Parkipex (Pramipexole) 100 Tablets

PARKİPEX 0.25 mg tablet is taken orally.

Active Substance

Pramipexole.

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 PARKIPEX and what is it used for?

2. Things to consider before using the PARKIPEX

3. How to use PARKIPEX?

4. What are the possible side effects?

5. The storage of the PARKIPEX is

included.

2. What is PARKIPEX and what is it used for?

PARKIPEX 0.25 mg tablets each contain 0.25 mg pramipexole dihydrochloride monohydrate, equivalent to 0.18 mg pramipexole base.

• PARKIPEX is a group of drugs called dopamine antagonists.

• PARKIPEX is available in packages containing 30 and 100 tablets.

• PARKIPEX is used for the treatment of Parkinson's disease and restless leg syndrome.

3.How to use PARKIPEX?

Instructions for appropriate use and dose / frequency of administration instructed

Adults / elderly

Always take PARKIPEX exactly your doctor. If you're not sure, you should ask your doctor or pharmacist. Parkinson's disease The

daily dose is divided into three equal parts (3 x). Initial treatment

Dosage should be increased stepwise from an initial dose of 0.375 mg per day, as shown below, and dose increments should be made at intervals of 5-7 days. The dosage should be increased until the highest therapeutic effect is obtained, unless side effects are unacceptable.

If higher doses are required, the daily dose should be increased to 0.75 mg with weekly intervals. The highest daily dose is 4.5 mg.

Maintenance therapy

Daily individual doses should be in the range of 0.375 mg and a maximum of 4.5 mg. During the dose increase in the clinical trial, drug efficacy was observed at the early and later stages of the disease when the dose of 1.5 mg per day was started. Additional doses for treatment may be provided by the above doses.

The termination of treatment should be completed by

decreasing the number of steps in a few days. Dosage in patients

receiving levodopa treatment Together with PARKIPEX, it is recommended to reduce the dose of levodopa in both the dose increase and maintenance treatment periods. Thus, excessive stimulation of dopamine sensor constructs in the brain is avoided.

Restless leg syndrome The

recommended starting dose of PARKIPEX is 0.125 mg taken 2-3 hours before bedtime once a day. In patients who require further improvement in the symptoms, the dose may be increased by up to 0.75 mg daily by increasing every 4-7 days. The termination of treatment can be terminated

without reducing the dose of PARKIPEX.

Method and method

of administration The tablets should be taken orally and swallowed. Tablets can be opened or packed.

The use

and safety of PARKIPEX in children and adolescents up to 18 years has not

been established.

Elderly use The

expiration time of PARKIPEX may be longer in the elderly.

Specific use cases

Removal of pramipexole from the body is dependent on renal function and is closely related to creatinine clearance, which is indicative of renal function. On the basis of studies conducted in patients with renal impairment, patients with creatinine clearance above 20 mL / min are not required to reduce the daily dose.

Restless Legs Syndrome

There is no study on the use of pramipexole in patients with restless legs syndrome, a kidney disorder.

Hepatic impairment:

Dose reduction is not considered to be necessary in patients with hepatic impairment.

If you have an impression that the effect of PARKIPEX is too strong or weak, talk to your doctor or pharmacist.

If you use more PARKIPEX than you should use,use from

talk to a doctor or pharmacist if you have used more than you should PARKIPEX.

It is important to follow the dose prescribed by your doctor. If you accidentally or accidentally take more tablets, ask your doctor immediately without delay or contact the nearest hospital's emergency department.

if you forgot to use PARKIPEX

Parkinson's disease:

If you forget a dose, remember your medicine. However, if the next dose has arrived or is approaching, skip the missed dose and then continue to use it as you normally would. Restless Legs Disease:

If you forget to take your medication, remember this dose will not remember the same day. If you do not take your tablet the same day, please take your normal dose the next day. Do not take two doses on the same day.

Do not take double doses to compensate for forgotten doses.

Effects on discontinuation of treatment with PARKIPEX

If PARKIPEX treatment is stopped suddenly, fever, solidification, increased heart rate and / or impaired consciousness may occur.

The treatment may be discontinued in patients receiving PARKIPEX at doses up to 0.75 mg due to restless leg disease. However, the worsening of symptoms following the sudden discontinuation of treatment can rarely be seen.

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

4. What are the possible side effects?

As with all medicines, there may be side effects in people who are sensitive to substances in the content of PARKIPEX.

If you have any of the following, stop using PARKIPEX and tell your doctor immediately contact the emergency department of the hospital nearest you: May

or cause severe allergic reactions,

• Swelling of the face, mouth and throat,

• Hives,

• Shortness of breath.

Although this kind of side effect has not been seen until now with PARKIPEX, it is possible to occur as in all drugs.

