Pramipexole Tarbis 1.05 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pramipexol Tarbis 1.05 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Pramipexol Tarbis is and what it is used for
2. What you need to know before taking Pramipexol Tarbis
3. How to take Pramipexol Tarbis
4. Possible side effects
5. How to store Pramipexol Tarbis

Pack contents and additional information

1. What Pramipexole Tarbis 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 Tarbis 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 taking Pramipexol Tarbis

Do not take Pramipexol Tarbis

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 Pramipexol Tarbis. Inform your doctor if you have or have had any illness or symptom, 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 develop dyskinesia during the gradual dose increase of Pramipexol Tarbis.
• Dystonia.
• Inability to keep the trunk and neck upright (axial dystonia). Specifically, you may experience forward bending of the head and neck (also known as antecollis), forward bending of the lumbar region (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.
• Somnolence and sudden episodes of falling asleep.
• Behavioral changes (e.g., gambling disorder, compulsive shopping), increased libido (e.g., increased sexual appetite), binge eating.
• Psychosis (e.g., resembling symptoms of schizophrenia).
• Vision disturbances. You should undergo regular eye examinations during treatment with Pramipexol Tarbis.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the beginning of treatment, to prevent orthostatic 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 that are unusual for you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may need to adjust or stop 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

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

Taking Pramipexol Tarbis 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 health products, or nutritional supplements obtained without a prescription.

You must avoid using Pramipexol Tarbis together with antipsychotic medications.

Be cautious if you are taking the following medicines:

• cimetidine (used to treat excess stomach acid and stomach ulcers);
• amantadine (which may be used in the treatment of Parkinson's disease);
• mexiletine (used to treat irregular heartbeat, 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 Pramipexol Tarbis.

Be cautious if you are taking sedative medicines (with sedative effect) or drinking alcohol.

In these cases, Pramipexol Tarbis may affect your ability to drive or operate machinery.

Taking Pramipexol Tarbis with food and drink

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

You may take Pramipexol Tarbis 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 Pramipexol Tarbis.

The effect of pramipexole on the fetus is unknown. Therefore, do not take Pramipexol Tarbis during pregnancy unless your doctor tells you to.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole has been associated with somnolence and sudden episodes of falling asleep, 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.

3. How to take Pramipexol Tarbis

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

Take Pramipexol Tarbis prolonged-release tablets once daily, at the same time each day.

You may take Pramipexol Tarbis with or without food. The tablets must be swallowed whole with water.

Do not chew, divide, or crush the prolonged-release tablets. If you do, there is a risk of overdose, 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 once daily. 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 is also possible to reduce the maintenance dose to one prolonged-release tablet of Pramipexole Tarbis 0.26 mg daily.

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 tablets (immediate-release)

Your doctor will base your dose of Pramipexole Tarbis prolonged-release tablets on the dose of Pramipexole tablets you were previously taking.

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

If you take more Pramipexole Tarbis 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 the amount ingested.

If you forget to take Pramipexole Tarbis

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

If you forget to take your dose and more than 12 hours have passed, simply take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Pramipexole Tarbis

Do not stop your treatment with Pramipexole Tarbis without first consulting your doctor. If you need to stop 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 Tarbis 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 Tarbis, 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 everyone experiences 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 manner
• 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
• Visual 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 rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*
• Inappropriate secretion of antidiuretic hormone*
• Restlessness
• Dyspnea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge, or temptation to perform an action that could be harmful to you 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.*
• Uncontrollable excessive spending or shopping.*
• 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)*

Frequency not known:

• After stopping or reducing treatment with pramipexole: 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 adverse effects marked with *, a precise estimation of frequency cannot be provided, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely no higher than "uncommon".

Reporting of adverse effects

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

5. Storage of Pramipexole Tarbis

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of PramipexolTarbis

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 dihydrate, magnesium stearate and colloidal anhydrous silica.

Appearance of the medicinal product and contents of the pack

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

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

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 most recent revision of this leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/