Pexola (generic mirapex and parcopa) pramipexole 100 Tablets

Active Substance

Pramipekso1.

Each PEXOLA ER 3.0 milligrams extended release tablet contains 3.0 mg of pramipexole dihydrochloride monohydrate equivalent to 2.1 milligrams of pramipexole base.

Please read this INSTRUCTIONS carefully before you start using this medicine because 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 Operating Instructions:

1. What is PEXOLA ER and what is it used for?

2. Things to consider before using

3. PEXOLA ERHow to use PEXOLA ER

4. What are the possible side effects?

5. PEXOLA ER storage

headers are included.

2. What is PEXOLA ER and what is it used for?

PEXOLA ER extended release tablet contains a drug active substance called pramipexole and is included in a drug group called dopamine agonist. This group of drugs acts by stimulating the sensing agents (dopamine receptors) in the brain. Stimulation of dopamine receptors helps to control body movements by triggering nerve signals in the brain.

The PEXOLA ER extended release tablet can be used alone or in combination with levodopa (another drug used in Parkinson's disease) in the treatment of primary (first-time) symptoms of Parkinson's disease.

PEXOLA ER 3.0 milligrams extended release tablet, white-broken white, oval shape. The P4 code is printed on one side and the Boehringer Ingelheim company logo on the other.

3. How to use PEXOLA ER?

Always take the PEXOLA ER extended release tablet exactly as instructed by your doctor. Your doctor will tell you the dose you need.

The usual daily dose during the first week is 0.375 mg pramipexole. Your doctor will increase the dosage of your medicine every 5-7 days until your symptoms are controlled (maintenance dose).

4. What are the possible side effects?

Like all medicines, PEXOLA ER may have side effects in people who are sensitive to the substances contained in its contents.

The following frequency definitions are considered in the evaluation of side effects:

Very common (affects more than 1 person from 10 uses); common (affects 10 to 10); uncommon (influences up to 1 person from 100 uses); infrequent (influences up to 1 to 1000 people); very infrequent (it affects up to 1 person from 10,000); unknown (unpredictable).

The following side effects may occur:

Very common:

- abnormal in the arms and legs, uncontrolled movements (dyskinesias)

- Drowsiness

- Dizziness

- Nausea

Common:

Unusual tend to behave

Thereseeing things that are not, hearing or feeling (hallucinations)

Confusion (Confusion)

Fatigue

Insomnia Overdose

(peripheral edema), especially in the legs

- Headache

Decrease in blood pressure (hypotension)

Abnormal dreams Constipation

Vision disorders

- Vomiting

Weight loss including appetite reduction Uncommon:

- Fear of self-harm (paranoia)

- Delusion (delusion, delusions

- Excessive sleep and sudden sleep during the day

- Memory losses (Amnesia)

- Increase in movements and(hyperkinesis)

- Weight gain

nonstop- Alegiic reactions (eg, rash, itching, hypersensitivity)

- Fainting

- Cardiac failure (shortness of breath or foot wrist problems) *

- Unsuitable antidiuretic hormone release * (hormone regulating the body's water balance)

- Uneasiness

- Difficulty breathing (dyspnea)

- Hiccups

- Pneumonia (pneumonia)

- A behavior that can cause harm to yourself and others impulse, instinct or desire. These can include: The

urge to play an extreme and strong gamble despite serious personal or familial consequences.

Change or increase in sexual interest, behavior that causes serious anxiety in you and others, eg, increase in sex instinct.

Uncontrollable excessive shopping or spending

binge eating (in a short time to eat large quantities) or compulsive eating (normally eat more than the amount that will feed your amount and the hunger you eat) *

- clouding of consciousness, confusion, loss of sense of reality (delirium)

Rare:

- Tension, enthusiasm or extreme excitement (mania)

If any of these behaviors occur, tell your doctor. Your doctor will discuss ways to deal with or reduce these symptoms.

A precise frequency estimate for side effects marked with (*) is not possible; This was not observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is probably not greater than ”non-common Sık.

2.PEXOL ERshould be considered before using

er to PEXOL NOT use in the following

Docases;

- If you are allergic to any of the abovementioned excipients in the Pramipexole or PEXOLA ER extended release tablet formula.

CAREFULLY USEfollowing cases

PEXOLA ER in theBefore you start taking PEXOLA ER, consult your doctor.

