Neomidantan 100 mgcaps_pil_eng_01.2012_incl. drug-induced extrapyramidal reactions

Package leaflet: Information for the patient
Neomidantan® 100 mg hard capsules

Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1.
What Neomidantan® is and what it is used for What you need to know before you use Neomidantan® Contents of the pack and other information What Neomidantan® is and what it is used for
This medicine contains amantadine hydrochloride (referred to as amantadine throughout this leaflet), which belongs to a group of medicines called dopaminergic agents. This medicine reduces muscle stiffness, limitation of motion and movement slowness. Neomidantan® also is an antiviral agent. Neomidantan® is used - to treat Parkinson's disease, secondary Parkinsonism (characterized by tremor, rigidity or postural instability), including drug-induced extrapyramidal reactions. to treat or prevent a certain type of flu infection (influenza A) in adults and children above 10 years of age. to treat postherpetic neuralgia (painful condition affecting your nerve fibers and skin). What you need to know before you use Neomidantan®

Do not use Neomidantan®:
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if you are allergic to amantadine hydrochloride or any of the other ingredients of this medicine (listed in section 6); if you suffer from epilepsy (convulsions); if you have or ever had an ulcer in your stomach; Neomidantan® use is not recommended, if you have a problem with the pressure in your eyes called ‘angle-
closure glaucoma’ or suffer from benign prostatic hyperplasia.
Do not use together with memantine (medicine to treat dementia).
Warnings and precautions
Talk to your doctor before using Neomidantan®
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if you suffer from any liver or kidney disease. if you have any disease involving the heart and blood vessels (may worsen heart failure and ankle swelling). if you have any mental disorders, for example, confusion and hallucinations. If you use Neomidantan® concomitantly with other medicines affecting the central nervous system.
Abrupt discontinuation of Neomidantan® may result in symptoms resembling neuroleptic malignant
syndrome (NMS), as well as in cognitive manifestations. To avoid this Neomidantan® should not be stopped
abruptly in patients who are treated concurrently with neuroleptics. NMS has also been reported rarely
following withdrawal of amantadine in patients who were not taking concurrent neuroleptics. NMS may
manifest as muscle stiffness (difficulty in movement), fever, disturbed consciousness, unstable blood
pressure and pulse, fast heartbeat, heart rhythm disorders (see section 4). Stop taking Neomidantan® and
consult a doctor immediately, if you develop any of the mentioned symptoms.
Patients with kidney impairment are at risk of intoxication. Talk to a doctor, if you have any urinary tract
disorders.
Increase in liver enzyme levels have been reported in patients with liver impairment.
Patients with a known predisposition to cardiovascular insufficiency (heart failure) should discontinue
Neomidantan® and consult a doctor immediately, if palpitations, dizziness and/or loss of consciousness
appear.
Neomidantan® is not recommended for use in patients with untreated angle closure glaucoma (increased
pressure in the eye).
Livedo reticularis (“marbled skin” - mottled bluish discoloration of the skin) is commonly observed in
association with prolonged use of amantadine.
Peripheral oedema may occur in some patients with congestive heart failure during chronic treatment (not
usually before four weeks) with Neomidantan®. It may be prior to or accompanied by livedo reticularis.
Talk to a doctor if you develop any of these symptoms. Your doctor may need to reduce your dose or
discontinue Neomidantan®.

Other medicines and Neomidantan®
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Concurrent administration of amantadine and anticholinergic agents (such as atropine) or levodopa may
increase confusion, hallucinations, nightmares, gastrointestinal disorders, or other atropine-like side effects.
In isolated cases, worsening of psychotic symptoms has been reported in patients receiving amantadine and
antipsychotics (used to treat specific mental disorders).
Concurrent administration of amantadine and medicines acting on the CNS may result in additive CNS
toxicity.
Concomitant administration of amantadine and hydrochlorothiazide (used to increase urine production) or
triamterene (potassium-sparing diuretic) may increase amantadine toxic effects. It is not recommended to use
amantadine concomitantly with hydrochlorothiazide or triamterene.
Increased risk of CNS toxicity if amantadine is given together with memantine, therefore, concomitant
administration is contraindicated.
Bupropion (used to help stop smoking or to treat depression) increases the risk of side effects. Bupropion
should be used with extreme caution in patients with known low seizure threshold.
Domperidone (anti-sickness treatments) increases the risk of extrapyramidal side effects.
Methyldopa increases the risk of extrapyramidal side effects.
Quinine (used to treat malaria and leg cramps) may increase amantadine plasma levels.
Tetrabenazine (used to help problems controlling your muscle movement) increases the risk of
extrapyramidal side effects.
Neomidantan® with food, drink and alcohol
Alcoholic beverages should be avoided during the therapy.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Neomidantan® is contraindicated during pregnancy and breast-feeding.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, concentration loss or visual disturbances.

Important information about some of the ingredients of your medicine
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
3.
How to take Neomidantan®

