LYSOVIR

Posology Treatment:

It is advisable to start treating influenza as early as possible and to continue for 4 to 5 days. When amantadine is started within 48 hours of symptoms appearing, the duration of fever and other effects is reduced by one or two days and the inflammatory reaction of the bronchial tree that usually accompanies influenza resolves more quickly.

Prophylaxis:

Treat daily for as long as protection from infection is required. In most instances this is expected to be for 6 weeks. When used with inactivated influenza A vaccine, amantadine is continued for 2 to 3 weeks following inoculation.

Children over 10 years of age, adolescents and adults:

The posology is the same as in adults.

Children under 10 years of age:

Dosage not established.

Elderly:

Plasma amantadine concentrations are influenced by renal function. In elderly patients, the elimination half-life is longer and renal clearance of the compound is diminished in comparison to young people. A daily dose of less than 100mg, or 100mg given at intervals of greater than one day, may be appropriate.

Renal impairment In patients with renal impairment the dose of amantadine should be reduced. This can be achieved by either reducing the total daily dose, or by increasing the dosage interval in accordance with the creatinine clearance.

For example, Creatinine clearance (ml/min) Dose < 15 Lysovir/Amantadine capsules contra-indicated. 15 – 35 100mg every 2 to 3 days. > 35 100mg every day The above recommendations are for guidance only and physicians should continue to monitor their patients for signs of unwanted effects.

Method of administration For oral administration.

Summary of the safety profile Amantadine's undesirable effects are often mild and transient, usually appearing within the first 2 to 4 days of treatment and promptly disappearing 24 to 48 hours after discontinuation. A direct relationship between dose and incidence of side effects has not been demonstrated, although there seems to be a tendency towards more frequent undesirable effects (particularly affecting the CNS) with increasing doses.

The side effects reported after the pivotal clinical studies in influenza in over 1200 patients receiving amantadine at 100mg daily were mostly mild, transient, and equivalent to placebo. Only 7% of subjects reported adverse events, many being similar to the effects of influenza itself.

The most commonly reported effects were gastro-intestinal disturbances (anorexia, nausea), CNS effects (loss of concentration, dizziness, agitation, nervousness, depression, insomnia, fatigue, weakness), or myalgia. Tabulated list of adverse reactions The following list of adverse reactions is based on clinical trial experience and/or post-marketing use via spontaneous case reports and literature cases.

The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as “not known”. Undesirable effects are listed by MedDRA System Organ Classes.

Within each system organ class, ADRs are presented in order of decreasing seriousness.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥ 1/10 Common: ≥ 1/100 to < 1/10 Uncommon: ≥ 1/1,000 to < 1/100 Rare: ≥ 1/10,000 to < 1/1,000 Very rare: < 1/10,000 Not known: cannot be estimated from the available data. 4) Investigations Very rare hepatic enzyme increased *See section ‘Description of selected adverse reactions’ Description of selected adverse reactions Nightmares are more common when amantadine is administered concurrently with anticholinergic agents or when the patient has an underlying psychiatric disorder.

4 Special warnings and precautions for use). Corneal lesions such as punctate subepithelial opacities which might be associated with superficial punctate keratitis. Livedo reticularis can develop usually after very high doses or use over many months.

4 Special warnings and precautions for use). 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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Lysovir/Amantadine capsules should be used with caution in patients with confusional or hallucinatory states or underlying psychiatric disorders, in patients with liver or kidney disorders, and those suffering from, or who have a history of, cardiovascular disorders.

5, Interactions with other medicaments and other forms of interaction). Discontinuation of amantadine Lysovir/Amantadine capsules should not be stopped abruptly in patients who are treated concurrently with neuroleptics. There have been isolated reports of precipitation or aggravation of neuroleptic malignant syndrome or neuroleptic- induced catatonia following the withdrawal of amantadine in patients taking neuroleptic agents.

A similar syndrome has also been reported rarely following withdrawal of amantadine and other anti-Parkinson agents in patients who were not taking concurrent psychoactive medication. Resistance to amantadine occurs during serial passage of influenza virus strains in vitro or in vivo in the presence of the drug.

Apparent transmission of drug-resistant viruses may have been the cause of failure of prophylaxis and treatment in household contacts and in nursing-home patients. However, there is no evidence to date that the resistant virus produces a disease that is in any way different from that produced by sensitive viruses.

Some individuals have attempted suicide and cases of suicidal ideation and behaviour have been reported during treatment with amantadine. Patients should be monitored for signs of suicidal ideation and behaviour and treatment initiated as needed.

Patients (and caregivers of patients) should be advised to seek medical advice if any signs of suicidal ideation or behaviour emerge. Prescriptions should be written for the smallest quantity consistent with good patient management.

Peripheral oedema Peripheral oedema (thought to be due to an alteration in the responsiveness of peripheral vessels) may occur in some patients during chronic treatment (not usually before 4 weeks) with amantadine. This should be taken into account in patients with congestive heart failure.

Anticholinergic effects Amantadine has anticholinergic effects, it should not be given to patients with untreated angle closure glaucoma. If blurred vision or other visual problems occur an ophthalmologist should be contacted to exclude corneal oedema.

In case that corneal oedema is diagnosed treatment with amantadine should be discontinued. Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders, including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with products with a dopaminergic effect, including amantadine.

Dose reduction or tapered discontinuation should be considered if such symptoms develop. Hypothermia Hypothermia has been observed in children, especially in those younger than 5 years of age. 2 Posology and method of administration).

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Individuals subject to convulsions. A history of gastric ulceration. Severe renal disease. Pregnancy.