Timonil

/ Megapharm

Treatment with Timonil retard should be started with a low, individualised, initial dose depending on the nature and severity of the disease. This is then gradually increased until the most effective maintenance dose is found.
The daily dose is generally given in 1 – 2 single doses.
The general daily dosage range lies between 400 -1200 mg carbamazepine.
A total daily dose of 1600 mg should generally not be exceeded, since increased side effects occur at higher doses.
See prescribing information for full details.

Epilepsy, Trigeminal neuralgia, Mania, Prophylactic in manic depressive illness.

– patients with a history of bone marrow damage or bone marrow depression
– atrioventricular block
– hypersensitivity to the active substance or to any of the excipients,
– known hypersensitivity to structurally related medicinal products such as tricyclic antidepressants (e.g. amitriptyline, desipramine, nortriptyline)
– hepatic porphyria or even a history thereof (e.g. acute intermittent porphyria, porphyria variegata, porphyria cutanea tarda)
– concomitant treatment with monoamine oxidase inhibitors (MAOI) or within 14 days after discontinuation of treatment with MAOI
– concomitant treatment with voriconazole, since patients may fail to respond to this medicinal product.

Potentially-fatal blood cell anomalies have been reported following treatment. Complete pretreatment blood counts should be obtained. Any significant abnormalities should preclude the use of this drug. Tests should be repeated at frequent intervals (weekly during the first 3 months and monthly thereafter, for at least 2-3 years). Use in pregnancy and lactation, children under 6 years of age. Increased intraocular pressure, possibility of activating latent psychosis, or confusion or agitation in elderly patients may occur. Should be administered only after benefit-to-risk appraisal in patients with a history of cardiac, hepatic or renal damage, adverse hematological reactions to other drugs or interrupted courses of therapy with the drug. Liver function tests should be performed at regular intervals. Thyroid function tests have been reported to show decreaseed values with carbamazepine administered alone.

Dizziness, drowsiness, unsteadiness, nausea, and vomiting are the most frequent adverse reactions. Abnormal liver function tests, cholestatic and hepatocellular jaundice, hepatitis. Urinary frequency, acute urinary retention, oliguria with hypertension, renal failure, azotemia, impotence, proteinuria, glycosuria, elevated blood urea nitrogen (BUN), microscopic deposits in urine. Disturbances of coordination, confusion, headache, fatigue, speech disturbances, abnormal involuntary movements, peripheral neuritis, paresthesias, depression with agitation, nystagmus, talkativeness, tinnitus, hyperacusis, behavioral changes in children, paralysis and other symptoms of cerebral arterial insufficiency. Pulmonary hypersensitivity. Pruritic and erythematous rashes, urticaria, Stevens-Johnson syndrome, photosensitivity reactions, alterations in pigmentation, exfoliative dermatitis, alopecia, diaphoresis, erythema multiforme and nodosum, purpura, aggravation of lupus erythematosus. Congestive heart failure, aggravation of hypertension, hypotension, syncope and collapse, edema, primary thrombophlebitis, recurrence of thrombophlebitis, aggravation of coronary artery disease, arrhythmias and atrioventricular (AV) block, adenopathy or lymphadenopathy. Some cardiovascular complications have resulted in fatalities. Blurred vision, visual hallucinations, transient diplopia and oculomotor disturbances. Scattered punctate cortical lens opacities, conjunctivitis and ophthalmoplegia. Aching joints and muscles, fever and chills, inappropriate antidiuretic hormone syndrome, hypocalcemia.

MAOI’s, sodium valproate, erythromycin, clarithromycin, cimetidine, diltiazem, danazol, verapamil, isoniazid, fluoxetine, fluvoxamine, acetazolamide, desipramine, nicotinamide (high doses in adults), combined oral contraceptives, lithium, vitamin D, steroids, theophylline, digitoxin, digoxin, clonazepam, clobazam, alprazolam, mianeserin, tricyclic antidepressants, butyrophenones, thyroid hormones, doxycycline, oral hypoglycemics, phytoin, primidone, ethosuximide, barbituarates, flecainide, coumarin anticoagulants, felodipine, nifedipine, cyclosporin, methadone, phenobarbitone, phytoin, primidone, theophylline, clonazepam, hydrochlorothiazide, frusemide, pancuronium and other non-depolarizing muscle relaxants, haloperidol, thioridazine, metoclopramide, isotretinoin, alcohol.