PRAMIPEXOL CINFA 1.05 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Pramipexole Cinfa

Do not take Pramipexole Cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Pramipexole Cinfa.

Tell your doctor if you have or have had any disease 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 using levodopa, you may experience dyskinesia during the gradual increase in pramipexole dose.
• 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), forward bending of the lumbar region (also called camptocormia), or sideways bending of the back (also called pleurothotonus or Pisa syndrome).
• Somnolence and sudden sleep episodes.
• Psychosis (e.g., similar to symptoms of schizophrenia).
• Visual impairment. You should have regular eye exams during treatment with pramipexole.
• Severe heart or blood vessel disease. You should have regular blood pressure checks, especially at the start 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 urges to behave abnormally and cannot resist the impulse, instinct, or temptation to perform 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 increased concern about increased thoughts and feelings of sex. Your doctor may need to adjust or stop your 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 stop your dose.

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

Tell your doctor if you notice inability to keep your trunk and neck straight and upright (axial dystonia). In this case, your doctor may decide to adjust or modify your treatment.

Pramipexole Cinfa prolonged-release tablets are specially designed to release the active substance gradually once the tablet is swallowed. Sometimes, parts of the tablets may be excreted and seen in the stool, which may look like whole tablets. Tell your doctor if you find tablet fragments in your stool.

Children and adolescents

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

Taking Pramipexole Cinfa 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 pramipexole 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 (to treat 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 (to treat irregular heartbeat).

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

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

Taking Pramipexole Cinfa with food, drinks, and alcohol

Be cautious if you drink alcohol during treatment with pramipexole.

You can take pramipexole with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 pramipexole.

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

Pramipexole should not be used during breastfeeding. Pramipexole may decrease milk production. Additionally, it may pass into breast milk and reach your baby. If the use of pramipexole is essential, breastfeeding should be discontinued.

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

Driving and using machines

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

Pramipexole may cause somnolence and sudden sleep episodes. If this happens, do not drive vehicles or perform activities where lack of attention may pose a risk, putting you or others in danger of death or serious harm (e.g., using machines), until these episodes and/or somnolence have disappeared.

3. How to take Pramipexole Cinfa

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will tell you the correct dosage.

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

You can take pramipexole 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 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 pramipexole.

This dose will be increased every 5-7 days according to your doctor's instructions until your symptoms are controlled (maintenance dose).

The recommended 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 pramipexole tablets 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 0.26 mg per day.

Patient with kidney disease

If you have kidney disease, your doctor may advise you to take the recommended 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 one prolonged-release tablet of 0.26 mg per day. If it is necessary to increase your dose further, your doctor may adjust your dose in levels of 0.26 mg of pramipexole.

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

If you are switching from Pramipexole immediate-release tablets

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

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

If you take more Pramipexole Cinfa than you should

If you accidentally ingest too many tablets:

• consult your doctor or the emergency department of the nearest hospital immediately.
• 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, 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 Pramipexole Cinfa

If you forget to take your dose of pramipexole 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 Pramipexole Cinfa

Do not stop your treatment with pramipexole without consulting your doctor first. If you need to stop your treatment with 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 your treatment with pramipexole abruptly. Sudden interruption can cause a condition 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 treatment or reduce the dose of pramipexole cinfa, you may also experience a medical condition 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 product, 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 abnormally
• 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)
• Delusion
• Excessive daytime somnolence and sudden sleep episodes
• 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 behavior that is concerning to 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 pramipexole: 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 accurate estimate of the frequency, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexole. The frequency category is likely not 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. Storage of Pramipexole Cinfa

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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Pramipexol cinfa

• The active ingredient is pramipexole. Each prolonged-release tablet contains 1.05 mg of pramipexole as 1.5 mg of pramipexole dihydrochloride monohydrate.
• The other components are: hypromellose, calcium hydrogen phosphate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Pramipexol cinfa 1.05 mg prolonged-release tablets are 10 mm, white or almost white, cylindrical, biconvex tablets with "105" embossed on one side. Each package contains 30 tablets in Alu/Alu-PVC-OPA blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarre) - Spain

Manufacturer

Normon Laboratories, S.A.

Valdecarrizo Ring Road, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarre) - Spain

Date of the Last Revision of this Leaflet: April 2020

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

You can access detailed and updated information on this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80053/P_80053.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80053/P_80053.html