Pramipexole Ratiopharm 1.05 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole ratiopharm 1.05 mg prolonged-release tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pramipexole ratiopharm is and what it is used for
2. What you need to know before taking Pramipexole ratiopharm
3. How to take Pramipexole ratiopharm
4. Possible side effects
5. How to store Pramipexole ratiopharm
6. Contents of the pack and other information

1. What Pramipexole ratiopharm is and what it is used for

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

Pramipexole 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).

2. What you need to know before starting Pramipexole ratiopharm

Do not take Pramipexole ratiopharm

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pramipexole ratiopharm. Inform your doctor if you have or have had any illness 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 taking levodopa, you may develop dyskinesia during the gradual increase in dose of Pramipexole ratiopharm.
• Dystonia (inability to maintain the trunk and neck straight and upright [axial dystonia]). Specifically, you might experience forward bending of the head and neck (also known as antecollis), forward bending of the lower back (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome). In such cases, your doctor may consider modifying your treatment.
• Drowsiness and sudden sleep episodes.
• Compulsive use and craving for the medicine.
• Psychosis (e.g., symptoms resembling schizophrenia).
• Vision disorders. You should undergo periodic eye examinations during treatment with pramipexole.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in ways unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm you or others. This is called impulse control disorder and may include behaviors such as pathological gambling, excessive eating or spending, abnormally increased sex drive, or preoccupation with 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 (reduced awareness, confusion, loss of touch with reality). Your doctor may need to adjust or interrupt your dose.

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

Children and adolescents

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

Taking Pramipexole ratiopharm with other medicines

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

You must avoid using pramipexole together with antipsychotic medicines.

Use caution if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and ulcers);
• amantadine (which may be used in the treatment of Parkinson’s disease);
• mexiletine (used to treat 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 (used to treat various types of cancer);
• quinine (which may be used to prevent painful leg cramps at night and to treat a type of malaria known as falciparum malaria (malignant malaria));
• procainamide (used to treat irregular heartbeat).

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

Use caution if you are taking sedative medicines (with sedative effects) or drinking alcohol. In these cases, pramipexole may affect your ability to drive or operate machinery.

Taking Pramipexole ratiopharm with food and drink

You should be cautious if you drink alcohol during treatment with pramipexole. You may take pramipexole with or without food.

Pregnancy, breastfeeding, and fertility

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

The effect of pramipexole on the unborn baby is unknown. Therefore, do not take pramipexole during pregnancy unless your doctor tells you to do so.

Pramipexole should not be used during breastfeeding. Pramipexole may reduce breast milk production. In addition, it may pass into breast milk and reach your baby. If pramipexole use is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

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

3. How to take Pramipexole ratiopharm

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will determine the correct dosage for you.

Take this medicine once daily at approximately the same time each day.

Pramipexole may be taken with or without food. The tablets must be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. Doing so may result in overdose, as the medicine could be released into your body too quickly.

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).

• Not available in Pramipexole ratiopharm prolonged-release tablets. Use other commercial presentations with the same active substance.

The usual maintenance dose is 1.05 mg per day. However, your dose may need to be increased further. If necessary, your doctor may increase your tablet dose up to a maximum of 3.15 mg of pramipexole per day. It may also be possible to reduce the maintenance dose to one prolonged-release pramipexole 0.26 mg tablet per day.

Patients 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.

Afterwards, your doctor may increase the frequency to one 0.26 mg prolonged-release tablet daily. If further dose increases are needed, your doctor may adjust your dose in increments of 0.26 mg of pramipexole.

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

If you are switching from pramipexole immediate-release tablets

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

On the day before the switch, take your pramipexole tablets as usual. On the following morning, take your Pramipexole ratiopharm prolonged-release tablet and do not take any further pramipexole immediate-release tablets.

If you take more Pramipexole ratiopharm than 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 side effects).

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

If you forget to take Pramipexole ratiopharm

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

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

If you stop taking Pramipexole ratiopharm

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

If you have Parkinson's disease, you must not stop treatment with pramipexole abruptly. Sudden discontinuation may cause a condition called neuroleptic malignant syndrome, which may pose a serious health risk. 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 pramipexole, you may also experience a medical condition called dopamine agonist withdrawal syndrome. 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

You may experience the following adverse effects:

Very common:

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

Common:

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing, or feeling things that are not present)
• Confusion
• Fatigue
• Insomnia
• Fluid retention, usually in the legs (peripheral edema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Vision disturbances
• Vomiting (feeling sick)
• Weight loss, including loss of appetite

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delirium
• Excessive daytime sleepiness and sudden sleep episodes
• Amnesia (memory impairment)
• Hyperkinesia (increased movements and inability to stay still)
• Weight gain
• Allergic reactions (e.g., skin rashes, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or swollen ankles)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:
  • Strong urge to gamble excessively despite serious personal or family consequences.*
  • Altered or increased sexual interest and behavior that is concerning to you or others, for example, increased libido.*
  • Compulsive or uncontrolled shopping or spending.*
  • Binge eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger)*
  • Delirium (reduced 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).

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

For the adverse effects marked with *, a precise frequency estimation is not available, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexol. The frequency category is likely no higher than "uncommon."

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexol ratiopharm

The active substance is pramipexole. Each tablet contains 1.05 mg of pramipexole as 1.5 mg of pramipexole dihydrochloride monohydrate.

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

Appearance of the medicinal product and contents of the pack

Pramipexol ratiopharm 1.05 mg are prolonged-release tablets, white or almost white, round and biconvex, marked with "105" on one side. Each pack contains 30 tablets.

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura, nº 11, Edificio Albatros B, 1st floor
28108 Alcobendas - Madrid, Spain

Manufacturer responsible for production

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: April 2026.

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