Sandoz Pramipexole: Uses, Side Effects and Dosage

What is Sandoz Pramixepole used for?

Sandoz Pramipexole is used in adults to treat:

• the signs and symptoms of Parkinson’s disease. It may be used alone or with another medicine called levodopa.
• the symptoms of moderate to severe Restless Legs Syndrome.

How does Sandoz Pramipexole work?

Sandoz Pramipexole belongs to a group of medicines known as dopamine agonists. It is thought to work by stimulating dopamine receptors in the brain. Dopamine is a naturally occurring chemical produced by certain brain cells. It has the role of relaying messages in certain regions of the brain that control muscle movement. Difficulty in movement results when too little dopamine is produced. In many patients, this reduces the symptoms of Parkinson’s disease and Restless Legs Syndrome.

What are the ingredients in Sandoz Pramipexole?

Medicinal ingredient: Pramipexole dihydrochloride monohydrate.

Serious Warnings and Precautions

You may feel sleepy, drowsy, or, rarely, may suddenly fall asleep without warning (i.e., without feeling sleepy or drowsy) when taking Sandoz Pramipexole. When you are taking Sandoz Pramixepole, you should not drive, operate machinery, or take part in activities that require you to be alert. You may put yourself and others at risk for serious injury or death. Falling asleep suddenly without warning has also been reported in patients taking similar medicines to treat Parkinson’s disease.

Talk to your healthcare professional right away if you:

• feel drowsy or
• suddenly fall asleep

Non-medicinal ingredients: Betacyclodextrin-Kleptose, microcrystalline cellulose, magnesium stearate, povidone, corn starch and colloidal silicon dioxide.

Sandoz Pramipexole comes in the following dosage forms:

Tablet: 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg.

Do not use Sandoz pramipexole if:

• you are allergic to pramipexole, or any of the non-medicinal ingredients in Sandoz Pramipexole.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Pramipexole. Talk about any health conditions or problems you may have, including if you:

• have blood pressure problems;
• have kidney problems;
• have heart or blood vessel problems (cardiovascular disease);
• have albinism (reduced amount of melanin or no melanin at all) or ocular albinism (reduced color in the colored part of the eye and the retina);

• are pregnant, think you might be pregnant or are planning to become pregnant. Your healthcare professional will advise you whether you should take Sandoz Pramipexole while you are pregnant;

• are breast-feeding or plan to breast-feed;
• have any mental health problems;
• are taking levodopa, a medication used to treat the symptoms of Parkinson’s disease;
• suffer from muscle twitching or unusual/abnormal movement of the face, arms, legs or other parts of your body (dyskinesia);
• are taking medication to treat mental health problems;
• are 65 years of age or older

Other warnings you should know about:

Blood pressure: Sandoz Pramipexole may cause low blood pressure at any time or when you go from sitting or lying down to standing. This may be more likely to happen when your dose is increased. Your healthcare professional should monitor you for signs and symptoms of low blood pressure.

Augmentation of Restless Legs Syndrome symptoms: If you are taking Sandoz Pramipexole for Restless Legs Syndrome (RLS), Sandoz Pramipexole may cause augmentation. Augmentation is when you experience symptoms earlier in the evening (or even in the afternoon), increased intensity of symptoms, and spread of symptoms to other parts of your body. Sometimes augmentation may happen when your dose of Sandoz Pramipexole is increased. Your healthcare professional will monitor you to see if your symptoms become worse. They may change your dose or stop your treatment with Sandoz Pramipexole. Stopping Sandoz Pramipexole can also cause rebound RLS. This means your RLS symptoms can come back in the early morning and be worse than before you started taking pramipexole.

Reducing your dose of Sandoz Pramipexole or stopping your treatment: Do NOT suddenly stop taking Sandoz Pramipexole or lower your dose without talking to your healthcare professional first. If you do this, it may cause you to have:

• symptoms resembling Neuroleptic Malignant Syndrome. This is a disorder that causes you to have a fever, muscle stiffness, confusion, altered mental status, unstable blood pressure, and increased heartbeat
• Dopamine Agonist Withdrawal Syndrome (DAWS), a drug withdrawal syndrome. This includes withdrawal symptoms such as apathy, anxiety, depression, fatigue, sweating, panic attacks, insomnia, irritability, and pain

Stopping your treatment must be a gradual process that you discuss with your healthcare professional. Your healthcare professional should monitor you when your dose is reduced or when you stop taking Sandoz Pramipexole.

Impulse control disorders: During treatment with Sandoz Pramipexole, impulse control disorders have been observed, which signs and symptoms may include:

• developing urges or cravings to behave in ways that are unusual for you; or
• you are unable to resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others.

Tell your healthcare professional right away if you, your family, or caregiver notices that you are showing signs of impulse control disorders. This can include:

• addictive gambling;
• excessive buying or spending;
• binge eating or compulsive eating; and
• abnormally high sex drive or an increase in sexual activity.

