Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sifrol

Document Subject

Generated Narrative: MedicinalProductDefinition mp00c9db2c528dacf2cdd39b041aea9315

identifier: http://ema.europa.eu/identifier/EU/1/97/050/001-002

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: SIFROL 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-00c9db2c528dacf2cdd39b041aea9315

identifier: http://ema.europa.eu/identifier/EU/1/97/050/001-002

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - sifrol

Attesters

What is in this leaflet:

1. What SIFROL is and what it is used for
2. What you need to know before you take SIFROL
3. How to take SIFROL
4. Possible side effects
5. How to store SIFROL
6. Contents of the pack and other information

SIFROL 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. SIFROL 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 SIFROL

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 SIFROL. 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 SIFROL.

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 SIFROL.

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).

Restless legs augmentation syndrome. If you experience that symptoms start earlier than usual in the evening (or even the afternoon), are more intense or involve larger parts of the affected limbs or involve other limbs. Your doctor may lower your dose or stop the treatment. 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 SIFROL 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 SIFROL is not recommended for use in children or adolescents under 18 years. Other medicines and SIFROL 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 SIFROL 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 SIFROL. 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 SIFROL may affect your ability to drive and operate machinery. SIFROL with food, drink and alcohol You should be cautious while drinking alcohol during treatment with SIFROL. SIFROL 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 SIFROL. The effect of SIFROL on the unborn child is not known. Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so. SIFROL should not be used during breast-feeding. SIFROL can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of SIFROL is unavoidable, breast-feeding should be stopped. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines SIFROL can cause hallucinations (seeing, hearing or feeling things that are not there). If affected, do not drive or use machines. SIFROL 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.

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 SIFROL 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 SIFROL 0.088 mg three times a day (equivalent to 0.264 mg daily): 1st week Number of tablets 1 tablet SIFROL 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 SIFROL 0.18 mg three times a day OR 2 tablets SIFROL 0.088 mg three times a day 1 tablet SIFROL 0.35 mg three times a day OR 2 tablets SIFROL 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 SIFROL 0.088 mg tablets a day is also possible. Lowest maintenance dose Highest maintenance dose Number of tablets 1 tablet SIFROL 0.088 mg three times a day 1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.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 SIFROL 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet SIFROL 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 SIFROL 0.088 mg once a day (equivalent to 0.088 mg daily): 1st week Number of tablets 1 tablet SIFROL 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 SIFROL 0.18 mg OR 2 tablets SIFROL 0.088 mg 1 tablet SIFROL 0.35 mg OR 2 tablets SIFROL 0.18 mg OR 4 tablets SIFROL 0.088 mg 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mg OR 3 tablets SIFROL 0.18 mg OR 6 tablets SIFROL 0.088 mg Total daily dose (mg) 0.0.0.The daily dose should not exceed 6 tablets SIFROL 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, SIFROL may not be a suitable treatment for you. If you take more SIFROL 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 SIFROL 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 SIFROL Do not stop taking SIFROL 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 SIFROL 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 SIFROL 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 SIFROL 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)

Symptoms that start earlier than usual, are more intense or involve other limbs (Restless legs augmentation syndrome). 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 SIFROL 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 after EXP. The expiry date refers to the last day of that month. Do not store above 30 C. Store in the original package to protect the tablets from light. 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 SIFROL 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, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate. What SIFROL looks like and contents of the pack SIFROL 0.088 mg tablets are white, of round shape, flat, and without scoring. SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, of oval shape, and flat. Tablets are scored on both sides and breakable in halves. SIFROL 0.7 mg tablets are white, of round shape, and flat. Tablets are scored on both sides and breakable in halves. All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg, respectively. All strengths of SIFROL are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets). Not all pack sizes may be marketed. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 55216 Ingelheim am Rhein Germany Rottendorf Pharma GmbH Ostenfelder Strasse 51 59320 Ennigerloh Germany Boehringer Ingelheim France 100-104 avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien SCS Boehringer Ingelheim Comm.V T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595 . -

: +359 2 958 79 Luxembourg/Luxemburg SCS Boehringer Ingelheim Comm.V T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel: +36 1 299 89 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13
Boehringer Ingelheim Ellas A.E. T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp.zo.o. Tel: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucure ti Tel: +40 21 302 28 Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102
Boehringer Ingelheim Ellas A.E. T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: