Pramipexole Teva 2.1 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pramipexole Teva 2.1 mg prolonged-release tablets EFG

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

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Pramipexole Teva is and what it is used for

Pramipexole Teva belongs to a group of medicines called dopamine agonists, which stimulate the dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain that help control body movements.

Pramipexole Teva is used to treat the symptoms of idiopathic Parkinson's disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson's disease).

2. What you need to know before taking Pramipexol Teva

Do not take Pramipexol Teva

• if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to take Pramipexol Teva. Inform your doctor if you have or have had any illness or symptoms, especially any of the following:

• Kidney disease.
• Hallucinations (seeing, hearing, or feeling things that are not present). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson’s disease and are also taking levodopa, you may develop dyskinesia during the gradual dose escalation of Pramipexol Teva.
• Dystonia: Inability to keep the trunk and neck straight and upright (axial dystonia). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward curvature of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). If this occurs, your doctor may change your medication.
• Drowsiness and sudden sleep episodes.
• Compulsive use and craving for the medicine.
• Psychosis (e.g., symptoms similar to schizophrenia).
• Vision problems. You should have regular eye examinations during treatment with Pramipexol Teva.
• Severe heart or blood vessel disease. You should have regular blood pressure monitoring, especially at the beginning of treatment, to prevent orthostatic hypotension (a drop in blood pressure upon standing).

Inform your doctor if you, your family, or caregivers notice that you are developing urges or impulses to behave in ways that are unusual for you and that you cannot resist the urge, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally increased sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop your dose.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling elated or overexcited) or delirium (reduced awareness, confusion, loss of touch with reality). Your doctor may need to adjust or stop your dose.

Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain when stopping or reducing treatment with Pramipexol Teva. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Pramipexol prolonged-release tablets are specially designed tablets from which the active ingredient is gradually released after the tablet is swallowed. Occasionally, parts of the tablets may be excreted and seen in the stools, which may resemble intact tablets.

Inform your doctor if you find tablet fragments in your stools.

Children and adolescents

Pramipexol Teva is not recommended for use in children or adolescents under 18 years of age.

Taking Pramipexol Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines, herbal remedies, natural foods, or nutritional supplements obtained without a prescription.

You must avoid using Pramipexol Teva together with antipsychotic medicines.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers);
• amantadine (which may be used in the treatment of Parkinson’s disease);
• mexiletine (used to treat irregular heartbeats, a condition known as ventricular arrhythmia);
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a disease of the human immune system);
• cisplatin (used to treat various types of cancer);
• quinine (which may be used to prevent painful leg cramps at night and to treat a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (used to treat irregular heartbeat).

If you are taking levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexol Teva. Be cautious if you are taking sedative medicines (with sedative effect) or drinking alcohol. In these cases, Pramipexol Teva may affect your ability to drive or operate machinery.

Taking Pramipexol Teva with food, drinks, and alcohol

Be cautious if you drink alcohol during treatment with Pramipexol Teva.

You may take Pramipexol Teva with or without food.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will advise you whether you should continue treatment with Pramipexol Teva.

The effect of Pramipexol Teva on the fetus is unknown. Therefore, do not take Pramipexol Teva if you are pregnant unless your doctor tells you to do so.

Pramipexol Teva must not be used during breastfeeding. Pramipexol Teva may reduce the production of breast milk.

In addition, it may pass into breast milk and reach your baby. If the use of Pramipexol Teva is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pramipexol Teva may cause hallucinations (seeing, hearing, or feeling things that are not present). If this happens, do not drive or operate machinery.

Pramipexol Teva has been associated with drowsiness and sudden episodes of falling asleep, especially in patients with Parkinson’s disease. If you experience these side effects, you must not drive or operate machinery.

Inform your doctor if this happens to you.

3. How to take Pramipexole Teva

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again. Your doctor will tell you the correct dose.

Take Pramipexole Teva prolonged-release tablets once daily, at the same time each day.

You may take Pramipexole Teva with or without food. The tablets must be swallowed whole with water.

During the first week, the usual daily dose is 0.26 mg of pramipexole.

This dose will be increased every 5–7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.05 mg daily. However, your dose may need to be increased further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.15 mg of pramipexole per day. It may also be possible to reduce the maintenance dose to one prolonged-release Pramipexole Teva 0.26 mg tablet daily.

Patients with renal disease:

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg prolonged-release tablets on alternate days during the first week.

Afterwards, your doctor may increase the frequency to one 0.26 mg prolonged-release tablet daily. If further dose increases are needed, your doctor may adjust your dose in increments of 0.26 mg of pramipexole.