Your healthcare professional may change your dose if you develop an impulse control disorder or signs of one.

Dopamine Dysregulation Syndrome: You may feel a craving to take more Sandoz Pramipexole than you are supposed to take. This is called Dopamine Dysregulation Syndrome and can lead to you taking too much Sandoz Pramipexole. If you feel the desire to take more Sandoz Pramipexole than you are supposed to take, talk to your healthcare professional.

Mental health problems and hallucinations: Sandoz Pramipexole may cause:

• hallucinations (seeing or hearing things that are not there) and confusion. This may be more likely to happen if you are 65 years of age or older.
• thoughts, feelings, or actions of suicide
• psychotic-like behaviour such as delusions, paranoia, and trouble thinking clearly and logically.

Tell your healthcare professional right away if you start to develop unusual behaviour, feel depressed or have thoughts of suicide.

Skin cancer: People with Parkinson’s disease have a higher risk of developing skin cancer (melanoma). Your healthcare professional should monitor you for skin cancer while you are taking Sandoz Pramipexole. Tell your healthcare professional if you have:

• suspicious, undiagnosed changed patches of pigmented skin
• irritated or irregular moles
• moles in which you have noticed changes

Dystonia: A movement disorder called dystonia may happen when you first start taking Sandoz Pramipexole, several months after starting Sandoz Pramipexole or when your dose of Sandoz Pramipexole is changed. Tell your healthcare professional if you are unable to keep your body and neck straight and upright or have twisting movements that you cannot control. If this happens your healthcare professional may change your dose of Sandoz Pramipexole.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Sandoz Pramipexole:

• Levodopa/carbidopa (used to treat Parkinson’s disease).
• Amantadine (used to treat Parkinson’s disease and used to treat viral infections);
• Medications used to treat ulcers (such as cimetidine and ranitidine);
• Medications used to treat high blood pressure and chest pain (such as diltiazem and verapamil);
• Triamterene (used to treat fluid retention in people with heart failure);
• Quinidine (used to treat heart rhythm conditions);
• Quinine (used to treat malaria);
• Antipsychotic medications (such as phenothiazines, butyrophenones, thioxanthines and metoclopramide).
• Avoid alcohol or other sedatives while taking Sandoz Pramipexole.

How to take Sandoz Pramipexole:

• Take Sandoz Pramipexole exactly as your healthcare professional has told you. Talk to your healthcare professional if you are not sure.
• Do NOT stop taking Sandoz Pramipexole, reduce the amount of Sandoz Pramipexole you take or change your dose unless your healthcare professional tells you to.

• Swallow Sandoz Pramipexole with water. It can be taken with or without food.

Usual dose:

Note: Sandoz Pramipexole is NOT available in 0.125 mg strength.

Parkinson’s disease

Usual starting dose: Your healthcare professional will determine the starting dose that is right for you. The usual starting dose is 0.125 mg three times a day. If you have kidney problems, your healthcare professional may start you at a lower dose.

Depending on your response and tolerance, your healthcare professional will increase your dose to find the right dose for you.

Maximum daily dose: 4.5 mg a day.

Restless Legs Syndrome

Usual starting dose: 0.125 mg once a day taken 2-3 hours before bedtime. Depending on your response and tolerance, your healthcare professional will increase your dose to find the right dose for you.

Maximum daily dose: 0.5 mg a day.

Overdose:

Signs of an overdose may include:

• nausea
• vomiting
• excessive movement
• hallucinations
• feeling agitated
• low blood pressure

Missed dose:

If you have missed a dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the one you missed.

What are the possible side effects from using Sandoz Pramipexole?

These are not all the possible side effects you may have when taking Sandoz Pramipexole. If you experience any side effects not listed here, tell your healthcare professional.

If you think you, or a person you caring for, have taken too much Sandoz Pramipexole, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Side effects include:

• nausea
• constipation
• sleepiness
• dizziness
• unusual dreams
• memory loss
• fatigue
• muscle weakness
• restlessness
• changes in weight
• increased or decreased appetite
• hiccups
• increase in cholesterol
• lung infection (pneumonia)
• headache
• unusually overactive movement (hyperkinesia)
• fainting
• vision problems such as seeing double, blurred vision, reduced vision
• shortness of breath
• vomiting
• swelling of hands, ankles or feet
• diarrhea
• accidental injury
• spontaneous erection of the penis

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage

• Store at room temperature (15 to 30°C) and protect from light.
• The expiry date of this medicine is printed on the original container. Do not use the medicine after this date.
• Keep out of reach and sight of children.

If you want more information about Sandoz Pramipexole:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.sandoz.ca),or by calling 1-800-361-3062

Last revised: JUL 05, 2024