PATIENT INFORMATION LEAFLET

Amantadine Level 100 mg Hard Capsules

Amantadine (amantadine hydrochloride)

Read this leaflet carefully before you start to take this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Amantadine is a medication that belongs to a group of medications called dopaminergic agents that can act as an antiviral and as an antiparkinsonian, and is used in adults and children over 10 years old for:

• To treat the characteristic symptoms of flu caused by the virusInfluenzaA,when the virus (InfluenzaA) is circulating in the community.
• To prevent flu when the virus (InfluenzaA) is circulating in the community.
• To treat the symptoms of Parkinson's disease, such as rigidity, tremor, hypokinesia, and akinesia (movement difficulties).

Amantadine Level is not a substitute for the flu vaccine. You should consult your doctor to determine the need for administering the vaccine.

Do not take Amantadine Level

• If you are allergic (hypersensitive) to amantadine or rimantadine or any other component of Amantadine Level.
• If you have or have had heart disease (such as heart failure, myocarditis, bradycardia, severe ventricular arrhythmias, includingtorsades de pointes).
• If you have a prolonged QT interval or if you have a family history of congenital QT syndrome (a defect in the heart's electrical system that can cause an abnormal heart rhythm).
• If you are being treated with budipine or other medications that cause alterations in the electrocardiogram.
• If you are pregnant or breastfeeding a baby.
• If you have seizures.
• If you have or have had stomach bleeding (gastric ulcer).
• If you are not producing or producing very little urine (severe kidney failure).
• If you have increased pressure in the eye (angle-closure glaucoma).

Be especially careful with Amantadine Level

Before starting treatment with Amantadine Level, be especially careful:

• If you have an enlarged prostate (hypertrophy).
• If you have kidney or liver disease (renal or hepatic insufficiency), your doctor will adjust the dose.
• If you have been agitated or confused or have had hallucinations.
• If you have or have had epilepsy (a chronic brain disease) or psychiatric disorders, such as delirium.
• If you are being treated with memantine (used to treat the symptoms of Alzheimer's disease).
• If you have or have had any heart problems, consult your doctor to take the necessary precautions.
• If you have organic brain syndrome (decreased mental function) or if you are prone to dizziness.
• If you have orthostatic hypotension (decrease in blood pressure caused by a sudden change in body position) or peripheral edema (abnormal accumulation of fluid in the legs, feet, and ankles, causing swelling in these areas).
• If you have eczema or skin rash. In some cases, amantadine can exacerbate this condition.

During treatment of Parkinson's disease with amantadine, it is not recommended to administer supplementary amantadine for prophylaxis and treatment of influenza A infection, due to the risk of overdose.

Inform your doctor if you or your family/caregiver notice that you are developing impulses or desires to behave in an unusual way for you and are unable to resist the impulse, desire, or temptation to perform certain activities that could harm you or others. These behaviors are called impulse control disorders and may include excessive gaming, ingestion, or spending, abnormally high sexual impulse, or increased thoughts or appetite for sex. Your doctor may need to adjust or discontinue your Amantadine Level dose.

Cases of suicidal thoughts and actions have been reported during amantadine treatment. If you have thoughts or attempts of self-harm or suicide, contact your doctor immediately.

If blurred vision or other visual problems occur, contact your ophthalmologist immediately.

Use of other medications

Inform your doctor or pharmacist if you are using or have used recently other medications, including those obtained without a prescription.

These instructions may also apply to medications that have been taken before or may be taken after.

The simultaneous use of amantadine and medications that cause QT interval prolongation is contraindicated, including the following cases:

• Medications used to suppress or prevent heart rhythm alterations (antiarrhythmics), such as class A antiarrhythmics (e.g., quinidine, disopyramide, procainamide) and class III antiarrhythmics (e.g., amiodarone, sotalol).
• Antipsychotics or major tranquilizers (e.g., thioridazine, chlorpromazine, haloperidol, pimozide).
• Tricyclic and tetracyclic antidepressants (e.g., amitriptyline).
• Antihistamines, which help treat allergy symptoms (e.g., astemizole, terfenadine).
• Macrolide antibiotics (e.g., erythromycin, clarithromycin).
• Some quinolones, a specific group of antibiotics (e.g., sparfloxacin and grepafloxacin).
• Medications used to treat fungal infections (antimycotics), specifically azoles.
• Other medications such as halofantrine and quinine (used to treat malaria), cotrimoxazole (a combination of trimethoprim and sulfamethoxazole, used as an antibiotic), pentamidine (an antiprotozoal used to treat certain infections), cisapride (a gastrointestinal prokinetic agent used to treat gastroesophageal reflux disease), and bepridil (a calcium channel blocker used to alleviate and control angina pectoris).

Amantadine can be administered in combination with other antiparkinsonian medications (e.g., levodopa, memantine, budipine). Although to avoid adverse reactions, it may be necessary to reduce the dose of one or more of the medications or their combination.

There are other medications that may interact with amantadine, including:

• Anticholinergics, which have many clinical uses such as antispasmodics, bronchodilators, in Parkinson's disease, in ophthalmology, etc. (trihexyphenidyl, benzotropine, scopolamine, biperiden, orphenadrine, etc).
• Sympathomimetics of the CNS, medications that stimulate the brain's psychological functions (such as consciousness, orientation, attention, or concentration), increasing the levels of motor activity (or movement) and cognitive (or knowledge) activity, as well asattention.
• Diuretics (medications used to increase urine elimination) such as hydrochlorothiazide or triamterene.
• Avoid taking trimethoprim (antibiotic).

Taking Amantadine Level with food and drinks

It is recommended not to consume alcohol during Amantadine Level treatment, as it may produce effects on the central nervous system such as dyskinesia (involuntary movements), confusion, fainting, and orthostatic hypotension.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

It is recommended not to take Amantadine Level if you are pregnant or breastfeeding a baby.

