18mg/ml. • Sodium – this medicine contains less than 1mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium-free’.

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