Pramipexole Teva

Package leaflet: Information for the user

Pramipexole Teva 0.088 mg tablets, 0.18 mg tablets, 0.35 mg tablets, 0.7 mg tablets

pramipexole
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Pramipexole Teva is and what it is used for
2. What you need to know before taking Pramipexole Teva
3. How to take Pramipexole Teva
4. Possible side effects
5. How to store Pramipexole Teva
6. 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 and belongs to a group of medicines
known as dopaminergic agonists, which stimulate dopamine receptors located in the brain.
Stimulation of dopamine receptors in the brain triggers nerve impulses that help control body movements.
Pramipexole Teva is used for:

• the treatment of symptoms of idiopathic Parkinson’s disease in adults. It may be used alone or in combination with levodopa (another medicine for Parkinson’s disease).
• the treatment of moderate to severe idiopathic restless legs syndrome (RLS) 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 taking Pramipexole Teva. Inform your doctor if you have (had) or develop any medical condition or symptom, especially if you belong to the following list:

• Kidney disease.
• Hallucinations (seeing, hearing or sensing things that are not real). Most hallucinations are visual.
• Dyskinesias (e.g., abnormal, uncontrollable movements of limbs). If you have advanced Parkinson's disease and are also taking levodopa, you may develop dyskinesia during the titration phase of Pramipexole Teva.
• Dystonia (inability to maintain an upright posture of body and neck (axial dystonia)). In particular, forward bending of head and neck (also known as anterocollis), forward flexion of the lumbar spine (also known as camptocormia), or lateral curvature of the spine (also known as pleurothotonus or Pisa syndrome) may occur.
• Drowsiness and sudden onset of sleep episodes.
• Psychosis (e.g., symptoms comparable to schizophrenia).
• Vision disturbances. During treatment with Pramipexole Teva, you should undergo regular eye examinations.
• Severe heart or blood vessel diseases. Especially at the beginning of treatment, your blood pressure should be monitored regularly to avoid postural hypotension (a drop in blood pressure upon standing).
• Worsening of restless legs syndrome symptoms. If you notice that symptoms occur earlier than usual in the evening (or even in the afternoon), are more intense, affect larger areas of the affected limbs, or involve other limbs, your doctor may reduce the dose or discontinue treatment.

Inform your doctor if you, your family members, or caregivers notice that you are developing an urge or desire 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.
These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, binge eating, excessive spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations. Your doctor may need to adjust the dose or discontinue therapy.
Inform your doctor if you or a family member or caregiver notices that you are developing mania (agitation, feelings of euphoria or overexcitement) or delirium (reduced awareness, confusion, or loss of sense of reality). Your doctor may consider it necessary to adjust the dose or discontinue treatment.
Inform your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of Pramipexole Teva. If symptoms persist for more than a few weeks, your doctor may need to adjust your therapy.
Inform your doctor if you experience inability to maintain an upright posture of body and neck (axial dystonia). If these symptoms occur, your doctor may decide to adjust or change your treatment.

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

Other medicines and Pramipexole Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal remedies, dietary products, or supplements obtained without a prescription.
You must avoid taking Pramipexole Teva together with antipsychotic medicines.
Be cautious if you are taking any of the following medicines:

• cimetidine (used to treat excess stomach acid and gastric ulcers)
• amantadine (which may be used to treat Parkinson's disease)
• mexiletine (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 (to treat various types of cancer)
• quinine (which may be used to prevent painful nocturnal cramps and to treat falciparum malaria (malignant malaria))
• procainamide (to treat irregular heartbeats)

If you are taking levodopa, it is recommended to reduce its dose when starting treatment with Pramipexole Teva.
Be cautious if you are taking any sedative (sedating) medicine or consuming alcohol. In these cases, Pramipexole Teva may impair your ability to drive or operate machinery.

Pramipexole Teva with food, drinks and alcohol
You should be cautious if consuming alcohol during treatment with Pramipexole Teva.
Pramipexole Teva may be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will discuss with you whether to continue taking Pramipexole Teva.
The effect of Pramipexole Teva on the fetus is unknown. Therefore, do not take Pramipexole Teva during pregnancy unless your doctor specifically instructs you to do so.
Pramipexole Teva must not be taken during breastfeeding. Pramipexole Teva may reduce milk production and may pass into breast milk and reach the infant. If taking Pramipexole Teva is unavoidable, breastfeeding must be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Pramipexole Teva may cause hallucinations (seeing, hearing or sensing things that are not real). If this occurs, do not drive or operate machinery.
Pramipexole Teva has been associated with drowsiness and sudden onset of sleep episodes, particularly in patients with Parkinson's disease. If these side effects occur, avoid driving and do not operate machinery. Inform your doctor if this happens.

Pramipexole contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take PRAMIPEXOLE TEVA

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Your doctor will tell you the correct dosage.
Pramipexole Teva may be taken with or without food. The tablets should be swallowed with water.

Parkinson's disease
The daily dose should be divided into 3 equal doses.
During the first week, the usual dose is 1 Pramipexole Teva 0.088 mg tablet three times a day (equivalent to 0.264 mg per day).

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

The usual maintenance dose is 1.1 mg daily. However, your dose may be further increased. If necessary, your doctor may increase the tablet dose up to a maximum of 3.3 mg of pramipexole daily. A lower maintenance dose may also be possible, consisting of three Pramipexole Teva 0.088 mg tablets daily.

