MANTADAN 100 mg Tabletki

Treść ulotki

1. What Mantadan is and what it is used for
2. What you need to know before taking Mantadan
3. How to take Mantadan
4. Possible side effects
5. How to store Mantadan
6. Contents of the pack and other information

Mantadan® 100 mg tablets
Amantadine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Mantadan is and what it is used for
• 2. What you need to know before you take Mantadan
• 3. How to take Mantadan
• 4. Possible side effects
• 5. How to store Mantadan
• 6. Contents of the pack and other information

1. What Mantadan is and what it is used for

Mantadan contains the active substance amantadine, which belongs to a group of medicines called
dopaminergic drugs.
Mantadan is indicated in adults and the elderly for the treatment of:

• Parkinson's disease (a central nervous system disease that prevents control of movement, which manifests for example with tremor, sensation of stiffness, slowing of movements, difficulty maintaining balance, due to a reduction in the central nervous system of a substance called dopamine)
• parkinsonisms (diseases that, due to their similarity with Parkinson's disease, are called parkinsonisms)
• bradipsychism of involutional age (diseases that determine a slowing of mental functions) even on an arteriosclerotic basis, with or without signs of extrapyramidal involvement (involvement of the area of the nervous system that controls movement).

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Mantadan

Do not take Mantadan

• if you are allergic to amantadine or any of the other ingredients of this medicine (listed in section 6);
• during pregnancy;
• if you have had allergic reactions to this medicine in the past;
• if you suffer from severe heart diseases such as severe decompensated heart failure, cardiomyopathies and myocarditis (diseases of the heart muscle);
• if you suffer from atrioventricular block of degree II and III (severe alteration of the heart's electrical conduction system);
• if you suffer from bradycardia (reduced heart rate, i.e. the number of heartbeats per minute) with a frequency of less than 55 beats/min;
• if you or a family member have been diagnosed with alterations in the ECG (electrocardiogram, a test to assess heart function) such as prolonged QT interval or appreciable U waves or congenital long QT syndrome;
• if you have had severe ventricular arrhythmias (irregular heartbeats) in the past, including torsade de pointes (a particular form of arrhythmia);
• if you are being treated with budipine or other medicines that cause alterations in the ECG, such as prolongation of the QT interval (see section “Other medicines and Mantadan”);
• in case of low levels of potassium and magnesium in the blood.

Warnings and precautions
Talk to your doctor or pharmacist before taking Mantadan.
Before starting therapy and after 1 and 3 weeks, your doctor will prescribe an examination called an
electrocardiogram (ECG) based on which he/she will assess the functionality of your heart. If the
doctor were to increase the dosage at a later time, the doctor will prescribe the ECG again before
increasing the dosage and after two weeks. Subsequently, the doctor will prescribe control ECGs at least
annually. Based on the ECG values before and during treatment with Mantadan, the doctor will assess
whether you should be excluded from treatment.

Talk to your doctor if you, a family member or the person who takes care of you notices that you are

developing an urge or craving to behave in a way that is unusual for you and that you cannot

resist the urge, desire or temptation to engage in activities that could harm you or others. These types of behavior are called impulse control disorders and can

include gambling addiction, overeating or excessive spending, increased sexual desire or increased thoughts or feelings of a sexual nature.

