Leaflet: information for the user

PramipexolTeva2,1 mg prolonged-release EFG tablets

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.Seesection4.

PramipexolTevabelongs to a group of medicines called dopamine agonists, which stimulatethereceptorsofdopamine in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brainthathelpto control body movements.

Pramipexol Tevais used totreat the symptoms of idiopathic Parkinson's disease in adults. It may be used alone orincombination with levodopa (another medicine for Parkinson's disease).

Do not takePramipexolTeva

• if you are allergic topramipexolor to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to takePramipexolTeva. Inform your doctor if you have or have had any disease or symptoms, especially any of the following:

• Kidney disease.
• Hallucinations (seeing, hearing, or feeling things that are not there). Most hallucinations are visual.
• Dyskinesia (e.g., abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also using levodopa, you may experience dyskinesia during the progressive increase indoseofPramipexolTeva.
• Dystonia: Inability to maintain the trunk and neck straight and upright (axial dystonia). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia), or lateral curvature of the back (also known as pleurototonus or Pisa syndrome). If this occurs, your doctor may change your medication.
• Drowsiness and sudden sleep episodes
• Excessive use and craving for the medication
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual disturbances. You should undergo periodic eye examinations during treatment withPramipexolTeva.
• Severe heart or blood vessel disease. You should undergo periodic blood pressure checks, especially at the beginning of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormally high sexual appetite, or excessive concern about an increase in 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 (decreased consciousness, confusion, loss of contact with reality). Your doctor may need to adjust or stop your dose.

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

Pramipexol prolonged-release tablets are specially designed tablets that release the active ingredient gradually once the tablet is ingested. Occasionally, parts of the tablets may be excreted and appear in the stool, which may resemble intact tablets.

Inform your doctor if you find fragments of tablets in your stool.

Children and adolescents

PramipexolTevais not recommended for use in children or adolescents under 18 years old.

Use ofPramipexolTevawith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications, herbal remedies, natural foods ornutritional supplements that you have obtained without a prescription.

You should avoid usingPramipexolTevawith antipsychotic medications.

Be cautious if you are using the following medications:

• cimetidine (for the treatment of excess acid and stomach ulcers);
• amantadine (which may be used in the treatment of Parkinson's disease);
• mexiletine (for the treatment of irregular heartbeats, aconditionknown asventricular arrhythmia).
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a diseaseofthehumanimmunologicalsystem);
• cisplatin (for treating various types of cancer);
• quinine (which may be used to prevent painful leg cramps that occur at night and to treat a type of malaria known as malignant malaria);
• procainamide (for treating irregular heartbeats).

If you are using levodopa, it is recommended to reduce the dose of levodopa when starting treatment with PramipexolTeva.

Be cautious if you are using tranquilizing medications (with sedative effect) or if you drink alcohol. In these casesPramipexolTevamay affect your ability to drive and operate machinery.

TakingPramipexolTevawith food, drinks, and alcohol

You should be cautious if you drink alcohol during treatment withPramipexolTeva.

You can takePramipexolTevawith or without food.

Fertility, pregnancy, and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctorbefore using this medication. Your doctor will tell you if you should continue treatment withPramipexolTeva.

The effect ofPramipexolTevaon the fetus is unknown. Therefore, do not takePramipexolTevaif you are pregnant unless your doctor tells you to.

PramipexolTevashould not be used during breastfeeding.PramipexolTevamay decrease milk production.

It may also pass into breast milk and reach your baby. If the use ofPramipexolTevais necessary, breastfeeding should be stopped.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

PramipexolTevamay cause hallucinations (seeing, hearing, or feeling things that are not there). Ifthishappens, do not drive or operate machinery.

PramipexolTevahas been associated with drowsiness and sudden sleep episodes, especially in patients with Parkinson's disease. If you experience these adverse effects, you should not drive or operate machinery.

Inform your doctor if this happens.

Follow exactly the administration instructions of this medication indicated by your doctor.
In case of doubt, consult your doctor again. Your doctor will indicate the correct dosage.

TakePramipexolTevaextended-release tablets once a day and at the same hour every day.

You can takePramipexolTevawith or without food. The tablets must be swallowed whole with water.

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

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 per day. However, it may be necessary to increase your dose further. If necessary, your doctor may increase your dose of tablets up to a maximum of 3.15 mg ofpramipexolper day. It is also possible to reduce the maintenance dose to 1 extended-release tablet ofPramipexol Teva0.26 mg per day.