If you experience any medical problems or symptoms, especially if one of the following conditions applies to you, tell your doctor:

- Kidney disease;

- Don't dream. (Hallucinations, seeing or hearing things that are not real) Most of the hallucinations are visual.

- Dyskinesia (For example, abnormal, uncontrollable movements in the arms and legs): If your Parkinson's disease is at an advanced stage and you are also using the drug levodopa, dyskinesia may occur during the period when the dose of PEXOLA ER is increased.

- Sleepy and suddenly falling asleep.

- Symptoms similar to schizophrenia symptoms (psychosis).

- Disorders in sight. You should have regular ophthalmic examinations during PEXOLA ER treatment.

- Severe cardiovascular diseases.You should check your blood pressure regularly, especially during the initial stages of your treatment. This is necessary to avoid postural hypotension (when you stand up).

If you or anyone interested in your care discovers that you have developed impulses and wishes that cause you to behave abnormally, and that you cannot prevent the instinct, drive, or excessive wishes that can cause harm to yourself or others, speak to your doctor immediately. These symptoms are called davranış impulse control disorders seks and include behaviors such as addiction gambling, over-eating, excessive spending of money, increased sexual feelings and thoughts in the form of abnormally excessive sex drive or obsession. Your doctor may need to adjust the dose of your medication or interrupt the treatment.

If you or anyone interested in your care realizes that you are experiencing mania (feeling of tension, enthusiasm or excessive excitement) or delirium (unconsciousness, confusion, detachment), contact your doctor immediately. Your doctor may need to adjust the dose of your medication or interrupt the treatment.

PEXOLA ER is a specially designed tablet and the active substance is released gradually in the body after the tablet is taken. Tablet parts may occasionally pass through the digestive tract and may appear in your stool. These tablet pieces can also be seen in the form of a whole tablet. Inform your doctor if you see tablet pieces in your stool.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using PEXOLAwith food and drink

ERYou should be careful when taking alcohol during PEXOLA ER prolonged release tablet therapy. The PEXOLAER extended release tablet can be taken with or without meals.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

If you are pregnant, suspect that you may be pregnant, or plan to become pregnant, report the condition to your doctor. Your doctor will then let you know if you can continue PEXOLA ER prolonged release tablet therapy.

The effects of the PEXOLA ER extended release tablet on the unborn baby are unknown. Therefore, if you are pregnant, do not use PEXOLA ER extended release tablets unless your doctor tells you otherwise.

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

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Mothers who breastfeed their baby should not use PEXOLA ER extended release tablets. PEXOLA ER can reduce breast milk. At the same time, it can pass to your milk and baby. If using PEXOLA ER is unavoidable, you should stop breastfeeding.

Use ofand machines

toolsDuring PEXOLA ER treatment, you can see, hear or feel things that are not in reality. If these symptoms occur, avoid the use of vehicles and machinery.

The PEXOLA ER extended release tablet has been associated with somnolence and sudden sleep disturbances, particularly in patients with Parkinson's disease. If you have these side effects, do not use tools and machinery. Report this to your doctor.

Important information on certain excipients in the content of

PEXOLA ER The excipients contained in the PEXOLA ER extended release tablet do not require any stimulatory information.

Use with other medications

If you are taking any other medication, if you have recently used it or if you are likely to use it, inform your doctor or pharmacist. These include other medicines, herbal remedies, healthy foodstuffs or food supplements that you can supply without prescription.

Do not use PEXOLA ER with antipsychotic drugs.

If you use any of the following medications, be sure to inform your doctor before taking PEXOLA ER prolonged release tablets and take care:

- Cimetidine (a drug used in the treatment of excess acid in the stomach and stomach ulcer)

- Amantadine (a drug that can be used in Parkinson's disease)

- Mexicin (is ventricular arrhythmia) "is used in the treatment of so-called irregular heartbeat)

- Zidovudine (human with a disease of the immune system" acquired inadequate immune system syndrome "(AIDS), a drug used to treat)

- Cisplatin (a drug used in various cancer diseases)

- quinine (night emerged painfulused for the treatment of malaria malaria)a type of leg cramps and malaria

Proxainamide (-- Procainamide (used for irregular heartbeats)

If you use levodopa, start treatment with PEXOLA ER levodopa dose reduction is recommended.

You should be careful when you are taking any other medicines or alcohol that have a sedative effect (sedative effect). In this case, the PEXOLA ER extended release tablet can affect your ability to drive and use machines.

