Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - pramipexole

Document Subject

Generated Narrative: MedicinalProductDefinition mp261a55b4cd341177b15693bfb98631a1

identifier: http://ema.europa.eu/identifier/EU/1/08/490/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Pramipexole Teva 0.088 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-261a55b4cd341177b15693bfb98631a1

identifier: http://ema.europa.eu/identifier/EU/1/08/490/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - pramipexole

Attesters

What is in this leaflet

1. What Pramipexole Teva is and what it is used for
2. What you need to know before you take 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

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

Pramipexole Teva is used to:

• treat the symptoms of primary 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 primary Restless Legs Syndrome in adults.

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. Tell your doctor if you have (had) or develop any medical conditions or symptoms, especially any of the following:

• Kidney disease.

• Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.

• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson s disease and are also taking levodopa, you might develop dyskinesia during the up- titration of Pramipexole Teva.

• Dystonia (inability of keeping your body and neck straight and upright (axial dystonia)). In particular, you may experience forward flexion of the head and neck (also called antecollis), forward bending of the lower back (also called camptocormia) or sidewards bending of the back (also called pleurothotonus or Pisa Syndrome).

• Sleepiness and episodes of suddenly falling asleep.

• Psychosis (e.g. comparable with symptoms of schizophrenia).

• Vision impairment. You should have regular eye examinations during treatment with Pramipexole Teva.

• Severe heart or blood vessels disease. You will need to have your blood pressure checked regularly, especially at the beginning of treatment. This is to avoid postural hypotension (a fall in blood pressure on standing up).

• Augmentation. You may experience that symptoms start earlier than usual, be more intense and involve other limbs.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Tell your doctor if you or your family/carer notices that you are developing mania (agitation, feeling elated or over-excited) or delirium (decreased awareness, confusion or loss of reality). Your doctor may need to adjust or stop your dose.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Pramipexole Teva treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

Tell your doctor if you are developing an inability of keeping your body and neck straight and upright (axial dystonia). If this happens, your doctor may want to adjust or change your medication.

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

Other medicines and Pramipexole Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.

You should avoid taking Pramipexole Teva together with antipsychotic medicines.

Take care if you are taking the following medicines:

• cimetidine (to treat excess stomach acid and stomach ulcers)
• amantadine (which can be used to treat Parkinson s disease)
• mexiletine (to treat irregular heartbeats, a condition known as ventricular arrhythmia)
• zidovudine (which can be used to treat the acquired immune deficiency syndrome (AIDS), a disease of the human immune system)
• cisplatin (to treat various types of cancers)
• quinine (which can be used for the prevention of painful night-time leg cramps and for the treatment of a type of malaria known as falciparum malaria (malignant malaria))
• procainamide (to treat irregular heart beat).

If you are taking levodopa, the dose of levodopa is recommended to be reduced when you start treatment with Pramipexole Teva.

Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol. In these cases Pramipexole Teva may affect your ability to drive and operate machinery.

Pramipexole Teva with food, drink and alcohol You should be cautious while drinking alcohol during treatment with Pramipexole Teva. Pramipexole Teva can be taken 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 then discuss with you if you should continue to take Pramipexole Teva.

The effect of Pramipexole Teva on the unborn child is not known. Therefore, do not take Pramipexole Teva if you are pregnant unless your doctor tells you to do so.

Pramipexole Teva should not be used during breast-feeding. Pramipexole Teva can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of Pramipexole Teva is unavoidable, breast-feeding should be stopped.

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

Driving and using machines Pramipexole Teva can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines.

Pramipexole Teva has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson s disease. If you experience these side effects, you must not drive or operate machinery. You should tell your doctor if this occurs.

Pramipexole Teva contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The doctor will advise you on the right dosing.

You can take Pramipexole Teva with or without food. Swallow the tablets with water.

Parkinson s disease The daily dose is to be taken divided into 3 equal doses.

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

1st week Number of tablets 1 tablet Pramipexole Teva 0.088 mg three times a day Total daily dose (mg) 0.This will be increased every 5-7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

2nd week 3rd week Number of tablets 1 tablet Pramipexole Teva 0.18 mg three times a day OR 2 tablets Pramipexole Teva 0.088 mg three times a day 1 tablet Pramipexole Teva 0.35 mg three times a day OR 2 tablets Pramipexole Teva 0.18 mg three times a day

Total daily dose (mg) 0.1.1

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

Lowest maintenance dose Highest maintenance dose Number of tablets 1 tablet Pramipexole Teva 0.088 mg three times a day 1 tablet Pramipexole Teva 0.7 mg and 1 tablet Pramipexole Teva 0.35 mg three times a day Total daily dose (mg) 0.3.Patients with kidney disease If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will have to take the tablets only once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet Pramipexole Teva 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole Teva 0.088 mg a 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 Pramipexole Teva 0.088 mg once a day (equivalent to 0.088 mg daily):

1st week Number of tablets 1 tablet Pramipexole Teva 0.088 mg Total daily dose (mg) 0.This 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 Pramipexole Teva 0.18 mg OR 2 tablets Pramipexole Teva 0.088 mg 1 tablet Pramipexole Teva 0.35 mg OR 2 tablets Pramipexole Teva 0.18 mg OR 4 tablets Pramipexole Teva 0.088 mg 1 tablet Pramipexole Teva 0.35 mg and 1 tablet Pramipexole Teva 0.18 mg OR 3 tablets Pramipexole Teva 0.18 mg OR 6 tablets Pramipexole Teva 0.088 mg Total daily dose (mg) 0.0.0.The daily dose should not exceed 6 tablets Pramipexole Teva 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).