Patients with renal disease
If you have moderate or severe renal disease, your doctor will prescribe a lower dose. In this case,
you will need to take the tablets only once or twice a day. If you have moderate renal disease, the usual
starting dose is 1 tablet of Pramipexole Teva 0.088 mg twice daily. In case of severe renal disease, the
usual starting dose is only 1 tablet of Pramipexole Teva 0.088 mg once daily.
Restless legs syndrome
The dose is usually taken once daily in the evening, 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):

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

The daily dose 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 the medication for more than a few days and wish to restart treatment, you must begin again with the lowest dose. You can then gradually return to your previous dose, as done initially. Ask your doctor for advice.
Your doctor will review your treatment after 3 months to decide whether it should continue.

Patients with kidney disease
If you have severe kidney disease, treatment with Pramipexole Teva may not be suitable for you.

If you take more Pramipexole Teva than you should
If you accidentally take too many tablets:

• contact your doctor immediately or go to the nearest hospital emergency department.
• You may experience vomiting, restlessness, 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 completely and take the next dose at your usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Pramipexole Teva
Do not stop taking Pramipexole Teva without first talking to 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 stop treatment with Pramipexole Teva abruptly. Sudden discontinuation may lead to a medical condition called neuroleptic malignant syndrome, which could pose a greater health risk. Symptoms include:

• akinesia (loss of muscle movement)
• muscle rigidity
• fever
• unstable blood pressure
• tachycardia (increased heart rate)
• confusion
• reduced level of consciousness (e.g. coma)

If you stop or reduce treatment with Pramipexole Teva, you may also develop 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The assessment 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. involuntary, abnormal limb movements)
• Somnolence (sleepiness)
• Dizziness
• Nausea (feeling unwell)

Common:

• Impulse to behave in an unusual way
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Fatigue (feeling of tiredness)
• Sleeplessness (insomnia)
• Fluid retention, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual disturbances
• Vomiting (feeling unwell)
• Weight loss accompanied by reduced appetite

Uncommon:

• Paranoia (e.g. excessive fear for one's own well-being)
• Delirium
• Excessive daytime sleepiness and sudden onset sleep episodes
• Amnesia (memory disturbances)
• Hyperkinesia (increased movements and inability to stay still)
• Weight gain
• Allergic reactions (e.g. skin rashes, itching, hypersensitivity)
• Fainting
• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)
• Inability to resist the impulse, urge or temptation to carry out an action that could 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 causing significant concern to you or others, for example increased sexual drive
• Excessive and uncontrollable shopping or spending
• Uncontrolled 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 your appetite)*
• Delirium (reduced awareness, confusion, loss of sense of reality)

Rare:

• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of Pramipexole Teva, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; they will explain how to manage or
reduce the symptoms.
For side effects marked with *, it is not possible to estimate the frequency precisely, as these side effects were not observed in clinical studies involving 2,762 patients treated with pramipexole. The frequency category is likely no greater than "uncommon".

If you have restless legs syndrome, you may experience the following side effects:
Very common:

• Nausea (feeling unwell)
• Symptoms occurring earlier than usual, being more intense, or affecting other limbs (worsening of restless legs syndrome symptoms)

Common:

• Sleep disturbances, such as difficulty sleeping (insomnia) and somnolence (sleepiness)
• Fatigue (feeling of tiredness)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (feeling unwell)

Uncommon:

• Impulse to behave in an unusual way*
• Heart failure (heart problems that may cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Dyskinesia (e.g. involuntary, abnormal limb movements)
• Hyperkinesia (increased movements and inability to stay still)*
• Paranoia (e.g. excessive fear for one's own well-being)*
• Delirium*
• Amnesia (memory disturbances)*
• Hallucinations (seeing, hearing or sensing things that are not there)
• Confusion
• Excessive daytime sleepiness and sudden onset sleep episodes
• 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 disturbances
• Weight loss accompanied by reduced appetite
• Dyspnoea (difficulty breathing)
• Hiccups
• Pneumonia (lung infection)*
• Inability to resist the impulse, urge or temptation to carry out an action that could 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 causing significant concern to you or others, for example increased sexual drive.*
• Excessive and uncontrollable shopping or spending*
• Uncontrolled 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 your appetite)*
• Mania (agitation, feeling of euphoria or over-excitement)*
• Delirium (reduced awareness, confusion, loss of sense of reality)*

Rare:

• Spontaneous penile erection

Not known:

• After stopping or reducing the dose of Pramipexole Teva, symptoms such as depression, apathy, anxiety, feeling of fatigue, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; they will explain how to manage or
reduce the symptoms.
For side effects marked with *, it is not possible to estimate the frequency precisely, as these side effects were not observed in clinical studies involving 1,395 patients treated with pramipexole. The frequency category is likely no greater than "uncommon".

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PRAMIPEXOLE 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 label of the pack, blister, or bottle after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep in the original packaging to protect the tablets from light and moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pramipexole Teva contains
The active substance is pramipexole.
Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg or 0.7 mg of pramipexole, corresponding to
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 carboxymethyl starch, povidone,
magnesium stearate, sodium stearyl fumarate, anhydrous colloidal silica.

Description of the appearance of Pramipexole Teva 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.
• Pramipexole Teva 0.18 mg tablets are white, round tablets, with a score line and marked with “P2” above and below the score on one side and “93” on the other side. The tablet can be divided into two equal parts.
• Pramipexole Teva 0.35 mg tablets are white, oval, biconvex tablets, engraved with “9” and a vertical score line and “3” on one side, and “8.023” on the other side. The tablet can be divided into two equal parts.
• Pramipexole Teva 0.7 mg tablets are white, round tablets with a score line, marked with “8024” above and below the score on one side and “93” on the other side. The tablet can be divided into two equal parts.
• Pramipexole Teva tablets are available in blister packs of 30, 30 × 1, 50 × 1, 100 × 1 and 100 tablets, and in bottles containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Teл.: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos,
Tél: +33 155917800 Lda.
Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.