If you have severe kidney disease, your doctor may consider switching you to a different pramipexole-containing medicine. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are switching from pramipexole immediate-release tablets

Your doctor will base your dose of Pramipexole Teva prolonged-release tablets on the dose of pramipexole immediate-release tablets you were previously taking.

On the day before switching, take your pramipexole immediate-release tablets as usual. On the following morning, take your Pramipexole Teva prolonged-release tablet and do not take any further pramipexole immediate-release tablets.

If you take more Pramipexole Teva than you should

If you accidentally take too many tablets, you may experience vomiting, agitation, or any of the adverse effects described in section 4 (Possible side effects).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pramipexole Teva

If you forget to take your dose of Pramipexole Teva but remember within 12 hours of your usual time, take your tablet and continue with your next dose at the usual time.

If you forget to take your dose more than 12 hours after your usual time, simply take the next dose at your regular time. Do not take a double dose to make up for the missed dose.

If you stop taking Pramipexole Teva

Do not stop your treatment with Pramipexole Teva without first consulting your doctor. If you need to discontinue treatment with this medicine, your doctor will gradually reduce your dose. This reduces the risk of worsening symptoms.

If you have Parkinson's disease, you should not stop treatment with Pramipexole Teva abruptly.

Sudden discontinuation may cause a condition called neuroleptic malignant syndrome, which may pose a serious health risk. These symptoms include:

• akinesia (loss of muscular movement)
• muscle rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• decreased level of consciousness (e.g. coma)

If you stop treatment or reduce the dose of pramipexole, you may also experience a medical condition known as dopamine agonist withdrawal syndrome. Symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

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

4. Possible adverse effects

Like all medicines, Pramipexole Teva can cause adverse effects, although not everyone experiences them. The classification of adverse effects is based on the following frequencies:

If you have Parkinson's disease, you may experience the following adverse effects:

Very common:

• Dyskinesia (e.g., abnormal involuntary movements of limbs)
• Somnolence
• Dizziness
• Nausea

Common:

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling sick)
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)

• Delirium

• Excessive daytime sleepiness and sudden onset of sleep episodes

• Amnesia (memory impairment)

• Hyperkinesia (increased movements and inability to remain still)

• Weight gain

• Allergic reactions (e.g., skin rash, itching, hypersensitivity)

• Fainting

• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*

• Inappropriate antidiuretic hormone secretion*

• Restlessness

• Dyspnea (difficulty breathing)

• Hiccups

• Pneumonia (lung infection)

• Inability to resist the impulse, drive, or temptation to perform an action that could be harmful to yourself or others, which may include:

• Strong urge to gamble excessively despite serious personal or family consequences.

• Altered or increased sexual interest and behavior that is concerning to you or others, e.g., increased libido.

• Compulsive buying or spending.

• Binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)*

• Delirium (reduced awareness, confusion, loss of touch with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

• After stopping or reducing treatment with Pramipexole Teva: depression, apathy, anxiety, fatigue, sweating, or pain may occur (known as dopamine agonist withdrawal syndrome or DAWS).

Inform your doctor if you experience any of these behaviors; he or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, a reliable estimate of frequency cannot be established, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon."

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexol Teva prolonged-release tablets

The active substance is pramipexole.

Each tablet contains 2.1 mg of pramipexole as 3 mg of pramipexole dihydrochloride monohydrate. The other components are: hypromellose, calcium hydrogen phosphate, colloidal anhydrous silica, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Pramipexol Teva 2.1 mg prolonged-release tablets are 10 mm white or almost white, cylindrical, biconvex tablets, with "210" embossed on one side.

Al/OPA-Al-PVC blisters: 10, 30 or 100 prolonged-release tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
28108– Alcobendas (Madrid)
Spain

Manufacturer

Laboratorios Normon, S.A
Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid
Spain

Merckle GmbH
Ludwig-Merckle-Strasse, 3 - Blaubeuren - D-89143 - Germany

Teva Pharma B.V.
Swensweg, 5 - Haarlem - 2031 GA - The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: PRAMIPEXOL Genericon 2.1 mg Retardtabletten
Germany: PRAMIPEXOL ratiopharm 2.1 mg Retardtabletten
Hungary: Erimexol 2.1 mg retard tabletta
Italy: PRAMIPEXOLO Teva Italia 2.1 mg compresse a rilascio prolungato
Spain: PRAMIPEXOL Teva 2.1 mg prolonged-release tablets EFG
Sweden: PRAMIPEXOL FERRER

Date of the latest revision of this leaflet: December 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/