Parkintreat

PARKINTREAT 1 mg tablets

WHAT PARKINTREAT IS AND WHAT IT IS USED FOR

  • PARKINTREAT is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease as initial monotherapy and as adjunct therapy to levodopa (another medicine that is used to treat Parkinson’s disease).
  • With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. PARKINTREAT helps to increase and sustain levels of dopamine in the brain.

HOW TO TAKE PARKINTREAT

Always take PARKINTREAT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

  • Monotherapy: PARKINTREAT 1 mg once daily
  • As adjunct to levodopa: PARKINTREAT 0.5 mg once daily. Dose increase to 1 mg daily as required for sufficient clinical response.
  • Patients with mild hepatic impairment: PARKINTREAT 0.5 mg once daily should not be exceeded. PARKINTREAT should not be used in patients with moderate or severe hepatic impairment.
  • Rasagiline has not been studied in patients with severe renal impairment. Patients taking ciprofloxacin or other CYP1A2 inhibitors: PARKINTREAT 0.5 mg once daily should not be exceeded.

If you take more PARKINTREAT than you should

If you think that you may have taken too many PARKINTREAT tablets, contact your doctor or pharmacist immediately. Take the PARKINTREAT carton with you to show the doctor or pharmacist.

If you forget to take PARKINTREAT

Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.

If you stop taking PARKINTREAT

Do not stop taking PARKINTREAT without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

BEFORE YOU TAKE PARKINTREAT

Do not take PARKINTREAT

if you are allergic (hypersensitive) to rasagiline or any of the other ingredients of PARKINTREAT.

if you have moderate or severe liver problems.

Do not take the following medicines while taking PARKINTREAT:

The use of PARKINTREAT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

monoamine oxidase (MAO) inhibitors (selective or non-selective) (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.

pethidine or meperidine ,tramadol, methadone ,propoxyphene , (strong pain killers).

dextromethorphan, or cyclobenzaprine

Take special care with PARKINTREAT

Coadministration with Antidepressants:

Severe CNS toxicity associated with hyperpyrexia has been reported with the combined treatment of an antidepressant. These adverse reactions are often described as “serotonin syndrome” which can result in death.

Ciprofloxacin and Other CYP1A2 Inhibitors:

patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should use 0.5 mg daily of PAKINTREAT

Hepatic Impairment:

Patients with mild hepatic impairment should be given the dose of 0.5 mg/day. PAKINTREAT should not be used in patients with moderate or severe hepatic impairment.

Risk for Hypertensive Crisis and other adverse reactions associate d with nonselective inhibition of MAO Above The Recommended Doses

Dietary tyramine

restriction is not ordinarily required with recommended doses of PAKINTREAT. However, certain foods ( e. g. , aged cheeses, such as Stilton cheese) may contain very high amounts ( i. e. , > 150 mg) of tyramine and could potentially cause a hypertensive “ cheese” reaction in patients taking PAKINTREAT even at the recommended dose due to mild increased sensitivity to tyramine. The selectivity for inhibiting MAO- B diminishes in a dose- related manner as the dose is progressively increased above the recommended daily dose.

Melanoma:Patients being treated with PAKINTREAT should be advised to have periodic skin examination that should be performed by appropriately qualified individuals (e.g., dermatologists).

Dyskinesia Due to Levodopa Treatment:

decreasing the dose of levodopa may ameliorate this side effect.

Lowering of Blood Pressure and Postural/Orthostatic Hypotension:

postural hypotension occurs most frequently in the first two months of rasagiline treatment and tends to decrease over time.

Elevation of Blood Pressure

Hallucinations / Psychotic-Like Behavior :

Patients should be cautioned of the possibility of developing hallucinations. Patients with a major psychotic disorder should ordinarily not be treated with PAKINTREAT because of the risk of exacerbating the psychosis.In addition, many treatments for psychosis that decrease in central dopaminergic tone may decrease the effectiveness of PAKINTREAT

Withdrawal-Emergent Hyperpyrexia and Confusion

A symptom complex resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in drugs that increase central dopaminergic tone.

Impulse Control/ Compulsive Behaviors:

Patient s should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking rasagiline. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking rasagiline

Taking other medicines

Please tell your doctor or pharmacy if you are taking or have recently taken any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.

Ask your doctor for advice before taking any of the following medicines together with PARKINTREAT:

Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants) The use of PARKINTREAT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with PARKINTREAT, you should wait at least 5 weeks after stopping fluoxetine treatment. If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping PARKINTREAT treatment.

  • monoamine oxidase (MAO) inhibitors (selective or non-selective) (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.
  • pethidine or meperidine ,tramadol, methadone ,propoxyphene , (strong pain killers).
  • You must wait at least 14 days after stopping PARKINTREAT treatment and starting treatment with MAO inhibitors or pethidine and other pain killers.
  • the antibiotic ciprofloxacin used against infections: PARKINTREAT 0.5 mg once daily should not be exceeded.
  • the cough suppressant dextromethorphan
  • sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine Levodopa/ Carbidopa: Dyskinesia .

Taking PARKINTREAT with food and drink

  • PARKINTREAT may be taken with or without food.
  • Special care when taking Foods containing high amount of tyramine.

Pregnancy and breast-feeding

  • There are no adequate and well-controlled studies of rasagiline in pregnant women. Therefore, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Rasagiline inhibits prolactin secretion and may inhibit milk secretion. It is not known whether rasagiline is excreted in human milk. Use with caution

HOW TO STORE PARKINTREAT

Keep out of the reach and sight of children. Keep at a temperature not exceeding 30 ͦ C

FURTHER INFORMATION

What PARKINTREAT contains

Each tablet contains:

  • The active substance: Rasagiline mesylate 1.56 mg Eq. to 1 mg Rasagiline.
  • The other ingredients are Mannitol, Pregelatinised Starch, Talc powder, Stearic acid.

What PARKINTREAT looks like and contents of the pack

  • 1, 2 or 3 AL/Al blisters, each of 10 tablets in carton box with insert leaflet.