Pramipexole Teva 0.18 mg tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pramipexole Teva 0.088 mg tablets EFG

Pramipexole Teva 0.18 mg tablets EFG

Pramipexole Teva 0.35 mg tablets EFG

Pramipexole Teva 0.7 mg tablets EFG

pramipexole

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 must not be given 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 they are effects not listed in this leaflet. See section 4.

Leaflet contents

What Pramipexole Teva is and what it is used for
What you need to know before taking Pramipexole Teva
How to take Pramipexole Teva
Possible side effects
How to store Pramipexole Teva
Contents of the pack and other information

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

Pramipexole Teva contains the active substance pramipexole, which belongs to a group of medicines called dopamine agonists that stimulate dopamine receptors in the brain. Stimulation of dopaminergic receptors triggers nerve impulses in the brain that help control body movements.

Pramipexole Teva 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).
treat moderate to severe idiopathic Restless Legs Syndrome in adults.

2. What you need to know before taking Pramipexole Teva

Do not take Pramipexole Teva

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 before starting to take Pramipexole Teva. Inform your doctor if you have or have had any illness 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 taking levodopa, you may experience dyskinesia during the gradual dose increase of Pramipexole Teva.
Dystonia (inability to keep the trunk and neck straight and upright (axial dystonia)). Specifically, you may 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 sleep episodes.
Psychosis (e.g., symptoms similar to schizophrenia).
Vision problems. You should have periodic eye examinations during treatment with Pramipexole Teva.
Severe heart or blood vessel disease. You should have periodic blood pressure checks, especially at the beginning of treatment, to prevent postural hypotension (a drop in blood pressure upon standing).
Worsening of symptoms. You may experience symptoms starting earlier than usual, being more intense, or affecting other limbs.

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, drive, 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 compulsive gambling, 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, or loss of contact with reality). Your doctor may need to adjust or interrupt 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 Teva. If these problems persist for more than a few weeks, your doctor may need to adjust your treatment.

Inform your doctor if you experience difficulty maintaining an upright posture of the trunk and neck (axial dystonia). In such cases, your doctor may decide to adjust or modify your treatment.

Children and adolescents

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

Other medicines and Pramipexole Teva

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

You must avoid using Pramipexole Teva together with antipsychotic medicines.

Be cautious if you are taking 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 disease of the human immune system)
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 Teva.

Be cautious if you are taking sedative medicines (with sedative effect) or drinking alcohol. In these cases, Pramipexole Teva may affect your ability to drive or operate machinery.

Taking Pramipexole Teva with food, drinks, and alcohol

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

You may take Pramipexole Teva 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 before using this medicine. Your doctor will advise you whether you should continue treatment with Pramipexole Teva.

The effect of Pramipexole Teva on the fetus is unknown. Therefore, do not take Pramipexole Teva during pregnancy unless your doctor tells you to do so.

Pramipexole Teva must not be used during breastfeeding. Pramipexole Teva may reduce the production of breast milk. In addition, it may pass into breast milk and reach your baby. If the use of Pramipexole Teva is essential, breastfeeding must be discontinued.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Pramipexole Teva has been associated with drowsiness and sudden sleep episodes, especially in patients with Parkinson’s disease. If you experience these adverse effects, you must not drive or operate machinery. Inform your doctor if this happens.

Pramipexole 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 Pramipexole Teva

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

You may take Pramipexole Teva with or without food. The tablets should be swallowed with water.

Parkinson's disease

The daily dose should be taken in three equal doses.

During the first week, the usual dose is 1 tablet of Pramipexole Teva 0.088 mg three times daily (equivalent to 0.264 mg daily):

	Week 1
Number of tablets	1 tablet of Pramipexole Teva 0.088 mg three times daily
Total daily dose (mg)	0.264

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

2nd week

3rd week

Number of tablets

1 tablet of Pramipexole Teva 0.18 mg three times a day

2 tablets of Pramipexole Teva 0.088 mg three times a day

1 tablet of Pramipexole Teva 0.35 mg

three times a day

2 tablets of Pramipexole Teva 0.18 mg

three times a day

Total daily dose (mg)

0.54

1.1

The usual maintenance dose is 1.1 mg per day. However, your dose may need to be increased further. If necessary, your doctor could increase your tablet dose 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 Pramipexole Teva 0.088 mg per day.