Driving and operating machines

Do not drive or operate tools or machinery because Amantadine Level may cause adverse reactions (e.g., drowsiness, visual disturbances, dizziness, vertigo) that may decrease your ability to concentrate and react.

Follow exactly the administration instructions for Amantadine Level as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Amantadine Level. Do not discontinue treatment without consulting your doctor first.

You may be administered a higher dose at the discretion of your doctor and under strict medical supervision.

If you estimate that the action of Amantadine Level is too strong or too weak, inform your doctor or pharmacist.

Amantadine Level is administered byoral route.

Treatment of the flu:

• One capsule (100 mg of amantadine hydrochloride) twice a day.

The dose will not exceed 200 mg/day (two capsules a day).

The start and duration of treatment will be established by your doctor.

Prophylaxis of the flu:

• One capsule (100 mg of amantadine hydrochloride) twice a day.

The start and duration of treatment will be established by your doctor, on an individual basis, for as long as necessary to protect against infection, up to a maximum of 6 weeks.

When administered with inactivated Influenza A vaccine, treatment will continue for 2-4 weeks after inoculation.

Treatment of Parkinson's disease:

• Treatment will begin with 100 mg daily for the first week, followed by one capsule (100 mg of amantadine hydrochloride) twice a day.

Do not take more than 4 capsules a day (400 mg).

Administration form:

Amantadine Level capsules should be taken with a little liquid.

Amantadine may cause insomnia (difficulty sleeping) with some frequency. Try to adjust the dosage so that the last dose is not taken in the late afternoon or evening.

In the treatment of patients with Parkinson's disease, treatment should be started gradually and should not be discontinued abruptly.

Patients with renal insufficiency:

It will be administered with great caution in these patients. In these cases, the doctor will adjust the dose based on the patient's creatinine clearance (a laboratory test that evaluates kidney function).

Use in elderly patients:

These patients may be more susceptible to the effects of amantadine, so the dose to be used should be the lowest possible.

Use in children:

Children over 10 years old: One capsule (100 mg of amantadine hydrochloride) a day.

Use is not recommended in children under 10 years old, as experience is limited in this age group.

If you take more Amantadine Level than you should:

Consult your doctor or pharmacist immediately.

The symptoms of overdose are: nausea, vomiting, hyperexcitability, tremors, uncontrolled movements (ataxia), blurred vision, drowsiness, depression, difficulty speaking (dysarthria), and seizures. It may also cause irregular heartbeats (arrhythmias), fluid retention in the lungs (pulmonary edema), repeated seizures (status epilepticus), and toxic psychosis (a state of confusion that can lead to coma).

In case of overdose, induction of vomiting and/or gastric lavage will be performed immediately. There is no specific antidote. Treatment will be aimed at promoting the elimination of the medication through urine acidification and symptomatic treatment, including, if necessary, the use of sedatives and anticonvulsants.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, indicating the medication and the amount used. It is recommended to bring the packaging and leaflet of the medication to the healthcare professional.

If you forget to take Amantadine Level:

Do not take a double dose to compensate for the missed dose. It is best to take the dose as soon as possible.

If you interrupt treatment with Amantadine Level:

If you have Parkinson's disease, avoid abrupt discontinuation of treatment. It may cause a rebound effect with the appearance of rigidity, confusion, or bulbar paralysis.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Amantadine Level may produce adverse effects, although not all people will experience them.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

• Very frequent (1 in 10 treated patients): Swelling in legs, red or blue patches on the skin known as "livedo reticularis" (usually after high doses).

• Frequent (between 1 and 10 in 100): Drowsiness or insomnia, depression, states of agitation, dizziness, headache, hallucinations, confusion, dizziness, lethargy (continuous and deep sleep often accompanied by muscle relaxation), nightmares, uncoordinated movements (ataxia), difficulty speaking, decreased blood pressure caused by a sudden change in body position(orthostatic hypotension), palpitations, dry mouth, nausea, loss of appetite (anorexia), vomiting, constipation, sweating,myalgia (muscle pain).

-Infrequent:Blurry vision.

• Rare (between 1 and 10 in 1,000): Seizures, disorientation, psychosis (altered mental state), tremor, abnormal movements (dyskinesia), neuroleptic syndrome (among other symptoms causes altered consciousness), diarrhea, skin eruptions, corneal injury,corneal edema, decreased visual acuity, urinary retention or incontinence.

• Very rare (1 in 10,000): Decreased white blood cells (leucopenia), reversible increase in liver enzymes, congestive heart failure, heart failure, photosensitivity.

- Unknown frequency (cannot be estimated from available data):Unusual desire to behave in an unusual way for you: strong impulse to play excessively, increased or altered sexual interest, excessive and uncontrollable spending or purchases, binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more than normal and necessary to satisfy hunger).

All secondary effects cease when treatment is suspended and most disappear within a few days of continued therapy.

Keep out of reach and sight of children.

Do not use Amantadine Level after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Amantadine Level Composition

• The active ingredient is amantadine (as amantadine hydrochloride). Each capsule contains 100 mg of amantadine hydrochloride.
• The other components are dihydrate calcium phosphate, magnesium stearate, and sodium carboxymethylcellulose. The gelatin capsule is composed of: gelatin, indigo carmine (E132), quinoline yellow (E104), and titanium dioxide (E171).

Product Appearance and Packaging Contents

Amantadine Level is a medication presented in the form of hard capsules. Each box contains 20 capsules.

Marketing Authorization Holder

Laboratorios ERN, S.A.

C/Perú, 228 - 08020 Barcelona, Spain

Manufacturer Responsible

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain.

This leaflet was approved in January 2025.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/