AMANTADINE 100 mg HARD CAPSULES

Introduction

PROSPECTUS: INFORMATION FOR THE USER

Amantadine Level 100 mg hard capsules

Amantadine (amantadine hydrochloride)

Read the entire prospectus carefully before starting to take the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Contents of the prospectus:

1. What Amantadine Level is and what it is used for
2. Before taking Amantadine Level
3. How to take Amantadine Level
4. Possible side effects
5. Storage of Amantadine Level
6. Additional information

1. What Amantadine Level is and what it is used for

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

• Treating the characteristic symptoms of flu caused by the InfluenzaA virus, when the virus (InfluenzaA) is circulating in the community.
• Preventing flu when the virus (InfluenzaA) is circulating in the community.
• Treating the symptoms of Parkinson's disease, such as rigidity, tremors, hypokinesia, and akinesia (movement difficulties).

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

2. Before taking Amantadine Level

Do not take Amantadine Level

• If you are allergic (hypersensitive) to amantadine or rimantadine or any of the other components of Amantadine Level.
• If you have or have had heart diseases (such as heart failure, myocarditis, bradycardia, severe ventricular arrhythmias, including torsade 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 produce 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 do not produce or produce very little urine (severe renal failure).
• If you have increased pressure in the eye (narrow-angle glaucoma).

Be careful with Amantadine Level

Before starting treatment with Amantadine Level, be especially careful:

• If you have an enlarged prostate (prostate hypertrophy).
• If you have kidney or liver disorders (renal or hepatic insufficiency), your doctor will adjust the dose.
• If you have been found to be agitated or confused or have suffered hallucinations.
• If you have or have a history of epilepsy (a chronic brain disease) or psychiatric disorders, such as delirium.
• If you are being treated with memantine (used to treat Alzheimer's disease symptoms).
• If you have or have had any heart problems, you should consult your doctor to take control measures.
• 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 ankles, feet, and legs causing swelling in these areas).
• If you have eczema or skin rash. In some cases, amantadine can worsen this condition.

During Parkinson's treatment with amantadine, it is not recommended to administer additional amantadine for flu A prophylaxis and treatment 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 that you 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 addiction to gambling, excessive eating or spending, abnormally high sexual impulse, or increased sexual thoughts or appetite. Your doctor may need to adjust or interrupt your Amantadine Level dose.

There have been reports of suicidal thoughts and actions during treatment with amantadine. If you have thoughts or attempts to harm yourself or commit suicide, contact your doctor immediately.

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

Use of other medications

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

Note that 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, as in the following cases:

• Medications used to suppress or prevent heart rhythm disorders (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)
• Certain quinolones, a specific group of antibiotics (e.g., sparfloxacin and grepafloxacin)
• Medications used for 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), and bepridil (a calcium channel blocker used to relieve and control angina pectoris).

It is possible to administer amantadine in combination with other antiparkinsonian medications (e.g., levodopa, memantine, budipine). However, to avoid adverse reactions, it may be necessary to reduce the dose of one 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, ... (trihexyphenidyl, benzotropine, scopolamine, biperiden, orphenadrine, etc.).
• Sympathomimetics of the CNS, medications that stimulate psychic functions (such as consciousness, orientation, attention, or concentration), increasing motor activity levels (or movement) and cognitive (or knowledge), as well as attention.
• Diuretics (medications used to increase urine elimination) such as hydrochlorothiazide or triamterene.
• You should avoid taking trimethoprim (an antibiotic).

Taking Amantadine Level with food and drinks

It is recommended not to drink alcohol during treatment with Amantadine Level, 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 using machines

Do not drive or operate tools or machinery because Amantadine Level frequently produces adverse reactions (such as drowsiness, visual disturbances, vertigo, dizziness) that could decrease your ability to concentrate and react.

3. How to take Amantadine Level

Follow the administration instructions of Amantadine Level indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

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

A higher dose may be administered according to medical criteria and with patients under strict medical control.

If you think the effect of Amantadine Level is too strong or too weak, inform your doctor or pharmacist.

Amantadine Level is administered orally.

Flu treatment:

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

Do not exceed the dose of 200 mg/day (two capsules per day).

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

Flu prophylaxis:

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

The start and duration of treatment will be determined by your doctor, individually, for the necessary time to protect against infection, up to a maximum of 6 weeks.

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

Parkinson's treatment:

• Treatment will start with 100 mg per day for the first week, continuing with one capsule (100 mg of amantadine hydrochloride) twice a day.

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

Method of administration

Amantadine Level capsules should be taken with a little liquid.

Amantadine frequently produces insomnia (difficulty sleeping). Try to adjust the dosage so that the last intake is not administered in the late afternoon or evening.

In the treatment of patients with Parkinson's syndrome, treatment should be started gradually and should not be suddenly suspended.

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) per day.

It is not recommended to use in children under 10 years old, as experience is limited in this population 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, speech problems (dysarthria), and convulsions. It can also cause irregular heartbeats (arrhythmias), fluid retention in the lungs (pulmonary edema), repeated convulsions (status epilepticus), and toxic psychosis (a state of confusion that can lead to coma).

In case of overdose, vomiting will be induced immediately and/or stomach lavage will be performed. There is no specific antidote. An attempt will be made to favor the elimination of the medication through acidification of the urine, and symptomatic treatment will be initiated, 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, phone: 915 620 420, indicating the medication and the amount used. It is recommended to bring the packaging and prospectus of the medication to the healthcare professional.

If you forget to take Amantadine Level

Do not take a double dose to make up for forgotten doses. It is convenient to take the dose as soon as possible.

If you interrupt treatment with Amantadine Level

If you have Parkinson's disease, you should avoid sudden suspension of treatment. It can 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.

4. Possible side effects

Like all medications, Amantadine Level can produce side effects, although not all people experience them.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

• Very common (1 in 10 patients treated): Edema in legs, reddish or bluish spots on the skin called "livedo reticularis" (usually after high doses).

• Common (between 1 and 10 out of 100): Drowsiness or insomnia, depression, agitation, dizziness, headache, hallucinations, confusion, dizziness, lethargy (prolonged and deep sleep that is usually accompanied by muscle relaxation), nightmares, uncoordinated movements (ataxia), speech difficulties, decrease in blood pressure caused by a sudden change in body position (orthostatic hypotension), palpitations, dry mouth, nausea, loss of appetite (anorexia), vomiting, constipation, sweating, muscle pain (myalgia).

• Rare: Blurred vision.

• Rare (between 1 and 10 out of 1,000): Convulsions, disorientation, psychosis (altered mental state), tremors, abnormal movements (dyskinesia), neuroleptic syndrome (among other symptoms, it causes altered consciousness), diarrhea, skin rashes, corneal injury, corneal edema, decreased visual acuity, urinary retention or incontinence.

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

• Frequency not known (cannot be estimated from available data): Desire to behave in an unusual way for you: strong impulse to gamble excessively, increased or altered sexual interest, excessive and uncontrollable purchases or spending, binge eating (eating large amounts of food in a short period) or compulsive eating (eating more than normal and necessary to satisfy hunger).

All side effects cease when treatment is suspended, and most also disappear after a few days of continued therapy.

5. Storage of Amantadine Level

Keep out of the reach and sight of children.

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

No special storage conditions are required.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Amantadine Level

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

Appearance of the product and packaging content

Amantadine Level is a medication that comes 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

Laboratorios ERN, S.A.

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

This prospectus was approved in January 2025.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/