Leaflet: information for the user

Pramipexol Teva 0.088mg tablets EFG

Pramipexol Teva 0.18mg tablets EFG

Pramipexol Teva 0.35mg tablets EFG

Pramipexol Teva 0.7mg tablets EFG

pramipexol

Read this 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 prescribedonlyfor you, and you should not give it to others even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceany side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section4.

1.What is Pramipexol Teva and what it is used for

2.What you need to knowbeforestarting totake Pramipexol Teva

3.How to take Pramipexol Teva

4.Possible side effects

5Storage of Pramipexol Teva

6.Contents of the pack and additional information

Pramipexol Tevacontains the active ingredient pramipexol whichbelongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptorstriggers nerve impulsesin the brain thathelp to control the body's movements.

Pramipexol Teva is used for:

• treating the symptoms of idiopathic Parkinson's diseasein adults. It may be usedalone or in combination with levodopa (another medicine for Parkinson's disease).
• treating the symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults.

Do not take Pramipexol Teva

• if you are allergic to pramipexol or any of the other ingredients in this medication (listed in section 6)

Warnings and precautions

Consult your doctor before starting to take Pramipexol Teva.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.
• discinesia (abnormal involuntary movements of the limbs). If you have advanced Parkinson's disease and are also using levodopa, you may experience discinesia during the progressive increase in Pramipexol Teva dosage.
• distonía (inability to maintain the trunk and neck straight and upright (axial distonía)). Specifically, you may experience forward flexion of the head and neck (also known as antecolis), forward curvature of the lumbar region (also known as camptocormia), or lateral curvature of the back (also known as pleurotónos or Pisa syndrome). Somnolence and sudden onset of sleep.
• psychosis (e.g. similar to schizophrenia symptoms).
• vision alteration. You should undergo periodic eye exams during treatment with Pramipexol Teva.
• severe heart or blood vessel disease. You should undergo periodic blood pressure checks, especially at the beginning of treatment, to avoid postural hypotension (a drop in blood pressure when standing up).
• increased symptoms. You may experience symptoms starting earlier than usual, being more intense, and affecting other limbs.

Inform your doctor if you, your family, or caregivers notice that you are developing impulses or urges to behave in an unusual way that you cannot resist, which may harm you or others. This is known as impulse control disorder and may include behaviors such as excessive gaming, eating, or spending, abnormal high sex drive, or excessive concern about increased sexual thoughts and feelings.Your doctor may need to adjust or stop your dosage.

Inform your doctor if you, your family, or caregivers notice that you are developing mania (agitation, feeling overexcited or overstimulated) or delirium (decreased consciousness, confusion, or loss of contact with reality).Your doctor may need to adjust or stop your dosage.

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

Inform your doctor if you are noticing inability to maintain the trunk and neck straight and upright (axial distonía). In this case, your doctor may decide to adjust or modify your treatment.

Children and adolescents

Pramipexol Teva is not recommended for use in children or adolescents under 18 years old.

Other medications and Pramipexol Teva

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

Avoid using Pramipexol Teva with antipsychotic medications.

Be cautious if you are using the following medications:

• 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 human immunodeficiency disease)
• cisplatin (for treating 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 malignant malaria)
• procainamide (for treating irregular heartbeats)

If you are using levodopa, it is recommended to reduce the levodopa dosage when starting treatment with Pramipexol Teva.

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

Taking Pramipexol Teva with food, drinks, and alcohol

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

You can take Pramipexol Teva with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medication. Your doctor will inform you if you should continue treatment with Pramipexol Teva.

Pramipexol Teva has not been shown to have an effect on the fetus. Therefore, do not take Pramipexol Teva if you are pregnant unless your doctor tells you to.

Pramipexol Teva should not be used during breastfeeding. Pramipexol Teva may decrease milk production. Additionally, Pramipexol Teva may pass into breast milk and reach your baby. If the use of Pramipexol Teva is necessary, breastfeeding should be interrupted.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Pramipexol Teva has been associated with somnolence and sudden onset of sleep, especially in patients with Parkinson's disease. If you experience these adverse effects, do not drive or operate machinery. Inform your doctor if this happens.

Pramipexol Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor.In case of doubt, consult your doctor again.Your doctor will indicate the correct dosage.

You can takePramipexol Tevawith or without food. The tablets must be swallowed with water.

Parkinson's Disease

The daily dose must be taken divided into 3 equal doses.

During the first week, the usual dose is 1 tablet ofPramipexol Teva0.088mg three times a day (equivalent to 0.264mg per day):

This dose will be increased every 5‑7 days as indicated by your doctor, until your symptoms are controlled (maintenance dose).

The usual maintenance dose is 1.1mg 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 3.3mg of pramipexol per day. It is also possible to reduce the maintenance dose to three tablets ofPramipexol Teva0.088mg per day.

Patients with kidney disease

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you must take the tablets only once or twice a day. If you have moderate renal insufficiency, the usual starting dose is 1 tablet of Pramipexol Teva 0.088mg twice a day. If you have severe renal insufficiency, the usual starting dose is 1 tablet of Pramipexol Teva0.088mg per day.

Restless Legs Syndrome

The dose is usually administered once a day, at night, 2‑3hours before bedtime.

