GLEPARK 0.35 MG TABLETS - patient leaflet, side effects, dosage

1. WHATGLEPARKIS ANDWHATITISUSEDFOR

GLEPARK 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 bodymovements.

GLEPARK is usedto:

• – treat the symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicineforPar­kinson'sdisea­se).

• – treat the symptoms of moderate to severe primary Restless Legs Syndrome(RLS) inadults.

• 2. WHATYOUNEED­TOKNOWBEFOREY­OUTAKEGLEPARK

DO NOTtake GLEPARK

• – if you are allergic to pramipexole or to any of the other ingredients ofthismedicine(lis­ted insection6).

Warningsandpre­cautions

Talktoyourdoc­torbeforetakin­gGLEPARK.

Tell your doctor if you have (had) or develop any medical conditions orsymptoms, especiallyany­ofthefollowin­g:

• – Kidneydisease.

• – Hallucinations (seeing, hearing or feeling things that are not there). Mosthallucina­tionsarevisual.

• – Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) – If you have advanced Parkinson's disease and are also taking levodopa, you might develop dyskinesias during the uptitration of GLEPARK.

• – 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). If this happens, your doctor may want to change your medication Sleepiness and episodes of suddenly falling asleep

• – Psychosis, (e.g. comparablewit­hsymptomsofschi­zophrenia)

• – Vision impairment. You should have regular eye examinations duringtreatmen­twithGLEPARK

• – 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 pressureonstan­dingup).

• – Augmentation. You may experience that symptoms start earlier than usual, bemoreintenseand involveotherlimbs.

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 orfeelings. Yourdoctor may need to adjustorstop yourdose.

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). Yourdoctormay need to adjust orstop yourdose.

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

Childrenandado­lescents

GLEPARK is not recommended for use in children or adolescents under18years.

Othermedicinesand GLEPARK

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 GLEPARK 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 ventriculararrhyt­hmia).

• – 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(whichcan be used for the prevention of painful night-time leg cramps and for the treatment ofa type of malaria known as falciparummala­ria(malignantma­laria));

• – procainamide(to­treatirregular­heartbeat).

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

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 GLEPARKmayaffec­tyourabilityto­driveandopera­temachinery.

GLEPARKwithfood, drinkandalcohol

You should be cautious while drinking alcohol during treatment with GLEPARK.

GLEPARK can be taken with or without food.

Pregnancyand 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 continuetotakeG­LEPARK.

The effect of GLEPARK on the unborn child is not known. Therefore, do not take GLEPARK if you are pregnant unless your doctor tells you todoso.

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

Ask your doctor or pharmacist for advice beforetakinga­nymedicine.

Drivingand using machines

GLEPARK can cause hallucinations (seeing, hearing or feeling thingsthatare­notthere). If affected, do not drive or use machines.

GLEPARK 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.

3. HOWTOTAKEGLEPARK

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 onthe rightdosing.

You can take GLEPARK with or without food. Swallow the tablets withwater.

Parkinson'sdisease

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

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

	1st week
Number of tablets	1 tablet GLEPARK 0.088 mg three times a day
Total daily dose (mg)	0.264

Thiswill 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 GLEPARK 0.18 mg three times a day OR 2 tablets GLEPARK 0.088 mg three times a day	1 tablet GLEPARK 0.35 mg three times a day OR 2 tablets GLEPARK 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 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 GLEPARK 0.088 mg tablets a day is also possible.

	Lowest maintenance dose	Highest maintenance dose
Number of tablets	1 tablet GLEPARK 0.088 mg three times a day	1 tablet Pramipexole 1.1 mg three times a day
Total daily dose	0.264	3.3

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 GLEPARK 0.088 mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet GLEPARK0.088mgaday.

Restless LegsSyndrome

The dose is usually taken once a day, in the evening, 2–3 hours beforebedtime.

During the first week, the usual dose is 1 tablet GLEPARK 0.088 mg once a day (equivalent to 0.088 mg daily):

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

Thiswill 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 GLEPARK 0.18 mg OR 2 tablets GLEPARK 0.088 mg	1 tablet GLEPARK 0.35 mg OR 2 tablets GLEPARK 0.18 mg OR 4 tablets GLEPARK 0.088 mg	1 tablet GLEPARK 0.35 mg and 1 tablet GLEPARK 0.18 mg OR 3 tablets GLEPARK 0.18 mg OR 6 tablets GLEPARK 0.088 mg
Total daily dose (mg)	0.18	0.35	0.54

The daily dose should not exceed 6 tablets GLEPARK 0.088 mg ora doseof0.54mg(0­.75mgpramipexo­lesalt).

