Pk-Merz (Amantadine Sulfate) 100 Mg 30 Tablets

PK-MERZ 100 mg Tablet

is taken orally.

Excipients

Lactose monohydrate, Microcrystalline cellulose, Potato starch, Gelatin, Polyvinylpyrrolidone, Croscarmellose sodium, Talc, Colloidal anhydrous silica, Magnesium stearate, Titanium dioxide, Talc, Magnesium stearate, Butylmethacrylate- (2-dimethyl-aminoethyl) -methacrylate-methylmethacrylate-copolymer located.

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is PK-MERZ and what is it used for?

2. Considerations before using

3. PK-MERZow to use PK-MERZ?

4. What are the possible side effects?

5. Storage of PK-MERZ

2. What isand what is it used for?

PK-MERZ is a tablet form of antiparkinsonian medicines. PK-MERZ contains amantadine sulfate.

In 3 blisters each containing 10 tablets, in a box with a total of 30 tablets, it is supplied with the instructions for use.

PK-MERZ is used in the following cases:

S In the treatment of muscle response caused by drugs by treatment with Parkinson's (muscle hardening,

tremors, dyskinesia, activity or reduction or stopping of motor functions) S in the treatment of symptoms (motor function disorders such as chills) after stereotaxic operations

. How to use PK-MERZ

If the instructions for proper use and dosage / administration

are not recommended by the physician, the following uses are recommended:

Parkinson's: If the PK-MERZ treatment is started for the first time, treatment with 2 tablets per day should be started. The full activity begins within 48 hours.

At the same time, treatment should be started with 1 tablet (100 mg / day) per day in patients with another medical disease or in high doses of other antiparkinsonian drugs. After one week of treatment, the dose may be increased to 1 tablet level (200 mg / day) taken twice a day at the standard level.

In patients who do not respond to a dose of 2 tablets (200 mg) per day, the dose may be increased to 4 tablets (400 mg) divided by day. The dose should not exceed 6 tablets (600 mg) per day.

The effect of treatment on patients who initially benefit from amantadine treatment does not decrease over time. In case of symptoms with the discontinuation of the drug, with the resumption of treatment, the previously acquired wellness returns again.

If it is to be administered with other antiparkinsonian treatments, the dose should be adjusted according to the drug used and the personal characteristics.

Patients who do not respond to anticholinergic treatments may respond to amantadine. When used in combination with anticholinergic drugs, it promotes treatment by increasing the effect of anticholinergic drugs. When administered with amantadine and levodopa, the patient responds quickly to treatment.

Treatment of extrapyramidal reactions with drugs: The standard dose is 100 mg administered twice a day. Often, patients may need to increase this dose. The optimal dose is 300 mg daily.

If previously treated with PK-MERZ Infusion, the initial dose with the tablet may be higher.

PK-MERZ treatment should not be stopped suddenly. Otherwise, the disease findings may be severe.

Method of:

administrationPK-MERZ is taken orally. One tablet is swallowed with some water.

PK-MERZ treatment should not be stopped suddenly. The dose should be dropped gradually by weekly reduction.

Additional information on specific populations

Dose should be reduced in patients with respiratory insufficiency, edema, liver disease, pronounced disease, peripheral edema, low blood pressure seen from sitting or lying from the supine position.

Kidney / Liver Failure:

Amantadine is the main elimination pathway for kidney function disorders, amantadine accumulates in the blood. Therefore, patients with impaired renal function and patients over 65 years of age should be reduced. Amantadine cannot be removed sufficiently by hemodialysis.

Pediatric population:

Elderly use

Geriatric population: In

elderly patients, especially in patients with restlessness and confusion, a stable dose should be used in cases of predilirium or delirium.

If you use PK-MERZ more than you should use.

High doses of amantadine may cause acute nausea, nausea, vomiting, excessive flurry, tremors in the hands, ataxia, blurred vision, drowsiness, depression, speech disorder and contraction. In case of overdose, epileptic seizures have been reported.

These effects were observed during the use of other antiparkinsonian drugs with a very high amantadine dose.

There is no specific drug treatment or antidote known to treat intoxication. In case of poisoning with amantadine the patient should be vomited and gastric lavage should be performed.

