PRAMIPEXOL TEVA 0.7 mg TABLETS

Introduction

Package Leaflet: Information for the User

Pramipexol Teva 0.088 mg tablets EFG

Pramipexol Teva 0.18 mg tablets EFG

Pramipexol Teva 0.35 mg tablets EFG

Pramipexol Teva 0.7 mg tablets EFG

pramipexol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

5 Storage of Pramipexol Teva

1. Contents of the pack and further information

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

Pramipexol Teva contains the active substance pramipexole, which belongs to a group of medicines known as dopamine agonists. These medicines stimulate the dopamine receptors in the brain, which helps to control movement.

Pramipexol Teva is used to:

• treat the symptoms of idiopathic Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
• treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome in adults.

2. What you need to know before you take Pramipexol Teva

Do not take Pramipexol Teva

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

Warnings and precautions

Tell your doctor before you start taking Pramipexol Teva. Inform your doctor if you have or have had any of the following conditions or symptoms, especially:

• 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 experience dyskinesia during the gradual increase in dose of Pramipexol Teva.
• Dystonia (inability to maintain the trunk and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward flexion of the lumbar region (also called camptocormia) or sideways curvature of the back (also called pleurothotonus or Pisa syndrome). Somnolence and sudden episodes of sleep.
• Psychosis (e.g. similar to symptoms of schizophrenia).
• Impaired vision. You should have regular eye examinations during treatment with Pramipexol Teva.
• 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 on standing up).
• Increased symptoms. You may experience that your symptoms start earlier than usual, are more intense and affect other limbs.

Tell your doctor if you, your family or caregivers notice that you are developing impulses or cravings to behave in ways that are unusual for you and that you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. This is called impulse control disorder and can include behaviours such as addiction to gambling, excessive eating or spending, abnormally high libido or increased sexual thoughts and feelings. 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 or 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 Pramipexol Teva. If the problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you notice inability to maintain the trunk and neck straight and upright (axial dystonia). 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 of age.

Other medicines and Pramipexol Teva

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 taking Pramipexol Teva with antipsychotic medicines.

Be cautious if you are taking 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 immune deficiency syndrome (AIDS), a disease of the human immune system)
• cisplatin (for the treatment of 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 (for the treatment of irregular heartbeat)

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

Be cautious if you are taking sedative medicines (with a calming 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

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

You can take Pramipexol Teva with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will tell you if you should continue treatment with Pramipexol Teva.

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

Pramipexol Teva should not be used during breast-feeding. Pramipexol Teva may decrease milk production. Also, it may pass into breast milk and reach your baby. If the use of Pramipexol Teva is essential, breast-feeding should be discontinued.

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

Driving and using machines

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

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

Pramipexol Teva contains sodium

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

3. How to take Pramipexol Teva

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Your doctor will tell you the correct dose.

You can take Pramipexol Teva with or without food. The tablets should be swallowed with water.

Parkinson's disease

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

During the first week, the usual dose is 1 tablet of Pramipexol Teva 0.088 mg three times a day (equivalent to 0.264 mg per day):

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 1.1 mg 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 3.3 mg of pramipexole per day. It is also possible to reduce the maintenance dose to three tablets of Pramipexol Teva 0.088 mg per day.

Patient with renal impairment

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

Restless Legs Syndrome

The dose is usually taken once a day, in the evening, 2-3 hours before bedtime.

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

This dose will be increased every 4-7 days according to your doctor's instructions, until your symptoms are controlled (maintenance dose).

The daily dose for the treatment of Restless Legs Syndrome should not exceed 6 tablets of Pramipexol Teva 0.088 mg or a dose of 0.54 mg (0.75 mg of pramipexole salt).

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

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

Patient with renal impairment

If you have severe kidney disease, Pramipexol Teva may not be a suitable treatment for your Restless Legs Syndrome.

If you take more Pramipexol Teva than you should

If you accidentally take too many tablets,

• contact your doctor or the nearest hospital emergency department immediately.
• You may experience vomiting, restlessness or any of the side effects described in section 4 (Possible side effects).

If you forget to take Pramipexol Teva

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Pramipexol Teva

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

If you have Parkinson's disease, you should not stop your treatment with Pramipexol Teva abruptly. Sudden stopping may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. 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 or reduce treatment with Pramipexol Teva, you may also experience a 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 medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Very Common:

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

Common:

• Need to behave in an unusual way
• 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 disturbance
• Vomiting (nausea)
• Weight loss including loss of appetite

Uncommon:

• Paranoia (e.g. excessive concern for one's health)
• Delirium
• Excessive daytime somnolence and sudden episodes of sleep.
• 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 disturbing behavior for you or others, for example, increased sexual appetite.
  • Uncontrolled excessive shopping.
  • Binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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 Pramipexol Teva: depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS) may occur.

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

For the adverse effects marked with *, it is not possible to have a precise estimate of the frequency, as these adverse effects were not observed in clinical trials among 2,762 patients treated with pramipexol. The frequency category is probably no higher than "uncommon".

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

Very Common:

• Nausea

Common:

• Changes in sleep patterns, such as insomnia and somnolence
• Fatigue
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (nausea)

Uncommon:

• Need to behave in an unusual way*
• Heart failure (heart problems that can cause shortness of breath or swelling of the ankles)*
• Inadequate secretion of antidiuretic hormone*
• Dyskinesia (e.g. abnormal involuntary movements of the limbs)
• Hyperkinesia (increased movement and inability to remain still)*
• Paranoia (e.g. excessive concern for one's health)*
• Delusion*
• Amnesia (memory impairment)*
• Hallucinations (seeing, hearing or feeling things that are not present)
• Confusion
• Excessive daytime somnolence and sudden episodes of sleep
• Weight gain
• Hypotension (low blood pressure)
• Excess fluid, usually in the legs (peripheral edema)
• Allergic reactions (e.g. skin rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual disturbance
• Weight loss including loss of appetite
• 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 disturbing behavior for you or others, for example, increased sexual appetite*
• Uncontrolled excessive shopping*
• Binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger)*

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

Frequency Not Known:

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

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

For the adverse effects marked with *, it is not possible to have a precise estimate of the frequency, as these adverse effects were not observed in clinical trials among 1,395 patients treated with pramipexol. The frequency category is probably 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 that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexol Teva

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, blister or label of the bottle after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

Store in the original packaging to protect from light and moisture.

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

6. Contents of the Pack and Further Information

Composition of Pramipexol Teva

The active substance 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 pramipexol dihydrochloride monohydrate, respectively.

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

Appearance and Packaging of the Product

• 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 packs of 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets and bottles containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Manufacturer

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 obtain further information on this medicine from the local representative of the Marketing Authorisation Holder:

Date of Last Revision of this Leaflet: {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.