During the first week, the usual dose is 1tablet of Pramipexol Teva 0.088mg once a day (equivalent to 0.088mg per day):

This dose will be increased every 4‑7days as indicated by your doctor, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of restless legs syndrome should not exceed 6tablets ofPramipexol Teva0.088mg or a dose of 0.54mg (0.75mg of pramipexol base).

If you stop taking your tablets for a few days and want to resume treatment, you must start again with the smallest dose and then gradually increase the dose as you did the first time. Consult your doctor if you have any doubts.

Your doctor will evaluate your treatment after 3months, to decide whether to continue or not with the treatment.

Patients with kidney disease

If you have severe kidney disease, Pramipexol Teva may not be an appropriate treatment for your restless legs syndrome

If you take more Pramipexol Teva 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 section4 (Possible adverse effects).

If you forget to take Pramipexol Teva

Do not worry. Simply omit that dose completely and take the next dose at the correct time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pramipexol Teva

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

If you have Parkinson's disease, you should not stop your treatment with Pramipexol Teva abruptly. Sudden discontinuation may cause the appearance of a condition called neuroleptic malignant syndrome, which can represent a very serious risk to your health. These symptoms include:

• akinesia (loss of muscular movement)
• muscular 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 Teva, 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The classification of these side effects is based on the following frequencies:

If you have Parkinson's disease, you may experience the following side effects:

Very common:

• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Drowsiness
• Dizziness
• Nausea (feeling of dizziness)

Common:

• Need to behave in an unusual way
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Fatigue (tiredness)
• Insomnia
• Excess fluid, usually in the legs (peripheral edema)
• Headache
• Low blood pressure
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (urge to vomit)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern about your health)
• Delirium
• Excessive daytime somnolence and sudden sleep episodes.
• Amnesia (alteration of memory)
• Hypokinesia (increase in movement and inability to remain still)
• Weight gain
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of the antidiuretic hormone*
• Anxiety
• Dyspnea (difficulty breathing)
• Hypophonia (soft voice)
• 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.
  • Uncontrollable excessive spending.
  • Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger)*

• Delirium (diminished consciousness, confusion, loss of contact with reality)

Rare:

• Mania (agitation, feeling elated or overexcited)

Frequency not known:

• After stopping or reducing treatment with Pramipexol Teva: may occur depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS).

Inform 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 provide a precise estimate of the frequency, as these side effects were not observed in clinical trials involving 2,762 patients treated with pramipexol. The frequency category is likely to be no higher than "uncommon".

If you have Restless Legs Syndrome, you may experience the following side effects:

Very common:

• Nausea

Common:

• Changes in sleep pattern, such as insomnia and somnolence
• Fatigue (tiredness)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (urge to vomit)

Uncommon:

• Need to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of the antidiuretic hormone*
• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Hypokinesia (increase in movement and inability to remain still)*
• Paranoia (e.g. excessive concern about your health)*
• Delusion*
• Amnesia (alteration of memory)*
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Excessive daytime somnolence and sudden sleep episodes
• Weight gain
• Low blood pressure
• Excess fluid, usually in the legs (peripheral edema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Syncope (fainting)
• Anxiety
• Visual disturbances
• Weight loss including loss of appetite
• Dyspnea (difficulty breathing)
• Hypophonia (soft voice)
• 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.*
• Uncontrollable excessive spending.*
• Binge eating (ingestion of large amounts of food in a short period of time) or compulsive eating (ingestion of more food than normal and more than needed to satisfy hunger)*

• Mania (agitation, feeling elated or overexcited)*
• Delirium (diminished consciousness, confusion, loss of contact with reality)*

Frequency not known:

• After stopping or reducing treatment with Pramipexol Teva: may occur depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS).

Inform 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 provide a precise estimate of the frequency, as these side effects were not observed in clinical trials involving 1,395 patients treated with pramipexol. The frequency category is likely to be no higher than "uncommon".

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on thebox, blister pack, or label of the bottleafter EXP.The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Store in the original packaging to protect it from light andhumidity.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Pramipexol Teva

The active ingredient is pramipexol.

Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg of pramipexol as 0.125 mg, 0.25 mg, 0.5 mg or 1 mg of dihydrochloride monohydrate of pramipexol, respectively.

The other components are mannitol, microcrystalline cellulose, sodium glycolate starch, povidone, magnesium stearate, sodium monoestearate fumarate, colloidal silicon dioxide.

Appearance of the product and contents of the package

• Pramipexol Teva 0.088 mg tablets are white, round, engraved with "93" on one side and "P1" on the other side.
• Pramipexol Teva 0.18 mg tablets are white, round, scored, engraved with "P2" over "P2" on the scored side and "93" on the other side. The tablet can be divided into two equal halves.
• Pramipexol Teva 0.35 mg tablets are white, oval, biconvex, engraved with 9 vertically to the score, 3 on the scored side, and 8023 on the other side.The tablet can be divided into two equal halves.
• Pramipexol Teva 0.7 mg tablets are white, round, scored, engraved with "8024" over "8024" on the scored side and "93" on the other side. The tablet can be divided into two equal halves.
• Pramipexol Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1, and 100 tablets, and bottles containing 90 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

Pharmachemie B.V.

Swensweg 5,

Postbus 552,

2003 RN Haarlem

Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305

747 70 Opava-Komarov

Czech Republic

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last review of this leaflet: {MM/AAAA}

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.