If you have used more than you should use from PK-MERZ, talk to a doctor or pharmacist.

If you have forgotten to use PK-MERZ If the

tablet is forgotten, you should wait for the next tablet. It is recommended not to increase the normal dose to compensate the forgotten dose.

Do not take double doses to compensate for forgotten doses.

The effects of

PK-MERZ treatment with PK-MERZ should be terminated only with the guidance of the physician. It is recommended that patients with Parkinson's should not discontinue amantadine treatment suddenly. In this case, it was reported that Parkinson's crisis occurred in a small group of patients. If an atropine-like effect occurs, the dose of amantadine or the anticholinergics used should be reduced.

It has been reported that neuroleptic malignant syndrome may occur in sporadic cases due to abrupt discontinuation of amantadine. Therefore, if amantadine treatment is to be terminated suddenly and the patient is especially used neuroleptics, close follow-up of the patient is required.

4. What are the possible side effects?

Like all medicines, PK-MERZ may have side effects in people who are sensitive to the substances contained in its content.

The side effects of PK-MERZ in clinical trials are as follows. The evaluation of side effects is based on the following frequency data.

- Very common: more than 1 in 10 people treatedMore than 1

- Common:in 100 people treated - Uncommon: more than 1

in 1000 treated people

- Rare: More than 1 in 10,000 treated people

- Very rare: 1 or less of 10,000 people treated, including isolated cases Common:

- Sleep disorders

- Motor and physiological disturbance

- Urinary incontinence in patients with prostate gland growth

Delusional (paranoid) exogenous psychosis with visual hallucinations in elderly patients with particular tendency perception and behavior disorders) can be triggered.

These adverse effects may occur in combination with other antiparkinsonian drugs (such as levodopa, bromocriptine) or memantine.

- Characteristic skin reactions of amantadine, sometimes livedo reticularis (skin of different colors) with edema in the lower leg and ankle

- Nausea

- Dizziness

- Mouth dry

- Disorders of circulation regulation when standing up or standing (orthostatic irregularities)

Sparse:

- Blurred vision Very rare:

- Hematological side effects such as leukopenia and thrompositopenia

. Many of these cases are included in the risk factors for overdose, some co-medications or cardiac arrhythmias (see section 2. "Do not use PK-MERZ" and "Use with other drugs").

- Transient loss of vision

- Increased light sensitivity

- Irregular heart rhythm with increased heart ratepatients

- Common seizures inusing more than the recommended dose

- Stresses in the muscles and sensations in the arms The

above side effectsfollowing PK-MERZ treatment very rarely were reported.

Very rare:

- Acute general allergic reactions after an infusion therapy (anaphylactic reaction) Unknown:

reversible corneal edema, returned to normal by drug release.

Consult your ophthalmologist as soon as possible in the presence of visual disturbances (loss of vision) or blurred vision. prevent the risk of corneal edema.

Dyestuff can trigger allergic reactions.

All these are serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

Tell your doctor or pharmacist if you experience any of these side effects or a side effect that is not on the list.

2.PK-MERZ should be considered before use

DO NOT use PK-MERZ in the following cases

S If you are hypersensitive to PK-MERZ or any ingredients found in the formulation of the drug

S If you have severe heart failure S If you have heart failure and heart muscleyouinflammation,

IfhaveII. or III. If there is AV-block S If your heart rate is less than 55 beats per minute S If you have QT interval in ECG or if you have congenital QT syndrome S If you have severe prolonged cardiac rhythm S If Q and S levels are low in potassium and magnesium blood S Usepresence of any other medication that may prolong its interval

PK-MERZ in the

S If there is prostate enlargement, S If there is narrow angled eye pressure, S If there is renal failure S If there is restlessness or confusion If you have a pacemakerif

oryou are using a diuretic, orelectrolyte imbalance due to frequent vomiting or diarrhea

if you have, S If you have agitation, confusion,

S is due to respiratory failure due to heart failure, edema, fairy Fetal edema, sitting or lying down from the position of your blood pressure if you have a low S If you had previously been told by your doctor that you are intolerant against some sugars

These warnings, even if you apply for any period in the past, please consult with your doctor.

