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What is Pramipexole Sandoz and what it is used
Sandoz Pramipexole belongs to a group of medicines called dopamine agonists which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain, which helps to control the movements of the body.
Sandoz Pramipexole is used to:
treat the symptoms of primary Parkinson's disease. It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
2. Before you take Sandoz Pramipexole
Do NOT take Sandoz Pramipexole:
if you are allergic (hypersensitive) to pramipexole or any of the other ingredients of the tablets (see section 6. Further information).
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking Sandoz Pramipexole.
Take special care with Pramipexole Sandoz
Tell your doctor if you have (or have had) or develop any conditions or symptoms, especially these:
hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual;
Dyskinesia (eg. abnormal, uncontrolled movements of the limbs). If you suffer from advanced Parkinson's disease and are also taking levodopa, can appear dyskinesia when increasing the dose of Sandoz Pramipexole;
somnolence and episodes of sudden sleep onset;
changes in behavior (eg. pathological gambling, binge shopping), increased libido (eg. increased sexual desire), binge eating;
psychosis (eg. comparable with symptoms of schizophrenia);
visual impairment. Must undergo regular eye examinations during treatment with Pramipexole Sandoz;
severe disease of the heart or blood vessels. You should regularly check the values of blood pressure, especially at the beginning of treatment. This is to avoid postural hypotension (drop in blood pressure upon standing);
deterioration. Symptoms may start earlier than usual, be more intense and affect other limbs.
Tell your doctor if you or your family members / caregivers notice that develop tendency or urge to behave in a way that is not typical for you and you can not resist the impulse, desire or temptation to perform certain activities that can harm you or others. Such events are called disorders of impulse control and may include behaviors such as addiction to gambling, excessive eating and spending, unusually high sex drive, enhance sexual thoughts or feelings. You may need your doctor to adjust the dose or discontinue the treatment.
Children and adolescents
Sandoz Pramipexole is not recommended for children and adolescents under 18 years of age.
Other medicines and Sandoz Pramipexole
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 and supplements that you bought without a prescription.
You should avoid taking Pramipexole Sandoz together with antipsychotic medicines.
Note if you are taking the following medicines:
cimetidine (for treating increased acidity in the stomach 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 (used for syndrome acquired immune deficiency - AIDS disease of the immune system in humans);
cisplatin (to treat various types of cancer);
quinine (used to prevent painful nocturnal leg cramps and for the treatment of one type of malaria called falciparum malaria or malignant malaria);
procainamide (to treat irregular heart beat).
If you are taking levodopa recommended dose of levodopa to be reduced when you start treatment with Sandoz Pramipexole.
Note if you are taking sedatives (have a sedative effect) or if you drink alcohol. In these cases Pramipexole Sandoz can affect your ability to drive and use machines.
Taking Pramipexole Sandoz with food and drink
You must be careful when you drink alcohol during treatment with Sandoz Pramipexole. Sandoz Pramipexole may be taken with or without food.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Tell your doctor if you are pregnant, think you may be pregnant or intend to become pregnant. Then your doctor will discuss with you if you should continue taking Sandoz Pramipexole. The effect of Sandoz Pramipexole on the unborn child is not known. Therefore, do not take Sandoz Pramipexole if you are pregnant unless your doctor tells you to take it.
Sandoz Pramipexole should not be used during breastfeeding. Sandoz Pramipexole can reduce the production of milk. Also can pass into breast milk and can reach your baby. If the application of Sandoz Pramipexole is imperative that breast-feeding should be discontinued.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Sandoz Pramipexole may cause hallucinations (seeing, hearing or feeling things that are not there). If this happens to you, do not drive or operate machinery. Sandoz Pramipexole is associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. If you have these side effects should not drive or operate machinery. If this happens, you should inform your doctor.
3. How to take Sandoz Pramipexole
Always take Pramipexole Sandoz exactly as your doctor tells you. The doctor will tell you what the correct dose.
You can take Sandoz Pramipexole with or without food. Swallow the tablets with water.
The daily dose should be administered divided in three equal doses.
During the first week, the usual dose is 1 tablet Pramipexole Sandoz 0,088 mg three times daily (equivalent to 0,264 mg daily):
Number of tablets 1 tablet Sandoz Pramipexole 0.088 mg three times daily
Total daily dose (mg) 0,264
The dose will be increased every 5-7 days as directed by your doctor to achieve control of your symptoms (maintenance dose).