Patients with kidney disease:

If you have kidney disease, your doctor may advise you to take the usual starting dose of 0.26 mg extended-release tablets every other day during the first week.

After that, your doctor may increase the frequency of doses to 1 extended-release tablet of 0.26 mg per day. If you need to increase your dose further, your doctor may adjust your dose in increments of 0.26 mg of pramipexol

If you have severe kidney disease, your doctor may consider it necessary to change to a different pramipexol medication. If during treatment your kidney problems worsen, contact your doctor as soon as possible.

If you are switching frompramipexolimmediate-release tablets

Your doctor will base your dose ofPramipexolTevaextended-release tablets on the dose ofpramipexolimmediate-release tablets you were taking.

The day before the switch, take yourpramipexolimmediate-release tablets as you normally would. The next morning, take yourPramipexolTevaextended-release tablet and do not take any morepramipexolimmediate-release tablets.

If you take morePramipexolTevathan you should

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

Incaseofoverdoseoraccidentalingestion, consult your doctor or pharmacist immediately orcalltheToxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takePramipexolTeva

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

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

If you interrupt treatment withPramipexolTeva

Do not interrupt your treatment withPramipexolTevawithout consulting your doctor first. If you need to interrupt your treatment with this medication, your doctor will gradually reduce your dose. This reduces the risk of worsening your symptoms.

If you have Parkinson's disease, you should not interrupt your treatment withPramipexolTevaabruptly.

A sudden interruption may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a very serious risk to your health. These symptoms include:

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

If you interrupt treatment or reduce the dose of pramipexol, you may also experience a medical condition called dopamine agonist withdrawal syndrome. The symptoms include depression, apathy, anxiety, fatigue, sweating, or pain. If you experience these symptoms, you should contact your doctor.

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

Like all medications,PramipexolTevacan cause side effects, although not
everyone experiences them. The classification of side effects is based on the following frequencies:

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

Very common:

• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Drowsiness
• Dizziness
• Nausea

Common:

• Need to behave in an unusual way
• Hallucinations (seeing, hearing or feeling things that are not present)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delirium
• Excessive daytime sleepiness and sudden episodes of sleep
• Amnesia (memory disturbance)
• Hypokinesia (increase in movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of the antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hypophonia (low voice)
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you or others, which may include:

• Strong impulse to gamble excessively despite serious personal or family consequences.
• Altered or increased sexual interest and concerning behavior for you or others, for example, increased sexual appetite.
• Uncontrollable excessive spending.
• Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger)*
• Delirium (decreased consciousness, confusion, loss of contact with reality)
  

Rare:

• Mania (agitation, feeling elated or overexcited)

Unknown frequency:

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

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

The side effects marked with * cannot be estimated precisely, as these side effects were not observed in clinical trials involving 2,762 patients treated withpramipexol. The frequency category is likely not higher than “uncommon”.

Reporting of side effects:

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.Alsoyou canreport them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after CAD.

The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and themedicines that you no longer need at the SIGRE collection pointofthePharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition ofPramipexolTevatabletsofprolonged release

The active ingredient is Pramipexol.

Each tablet contains2.1 mg of pramipexol as 3 mg of dihydrochloride of pramipexol monohydrate. The other components are: hypromellose, calcium hydrogen phosphate,colloidal anhydrous silica and magnesium stearate.

Appearance of the product and contents of the package

PramipexolTeva2.1 mg prolonged release tablets are white or almost white, cylindricaltablets, biconvex and have written inrelief 2100on one side.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108– Alcobendas (Madrid)

Spain

Responsible for Manufacturing

Ferrer Internacional, S.A

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès (Barcelona)

Laboratorios Normon, S.A

Ronda de Valdecarrizo, 6, Tres Cantos, 28760 Madrid

Merckle GMBH

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

Teva Pharma B.V.

Swensweg, 5 - Haarlem - 2031 GA - Netherlands

This medicine is authorized in the member states of the European Economic Area with thefollowing names:

Austria:PRAMIPEXOL Genericon 2.1 mg Retardtabletten

Germany:PRAMIPEXOLratiopharm2.1 mg Retardtabletten

Hungary:Erimexol 2.1 mg retard tabletta

Italy:PRAMIPEXOLO TevaItaly2.1 mg prolonged release tablets

Spain:PRAMIPEXOL Teva 2.1 mg prolonged release tablets EFG

Sweden:PRAMIPEXOL FERRER

Last review date of this leafletDecember 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/