Pipexus 0.26 mg Prolonged-release Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

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

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

Talk to your doctor before taking Pipexus. 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 Pipexus.
• 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 Pipexus.
• 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).

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 Pipexus 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.

Pipexus prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested. Parts of tablets may occasionally be passed and seen in the stool (faeces) and may look like whole tablets. Inform your doctor if you find tablet pieces in your faeces.

Pipexus 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 Pipexus 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 Pipexus.

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 Pipexus may affect your ability to drive and operate machinery.

You should be cautious while drinking alcohol during treatment with Pipexus. Pipexus 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 or pharmacist for advice before taking this medicine. Your doctor will then discuss with you if you should continue to take Pipexus.

The effect of Pipexus on the unborn child is not known.

Therefore, do not take Pipexus if you are pregnant unless your doctor tells you to do so.

Pipexus should not be used during breast-feeding. Pipexus can reduce the production of breast milk. Also, it can pass into the breast milk and can reach your baby. If use of Pipexus is unavoidable, breast-feeding should be stopped. Ask your doctor or pharmacist for advice before taking any medicine.

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

Pipexus 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.

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 a dose of Pipexus, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.

Do not stop taking Pipexus 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 Pipexus 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 Pipexus 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.

Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, or 4.5 mg pramipexole dihydrochloride monohydrate, respectively

The other excipient(s) are hypromellose, calcium hydrogen phosphate, magnesium stearate and colloidal silica.

Pipexus 0.26 mg prolonged-release tablets: The round tablets of 9 mm diameter are white or nearly white, have a flat surface with bevelled edges and are marked with 026 on one side

Pipexus 0.52 mg prolonged-release tablets: The round tablets of 10 mm diameter are white or nearly white, biconvex and are marked with 052 on one side

Pipexus 1.05 mg prolonged-release tablets: The round tablets of 10 mm diameter are white or nearly white, biconvex, and are marked with 105 on one side

Pipexus 1.57 mg prolonged-release tablets: The round tablets of 10 mm diameter are white or nearly white, biconvex and are marked with 157 on one side

Pipexus 2.1 mg prolonged-release tablets: The round tablets of 10 mm diameter are white or nearly white, biconvex and are marked with 210 on one side

Pipexus 2.62 mg prolonged-release tablets: The round tablets of 10 mm diameter are white or nearly white, biconvex and are marked with 262 on one side

Pipexus 3.15 mg prolonged-release tablets: The round tablets of 11 mm diameter are white or nearly white, have a flat surface with bevelled edges and are marked with 315 on one side

Pipexus is available in packs containing 10, 30 and 100 prolonged-release tablets in aluminium blisters.

Not all pack sizes may be marketed.