Using PK-MERZ with food and drink

PK-MERZ is not a drawback with food. However, it should not be used together because it reduces the tolerance to alcohol.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

There is insufficient data on the use of amantadine in pregnant women. Animal research has shown reproductive toxicity. The potential risk for humans is unknown. In this period, drug use is only by the decision of the physician, whose benefit / benefit relationship is very carefully evaluated.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Breastfeeding

Use of

vehicles and machines However, depending on the nature of Parkinson's disease and some of the drugs used for this disease affect the use of vehicles and machinery in general, these patients need to be careful in the use of vehicles and machinery. In the case of alcohol use, this risk increases more.

PK-MERZ

contains lactose monohydrate. If you have been told by your doctor that you are intolerant of some sugars, contact your doctor before taking this medicinal product.

Use with other drugs

Amantadine should not be used with the following drugs known to cause prolongation of the QT distance in the ECG:

S CertainI (quinidine, disopyramide,used against some cardiac rhythm disorders

drugs of the typeprocainamide) and Class III (amidarone, sotalol)S Some antipsychotics (Thioridazine, chlorpromazine, haloperidol, pimozide) S Some tricyclic and tetracyclic-type antidepressants (amitriptyline) S Effective against certain allergic diseases (astemizole, terfenadine) S Some macrolide antibiotics (erythromycin, clarithromycin) S Antibiotics with certain fluoroquinone groups (such as sparfloxacin inhibitors) S Azol group fungicides and other drugs (budipin, halofantrin, co-trimoxazole, pentamidine, cisapride and bepridil)

PK-MERZ can be used with other antiparkinsonian drugs. In order to avoid side effects such as psychotic reactions, the dose of the other drug may need to be reduced.

Some reactions can be expected when PK-MERZ is used with other drugs. For this reason, you should consult your doctor during treatment with PK-MERZ. Amantadine may be used with other antiparkinsonian drugs. In case of co-use, doses should be adjusted.

5.PK-MERZ storage

Keep out of reach of children and keep them in their packaging. 25oStore at room temperature belowC.

Use in accordance with expiration dates.

Do not use PK-MERZ after the expiration date.

4. CLINICAL FEATURES

4.1. Therapeutic Indications

Z Treatment of extrapyramidal reactions (rigidity, tracer, dyskinesia, hypo or akinesia) associated with medication with Parkinson's treatment,

Z Treatment of symptoms (such as tremor) after sterotaxic surgeries.

4.2. Posology, route of administration:

Parkinson's disease: If PK-MERZ monotherapy is to be started for the first time, treatment with 2 tablets should be started daily. The full activity begins within 48 hours.

At the same time, patients who have another medical disease or who take other antiparkinsonian drugs at high doses should start with 1 tablet per day (100 mg / day). After one or several weeks of treatment, the dose may be increased to a level of 1 tablet (200 mg / day) to be taken twice a day at the standard level.

In patients who do not respond to a daily dose of 2 tablets (200 mg), the dose may be increased to 4 tablets (400 mg) divided in Day. The dose should not exceed 6 tablets (600 mg) per day.

The effect of treatment on patients who initially benefit from amantadine treatment does not decrease over time. In case of symptoms with the discontinuation of the drug, with the resumption of treatment, the previously acquired wellness returns again.

Dosing should be done if it is used in combination with other antiparkinsonian drugs.

Patients who do not respond to anticholinergic treatments may respond to amantadine. Anticholinergic drugs or amantadine can be used together to increase the effects. When amantadine and levodopa are administered together, the patient responds quickly to treatment. In the treatment of levodopa, amantadine 100mg or 100mg daily is sufficient to increase the dose. After reaching the optimal levodopa therapy, the desired maximum efficacy can be achieved by adding the benefits that cannot be seen in ievodopa treatment alone with amantadine treatment to be regulated according to need.

Treatment of extrapyramidal reactions with drugs: The standard dose is 100 mg twice daily. Often, patients may need to increase this dose. The optimal dose is then 300 mg daily.

In general, if you have a treatment with PK-MERZ Infusion previously, the starting dose may be higher with the tablet.

PK-MERZ treatment should not be stopped suddenly. Otherwise, the disease findings may be severe.

Method of:

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