Your doctor may need to adjust the dose or stop giving you

Mantadan.
Electrolyte imbalances
If you are at risk of electrolyte imbalances (alteration of the concentrations of salts normally dissolved in
the blood and body fluids), for example: if you are being treated with diuretics (medicines that
cause increased urine production), if you have frequent vomiting and/or diarrhea, if you use
insulin in emergency situations, if you have kidney disease or anorexia (loss of appetite), the
doctor will prescribe the necessary control tests and, if necessary, will restore adequate electrolyte
levels, in particular potassium and magnesium.
Cardiovascular diseases (affecting the heart and circulation)
If you suffer from heart and circulatory diseases, you should undergo regular medical check-ups during
treatment with Mantadan. During prolonged use of Mantadan, peripheral edema (swelling in some
parts of the body) may occur.
At the first sign of symptoms such as palpitations, dizziness or syncope (sudden and transient loss of
consciousness), you should stop taking Mantadan and contact your doctor immediately. The doctor will
assess – within 24 hours – any alterations in the electrocardiogram (ECG). If there are no alterations in
the ECG, the doctor will decide whether you can continue therapy with Mantadan, taking into account
contraindications and interactions (see also section “Other medicines and Mantadan”).
If you have a pacemaker (i.e. if you have undergone surgery in which an apparatus capable of electrically
stimulating the contraction of your heart has been applied to your heart), it is not possible to accurately
determine the ECG values. Therefore, the decision on therapy with Mantadan must be made on a case-by-case
basis, in agreement with your attending cardiologist.
Treatment with neuroleptics
If you are being treated simultaneously with neuroleptics (a class of medicines used in the treatment of
some mental illnesses) and Mantadan, you should not abruptly stop treatment with Mantadan, as there is a
risk of neuroleptic malignant syndrome (a serious nervous system disorder), which may pose a risk to your
life (see also the section “If you stop taking Mantadan”).
Kidney disorders
In the presence of kidney dysfunction, Mantadan must be used with caution as intoxication may occur.
Consult your doctor if you experience urinary disorders (difficulty urinating).
Nervous system disorders
Mantadan must be used with caution in the following cases:

• if you have suffered from organic brain syndrome and cerebral seizures (nervous system diseases) in the past, as individual symptoms of the disease may worsen and seizures may occur (see sections “Possible side effects” and “How to take Mantadan”);
• if you suffer from confusion or hallucinations or underlying psychiatric illnesses;
• if you have been prescribed Mantadan together with other medicines that act on the central nervous system (see also section “Other medicines and Mantadan”).

Other precautions for use
Often, patients with Parkinson's disease show symptoms of the disease such as hypotension (low
blood pressure), sialorrhea (excessive saliva production), generalized sweating, hyperthermia
(increased body temperature), heat stroke, water accumulation and depressive mood disorders,
which must be treated taking into account the side effects and interactions of
Mantadan (see sections “Possible side effects” and “Other medicines and Mantadan”).
If you experience blurred vision or other visual disturbances, consult an ophthalmologist immediately.

Children
There is insufficient experience in children, therefore the use of the product in children is not
recommended.

Other medicines and Mantadan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
During therapy with amantadine, you should not take other medicines that
cause an alteration in the ECG at the same time, including, for example:

• some antiarrhythmics (medicines used to treat irregular heartbeats) such as quinidine, disopyramide, procainamide, amiodarone, sotalol
• some antipsychotics (medicines used for some mental illnesses) such as thioridazine, chlorpromazine, haloperidol, pimozide
• some tricyclic and tetracyclic antidepressants (medicines used to treat depression) such as amitriptyline
• some antihistamines (medicines used to treat allergies) such as astemizole, terfenadine
• some antibiotics (such as erythromycin, clarithromycin, sparfloxacin)
• azole antifungals (medicines used for fungal skin infections)
• other medicines such as budipine (medicine for Parkinson's disease), halofantrine (medicine used to treat malaria), cotrimoxazole and pentamidine (antibacterial medicines used for infections), ziprasidone (medicine used to treat some mental illnesses) or bepridil (medicine used to treat angina pectoris, chest pain). This list may not be exhaustive. Before combining amantadine with any other medicine, consult your doctor or pharmacist.

