PRAMIPEXOL RATIOPHARM 2.1 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Pramipexol ratiopharm

Do not take Pramipexol ratiopharm

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking 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 taking levodopa, you may experience dyskinesia during the gradual increase in the dose of Pramipexol ratiopharm.
• 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) or curvature of the back to the sides (also called pleurothotonus or Pisa syndrome). In this case, your doctor may choose to modify your treatment.
• 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 exams during treatment with Pramipexol ratiopharm.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the beginning of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).

Tell your doctor if you, your family, or caregivers notice that you are developing impulses or cravings to behave in an unusual way for you and that you 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 gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings. Your doctor may need to adjust or stop the dose.

Tell 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.

Tell 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 of age.

Taking Pramipexol ratiopharm with other medicines

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

You should avoid using Pramipexol ratiopharm 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 immunodeficiency 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 taking levodopa, it is recommended to decrease the dose of levodopa when starting treatment with Pramipexol ratiopharm.

Be cautious if you are using sedative medicines (with a sedative effect) or if you drink alcohol. In these cases, Pramipexol ratiopharm may affect your ability to drive and operate machinery.

Taking Pramipexol ratiopharm with food and drinks

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

You can take Pramipexol ratiopharm with or without food.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will tell you whether you should continue treatment with Pramipexol ratiopharm.

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

Pramipexol ratiopharm should not be used during breast-feeding. Pramipexol may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of Pramipexol ratiopharm is essential, breast-feeding should be discontinued.

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

Driving and using machines

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 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. Tell your doctor if this happens to you.

3. How to take Pramipexol ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will tell you the correct dose.

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

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

Do not chew, divide, or crush the prolonged-release tablets. If you do, there is a risk of overdosing, as the medicine may be released into 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 further. 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.

Patient 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.

After that, your doctor may increase the frequency of administration to 1 prolonged-release tablet of 0.26 mg every day. If it is necessary 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 switch to a different pramipexol medicine. If your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are switching from Pramipexol immediate-release tablets

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

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

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 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 take Pramipexol ratiopharm

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

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

If you stop taking Pramipexol ratiopharm

Do not stop taking Pramipexol ratiopharm without consulting your doctor first. If you need to stop taking 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 taking Pramipexol ratiopharm abruptly. Sudden interruption can cause the appearance of a disorder 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
• Tachycardia (increased heart rate)
• Confusion
• Decreased level of consciousness (e.g., coma)

If you stop or reduce treatment with Pramipexol ratiopharm, you may also experience a medical disorder 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, this medicine can cause side effects, although not everybody gets 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)
• 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
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual impairment
• Vomiting
• 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 remain 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
• 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.*
  • Uncontrolled buying 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 Pramipexol ratiopharm: 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 among 2,762 patients treated with pramipexol. 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. How to store Pramipexol ratiopharm

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Pramipexol ratiopharm Composition

The active ingredient is pramipexole. Each tablet contains 2.1 mg of pramipexole as 3 mg of pramipexole dihydrochloride monohydrate.

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

Product Appearance and Packaging Content

Pramipexol ratiopharm 2.1 mg are prolonged-release tablets, white or almost white in color, cylindrical and biconvex, marked with 210 on one face. Each package contains 30 tablets.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, nº 11 Edificio Albatros B, 1ª planta

28108 Alcobendas - Madrid

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Pramipexol ratiopharm 0.26 mg prolonged-release tablets EFG. Pramipexol ratiopharm 1.05 mg prolonged-release tablets EFG.

Date of the Last Revision of this Leaflet:April 2020

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