Leaflet: information for the user

Pramipexol ratiopharm1.05mg 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 otherseven 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. See section 4.

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.

Pramipexol ratiopharm 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).

Do not take Pramipexol ratiopharm

If you are allergic to pramipexol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pramipexol ratiopharm.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 progressive increase in Pramipexol ratiopharm dosage.
• 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) or curvature of the back to the sides (also known as pleurototonos or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• Drowsiness and sudden episodes of sleep.
• Excessive use and craving for the medication.
• Psychosis (e.g., similar to schizophrenia symptoms).
• Visual disturbances. You should undergo periodic eye examinations during treatment with Pramipexol ratiopharm.
• 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 in you 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, excessive 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 dosage.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling overexcited or overstimulated) or delirium (diminished consciousness, confusion, loss of contact with reality).Your doctor may need to adjust or interrupt your dosage.

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

Children and adolescents

Pramipexol ratiopharm is not recommended for use in children or adolescents under 18 years old.

Taking Pramipexol ratiopharm with 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 or nutritional supplements that you have obtained without a prescription.

Avoid using Pramipexol ratiopharm with 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, a condition known as ventricular arrhythmia);
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immunological 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 dosage when starting treatment with Pramipexol ratiopharm.

Be cautious if you are using tranquilizers (sedative effect) or if you drinkalcohol. In these casesPramipexol ratiopharmmay affect your ability to drive and operate machinery.

Taking Pramipexol ratiopharm with food and drinks

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

You can take Pramipexol ratiopharm with or without food.

Pregnancy,lactationandfertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will tell you if you should continue treatment with Pramipexol ratiopharm.

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

Pramipexol ratiopharm should not be used during breastfeeding. Pramipexol may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of Pramipexol ratiopharm is necessary, breastfeeding should be interrupted.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Pramipexol has been associated with drowsiness and sudden episodes 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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Your doctor will indicate the correct dosage.

Take Pramipexol ratiopharm prolonged-release tablets once a day and at the same hour every day.

Pramipexol ratiopharm can be taken with or without food. The tablets should be swallowed whole with water.

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

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. 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 prolonged-release tablet of Pramipexol ratiopharm 0.26 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 prolonged-release tablets every other day during the first week.

After that, your doctor may increase the frequency of doses to 1 prolonged-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 your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are changingfromPramipexol tablets (ofimmediate release)

Your doctor will base your Pramipexol ratiopharm prolonged-release tablets dose 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 Pramipexol ratiopharm prolonged-release tablet and do not take any more Pramipexol tablets (immediate release).

If you take more Pramipexol ratiopharm than 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Pramipexol ratiopharm

If you forget to take the dose of Pramipexol ratiopharm, 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 the 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 Pramipexol ratiopharm

Do not stop your treatment with Pramipexol ratiopharm without 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 Pramipexol ratiopharm abruptly. Sudden discontinuation may cause the appearance of a condition called malignant neuroleptic 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).

Stopping treatment or reducing the dose of Pramipexol ratiopharm may also cause a medical condition called dopamine agonist withdrawal syndrome. 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
• Peripheral edema (excess fluid, usually in the legs)
• Headache
• Hypotension (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 somnolence and sudden onset of sleep
• Amnesia (memory alteration)
• Hypokinesia (increase in movements 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:

• Afterinterrupting or reducing treatment with Pramipexol ratiopharm: may produce 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 the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of the 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 ratiopharm

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, magnesium stearate and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/AnabelSegura,nº11EdificioAlbatrosB,1stfloor
28108Alcobendas-Madrid
Spain

Responsible for manufacturing

LABORATORIOSNORMON, 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 ratiopharm 0.26 mg prolonged-release tablets EFG.
Pramipexol ratiopharm 2.1 mg prolonged-release tablets EFG.

Last review date of this leaflet:April 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/