Mantadan can be combined with other medicines for Parkinson's disease.
There are no targeted studies on the effects of administering Mantadan together with other
antiparkinsonian or antidementia medicines (for example, bromocriptine, triesifenidile, etc.) (see the
section "Possible side effects").
Levodopa can be combined with Mantadan. The combination with levodopa increases
the therapeutic effect of both medicines.
Memantine may increase the activity and side effects of Mantadan (see section "Do not
take Mantadan").
To avoid side effects (such as psychotic reactions, i.e. mental disorders), the doctor
may need to reduce the dosage of other medicines or the combination.
During therapy with Mantadan, if you are taking the groups of medicines or
active ingredients listed below at the same time, the following conditions may occur:
Anticholinergics (medicines that block the effects of acetylcholine, a substance involved in the transmission
of nerve impulses)
In case of association with anticholinergics such as triesifenidile, benzatropine, ioscine,
biperidene, orphenadrine, etc., an increase in the side effects of anticholinergics
(confusion and hallucinations) may occur.
Centrally acting indirect sympathomimetics (a class of medicines that act on the central nervous
system)
Increased action of amantadine on the central nervous system.
Diuretics
The simultaneous administration of diuretics (medicines that cause increased
urine production) such as triamterene/hydrochlorothiazide may reduce the body's ability to
eliminate the medicine from the blood and therefore determine toxic concentrations of
amantadine in the blood. Therefore, you should avoid taking such medicines at the same time.

Mantadan with alcohol
Mantadan reduces tolerance to alcohol, you must take this into account if you consume alcohol during
treatment with Mantadan.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Mantadan if you are pregnant.
Breastfeeding
Amantadine is excreted in breast milk. Ask your doctor for advice before taking this
medicine.

Driving and operating machinery
The use of Mantadan may cause side effects such as dizziness or blurred vision. Take into account the
potential risks if you are driving vehicles or operating machinery that
requires attention and vigilance.

Mantadan contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to take Mantadan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults
The recommended dose is 1 tablet 2 times a day (in the morning and at noon).
The doctor will adjust the dosage taking into account any concomitant therapies you are undergoing
(levodopa, anticholinergics, etc.) and your response.
Before starting therapy and after 1 and 3 weeks, your doctor will prescribe you an examination
called an electrocardiogram (ECG) based on which he/she will evaluate the functionality of your heart.
If the doctor were to increase the dosage at a later time, the doctor will prescribe the ECG again
before increasing the dosage and after two weeks. Subsequently, the doctor will prescribe control ECGs at least annually.
Based on the ECG values before and during treatment with Mantadan, the doctor will evaluate whether you should
be excluded from treatment. In this way, and taking into account also the contraindications reported
in the paragraph “Do not take Mantadan”, it is possible to avoid the very rare, but
dangerous, side effect of torsade de pointes ventricular tachycardia (a particular form of arrhythmia,
alteration of the heart rhythm) (see the paragraph “Possible side effects”).
If you are undergoing therapy in association with other anti-Parkinson's drugs, the doctor
will adjust the dosage on a case-by-case basis.

Elderly
In the elderly, due to reduced renal clearance (reduced ability of the kidney to filter and cleanse the
blood) which determines higher levels of amantadine in the blood, the recommended dose is 100 mg per day
(1 tablet per day).

Patients with impaired renal function
In general, in case of impaired renal function, the doctor will adjust the dosage
evaluating the functionality of your kidneys based on the reduction of renal clearance (ability of the kidney to
filter and cleanse the blood, measured based on a parameter called glomerular filtration rate – GFR).

*) to be obtained by alternatingly administering once 1 tablet of 100 mg and once 2
tablets of 100 mg of amantadine hydrochloride.

How to take the tablets
The tablets must be swallowed with some liquid, preferably in the morning and afternoon.
The last daily dose must be taken no later than 4 PM.

Duration of treatment
The duration of treatment depends on the type and severity of the clinical picture and will be established by your
treating physician. Do not discontinue the medicine on your own initiative.
Do not abruptly stop taking Mantadan, as otherwise you may experience
a severe worsening of symptoms, which can reach up to akinetic crisis (collapse of the
body due to temporary loss of muscle strength and tone), and there is a possibility that withdrawal symptoms may occur, which can reach up to delirium (see also the paragraph “If you stop taking Mantadan”).

Use in children
Sufficient experience in children is not available, therefore the use of the product in children is not
recommended.

If you take more Mantadan than you should
In case of accidental ingestion/taking of an excessive dose of Mantadan, you must immediately notify
your doctor or go to the nearest hospital.