2.PEXOL ERshould be considered before using

er to PEXOL NOT use in the following

Docases;

- If you are allergic to any of the abovementioned excipients in the Pramipexole or PEXOLA ER extended release tablet formula.

CAREFULLY USEfollowing cases

PEXOLA ER in theBefore you start taking PEXOLA ER, consult your doctor.

If you experience any medical problems or symptoms, especially if one of the following conditions applies to you, tell your doctor:

- Kidney disease;

- Don't dream. (Hallucinations, seeing or hearing things that are not real) Most of the hallucinations are visual.

- Dyskinesia (For example, abnormal, uncontrollable movements in the arms and legs): If your Parkinson's disease is at an advanced stage and you are also using the drug levodopa, dyskinesia may occur during the period when the dose of PEXOLA ER is increased.

- Sleepy and suddenly falling asleep.

- Symptoms similar to schizophrenia symptoms (psychosis).

- Disorders in sight. You should have regular ophthalmic examinations during PEXOLA ER treatment.

- Severe cardiovascular diseases.You should check your blood pressure regularly, especially during the initial stages of your treatment. This is necessary to avoid postural hypotension (when you stand up).

If you or anyone interested in your care discovers that you have developed impulses and wishes that cause you to behave abnormally, and that you cannot prevent the instinct, drive, or excessive wishes that can cause harm to yourself or others, speak to your doctor immediately. These symptoms are called davranış impulse control disorders seks and include behaviors such as addiction gambling, over-eating, excessive spending of money, increased sexual feelings and thoughts in the form of abnormally excessive sex drive or obsession. Your doctor may need to adjust the dose of your medication or interrupt the treatment.

If you or anyone interested in your care realizes that you are experiencing mania (feeling of tension, enthusiasm or excessive excitement) or delirium (unconsciousness, confusion, detachment), contact your doctor immediately. Your doctor may need to adjust the dose of your medication or interrupt the treatment.

PEXOLA ER is a specially designed tablet and the active substance is released gradually in the body after the tablet is taken. Tablet parts may occasionally pass through the digestive tract and may appear in your stool. These tablet pieces can also be seen in the form of a whole tablet. Inform your doctor if you see tablet pieces in your stool.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using PEXOLAwith food and drink

ERYou should be careful when taking alcohol during PEXOLA ER prolonged release tablet therapy. The PEXOLAER extended release tablet can be taken with or without meals.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

If you are pregnant, suspect that you may be pregnant, or plan to become pregnant, report the condition to your doctor. Your doctor will then let you know if you can continue PEXOLA ER prolonged release tablet therapy.

The effects of the PEXOLA ER extended release tablet on the unborn baby are unknown. Therefore, if you are pregnant, do not use PEXOLA ER extended release tablets unless your doctor tells you otherwise.

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

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Mothers who breastfeed their baby should not use PEXOLA ER extended release tablets. PEXOLA ER can reduce breast milk. At the same time, it can pass to your milk and baby. If using PEXOLA ER is unavoidable, you should stop breastfeeding.

4. CLINICAL FEATURES

4.1. Therapeutic indications

PEXOLA ER extended release tablet is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease in adults. It can be used alone (without levodopa), or in the course of the disease, when late effects of levodopa have begun to decrease, or when the therapeutic effect fluctuates (fluctuations in the end of dose or on / off), as the effect of the change becomes apparent Available in the form.

4.2. Posology and method of administration

Posology / frequency and duration of administration:

PEXOLA ER is an oral release formulation of pramipexole once daily.

Initial treatment: As

shown below, the dose should be increased incrementally from the initial dose of 0.375 mg salt (0.26 mg base) per day, and the dose increments should be made at intervals of 5-7 days. Dose titration should be performed in such a way that maximum therapeutic effect can be achieved unless undesirable adverse effects are observed in patients.

If the dose is to be increased further, the daily dose should be increased to a dose of 0.75 mg of salt (0.52 mg base) at weekly intervals, to a maximum daily dose of 4.5 mg salt (3.15 mg base). However, it should be kept in mind that the incidence of somnolence increases when the daily doses of 1.5 mg salt (1.05 mg base) are exceeded (see 4.8).

Patients who are currently taking PEXOLA tablets may switch to the PEXOLA ER extended release tablet at the same daily dose starting the following morning. After switching to the PEXOLA ER extended release tablet, the drug dose can be adjusted according to the patient's response to treatment (see 5.1).

&a