Parkintreat is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. Parkintreat is used alone or in combination with another medication to treat the symptoms of Parkinson’s disease (a slowly progressing disease of the nervous system causing a fixed face without expression, tremor at rest, slowing of movements, walking with shuffling steps, stooped posture and muscle weakness).
|Name and composition of the product: Parkintreat 1 mg tablets. Each tablet contains: Rasagiline mesylate 1 .56 mg Eq. to 1 mg Rasagiline… Parkintreat prevents dopamine metabolism irreversibly, thus increasing levels of dopamine, the result being a symptomatic benefit in patients with Parkinson’s disease (PD). It has demonstrated clinical efficacy in both early monotherapy and in advanced Parkinson’s disease (PD) as an adjunct to levodopa.|
Before taking Parkintreat
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking rasagiline it is important that your doctor or pharmacist knows:
- If you are pregnant, trying for a baby or breastfeeding.
- If you have a problem with the way your liver works.
- If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
- If you have ever had an allergic reaction to a medicine.
Posology and method of administration
- Parkintreat is administered orally, at a dose of 1 mg once daily with or without levodopa. It may be taken with or without food.
- Elderly: No change in dose is required for elderly patients.
- Paediatric population: Parkintreat is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
- Patients with hepatic impairment: Rasagiline use in patients with severe hepatic impairment is contraindicated. Rasagiline use in patients with moderate hepatic impairment should be avoided. Caution should be used when initiating treatment with rasagiline in patients with mild hepatic impairment. In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped.
- Patients with renal impairment: No change in dose is required for renal Impairment.
Parkintreat is usually taken once a day with or without food. Take Parkintreat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rasagiline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
- Your doctor may start you on a low dose of Parkintreat and may increase your dose based upon your body’s response to this medication.
- Do not stop taking Parkintreat without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking Parkintreat, you may experience withdrawal symptoms such as a fever; muscle stiffness; unsteadiness, wobbliness, or lack of coordination; or changes in consciousness. Tell your doctor if you experience any of these symptoms when your dose of Parkintreat is decreased.
|The cause of Parkinson’s disease is still unknown but the symptoms of tremor, stiffness and slow movement are due to there being less of a chemical called dopamine in your brain. Parkintreat (Rasagiline) increases the amount of dopamine in the brain and so helps to relieve these symptoms. You may be prescribed Parkintreat on its own as a treatment for Parkinson’s disease. It is also used alongside other treatments which contain a medicine called levodopa. When a dose of levodopa starts to wear off, the symptoms of Parkinson’s disease can return. This is known as an ‘end-of-dose fluctuation’. Taking Parkintreat helps to prevent this problem.|
What side effects can Parkintreat cause?
Dizziness, drowsiness, joint pain, heartburn, nausea, dry mouth, weight loss, or stomach/abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking Parkintreat.
|Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.|
Tell your doctor right away if you have any serious side effects, including: fainting, loss of balance, mental/mood changes (such as confusion, depression, hallucinations), worsening muscle stiffness/twitching/uncontrollable movements, swollen ankles/legs, easy bleeding/bruising, unusual strong urges (such as increased gambling, increased sexual urges).
Some people taking Parkintreat have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with Parkintreat even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
Parkintreat may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take. Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
Parkintreat may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. Get medical help right away if any of these serious side effects occur: severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (such as double/blurred vision), sudden sensitivity to light (photophobia).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system to
- Egyptian Pharmacovigilance center email: firstname.lastname@example.org.
- or to Inspire Pharma email: email@example.com.
Packing and Storage
- Shelf life 3 Years.
- Keep out of the reach and sight of children. Keep in a dry place, at a temperature not exceeding 30°C.
- Carton box containing 1, 2 or 3 blisters, each of 10 tablets in carton box with insert leaflet.
- Manufactured by ATCO Pharma for Pharmaceutical industries (A. R. E) for Inspire Pharmaceutical Co. (IPC pharma).
|N04BD02||rasagiline||ANTI-PARKINSON DRUGS||DOPAMINERGIC AGENTS||Monoamine oxidase B inhibitors||IPC pharma||Inspire Pharmaceutical Co.|
Parkintreat – Information Leaflet
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