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 doctorforadvice.

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, GLEPARK may notbea suitable treatmentforyou.

If you take more GLEPARK than you should

Ifyouaccidenta­llytaketoomany­tablets

• – Contact your doctor or nearest hospital casualty department immediatelyfo­radvice.

• – You may experience vomiting, restlessness, or any of the side effects as described in section 4 “Possible side effects”.

Ifyouforgetto­takeGLEPARK

Do not worry. Simply leave out that dose completely and then take yournextdoseatthe righttime.

Do not try to make up for the missed dose.

Ifyoustoptakin­gGLEPARK

Do not stop taking GLEPARK without first talking to your doctor. Ifyou 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 GLEPARK abruptly. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which mayrepresenta­majorhealth risk. Thesymptomsinclude:

• – akinesia (loss of muscle movement)

• – rigidmuscles

• – fever

• – unstableblood­pressure

• – tachycardia(in­creased heartrate)

• – confusion

• – depressed level of consciousness (e.g. coma)

If you stop or reduce GLEPARK you may also develop a medical conditioncalled­dopamineagonis­twithdrawalsyn­drome.

The symptoms include depression, apathy, anxiety, fatigue, sweating or pain. If you experience these symptoms you should contactyourphy­sician.

If you have any further questions on the use of this medicine, ask yourdoctororphar­macist.

4. POSSIBLESIDEEFFECTS

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:

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

Verycommon: (may affect morethanlinlO people)

• – Dyskinesia(e.g. abnormal, uncontrolledmo­vementsofthelim­bs)

• – Sleepiness

• – Dizziness

• – Nausea(sickness)

Common: (mayaffectupto1 in 10 people)

• – Urgetobehavei­nanunusualway

• – Hallucinations (seeing, hearingorfeelin­gthingsthatare­notthere)

• – Confusion

• – Tiredness (fatigue)

• – Sleeplessness(in­somnia)

• – Excessoffluid, usually in the legs (peripheral oedema)

• – Headache

• – Hypotension(Low­bloodpressure)

• – Abnormaldreams

• – Constipation

• – Visual impairment

• – Vomiting(beingsick)

• – Weightloss includingdecre­asedappetite

Uncommon: (mayaffectupto1in100 people)

• – Paranoia(e.g.ex­cessivefearfo­rone'sownwell-being)

• – Delusion

• – Excessive daytime sleepiness and suddenly falling asleep

• – Amnesia (memorydisturbance)

• – Hyperkinesia (increased movements and inabilitytoke­epstill)

• – Weight increase

• – Allergic reactions (e.g. rash, itching, hypersensitivity)

• – Fainting

• – Dyspnoea (difficultiesto breathe)

• – Pneumonia(infec­tionoflungs)

• – Cardiac failure (heart problems which can cause shortness of breathorankles­welling)

• – Inappropriate­antidiuretichor­monesecretion

• – Restlessness

• – Hiccups

• – Inability to resist the impulse, drive or temptation to perform an actionthatcou­ldbeharmfulto­youorothers, whichmayinclude:

• – Strong impulse to gamble excessively despite serious personal or familyconsequences.

• – 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 isneededtosatis­fyyourhunger).

• – Delirium (decreasedawa­reness, confusion, lossofreality)

Rare: (mayaffectupto1 in 1,000 people)

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

Not Known: (frequency cannot be estimated from the available data)

After stopping or reducing your GLEPARK 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; hewill 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:

Verycommon: (mayaffectmoret­han1in10people)

• – Nausea (sickness)

Common: (mayaffectupto1in10pe­ople)

• – Changes in sleep pattern, such as sleeplessness (insomnia) and sleepiness

• – Tiredness (fatigue)

• – Headache

• – Abnormaldreams

• – Constipation

• – Dizziness

• – Vomiting(beingsick)

Uncommon(mayaf­fectupto1 in 100 people)

• – Urgetobehavei­nanunusualway

• – Cardiac failure (heart problems which can casus shortness of breathorankles­welling)

• – Inappropriate­antidiuretichor­monesecretion

• – Dyskinesia (e.g. abnormal, uncontrolled movementsofthe­limbs)

• – Hyperkinesia (increased movements and inability to keep still)* – Paranoia(e.g. excessivefear­forone'sownwe­ll-being)

• – Delusion

• – Amnesia (memorydistur­bance)