If you stop taking your tablets for more than a few days and want to restart the treatment, you must start again at the lowest dose. You can then build up the dose again, as you did the first time. Ask your doctor for advice.

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

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

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

• Contact your doctor or nearest hospital casualty department immediately for advice.
• You may experience vomiting, restlessness, or any of the side effects as described in section 4. Possible side effects .

If you forget to take Pramipexole Teva
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not try to make up for the missed dose.

If you stop taking Pramipexole Teva Do not stop taking Pramipexole Teva without first talking to your doctor. If you have to stop taking this medicine, your doctor will reduce the dose gradually. This reduces the risk of worsening symptoms.

If you suffer from Parkinson s disease you should not stop treatment with Pramipexole Teva abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include:

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

If you stop or reduce Pramipexole Teva you may also develop 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 physician.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Evaluation of these side 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 Not known Frequency cannot be estimated from the available data

If you suffer from Parkinson s disease, you may experience the following side effects:

Very common:

• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
• Sleepiness
• Dizziness
• Nausea (sickness)

Common:

• Urge to behave in an unusual way
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Tiredness (fatigue)
• Sleeplessness (insomnia)
• Excess of fluid, usually in the legs (peripheral oedema)
• Headache
• Hypotension (low blood pressure)
• Abnormal dreams
• Constipation
• Visual impairment
• Vomiting (being sick)
• Weight loss including decreased appetite

Uncommon:

• Paranoia (e.g. excessive fear for one s own well-being)
• Delusion
• Excessive daytime sleepiness and suddenly falling asleep
• Amnesia (memory disturbance)
• Hyperkinesia (increased movements and inability to keep still)
• Weight increase
• Allergic reactions (e.g. rash, itching, hypersensitivity)
• Fainting
• Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Restlessness
• Dyspnoea (difficulties to breathe)
• Hiccups
• Pneumonia (infection of the lungs)
• Inability to resist the impulse, drive or temptation to perform an action that could 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 behaviour of significant concern to you or to others, for example, an increased sexual drive. Uncontrollable excessive shopping or spending Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
• Delirium (decreased awareness, confusion, loss of reality)

Rare:

• Mania (agitation, feeling elated or over-excited)

Not known:

• After stopping or reducing your Pramipexole Teva treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole. The frequency category is probably not greater than uncommon .

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

Very common:

• Nausea (sickness)

Common:

• Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness
• Tiredness (fatigue)
• Headache
• Abnormal dreams
• Constipation
• Dizziness
• Vomiting (being sick)

Uncommon:

• Urge to behave in an unusual way*
• Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
• Hyperkinesia (increased movements and inability to keep still)*
• Paranoia (e.g. excessive fear for one s own well-being)*
• Delusion*
• Amnesia (memory disturbance)*
• Hallucinations (seeing, hearing or feeling things that are not there)
• Confusion
• Excessive daytime sleepiness and suddenly falling asleep
• Weight increase
• Hypotension (low blood pressure)
• Excess of fluid, usually in the legs (peripheral oedema)
• Allergic reactions (e.g. rash, itching, hypersensitivity)
• Fainting
• Restlessness
• Visual impairment
• Weight loss including decreased appetite
• Dyspnoea (difficulties to breathe)
• Hiccups
• Pneumonia (infection of the lungs)*
• Inability to resist the impulse, drive or temptation to perform an action that could 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 behaviour of significant concern to you or to others, for example, an increased sexual drive.* Uncontrollable excessive shopping or spending* Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)*
• Mania (agitation, feeling elated or over-excited)*
• Delirium (decreased awareness, confusion, loss of reality)*

Not known:

• After stopping or reducing your Pramipexole Teva treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.

For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole. The frequency category is probably not greater than uncommon .

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

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 bottle label after EXP. The expiry date refers to the last day of that month.

Do not store above 25 C. Store in the original package in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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 pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively.

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

What Pramipexole Teva looks like and contents of the pack

• Pramipexole Teva 0.088 mg tablets are white, round tablets, embossed with "93" on one side and "P1" on the other side.
• Pramipexole Teva 0.18 mg tablets are white round, scored tablets embossed with "P2" over "P2" on the scored side 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, engraved with 9 vertical scoreline 3 on the scored side, 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 embossed with "8024" over "8024" on the scored side and "93" on the other side. The tablet can be divided into equal halves.
• Pramipexole Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1 and tablets and bottles containing 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Teva B.V. Swensweg 5, 2031GA Haarlem The Netherlands

Manufacturer TEVA Pharmaceutical Works Private Limited Company
Pallagi t 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. 747 70 Opava-Komarov Czech Republic

Merckle GmbH
Ludwig-Merckle-Stra e 3 89143 Blaubeuren Germany

Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600,
Bulgaria

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg
ratiopharm GmbH Allemagne/Deutschland T l/Tel: +49 73140 esk republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007Magyarorsz g
Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark
Teva Denmark A/S
Tlf: +45 44985Malta
Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland
Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar . . . . : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar . . . .

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija
UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: