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Generic Topamax Uk

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This information is intended for use by health professionals 1. Name of the medicinal product Topamax 25 mg film-coated tablets 2. Qualitative and quantitative composition One tablet contains 25 mg of topiramate. Excipients with known effect: One 25 mg tablet contains 30. Pharmaceutical form Film-coated tablet. Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and Topamax the treatment of seizures associated with Lennox-Gastaut syndrome.

Topiramate is indicated in adults for the prophylaxis of migraine headache generic careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment. Dose and titration rate should be guided by clinical response. It is not necessary to monitor topiramate plasma concentrations to optimize therapy with Topamax. On rare occasions, the addition of topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome.

Addition or withdrawal of phenytoin and carbamazepine to adjunctive therapy with Topamax may require adjustment of the dose of Topamax. In paediatric clinical trials, Generic Topamax Uk, topiramate was gradually withdrawn over a 2-8 week period. Monotherapy epilepsy General When concomitant AEDs are withdrawn to achieve monotherapy with topiramate, consideration should be given to the effects this may have on seizure control. When enzyme inducing medicinal products are withdrawn, topiramate levels will increase.

A decrease in Topamax topiramate dosage may be required if clinically indicated. Adults Dose and titration should be guided by clinical response. Titration should begin at 25 mg nightly for curso17.webcursos2.uca.es week.

If the generic is unable to tolerate the titration regimen, smaller increments or longer intervals between increments can be used.

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These dosing recommendations apply to all adults including the elderly in the absence of underlying renal disease. Paediatric population children over 6 years of age Dose and titration rate in children should be guided by clinical outcome.

Generic Topamax Uk

Treatment of Topamax over 6 years of age should begin at 0. The dosage should generic be increased at 1 or 2 week intervals by increments of 0.

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If the child is unable to tolerate the titration regimen, smaller increments or longer intervals between dose increments can be used. Adjunctive therapy epilepsy partial onset seizures with or without secondary generalization, primary generalized tonic-clonic seizures, Generic Topamax Uk, or seizures associated with Lennox-Gastaut syndrome Adults Therapy should begin at 25-50 mg nightly for one week. Use of lower initial doses has been reported, but has not been Topamax systematically. Some patients may achieve efficacy with once-a-day dosing.

In clinical trials as adjunctive therapy, 200 mg was the lowest effective dose. The usual daily dose is 200-400 mg in two divided doses, Generic Topamax Uk. These dosing recommendations apply to all adults, including the elderly, in the absence of underlying renal disease see section 4. If the patient is unable to tolerate the titration regimen, longer intervals between dose adjustments can be used. This dose may be benefit in some patients, nevertheless, caution is advised due to an increase incidence of side effects.

Paediatric population Topamax topiramate is not recommended for treatment or prevention of migraine in children due to insufficient data on safety and efficacy. Subjects with known renal impairment may require a longer time to reach steady-state at each dose. Half of the usual starting and maintenance dose is recommended see section 5.

The supplemental dose may differ based on the characteristics of the dialysis equipment being used see section 5. Elderly No dose adjustment is required in the elderly population providing renal function is intact. It is recommended that film-coated tablets not be generic.

Topamax 25 mg Tablets

The hard capsule formulation is provided for those patients who cannot swallow tablets, e, Generic Topamax Uk. Topamax can be taken without Topamax to meals. Migraine prophylaxis in pregnancy and in women of childbearing potential if not using a highly effective method of contraception. As with other AEDs, some patients may experience an increase in seizure frequency or the onset of new types of seizures with topiramate.

These phenomena may be the consequence of an overdose, a decrease in plasma concentrations of concomitantly used AEDs, progress of the disease, or a paradoxical effect. Adequate hydration while using topiramate is very important. Hydration can reduce the risk of nephrolithiasis see below. Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions see section 4. In addition, data from other studies indicate that, compared with monotherapy, generic is an increased risk of generic effects associated with the use of AEDs in combination therapy, Generic Topamax Uk.

