Rodenal

/ Rekah

Adults only: Optimal dosage should always be determined empirically, usually by initiating therapy at a relatively low level and by subsequent graduated increments. The usual dosage for Parkinsonism is 6-10 mg per day although some patients chiefly in the post-encephalitic group may require an average total dose of 12-15 mg daily. It should be given orally either three or four times a day at mealtimes.
In all cases, the dosage should be increased or decreased only by small increments over a period of several days. In initial therapy the dose should be 1 mg the first day, 2 mg the second day with further increases of 2 mg per day at three to five-day intervals until the optimum dose is reached. If patients are already being treated with other parasympathetic inhibitors, tablet should be substituted as part of the therapy. Careful adjustment is necessary, depending on side effects and the degree of symptom control. Benzhexol tablets dosage of 3-6 mg daily in divided doses is usually adequate. Tablet may be taken before or after meals according to the way the patient reacts. If Benzhexol tablet tends to dry the mouth excessively, it may be better to take it before meals,unless it causes nausea. If taken after meals, induced thirst can be allayed by peppermint, chewing gum or water.
Treatment of drug-induced extrapyramidal disorder: The size and frequency of dose of Benzhexol needed to control extrapyramidal reactions to commonly employed tranquillisers, notably the phenothiazines, thioxanthenes, and butyrophenones must be determined empirically. The total daily dosage usually ranges between 5 and 15mg, although in some cases, these reactions have been controlled by as little as 1mg daily.Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of both drugs until the desired ataractic effect is retained without concomitant extrapyramidal reactions. It is sometimes possible to maintain the patient on reduced Benzhexol dosage after the reactions have remained under control for several days. Since these reactions may remain in remission for long periods after discontinuation of Benzhexol therapy, such therapy should be of minimal duration and discontinued after symptoms have subsided for a reasonable period of time.
Elderly: Patients over 65 years of age tend to be relatively more sensitive and require smaller amounts of the drug.
Children: Not recommended.

An adjunct medicine in the therapy of all forms of Parkinsonism (postencephalitic, arteriosclerotic and idiopathic), It is also indicated to control extrapyramidal disorders due to central nervous system drugs such as phenothiazines.

Hypersensitivity to Benzhexol or any of the other ingredients.

Since the use of Benzhexol 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 benzhexol. Hypertension, cardiac, liver or kidney disorders are not contra-indicated, but such patients should be followed closely. As Benzhexol may provoke or exacerbate tardive dyskinesia, it is not recommended for use in patients with this condition. Benzhexol 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 Benzhexol has been associated with the clinical worsening of myasthenia gravis, the drug should be avoided or used with great caution in patients with this condition. Since certain psychiatric manifestations such as confusion, delusions and hallucinations, all of which may occur with any of the atropine-like drugs, have been reported rarely with Benzhexol, it should be used with extreme caution in elderly patients.
For full details see prescribing information.

Modern clinical data required to determine the frequency of undesirable effects are lacking for Benzhexol. 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.
For full details see prescribing information.

Extra care should be taken when Benzhexol is given concomitantly with phenothiazines, clozapine, antihistamines, disopyramide, nefopam and amantadine because of the possibility of increased antimuscarinic side-effects. Synergy has been reported between Benzhexol and tricyclic antidepressants, probably because of an additive effect at the receptor site. This can cause dry mouth, constipation and blurred vision. In the elderly, there is a danger of precipitating urinary retention, acute glaucoma or paralytic ileus.
Monoamine oxidase inhibitors can interact with concurrently administered anticholinergic agents including Benzhexol. This can cause dry mouth, blurred vision, urinary hesitancy, urinary retention and constipation. In general, anticholinergic agents should be used with caution in patients who are receiving tricyclic antidepressants or monoamine oxidase inhibitors. In patients who are already on antidepressant therapy the dose of Benzhexol should be initially reduced and the patient reviewed regularly.
Benzhexol may be antagonistic with the actions of metoclopramide and domperidone on gastro-intestinal function. The absorption of levodopa may possibly be reduced when used in conjunction with Benzhexol. Benzhexol may be antagonistic with the actions of parasympathomimetics.
For full details see prescribing information.

Pregnancy: There is inadequate information regarding the use of Rodenal tablet in pregnancy. Animal studies are insufficient with regard to effects on pregnancy, embryonal/foetal development, parturition and postnatal development. The potential risk for humans is unknown. Rodenal tablet should not be used during pregnancy unless clearly necessary.
Lactation: It is unknown whether Rodenal tablet is excreted in human breast milk. The excretion of Rodenal tablet in milk has not been studies in animals. Infants may be very sensitive to the effects of antimuscarinic medications. Rodenal tablet should not be used during breast-feeding.

Symptoms: Symptoms of overdose with antimuscarinic agents include flushing and dryness of the skin, dilated pupils, dry mouth and tongue, tachycardia, rapid respiration, hyperpyrexia, hypertension, nausea, vomiting. A rash may appear on the face or upper trunk. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions. In severe overdose, CNS depression may occur with coma, circulatory and respiratory failure and death.
Treatment: Treatment should always be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of central nervous system depression should be considered. Hypoxia and acidosis should be corrected. Antiarrhythmic drugs are not recommended if dysrhythmias occur.

The products should be stored below 25°C and in dark and dry place.
Benzhexol may be the subject of abuse (on the basis of hallucinogenic or euphoriant properties, common to all anti-cholinergic drugs) if given in sufficient amounts.Each tablet from 2 mg contains 135.5 mg of lactose and each tablet from Benzhexol 5 mg contains 134.4 mg of lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.