These are all very serious side effects.

If you have one of these, you may need emergency medical care or hospitalization.

All of these very serious side effects are very rare.

If you notice any of the following, report it immediately to your doctor or contact the nearest hospital emergency department:

• Sleepiness and sudden sleep failure.

The patients treated with pramipexole reported that they were sleeping during daily living activities. Some of these incidents occurred during the use of motor vehicles and sometimes resulted in accidents. Sleepiness is a common phenomenon in patients taking pramipexole at doses above 1.5 mg per day, and is always occurring before a deep sleep.

There is no clear link to the duration of treatment.

•

Excessive sexual activity For

Parkinson's disease, patients treated with dopamine antagonists, including PARKIPEX, exhibit pathological gambling, increased sexual desire and excessive sexual activity, particularly at high doses, and these It has been reported to be reversible by termination of treatment.

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

If you notice any of the following, tell your doctor:

• abnormal dreams,

• mind confusion,

• constipation,

• unreasonable and wrong thoughts,

• dizziness,

• body movement disorder,

• fatigue,

• seeing things that don't actually exist, or hearing, headache ,

• low blood pressure,

• eating too much food,

• insomnia,

• sexual desire disorder (increase or decrease),

• nausea,

• accumulation of fluid in body tissues (edema),

• the installation of meanings to the outside of the fact that events

•other abnormal behavior,

• weight gain,

• itching,

rash and other hypersensitivity reactions.

These are the slight side effects of PARKIPEX.

2.PARKIPEX should be considered before using

the parkipex NOT use in the following

Docases;

• Do not use if you are allergic to any of the active substances or excipients in PARKIPEX.

USE PARKIPEX CAREFULLY

if:

• If you have kidney disease; be sure to tell your doctor, because in this case the dose should be reduced.

• Seeing things that aren't real and hearing things that aren't real, and mental states of mind; These are known side effects of dopamine antagonists and levodopa treatments in patients with Parkinson's disease. It is more common to see things that are not real. Such a situation using your car etc. may adversely affect your skills.

• Behavioral changes such as the urge to gamble, an increase in sexual activity, an increase in sexual desire, and excessive eating may occur.

• If there are changes in your vision, you should contact your doctor.

• Especially when new treatment is started, blood pressure drops may occur. Blood pressure monitoring is recommended.

• Due to its calming effect, some patients experienced drowsiness or falling asleep during daily activities (eg, chatting, eating). Until you have an idea of ​​how the drug affects your body, you should not drive, mix complicated machines, or avoid activities that may be dangerous.

• In patients with Parkinson's disease, a type of skin cancer called melanoma was found to be higher than other people. However, this risk increase may be caused by the disease itself, or It is not clear whether it is due to other factors such as the drugs used for the treatment of the disease. Therefore, in the use of dopamine antagonist drugs such as pramipexole, it is important to monitor the symptoms of melanoma development on your skin.

For patients with Parkinson's disease:

• With the abrupt discontinuation of the drugs in this group, symptoms suggestive of the disease called neuroleptic malignant syndrome may occur. Therefore, do not stop your treatment. Please terminate the dose of medication over time, as recommended by your doctor.

For patients with restless legs syndrome:

• It is known that drugs in this group may increase the symptoms in this disease. For this reason, in spite of your treatment, contact your doctor.

Please These warnings are valid for you, even at any time in the past

consult your doctor if.

Use of PARKIPEX with food and drink You can

open PARKIPEX or swallow it with some water.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

Pregnancy

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 do not breastfeed their baby should not use PARKIPEX.

Use Machine and machine

of theSeeing or hearing things without sleep, drowsiness or falling asleep during daily activities (eg, chatting, eating). Due to the possibility that these conditions can lead to undesirable results, you should not drive, operate complex machines or avoid hazardous activities until you have enough experience to measure whether the medication adversely affects your body.

Important information on some of the excipients contained in PARKIPEX

Mannitol: No warning required due to its dose.

96% of ethyl alcohol: No warning required due to its dose.

Use with other medicines

If you use any of the following medications, please inform your doctor before taking PARKIPEX.

If you are taking drugs such as cimetidine, amantadine, the level of drug in the blood may rise and the dose may need to be reduced.

While increasing the dose of PARKIPEX in patients with Parkinson's disease, it is recommended to reduce the dose of levadopa and keep the doses of other Parkinson's medications constant.

Caution should be exercised when taking sedatives or taking alcohol; effect can be seen.

5.Protection of PARKIPEX in a place

PARKPUR Store Where children cannot and cannot be stored. Store at room temperature below '30 ° C. ' 'Keep in original packaging.'

Use in accordance with the expiration date.

Do not use the PARKIPEX after the expiration date in the packaging.

For any information on this medicinal product, please contact the Licensee.