Always take this medicine exactly as your doctor has told you. Your doctor will apply your dose and
duration of treatment. Check with your doctor if you are not sure.
It is recommended to take Neomidantan® after meals, swallowed whole with a sufficient amount of fluid.
Parkinson's disease, secondary Parkinsonism
Initially 100mg daily is recommended; after the first week increasing the dose to 100 mg twice daily. In
some patients higher dose is required. The maximum daily dose is 400 mg.
An enhanced therapeutic effect is achieved when the therapy is initiated at an early stage of the disease.
Doses exceeding 200mg daily may provide some additional relief, but may also be associated with increased
toxicity. The therapeutic effect is observed within a few days. Neomidantan® may appear to lose efficacy
within a few months of continuous treatment in some patients. Its effectiveness may be prolonged by
withdrawal for three to four weeks, which seems to restore activity. During this time, existing concomitant
antiparkinsonian therapy should be continued, or a low dose levodopa treatment initiated.
Neomidantan® should not be stopped abruptly. Neomidantan® withdrawal should be gradual, e.g. half the
dose at weekly intervals.
The desired therapeutic effect of antiparkinson agents is achieved gradually. Treatment is symptomatic; the
therapeutic effect is observed during and shortly after using Neomidantan®.
Combined treatment: any antiparkinson medicine already in use should be continued during initial
Neomidantan® treatment. It may then be possible to reduce the dose of other medicines gradually. In case of
increased side effect occurrence, the dosage should be reduced more quickly. In patients receiving large
doses of anticholinergic agents or levodopa, the initial phase of Neomidantan® treatment should be extended
to 2 weeks.
Treatment of influenza
It is recommended to start treating influenza as early as possible, advisably within 24 - 48 hours of symptoms
appearing.
Adults and children above 10 years of age: 100 mg 1-2 times per day for 5 days.
Prophylaxis of influenza
Adults and children above 10 years of age: 100 mg daily for up to 6 weeks. When used with inactivated
influenza A vaccine, amantadine is continued for 2 to 3 weeks following inoculation.
Postherpetic neuralgia
Treatment should be started as soon as possible after the diagnosis. The recommended dose is 100 mg twice
daily for 14 days. If necessary, treatment can be continued for a further 14 days.
Elderly (over 65 years of age)
The recommended dose is 100 mg a day. Elderly patients are at risk of kidney impairment, as a result
amantadine elimination half-life is prolonged and renal clearance of the compound is diminished, therefore,
toxicity risk increases. A daily dose of 100 mg a day given at intervals of greater than one day, may be
appropriate for this group of patients.
Kidney impairment
In patients with kidney impairment Neomidantan® dose should be reduced or the dose interval should be
increased in accordance with the creatinine clearance (see the chart).
Creatinine clearance (ml/min)
Children below 10 years of age
Neomidantan® is not suitable for use in children below 10 years of age due to the amount of amantadine in
one capsule.
If you feel that the effect of Neomidantan® is too week or too strong, please talk to your doctor.
If you take more Neomidantan® than you should
If you (or someone else) take too many Neomidantan® capsules, contact a doctor or seek medical attention
at the nearest hospital immediately.
Overdose symptoms are nausea, vomiting, tremor, movement disorders, dilated pupils with minimal reaction
to light, blurred vision, urine retention, acute psychosis with disorientation, hallucinations, aggression,
respiratory disorder and arrhythmia.

If you forget to take Neomidantan®
If you forget to take a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten
dose.
If you stop using Neomidantan®
If you want to stop taking Neomidantan® talk to your doctor first. Neomidantan® withdrawal should be
gradual. Sudden discontinuation of Neomidantan® may worsen Parkinsonism symptoms.
4.
Possible side effects

Like all medicines, Neomidantan® can cause side effects, although not everybody gets them.
Common (affects 1 to 10 users in 100): headache, anxiety, concentration loss, mood swings, sleep disorder,
insomnia, dizziness, slurred speech, tremor, appetite lost, palpitations, Livedo reticularis (“marbled skin”),
orthostatic hypotension (a form of low blood pressure that causes you to feel dizzy, lightheaded or faint),
nausea, vomiting, constipation, dry mouth, sweating increased, oedema peripheral (swelling of the shin and
ankle).
Rare (affects 1 to 10 users in 10,000): leucopoenia (reduced numbers of white blood cells), hallucinations,
depersonalisation (feeling detached from yourself), blurred vision, diarrhoea, rash, urinary retention, urinary
incontinence (in patients with prostatic hypertrophy).
Very rare (affects less than 1 in 10,000 users): heart failure, convulsions, movement disorders, neuroleptic
malignant syndrome (muscle stiffness (difficulty in movement), fever, disturbed consciousness, unstable
blood pressure and pulse, fast heartbeat, heart rhythm disorders, sweating, acute kidney failure), confusion,
psychosis, photosensitivity (increased sensitivity to light).

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
5.
How to store Neomidantan®
Do not store above 25 ºC. Protect from light and moisture. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton pack. The expiry date refers to the last day of that month. Contents of the pack and other information

What Neomidantan® contains
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The active substance is amantadine hydrochloride (Amantadini hydrochloridum) Each Neomidantan® 100 mg hard capsule contains 100 mg of amantadine hydrochloride. - Hard gelatin capsule content: lactose monohydrate 105,0 mg, potato starch, stearic acid.
Hard gelatin capsule shell: gelatin, titanium dioxide (E 171).
What Neomidantan® looks like and contents of the pack

Hard white/white gelatin capsules, containing white or almost white pellets.
10 capsules in a blister; 5 blisters (50 capsules) and the package leaflet in a carton pack.
Marketing Authorisation Holder and Manufacturer

Company name: Joint-Stock Company “OLAINFARM”
Address: 5 Rūpnīcu Street, Olaine, LV 2114
Country: Latvia
Telephone: +371-67013701
Telefax: +371-67013777
E-mail: olainfarm@olainfarm.lv
This leaflet was last revised in 07.2011.


Translation is carried out by Margarita Rungevica Regulatory Affairs specialist 20.01.2012 Approved by Uldis Armanis Head of Pharmacovigilance Group, QPPV JSC Olainfarm Date: 11.10.2011 Approved by Kristina Rizhanova Head of Regulatory Affairs, JSC Olainfarm Date: 12.10.2011

Source: http://olainfarm.lv/wp-content/uploads/2013/02/Neomidantan_Package-leaflet.pdf