• Symptoms The state of acute intoxication is characterized by nausea, vomiting, hyperexcitability, tremor, ataxia (progressive loss of muscle coordination), blurred vision, lethargy (state of deep sleep with reduced response to normal stimuli), depression, dysarthria (difficulty articulating words) and cerebral seizures; in one case, a malignant cardiac arrhythmia (malignant alteration of the heart rate, i.e. the number of beats per minute) has been reported.
• Therapeutic measures There is no specific pharmacological therapy, nor an antidote. In case of intoxication due to excessive ingestion of tablets, you must induce vomiting or resort to gastric lavage (to be performed in hospital by specialized personnel). In case of intoxications that pose a risk to your life, measures will also be necessary that will be established by the doctor.

If you forget to take Mantadan
Do not take a double dose to make up for the missed tablet.

If you stop taking Mantadan
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
Do not interrupt the treatment with Mantadan on your own initiative.
If you are undergoing concomitant treatment with neuroleptics (a class of drugs used in the treatment of
some mental illnesses) and Mantadan, do not abruptly stop the treatment with Mantadan,
as there is a risk that a neuroleptic malignant syndrome (severe nervous system disorder) may occur, which may pose a risk to your life.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Adverse reactions are listed below according to the following frequency:

Not known (frequency cannot be estimated based on available data):

• Urge to behave unusually
• strong urge to gamble, altered or increased sexual interest, excessive and uncontrollable spending or shopping, uncontrolled eating (consuming largeamounts of food in a short time) or compulsive eating (consuming amounts of foodgreater than normal and greater than the amount needed to satisfy hunger)

Common (may affect up to 1 in 10 people):

• motor and mental restlessness
• paranoid psychosis (unjustified feeling of persecution or grandiosity), accompanied by visual hallucinations, particularly in elderly patients predisposed. These side effects may manifest more commonly especially if Mantadan is combined with other antiparkinsonian or antidementia drugs (for example levodopa, bromocriptine, memantine)
• sleep disorders
• dizziness
• reduction of blood pressure upon sudden transition to an upright position accompanied by symptoms such as dizziness/lightheadedness (orthostatic hypotension)
• dry mouth
• nausea
• urinary retention (inability of the urinary bladder to empty completely) in the presence of prostatic hypertrophy (enlargement of the prostate)
• livedo reticularis (skin disease characterized by net-like patches), sometimes associated with swelling of legs and ankles due to fluid accumulation Uncommon (may affect up to 1 in 100 people):blurred visionRare (may affect up to 1 in 1,000 people):corneal injury, corneal edema, reduced visual acuity Very rare (may affect up to 1 in 10,000 people):
• reduction in the number of white blood cells (leukopenia)
• reduction in the number of platelets in the blood (thrombocytopenia)
• anorexia (loss of appetite)
• headache
• brief and involuntary contraction of one or more muscles (myoclonus)
• symptoms of peripheral neuropathy (disease of the peripheral nervous system)
• seizures
• temporary loss of vision
• increased sensitivity to light (photophobia)
• cardiac arrhythmias
• ventricular tachycardia (increased frequency of ventricular beats in the heart)
• ventricular fibrillation (disordered and very high frequency contraction of the ventricles)
• torsade de pointes (a particular form of arrhythmia)
• alteration of the ECG (see paragraphs “Do not take Mantadan” and “Other medicines and Mantadan”)
• vomiting
• diarrhea
• stomach pain

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can contribute to providing more
information on the safety of this medicine.

5. How to store Mantadan

This medicine does not require any special storage conditions.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mantadan contains

• the active ingredient is amantadine hydrochloride 100 mg
• the other ingredients are: corn starch, lactose monohydrate (see section 2 “What you need to know before you take Mantadan”), talc, magnesium stearate.

Description of the appearance of Mantadan and contents of the pack
20 tablets packaged in blisters.

Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B - Fervença
2705-906 Terrugem SNT
Portugal
Tel.: +351 219 608 410
Fax: +351 219 615 102
e-mail: [email protected]
Sales representative
Hikma Italia SpA
Viale Certosa 10
27100 Pavia

Manufacturer
Istituto De Angeli S.r.l.
Loc. Prulli 103/c - Reggello (Firenze)