Minimum maintenance dose

Maximum maintenance dose

Number of tablets

1 tablet of Pramipexole Teva 0.088 mg

three times daily

1 tablet of Pramipexole Teva 0.7 mg and 1 tablet of Pramipexole Teva 0.35 mg three times daily

Total daily dose (mg)

0.264

3.15

Patients with renal 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 renal impairment, the usual starting dose is 1 tablet of Pramipexole Teva 0.088 mg twice daily. If you have severe renal impairment, the usual starting dose is 1 tablet of Pramipexole Teva 0.088 mg once daily.

Restless Legs Syndrome

The dose is usually taken once daily, at night, 2–3 hours before going to bed.

During the first week, the usual dose is 1 tablet of Pramipexole Teva 0.088 mg once daily (equivalent to 0.088 mg daily):

	1st week
Number of tablets	1 tablet of Pramipexole Teva 0.088 mg
Total daily dose (mg)	0.088

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

2nd week

3rd week

4th week

Number of tablets

1 tablet of Pramipexole Teva 0.18 mg

2 tablets of Pramipexole Teva 0.088 mg

1 tablet of Pramipexole Teva 0.35 mg

2 tablets of Pramipexole Teva 0.18 mg

4 tablets of Pramipexole Teva 0.088 mg

1 tablet of Pramipexole Teva 0.35 mg and 1 tablet of Pramipexole Teva 0.18 mg

3 tablets of Pramipexole Teva 0.18 mg

6 tablets of Pramipexole Teva 0.088 mg

Total daily dose (mg)

0.18

0.35

0.54

The daily dose for the treatment of restless legs syndrome must not exceed 6 tablets of Pramipexole Teva 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).

If you stop taking your tablets for a few days and wish to restart treatment, you must begin 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 3 months to decide whether or not to continue treatment.

Patients with renal disease

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

If you take more Pramipexole 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, agitation, or any of the adverse effects described in section 4 (Possible side effects).

If you forget to take Pramipexole Teva

Do not worry. Simply skip the missed dose and take the next dose at the correct time.

Do not take a double dose to make up for a missed dose.

If you stop taking Pramipexole Teva

Do not stop your treatment with Pramipexole Teva 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 must not abruptly stop your treatment with Pramipexole Teva. 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 Pramipexole Teva, 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 must 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 these adverse effects is based on the following frequencies:

Very common	may affect more than 1 in 10 people
Common	may affect up to 1 in 10 people
Uncommon	may affect up to 1 in 100 people
Rare	may affect up to 1 in 1,000 people
Very rare	may affect up to 1 in 10,000 people
Frequency not known	cannot be estimated from the available data

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

Very common:

Dyskinesia (e.g., abnormal involuntary movements of limbs)
Somnolence
Dizziness
Nausea (feeling of sickness)

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 oedema)
Headache
Hypotension (low blood pressure)
Abnormal dreams
Constipation
Visual disturbance
Vomiting (feeling the need to vomit)
Weight loss including loss of appetite

Uncommon:

Paranoia (e.g., excessive concern about your health)
Delirium
Excessive daytime sleepiness and sudden episodes of falling asleep
Amnesia (memory impairment)
Hyperkinesia (increased movements and inability to stay still)
Weight gain
Allergic reactions (e.g., skin rash, itching, hypersensitivity)
Fainting
Heart failure (heart problems that may cause breathlessness or swelling of the ankles)*
Inappropriate antidiuretic hormone secretion*
Restlessness
Dyspnoea (difficulty breathing)
Hiccups
Pneumonia (lung infection)
Inability to resist the impulse, instinct or temptation to carry out an action that may 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 behaviour that is concerning to you or others, for example, increased libido.
- Compulsive buying or spending.
- Binge eating (eating 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 awareness, confusion, loss of contact with reality)

Rare:

Mania (agitation, feeling elated or over-excited)

Frequency not known:

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

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

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 2,762 patients treated with pramipexol. The frequency category is likely no higher than "uncommon".