• – Hallucination­s(seeing, hearingorfeelin­gthingsthatare­notthere)

• – Confusion

• – Excessive daytime sleepiness and suddenly falling asleep

• – Weightincrease

• – Hypotension(low­bloodpressure)

• – Excess of fluid, usually in the legs (peripheral oedema)

• – Allergicreacti­ons(e.g. rash, itching, hypersensitivity)

• – Fainting

• – Restlessness

• – Visual impairment

• – Weightlossinclu­dingdecreasedap­petite

• – Dyspnoea (difficulties tobreathe)

• – Hiccups

• – Pneumonia(infec­tionofthelungs)

• – Inability to resist the impulse, drive or temptation to perform an actionthatcou­ldbeharmfulto­youorothers, whichmayinclude:

• – Strong impulse to gamble excessively despite serious personal or family consequesces.

• – Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.

• – Uncontrollable­excessiveshop­pingorspendin­g.

• – Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than isneeded tosatisfyyourhun­ger).

• – Mania(agitation, feelingelatedorover-excited).

• – Delirium(decre­asedawareness, confusion, lossofreality).

Not Known: (frequency cannot be estimated from the available data)

• – After stopping or reducing your GLEPARK treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (calleddopami­neagonistwithdra­walsyndromeor­DAWS).

Tell your doctor if you experience any of these behaviors, hewill discusswaysof­managingorredu­cingthesymptom­s.

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 frequencycate­goryisprobably­notgreaterthan “uncommon”.

Reportingofsi­deeffects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. You can also report side effects directly via the Yellow Card Scheme website or search forMHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can helpprovidemo­reinformationon thesafetyofthis­medicine.

5. HOWTOSTOREGLEPARK

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 cartonand blister after <EXP>.

The expiry date refers to the last day of that month.

Store in the original package to protect the tablets from light. This medicinal product does not require any special temperature storageconditions.

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.

• 6. CONTENTSOF­THEPACK ANDOTHERINFOR­MATION

What GLEPARKcontains

Theactivesubstan­ceis pramipexole.

Each 0.088mg tablet contains 0.088mg of pramipexole base (as 0.125mg of pramipexole dihydrochloride monohydrate)

Each 0.18mg tablet contains 0.18mg of pramipexole base (as

0.25mgofprami­pexoledihydrochlo­ridemonohydra­te

Each 0.35 mg tablet contains 0.35mg of pramipexole base (as 0.5mg ofpramipexole­dihydrochlori­demonohydrate)

Each 0.7mg tablet contains 0.7mg of pramipexole base (as 1.0mg of pramipexole dihydrochloride monohydrate)

Theotheringre­dientsare:

mannitol (E 421); maize starch; povidone K 30 (E 1201); silica, colloidal anhydrous; magnesiumstea­rate(E470b)

What GLEPARK looks like and contents of the pack

0.088mg tablets: circular, white, flat bevelled tablets engraved with 'PX” ononesideandpla­inontheothersi­de

0.18mg tablets: oval, white, flat bevelled uncoated tablets engraved with ‚PX‘ and ‚1‘ on either side of score line on one side and score lineon the other side. Thetabletcanbe­dividedintoequ­alhalves.

0.35mg tablets: oval white, flat bevelled uncoated tablets engraved with'PX'and'2'on either side of score line on one side and score line onotherside. The tablet can be divided into equal halves.

0.7mg tablets: oval, white, flat bevelled uncoated tablets engraved with ‚PX‘ and ‚3‘ on either side of score line on one side and score lineonotherside. The tablet can be divided into equal halves.

GLEPARK 0.088mg, 0.18mg, 0.35mg, 0.7mg tablets are available in aluminium/alu­miniumblister­sof30, 100tablets

Not all pack sizes may be marketed

Marketing Authorisation­HolderandManu­facturer

Glenmark Pharmaceuticals Europe Ltd,

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow,

Middlesex, HA30BU. UnitedKingdom

Manufacturer

Glenmark Pharmaceuticals s.r.o.,

Hvezdova 1716/2b,14078 P­raha4, Czech Republic

Glenmark Pharmaceuticals Europe Limited,

Building 2, Croxley Green Business Park,

CroxleyGreen, Hertfordshire, WD188YA,

UnitedKingdom

PL25258/0004–7

This medicinal product is authorised in the Member States of the EEA underthefollo­wingnames:

Czech Republic, Denmark, Germany, Greece, Romania, Slovak Republic, TheNetherlands, UK: Glepark

This leaflet was last revised in May 2020

180 mm