Pramipexole CINFA 1.57 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole cinfa 1.57 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 adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Pramipexole cinfa contains the active substance pramipexole and 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 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 to take Pramipexole cinfa

Do not take Pramipexole cinfa

• 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 cinfa.

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 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 pramipexole.
• Dystonia (inability to keep 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 curvature of the lumbar region (also known as camptocormia), or sideways curvature of the back (also known as pleurothotonus or Pisa syndrome).
• Drowsiness and sudden episodes of falling asleep.
• Psychosis (e.g., symptoms resembling schizophrenia).
• Vision problems. 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 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 increased sex drive, or preoccupation with increased 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 contact with reality). 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.

Inform your doctor if you notice an inability to keep your trunk and neck straight and upright (axial dystonia). In such cases, your doctor may decide to adjust or modify your treatment.

Pramipexole cinfa prolonged-release tablets are specially designed tablets from which the active ingredient is gradually released after ingestion. Occasionally, parts of the tablets may be excreted and seen in the stools, which may resemble intact tablets. Inform your doctor if you find tablet fragments in your stools.

Children and adolescents

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

Taking Pramipexole cinfa 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 herbal medicines, natural health products, nutritional supplements, or any other medicines obtained without a prescription.

You should avoid using pramipexole together with antipsychotic medicines.

Use caution if you are taking any of 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 heartbeats, a condition known as ventricular arrhythmia)
• zidovudine (which may be used to treat acquired immunodeficiency syndrome (AIDS), a human immune system disease)
• cisplatin (used to treat various types of cancer)
• quinine (which may be used to prevent painful leg cramps occurring 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 levodopa dose when starting treatment with pramipexole.

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

Taking Pramipexole cinfa with food, drinks, and alcohol

Exercise caution if you drink alcohol during treatment with pramipexole.

You may take pramipexole with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might 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 fetus is unknown. Therefore, do not take pramipexole if you are pregnant unless your doctor tells you to do so.

Pramipexole 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 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 present). If this occurs, do not drive or operate machinery.

Pramipexole may cause drowsiness and sudden episodes of falling asleep. If this happens, you must not drive or engage in activities where lack of attention could result in death or serious harm to yourself or others (e.g., operating machinery), until these episodes and/or drowsiness have resolved.

3. How to take Pramipexole cinfa

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

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

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

Do not chew, split, 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 as directed by your doctor, until your symptoms are controlled (maintenance dose).

The recommended maintenance dose is 1.05 mg 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 pramipexole 0.26 mg tablet daily.

Patients with renal disease

If you have kidney disease, your doctor may advise you to take the recommended starting dose of one 0.26 mg prolonged-release tablet every other day 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 your kidney problems worsen during treatment, contact your doctor as soon as possible.

If you are switching from immediate-release pramipexole tablets

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

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

If you take more Pramipexol cinfa than you should
If you accidentally take too many tablets:

• consult your doctor or the nearest hospital emergency department immediately.
• 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pramipexol cinfa

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

If you stop taking Pramipexol cinfa

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 should not abruptly stop your treatment with pramipexole. 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 Pramipexol cinfa, 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 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 limbs)
• Somnolence
• Dizziness
• Nausea

Common:

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

Uncommon:

• Paranoia (e.g., excessive concern about your health)
• Delusion
• Excessive daytime sleepiness and sudden sleep episodes
• Amnesia (memory impairment)
• Hyperkinesia (increased movements and inability to remain still)
• Weight gain
• Allergic reactions (e.g., skin rash, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inappropriate antidiuretic hormone secretion*
• 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 concerning to you or others, for example, increased libido.*
  • Compulsive buying or uncontrolled spending.*
  • Binge eating (consuming 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 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; he or she will explain how to manage or reduce the symptoms.

For adverse effects marked with *, an accurate estimation of frequency is not possible, 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole cinfa

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 refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pramipexol cinfa

• The active substance is pramipexole. Each prolonged-release tablet contains 1.57 mg of pramipexole as 2.25 mg of pramipexole dihydrochloride monohydrate.
• The other components are: hypromellose, calcium hydrogen phosphate, magnesium stearate and colloidal anhydrous silica.

Appearance of the product and contents of the pack

Pramipexol cinfa 1.57 mg prolonged-release tablets are 10 mm, white or almost white, cylindrical, biconvex tablets, with "157" engraved in relief on one side. Each pack contains 30 tablets in Alu/Alu-PVC-OPA blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Normon, S.A.

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

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: April 2020

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80054/P_80054.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80054/P_80054.html