ARTANE 2 mg Tablet B/50

Tablet.
Box of 50, under thermoformed blister packs.

For one tablet:

Trihexyphenidyl hydrochloride: 2 mg

Excipients with known effect : Each tablet contains 112,20 mg of lactose and 63,83 mg of wheat starch corresponding to 6,383 micrograms of gluten (see section Warnings and precautions).

• Parkinson's disease
• Parkinsonian syndromes induced by neuroleptics.

Dosage

Parkinson's disease : 4 to 10 mg per day, i.e. 2 to 5 tablets per day, in 2 to 3 doses.

Extrapyramidal syndromes due to neuroleptics :

Adults: 4 to 15 mg per day in 2 to 3 doses.

Children over 15 years: 2 to 6 mg per day depending on age in 2 or 3 doses.

In elderly subjects: do not exceed 10 mg per day in 2 doses.

Method of administration

Oral use.

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section Composition,
• Risk of angle-closure glaucoma,
• Risks of urinary retention related to urethroprostatic disorders,
• Decompensated heart disease,
• This medicine is contraindicated in patients with an allergy to wheat (other than coeliac disease).

Special warnings

Psychiatric disturbances may result from the injudicious use of ARTANE 2 mg tablet used to achieve a euphoric state.

Lactose

This medicine contains lactose. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) must not take this medicine.

Wheat starch (containing gluten)

This medicine contains a very low level of gluten (derived from wheat starch) and is therefore unlikely to cause problems in cases of coeliac disease.

One tablet contains no more than 6,383 micrograms of gluten.

This medicine must not be administered in cases of wheat allergy (different from coeliac disease).

Precautions for use

In elderly subjects who may be more sensitive to the action of parasympatholytic substances, adjust the dosage very precisely.

In patients suffering from obstructive intestinal and urinary tract diseases, administer ARTANE 2 mg, tablet with caution.

Risk of worsening intellectual deterioration in dementias, particularly in parkinsonian patients.

If the patient shows signs of intolerance, reduce the doses or temporarily discontinue the treatment.

Avoid any abrupt interruption of anticholinergic treatment: risk of imbalance in the correction of parkinsonian syndrome.

The combination of two anticholinergic antiparkinsonian drugs should be avoided insofar as it can only increase side effects without increasing therapeutic efficacy.

Account must be taken of the fact that atropinic substances may add up their undesirable effects and more readily lead to urinary retention, an acute glaucoma attack, constipation, dry mouth, etc. The various atropinic medicines are represented by imipramine-type antidepressants, most atropinic H1 antihistamines, anticholinergic antiparkinsonian drugs, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.

Associations requiring precautions for use

+ Dopaminergic ergot of rye alkaloids

Risk of increased neuropsychiatric disorders.

Regular clinical and biological monitoring, particularly at the start of the combination.

Associations to be taken into account

+ Other atropinic medicines

Addition of atropinic undesirable effects such as urinary retention, constipation, dry mouth....

+ Anticholinesterases

Risk of reduced efficacy of the anticholinesterase through antagonism of acetylcholine receptors by the atropinic agent.

+ Morphinics

Significant risk of colonic akinesia, with severe constipation.

Pregnancy

Animal data are insufficient to draw a conclusion.

During the 1 trimester of pregnancy, clinical data for trihexyphenidyl, to date, although limited, do not point to an increased risk of malformation.

In the newborn, treatment with trihexyphenidyl late in pregnancy may be responsible for effects related to its atropinic properties (tachycardia, hyperexcitability, urinary retention, delay in passage of meconium).

In view of these data, it is preferable to avoid using trihexyphenidyl during pregnancy whatever the stage of gestation.

If it proves essential to prescribe treatment with trihexyphenidyl during pregnancy, take the previously described effects into account when monitoring the newborn.

Breast-feeding

Due to the atropinic effect, breastfeeding is not recommended.

The use of ARTANE 2 mg, tablet does not contraindicate driving except in cases of accommodation disorder or euphoric state.

It should be noted, however, that the indications for ARTANE 2 mg tablet most often concern patients for whom driving vehicles is not recommended.

At the doses usually used in therapy, adverse effects, most often of the atropine-like type, may be observed such as: dryness of the mouth, accommodation disorder, ocular hypertonia, micturition disorders and constipation.

In general, these effects are more frequent in elderly people, who may present hallucination and mental confusion.

A few cases have been reported:

• of suppurative parotitis secondary to dryness of the mouth,
• of skin eruptions,
• of colonic dilatation,
• of paralytic ileus.

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

• Symptoms

These are those of anticholinergics with dryness of the mouth, mydriasis, paralysis of accommodation, drying of secretions and especially tachycardia, agitation, mental confusion, hallucination, respiratory depression and hyperthermia.

• Treatment

Symptomatic treatment with cardiac and respiratory monitoring in a hospital setting.

Pharmacotherapeutic class: Anticholinergic antiparkinsonian agent, ATC code: N04AA01

Antiparkinsonian agent with central and peripheral anticholinergic action. It diminishes tremor and hypertonia but has little effect on akinesia.

It has been shown that approximately 60 % of the administered dose of trihexyphenidyl is excreted in the urine in metabolised form (hydroxylated derivatives) and that the level of unmetabolised trihexyphenidyl is too low to be measured by current techniques.

3 years.

Store at a temperature not exceeding 25 °C.

No special requirements.