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

Very common:

Nausea

Common:

Changes in sleep pattern, such as insomnia and somnolence
Tiredness (fatigue)
Headache
Abnormal dreams
Constipation
Dizziness
Vomiting (feeling the need to vomit)

Uncommon:

Urge to behave in an unusual way*
Heart failure (heart problems that may cause breathlessness or swelling of the ankles)*
Inappropriate antidiuretic hormone secretion*
Dyskinesia (e.g., abnormal involuntary movements of limbs)
Hyperkinesia (increased movements and inability to stay still)*
Paranoia (e.g., excessive concern about your health)*
Delusion*
Amnesia (memory impairment)*
Hallucinations (seeing, hearing or feeling things that are not present)
Confusion
Excessive daytime sleepiness and sudden episodes of falling asleep
Weight gain
Hypotension (low blood pressure)
Fluid retention, usually in the legs (peripheral oedema)
Allergic reactions (e.g., skin rash, itching, hypersensitivity)
Fainting
Restlessness
Visual disturbance
Weight loss including loss of appetite
Dyspnoea (difficulty breathing)
Hiccups
Pneumonia (lung infection)*
Inability to resist the impulse, instinct or temptation to carry out an action that may be harmful to you or others, including:
Strong urge to gamble excessively despite serious personal or family consequences.*
Altered or increased sexual interest and behaviour that is concerning to you or others, for example, increased libido.*
Compulsive buying or spending.*
Binge eating (eating 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)*
Mania (agitation, feeling elated or over-excited)*
Delirium (reduced awareness, confusion, loss of contact with reality)*

Frequency not known:

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

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

For adverse effects marked with *, a precise frequency estimate is not available, as these adverse effects were not observed in clinical trials involving 1,395 patients treated with pramipexol. The frequency category is likely no higher than "uncommon".

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pramipexole Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blister pack, or label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pramipexole Teva

The active substance is pramipexole.

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

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

Appearance of the product and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

The Netherlands

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

Pharmachemie B.V.

Swensweg 5,

Postbus 552,

2003 RN Haarlem

The 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

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:
















Belgium/Belgium/Belgium Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 38207373	Lithuania UAB Teva Baltics Tel: +370 52660203
Bulgaria Teva Bulgaria EOOD Tel: +359 24899585	Luxembourg/Luxembourg ratiopharm GmbH Germany/Germany Tel/Tel: +49 73140202
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Hungary Teva Gyógyszergyár Zrt. Tel: +36 12886400
Denmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117
Germany TEVA GmbH Tel: +49 73140208	Netherlands Teva Nederland B.V. Tel: +31 8000228400
Estonia UAB Teva Baltics Estonia branch Tel: +372 6610801	Norway Teva Norway AS Tlf: +47 66775590
Greece Specifar Α.Β.Ε.Ε. Tel: +30 2118805000	Austria ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Spain Teva Pharma, S.L.U. Tel: +34 913873280	Poland Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33155917800	Portugal Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550
Croatia Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenia Pliva Ljubljana d.o.o. Tel: +386 15890390
Iceland Teva Pharma Iceland ehf. Tel: +354 5503300	Slovakia TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Italy Teva Italia S.r.l. Tel: +39 028917981	Finland/Finland Teva Finland Oy Tel/Tel: +358 201805900
Cyprus Specifar Α.Β.Ε.Ε. Greece Tel: +30 2118805000	Sweden Teva Sweden AB Tel: +46 42121100
Latvia UAB Teva Baltics Latvia branch Tel: +371 67323666	United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117

Date of the most recent review of this summary: {MM/YYYY}

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