Amantadine level 100 mg hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amantadine Level 100 mg hard capsules

Amantadine (amantadine hydrochloride)

Read the entire leaflet carefully before you start taking 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Amantadine Level is and what it is used for
2. Before you take Amantadine Level
3. How to take Amantadine Level
4. Possible side effects
5. How to store Amantadine Level
6. Further information

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

Amantadine is a medicine that belongs to a group of medicines called dopaminergics, which can act as an antiviral and as an antiparkinsonian agent. It is used in adults and children over 10 years of age for:

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

Amantadine Level is not a substitute for the influenza vaccine. You should consult your doctor to assess whether you need to receive the vaccine.

2. Before taking Amantadine Level

Do not take Amantadine Level

• If you are allergic (hypersensitive) to amantadine or rimantadine or to 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 QT interval prolongation or have family members with a history of congenital QT syndrome (a defect in the heart's electrical system that may cause an abnormal heart rhythm).
• If you are being treated with budipine or other medicines that cause changes in the electrocardiogram.
• If you are pregnant or breastfeeding.
• If you have seizures.
• If you have or have had stomach bleeding (gastric ulcer).
• If you produce little or no urine (severe renal failure).
• If you have increased pressure in the eye (closed-angle glaucoma).

Take special care with Amantadine Level

Before starting treatment with Amantadine Level, take special care:

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

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

Inform your doctor if you or your family/caregiver notice that you are developing impulses or urges to behave in ways that are unusual for you and that you are unable to resist the impulse, desire, or temptation to carry out certain activities that could harm you or others. These behaviors are known as impulse control disorders and may include gambling addiction, excessive eating or spending, abnormally increased sex drive, or increased sexual thoughts or appetite. Your doctor may need to adjust or stop your dose of Amantadine Level.

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

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

Use of other medicines

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

Note that these instructions may also apply to medicines taken previously or that may be taken in the future.

The simultaneous use of amantadine and medicines that cause QT interval prolongation is contraindicated, such as in the following cases:

• Medicines used to suppress or prevent heart rhythm disturbances (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, which are a specific group of antibiotics (e.g., sparfloxacin and grepafloxacin)
• Medicines used for fungal infections (antifungals), specifically azole antifungals
• Other medicines 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 indicated for the treatment of gastroesophageal reflux), and bepridil (a calcium channel blocker used to relieve and control angina pectoris).

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

Other medicines that may interact with amantadine include:

• Anticholinergics, which have various clinical uses such as antispasmodics, bronchodilators, in Parkinson’s disease, ophthalmology, etc. (trihexyphenidyl, benztropine, scopolamine, biperiden, orphenadrine, etc.).
• Central nervous system (CNS) sympathomimetics, medicines that stimulate psychological functions (such as consciousness, orientation, attention, or concentration), increasing motor and cognitive activity as well as attention.
• Diuretics (medicines 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 consume alcohol during treatment with Amantadine Level, as it may cause central nervous system effects such as dyskinesia (involuntary movements), confusion, fainting, and orthostatic hypotension.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines

Do not drive or operate tools or machinery, as Amantadine Level frequently causes adverse reactions (e.g., drowsiness, visual disturbances, dizziness, vertigo) that could impair your ability to concentrate and react.

3. How to take Amantadine Level

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

Remember to take your medicine.

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

A higher dose may be prescribed at the physician's discretion, provided patients are under strict medical supervision.

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

Amantadine Level is administered orally.

Treatment of influenza:

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

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

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

Prophylaxis of influenza:

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

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

When administered together with the inactivated Influenza A vaccine, treatment should continue for 2–4 weeks after vaccination.

Treatment of Parkinson's disease:

• Treatment should begin with 100 mg daily during the first week, followed by one capsule (100 mg of amantadine hydrochloride) twice daily.

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

Method of administration

Amantadine Level capsules should be taken with some liquid.

Amantadine frequently causes insomnia (difficulty sleeping). Try to adjust the dosing schedule so that the last dose is not taken late in the afternoon or at night.

In the treatment of patients with Parkinson's syndrome, therapy should be initiated gradually, and abrupt discontinuation of treatment must be avoided.

Patients with renal impairment

This medication should be administered with great caution in such patients. Therefore, the physician will adjust the dose according to the patient's creatinine clearance (a laboratory test assessing kidney function).

Use in elderly patients

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

Use in children

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

Its use is not recommended in children under 10 years of age, as experience in this population group is limited.

If you take more Amantadine Level than you should

Contact your doctor or pharmacist immediately.

Symptoms of overdose include: nausea, vomiting, hyperexcitability, tremors, uncontrolled movements (ataxia), blurred vision, drowsiness, depression, speech difficulties (dysarthria), and seizures. It may also cause irregular heartbeats (arrhythmias), fluid accumulation in the lungs (pulmonary edema), repeated seizures (status epilepticus), and toxic psychosis (a state of confusion that may progress to coma).

In case of overdose, vomiting should be induced immediately and/or gastric lavage performed. There is no specific antidote. Elimination of the drug should be promoted by acidifying the urine, and symptomatic treatment should be initiated, including, if necessary, the use of sedatives and anticonvulsants.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medication and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Amantadine Level

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

If you stop taking Amantadine Level

If you have Parkinson's disease, you should avoid abruptly stopping treatment. This may cause a rebound effect with the onset of rigidity, confusion, or bulbar paralysis.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Amantadine Level can cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

• Very common (1 in 10 patients treated): Leg edema, reddish or bluish skin mottling known as “livedo reticularis” (usually after high doses).

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

• Uncommon: Blurred vision.

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

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

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

All side effects cease upon discontinuation of treatment, and most also disappear within 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 expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Information for the user

Composition of Amantadine Level

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

Appearance of the medicine and contents of the pack

Amantadine Level is a medicine presented as 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 Barberà del Vallès, Barcelona, Spain.

This leaflet was approved in January 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/