Pramipexole 0.35mg tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before taking Pramipexole. 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.
• Abnormal, uncontrolled movements of the limbs (dyskinesia).
  If you have advanced Parkinson’s disease and are also taking levodopa, you might develop dyskinesia during the up-titration of Pramipexole.
• 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 sideways 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. comparable with symptoms of schizophrenia).
• Vision impairment. You should have regular eye examinations during treatment with Pramipexole.
• 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 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, 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 treatment. If the problems persist more than a few weeks, your doctor may need to adjust your treatment.

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

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 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 heartbeat).

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

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 may affect your ability to drive and operate machinery.

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

Pramipexole can be taken with or without food.

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.

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

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

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

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

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

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

1st week

Number of tablets: 1 tablet Pramipexole 0.088mg three times a day

Total daily dose (mg): 0.264

This will be increased every 5 - 7 days as directed by your doctor until your symptoms are controlled (maintenance dose).

2nd week

Number of tablets: 1 tablet Pramipexole 0.18mg three times a day OR 2 tablets Pramipexole 0.088mg three times a day

Total daily dose (mg): 0.54

3rd week

Number of tablets: 1 tablet Pramipexole 0.35mg three times a day OR 2 tablets Pramipexole 0.18mg three times a day

Total daily dose (mg): 1.1

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

Lowest maintenance dose

Number of tablets: 1 tablet Pramipexole 0.088mg three times a day.

Total daily dose (mg): 0.264

Highest maintenance dosering the first week, the usual dose is 1 tablet Pramipexole 0.088m

Number of tablets: 1 tablet Pramipexole 1.1mg three times a day.

Total daily dose (mg): 3.3

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 0.088mg twice a day. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole 0.088mg a day.

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 0.088mg once a day (equivalent to 0.088mg daily):

1st week

Number of tablets: 1 tablet Pramipexole 0.088mg

Total daily dose (mg): 0.088

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

2nd week

Number of tablets: 1 tablet Pramipexole 0.18mg OR 2 tablets Pramipexole 0.088mg

Total daily dose (mg): 0.18

3rd week

Number of tablets: 1 tablet Pramipexole 0.35mg OR 2 tablets Pramipexole 0.18mg OR 4 tablets Pramipexole 0.088mg

Total daily dose (mg): 0.35

4th week

Number of tablets: 1 tablet Pramipexole 0.35mg and 1 tablet Pramipexole 0.18mg OR 3 tablets Pramipexole 0.18mg OR 6 tablets Pramipexole 0.088mg

Total daily dose (mg): 0.54

The daily dose should not exceed 6 tablets Pramipexole 0.088mg or a dose of 0.54mg (0.75mg 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.

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

Parkinson's disease and Restless Legs Syndrome

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”.

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.

Do not stop taking Pramipexole 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 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:

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

If you stop or reduce Pramipexole 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.

Very common (may affect more than 1 in 10 people):

• Abnormal, uncontrolled movements of the limbs (dyskinesia)
• Sleepiness
• Dizziness
• Sickness (nausea)

Common (may affect up to 1 in 10 people):

• 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
• Low blood pressure (hypotension)
• Abnormal dreams
• Constipation
• Visual impairment
• Vomiting (being sick)
• Weight loss including decreased appetite

Uncommon (may affect up to 1 in 100 people):

• Excessive fear for one’s own well-being (paranoia)
• Delusion
• Excessive daytime sleepiness and suddenly falling asleep
• Memory disturbance (amnesia)
• Increased movements and inability to keep still (hyperkinesia)
• 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
• Difficulty with breathing (dyspnoea)
• Hiccups
• Infections of the lungs (pneumonia)
• 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 (may affect up to 1 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 Pramipexole 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; they 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’.

Very common (may affect more than 1 in 10 people):

• Nausea (sickness)
• Symptoms that start earlier than usual, are more intense or involve other limbs (Restless legs augmentation syndrome).

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• Pathological gambling, especially when taking high doses of Pramipexole*
• Hypersexuality*
• Compulsive shopping*
• Urge to behave in an unusual way*
• Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)*
• Inappropriate antidiuretic hormone secretion*
• Increased eating (binge eating, hyperphagia)*
• 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 (difficulty with breathing)
• Hiccups
• Pneumonia (infection of the lungs)*
• Mania (agitation, feeling elated or over-excited)*
• Delirium (decreased awareness, confusion, loss of reality)*

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

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

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”.

You may experience the 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).

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

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 Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is pramipexole.

For 0.088mg:

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

For 0.18mg:

Each Pramipexole 0.18mg tablet contains 0.18mg of pramipexole base (as 0.25mg of pramipexole dihydrochloride monohydrate).

For 0.35mg:

Each Pramipexole 0.35mg tablet contains 0.35mg of pramipexole base (as 0.5mg of pramipexole dihydrochloride monohydrate).

For 0.7mg:

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

• The other ingredients are starch, pregelatinised (starch maize 1500); mannitol; cellulose, microcrystalline; povidone (27.0-32.4); talc and magnesium stearate.

0.088mg White, round tablets, marked on one side with a ‘0’ (zero).

0.18mg White, round tablets, marked on one side with a ‘1’ (one), scored on the other side.

0.35mg White, round tablets, marked on one side with a ‘2’ (two), scored on the other side.

0.70mg White, round tablets, marked on one side with a ‘3’ (three), scored on the other side.

Pramipexole is available in aluminium/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.