PRAMIPEXOL TEVA 1.05 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Pramipexole Teva

Do not takePramipexoleTeva

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

Warnings and precautions

Consult your doctor before starting to take Pramipexole Teva. 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 present). 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 gradual increase in the dose of Pramipexole Teva.
• Dystonia: Inability to keep the trunk and neck straight and upright (axial dystonia). In particular, you may experience forward bending of the head and neck (also called antecollis), forward bending of the lumbar region (also called camptocormia) or sideways bending of the back (also called pleurothotonus or Pisa syndrome). If this happens, your doctor may change your medication.
• Somnolence and sudden episodes of sleep
• Excessive use and craving for the medicine
• Psychosis (e.g. similar to symptoms of schizophrenia).
• Visual impairment. You should have regular eye examinations during treatment with Pramipexole Teva.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the start 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 cravings to behave abnormally and cannot resist the impulse, instinct or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sexual desire or increased concern about increased sexual thoughts and feelings. Your doctor may need to adjust or stop the 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 interrupt your dose.

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

Pramipexole prolonged-release tablets are specially designed tablets from which the active ingredient is gradually released once the tablet is swallowed. Sometimes, parts of the tablets may be excreted and seen in the stool, which may look like whole tablets.

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

Children and adolescents

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

Use ofPramipexoleTevawith other medicines

Inform your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines, herbal remedies, natural products or nutritional supplements that you have obtained without a prescription.

You should avoid using Pramipexole Teva with antipsychotic medicines.

Be cautious if you are using the following medicines:

• 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, a condition known as ventricular arrhythmia).
• zidovudine (which may be used to treat acquired immune deficiency syndrome (AIDS), a disease of the human immune system);
• cisplatin (for the treatment of 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 falciparum malaria (malignant malaria));
• procainamide (for the treatment of irregular heartbeat).

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

TakingPramipexoleTevawith food, drinks and alcohol

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

You can take Pramipexole Teva with or without food.

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will tell you if you should continue treatment with Pramipexole Teva.

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

Pramipexole Teva should not be used during breastfeeding. Pramipexole Teva may decrease milk production.

Additionally, it may pass into breast milk and reach your baby. If the use of Pramipexole Teva is essential, breastfeeding should be discontinued.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Pramipexole Teva has been associated with somnolence and sudden episodes of sleep, especially in patients with Parkinson's disease. If you experience these side effects, do not drive or operate machinery.

Inform your doctor if this happens to you.

3. How to take Pramipexole Teva

Follow exactly the instructions of your doctor. If you are unsure, consult your doctor again. Your doctor will tell you the correct dosage.

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

You can take Pramipexole Teva with or without food. The tablets should 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 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 of pramipexole per day. It is also possible to reduce the maintenance dose to one prolonged-release tablet of Pramipexole Teva 0.26 mg per day.

Patient with kidney 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 of administration to one prolonged-release tablet of 0.26 mg every day. If it is necessary to increase your dose further, your doctor may adjust the dose in increments of 0.26 mg of pramipexole.

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

If you are switching frompramipexoleimmediate-release

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

The day before switching, take your pramipexole immediate-release tablets as you normally would. The next morning, take your Pramipexole Teva prolonged-release tablet and do not take any more pramipexole immediate-release tablets.

If you take morePramipexoleTevathan you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to takePramipexoleTeva

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

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

If you stop takingPramipexoleTeva

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

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

A sudden stop may cause a condition called neuroleptic malignant syndrome, which can be a serious risk to your health. These symptoms include:

• akinesia (loss of muscle movement)
• muscle rigidity
• fever
• unstable blood pressure
• rapid 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 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pramipexole Teva can cause side effects, although not everybody gets 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)
• somnolence
• dizziness
• nausea

Common:

• need to behave in an unusual way
• hallucinations (seeing, hearing or feeling things that are not present)
• confusion
• fatigue
• insomnia
• excess fluid, usually in the legs (peripheral edema)
• headache
• low blood pressure
• abnormal dreams
• constipation
• visual impairment
• nausea (feeling sick)
• weight loss including loss of appetite

Uncommon:

• paranoia (e.g. excessive concern about your health)
• delirium
• excessive daytime somnolence and sudden episodes of sleep
• amnesia (memory impairment)
• hyperkinesia (increased movement and inability to stay still)
• weight gain
• allergic reactions (e.g. skin rash, itching, hypersensitivity)
• fainting
• heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• inadequate secretion of antidiuretic hormone*
• restlessness
• shortness of breath
• hiccups
• 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 behavior that is problematic for you or others, for example, increased sexual desire.
• uncontrolled or excessive shopping or spending.
• binge eating (eating large amounts of food in a short period) or compulsive eating (eating 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)

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).

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

For the side effects marked with * it is not possible to have an exact estimate of the frequency, as these side effects were not observed in clinical trials in 2,762 patients treated with pramipexole. The frequency category is probably no higher than "uncommon".

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexol Teva

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

Do not use this medicine after the expiration date stated on the carton after CAD.

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

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE Point of the Pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofPramipexolTevaprolonged-releasetablets

The active ingredient is Pramipexol.

Each tablet contains 1.05 mg of pramipexol as 1.5 mg of pramipexol dihydrochloride monohydrate. The other ingredients are: hypromellose, calcium hydrogen phosphate, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Pramipexol Teva 1.05 mg prolonged-release tablets are 10 mm white or almost white, cylindrical, biconvex tablets with "105" embossed on one face.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma S.L.U.

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

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 under the following names:

Austria:PRAMIPEXOL Genericon 1.05 mg Retardtabletten

Germany:PRAMIPEXOL ratiopharm 1.05 mg Retardtabletten

Hungary:Erimexol 1.05 mg retard tabletta

Italy:PRAMIPEXOLO Teva Italia 1.05 mg compresse a rilascio prolungato

Spain:PRAMIPEXOL Teva 1.05 mg comprimidos de liberación prolongada EFG

Sweden:PRAMIPEXOL FERRER

Date of the Last Revision of this LeafletDecember 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/