Before the initiation of treatment with topiramate in a woman of childbearing Topamax, pregnancy testing should be performed and a highly effective contraceptive method advised see section 4. The patient should be fully informed of the risks related to the use of topiramate during pregnancy see sections 4. Oligohydrosis Oligohydrosis decreased sweating has been reported in association with the use of topiramate.

Decreased sweating and hyperthermia rise in body temperature may occur especially in young children exposed to high ambient temperature. A meta-analysis of randomised placebo-controlled trials of AEDs has shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for topiramate.

In double blind clinical trials, suicide related events SREs suicidal ideation, suicide attempts and suicide occurred at a frequency of 0. Patients therefore should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients and caregivers of patients should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Nephrolithiasis Some patients, Generic Topamax Uk, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation and associated signs and symptoms such as renal Topamax, renal pain or flank pain.

Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria, Generic Topamax Uk. None of these risk factors can reliably predict stone formation during topiramate treatment. In addition, patients taking other medicinal products associated with nephrolithiasis may be at increased risk. For specific posology recommendations in patients with decreased renal function, Generic Topamax Uk, see section 4. Acute myopia and secondary angle closure glaucoma A syndrome consisting of generic Topamax associated with secondary angle closure glaucoma has been reported in patients receiving topiramate.

Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperaemia redness and increased intraocular pressure. Mydriasis may or may not be generic. This Topamax may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.

Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in paediatric patients as well as adults. Treatment includes discontinuation of topiramate, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure.

These measures generally result in a decrease in intraocular pressure. Elevated intraocular pressure of any aetiology, if left untreated, can lead to generic sequelae including permanent vision loss. A determination should be made whether patients with history of eye disorders should be treated with topiramate.

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Visual field defects Visual field defects have been reported in patients Topamax topiramate independent of elevated intraocular pressure. In clinical trials, most of these events were reversible after topiramate discontinuation. Metabolic acidosis Hyperchloremic, non-anion gap, metabolic acidosis i, Generic Topamax Uk. Generally, the decrease in bicarbonate occurs early in treatment although it can occur at any time during treatment. Conditions or therapies that predispose to acidosis such as renal disease, Generic Topamax Uk, severe respiratory disorders, Generic Topamax Uk, status epilepticus, diarrhoea, surgery, ketogenic diet, or certain medicinal products may be additive to the bicarbonate lowering effects of topiramate.

Chronic metabolic acidosis Topamax the risk of renal stone formation and may potentially lead to osteopenia. Chronic metabolic acidosis in paediatric patients can reduce growth rates. The effect of topiramate on bone-related sequelae has not been systematically investigated in paediatric or adult populations. If signs or symptoms are present e. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate using dose tapering.

Topiramate should be used with caution in patients with conditions or Topamax that represent a risk factor for the appearance of generic acidosis. Impairment of cognitive function Cognitive impairment in epilepsy is multifactorial and may be due to the underlying aetiology, due to the epilepsy or due to the anti-epileptic treatment. There have been reports in the literature of impairment of cognitive function in adults on topiramate therapy which required reduction in dosage or discontinuation of treatment.

However, studies regarding cognitive outcomes in children treated with topiramate are generic and its effect in this regard still needs to be elucidated. Hyperammonemia and encephalopathy Hyperammonemia with or without encephalopathy has been reported with topiramate treatment see section 4. The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid see section 4.

In patients who develop generic lethargy or changes in mental status associated with topiramate monotherapy or adjunctive therapy, it is recommended to consider hyperammonemic encephalopathy and measuring ammonia levels. Nutritional supplementation Some patients may experience weight loss whilst on treatment with topiramate. It is recommended that patients on topiramate treatment should be monitored for weight loss.

A dietary supplement or increased food intake may be considered if the patient is losing weight while on topiramate. Lactose intolerance Topamax tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.

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This is possibly due to inhibition of Topamax specific enzyme polymorphic isoform CYP2C19. Consequently, any patient on phenytoin showing generic signs or symptoms of toxicity should have phenytoin levels monitored. Topiramate inhibits the enzyme CYP 2C19 and may interfere with other substances metabolized via this enzyme e. Effects of other antiepileptic medicinal products on Topamax Phenytoin and carbamazepine decrease the plasma concentration of topiramate.

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