PRAMIPEXOL TEVA 0.7 mg TABLETS

2. What you need to know before taking Pramipexol Teva

Do not take Pramipexol Teva

• if you are allergic to pramipexol or any of the other components of this medicine (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 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 the dose of Pramipexol Teva.
• Dystonia (inability to keep 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 curvature of the lumbar region (also called camptocormia), or sideways curvature 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 undergo regular eye exams during treatment with Pramipexol Teva.
• Severe heart or blood vessel disease. You should undergo regular 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 that symptoms start earlier than usual, are more intense, and affect other limbs.

Inform 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 thoughts and feelings of sex. Your doctor may need to adjust or stop the dose.

Inform 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 interrupt your dose.

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 problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you notice inability to keep 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

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

You should avoid using Pramipexol Teva 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 (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 using levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramipexol Teva.

Be cautious if you are using sedative medicines (with a 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, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will indicate whether 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 indicates it.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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 sleep episodes, especially in patients with Parkinson's disease. If you experience these side effects, do not drive or operate machinery. Inform 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

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

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

Patient with kidney disease

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 kidney failure, the usual starting dose is 1 tablet of Pramipexol Teva 0.088 mg twice a day. If you have severe kidney failure, the usual starting dose is 1 tablet of Pramipexol Teva 0.088 mg per day.

Restless Legs Syndrome

The dose is usually administered once a day, at night, 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 pramipexol salt).

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

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

Patient with kidney disease

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 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 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 with this medicine, 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 interruption can cause a disorder 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 or reduce the dose of Pramipexol Teva, you may also experience a medical disorder 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 doubts about 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 or spending.
  • 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 provide 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 or spending*
• 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 provide 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 contribute to providing 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 stated.

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. Package Contents and Additional 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 monostearate fumarate, colloidal silicon dioxide.

Appearance of the Product and Package Contents

• 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 "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 request more information about this medicine by contacting the local representative of the marketing authorisation holder:

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

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