2 weeks 3 weeks
Number of tablets 1 tablet Sandoz Pramipexole 0.18 mg three times a day OR 2 tablets Sandoz Pramipexole 0,088 mg three times a day 1 tablet Pramipexole Sandoz 0,35 mg three times a day OR 2 tablets Pramipexole Sandoz 0,18 mg three times daily
Total daily dose (mg) 0,54 1,1
The usual maintenance dose is 1,1 mg per day. May be necessary, however, your dose to increase even more. If necessary, your doctor may increase your dose to a maximum of 3,3 mg Sandoz Pramipexole daily. It is also possible by a lower maintenance dose of three tablets Sandoz Pramipexole 0,088 mg daily.
Lowest maintenance dose Highest maintenance dose
Number of tablets 1 tablet Pramipexole Sandoz 0,088 mg three times a day 1 tablet Pramipexole Sandoz 1,1 mg three times daily
Total daily dose (mg) 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 Pramipexole Sandoz 0,088 mg twice daily. In severe kidney disease, the usual starting dose is just 1 tablet Pramipexole Sandoz 0,088 mg daily.
If you take more than the amount of Sandoz Pramipexole
If you accidentally take too many tablets:
immediately contact your doctor or the emergency room of the nearest hospital for advice;
may have vomiting, restlessness, or any of the side effects as described in section 4. Possible side effects.
If you forget to take Pramipexole Sandoz
Do not be nervous. Just skip the missed dose and then take your next dose at the usual time. Do not take a double dose to make up.
If you stop taking Sandoz Pramipexole
Do not stop taking Sandoz Pramipexole without first discussing it with your doctor. If you need 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 abruptly Sandoz Pramipexole. Abrupt discontinuation of treatment may lead to the development of a condition called neuroleptic malignant syndrome which may represent a major health risk.
These symptoms include:
akinesia (loss of muscle movement);
unstable blood pressure;
tachycardia (increased heart rate);
suppression of consciousness (eg. coma).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Sandoz Pramipexole may cause side effects, although not everybody gets them.
Assessment of adverse reactions is based on the following frequencies:
Very common: affects more than 1 user in 10;
Common: affects 1 to 10 users in 100;
Uncommon: affects 1 to 10 users in 1000;
Rare: affects 1 to 10 of 10,000 users;
Very rare: affects less than 1 in 10,000 users;
Not known: from the available data can not be estimated.
If you suffer from Parkinson's disease, where you may experience the following side effects:
dyskinesias (e. abnormal, involuntary movements of the limbs);
Urge to abnormal behavior;
hallucinations (seeing, hearing or feeling things that are not there);
retention of fluid, usually in the legs (peripheral edema);
hypotension (low blood pressure);
weight loss including decreased appetite.
Paranoia (eg excessive fear for their own well-being);
Excessive daytime sleepiness or sudden onset of sleep;
amnesia (memory disturbance);
hyperkinesias (increased movements and inability to keep still);
Increased sexual desire (eg increased libido);
allergic reactions (e. rash, pruritis, hypersensitivity);
Pathological gambling, especially when taking high doses of pramipexole;
heart failure (heart problems which can lead to shortness of breath or ankle swelling);
increased appetite (eating, hyperphagia) *;
excessive binge shopping;
dyspnea (difficulty breathing);
pneumonia (lung infection)
When adverse reactions marked with Asterix (*) can not establish the exact frequency, since they are not observed in clinical trials among 2,762 patients treated with pramipexole. If you need to categorize their frequency probably appropriate category would be "uncommon".
You may experience the following side effects:
Inability to resist the impulse, desire or temptation to perform actions that would be harmful to you or others, which may include:
Strong impulse gambling despite severe personal and family consequences;
Amended or increased sexual interest and behavior, which has significant consequences for you or others, such as increased sexual desire;
Uncontrollable shopping or spending money;
Overeating (ingestion of large amounts of food in a short period of time) or compulsive eating (receiving more food than usual hunger or satiety).
Tell your doctor if you experience any of these behaviors, they will discuss with you ways to overcome or reduce the symptoms.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Pramipexole Sandoz
Keep out of reach of children.
Do not use Pramipexole Sandoz after the expiry date stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month.
Alu-Alu blister and bottle HDPB:
This medicinal product does not require any special storage conditions.
Once opened, use within 3 months.
After first opening: do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Sandoz Pramipexole
The active ingredient pramipexole.
Pramipexole Sandoz 0,18 mg Tablets: Each tablet contains 0.18 mg pramipexole (such as 0,25 mg pramipexole dihydrochloride monohydrate). The tablets can be divided into two equal doses.
Pramipexole Sandoz 0,7 mg Tablets: Each tablet contains 0,7 mg of pramipexole (such as 1,0 mg pramipexole dihydrochloride monohydrate). The tablets can be divided into two equal doses.
The other ingredients are mannitol, microcrystalline cellulose, corn starch, silica, colloidal anhydrous, magnesium stearate.
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