Package Insert: Information for the User

PramipexolTarbis1.05 mg prolonged-release tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

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

PramipexolTarbisis 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).

Do not take PramipexolTarbis

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take PramipexolTarbis.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 in PramipexolTarbisdosage.
• Dystonia.
• Difficulty maintaining the trunk and neck in a straight and upright position (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 pleurototonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Drowsiness and sudden onset of sleep.
• Changes in behavior (e.g., compulsive buying, excessive libido), increased appetite, binge eating.
• Psychosis (e.g., similar to schizophrenia symptoms).
• Visual disturbances. You should undergo regular eye examinations during treatment with PramipexolTarbis.
• Severe heart or blood vessel disease. You should undergo regular 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 unusual impulses or urges to behave in a certain way that you cannot resist, which may harm you or others. This is known as impulse control disorder and may include behaviors such as compulsive gambling, excessive eating or spending, abnormal sexual appetite or excessive concern about increased sexual thoughts and feelings.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. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Children and adolescents

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

Taking PramipexolTarbiswith other medicines

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

You should avoid taking PramipexolTarbiswith 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 immunodeficiency syndrome (AIDS), a human immunodeficiency disease);
• 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 levodopa dose when starting treatment with PramipexolTarbis.

Be cautious if you are using tranquilizing medicines (with sedative effect) or if you drinkalcohol.

In these casesPramipexolTarbismay affect your ability to drive and operate machinery.

Taking PramipexolTarbiswith food and drink

You should be cautious if you drink alcohol during treatment with PramipexolTarbis.

You can take PramipexolTarbiswith or without food.

Pregnancy,breastfeedingandfertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.Your doctor will tell you if you should continue treatment with PramipexolTarbis.

Pramipexol has not been shown to affect the fetus. Therefore, do not take PramipexolTarbisif you are pregnant unless your doctor tells you to.

PramipexolTarbisshould not be used during breastfeeding. Pramipexol may decrease milk production. Additionally, pramipexol may pass into breast milk and reach your baby. If the use of PramipexolTarbisis necessary, you should stop breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

PramipexolTarbismay cause hallucinations (seeing, hearing or feeling things that are not there). If this happens, do not drive or operate machinery.

Pramipexol has been associated with drowsiness and sudden onset of sleep, especially in patients with Parkinson's disease. If you experience these adverse effects, do not drive or operate machinery. Inform your doctor if this happens.

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

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

You can take PramipexolTarbiswith or without food. The tablets should be swallowed whole with water.

Do not chew, divide, or crush the extended-release tablets. If you do, there is a risk of overdose, as the medication may be released in your body too quickly.

The usual daily dose for the first week is 0.26 mg of pramipexol.

This dose will be increased every 5-7 days as indicated by your doctor, 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. If necessary, your doctor may increase your dose of tablets up to a maximum of 3.15 mg of pramipexol per day. It is also possible to reduce the maintenance dose to 1 extended-release tablet of PramipexolTarbis0.26 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 necessary, 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 switch to a different pramipexol medication. If during treatment your kidney problems worsen, contact your doctor as soon as possible.

If you are changingfromPramipexol tablets (immediate-release)

Your doctor will base your dose of PramipexolTarbisextended-release tablets on the dose of Pramipexol tablets you were taking.

The day before the change, take your Pramipexol tablets as you normally would. The next morning, take your PramipexolTarbisextended-release tablet and do not take any more Pramipexol tablets.

If you take more PramipexolTarbisthan you should

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

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

If you forgot to take PramipexolTarbis

If you forgot to take your dose of PramipexolTarbis, 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 your usual time, simply take the next dose at your usual time.Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with PramipexolTarbis

Do not stop your treatment with PramipexolTarbiswithout consulting your doctor first. If you need to stop 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, do not stop your treatment with PramipexolTarbisabruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can pose a significant 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 stop treatment or reduce the dose of Pramipexol Tarbis, 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, contact your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. The classification of side effects is based on the following frequencies:

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 rashes, itching, hypersensitivity)
• 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)
• Hiccup
• 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)*

Frequency not known:

-After stopping or reducing treatment with pramipexol: 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 to manage or reduce the symptoms.

For the side effects marked with * it is not possible to provide a precise estimate of the frequency, as these side effects were not observed in clinical trials between 2,762 patients treated with pramipexol. The frequency category is likely to be no higher than “uncommon”.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Unused medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pramipexol Tarbis

The active ingredient is pramipexol. Each tablet contains 1.05 mg of pramipexol as 1.5 mg of dihydrochloride monohydrate of pramipexol.

The other components are: hypromellose, calcium phosphate dibasic anhydrous, magnesium stearate, and anhydrous colloidal silica .

Appearance of the product and content of the packaging

Pramipexol Tarbis 1.05 mg are prolonged-release tablets, white or almost white, cylindrical, and biconvex, marked with 105 on one side. Each package contains 30 tablets.

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9, 08173 Sant Cugat del Vallés, Barcelona (SPAIN)

OTHER PRESENTATIONS

Pramipexol Tarbis 0.26 mg prolonged-release tablets EFG.

Pramipexol Tarbis 2.1 mg prolonged-release tablets EFG.

Date of the last review of this prospectus: June 2020

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es/