PRAMIPREXIN 0.7 mg. 30 tablets

SOPHARMA
PRAMIPREXIN 0.7 mg. 30 tablets
€ 17.00
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What Pramiprexin and what it is used
Pramiprexin contains the active substance pramipexole belonging to a group of drugs known as dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors causes nerve impulses in the brain, which helps to control body movements.

Pramiprexin be used for:
treat the symptoms of primary Parkinson's disease. It can be used alone or in combination with levodopa;
treatment of moderate to severe Restless Legs Syndrome.

2. What you need to know before taking Pramiprexin
Do not take Pramipreksin:
if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions
Tell your doctor if you have (had) or develop these medical conditions or symptoms:
impaired kidney function;
hallucinations (seeing, hearing or feeling things that are not real). Most hallucinations are visual;
dyskinesia (abnormal, involuntary movements of the limbs). If you have advanced Parkinson's disease and are also taking levodopa may develop dyskinesia during the increase the dose of Pramipreksin;
somnolence and episodes of sudden sleep onset;
behavioral changes (eg pathological gambling), increased libido (eg increased sexual desire), binge eating;
psychoses (for example like symptoms of schizophrenia);
visual disturbances. You should have regular eye examinations during treatment with Pramipreksin;
severe heart or vascular disease. Regularly monitor blood pressure, especially at the beginning of treatment. This is necessary to avoid orthostatic hypotension (a sharp decrease in blood pressure when standing up from a horizontal to a vertical position);
deterioration. You may experience that symptoms start earlier than usual, they are more intense and occur in other limbs.
Children and adolescents
Not recommended for use Pramiprexin in children and adolescents under 18 years.

Other medicines and Pramipreksin
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

You should avoid taking Pramiprexin together with antipsychotic drugs (to treat psychoses).
Be especially careful if you are taking the following medicines:
cimetidine (to treat excess stomach acid and stomach ulcers);
amantadine (used to treat Parkinson's disease).
If you are taking levodopa, it is recommended to reduce the dose of levodopa when starting treatment with Pramiprexin
Be especially careful if you are taking any medication with sedative effect (sedatives) or drink alcohol. In these cases Pramiprexin can affect your ability to drive and use machines.

Pramipreksin with food, drink and alcohol
Caution for use of alcohol during treatment with Pramipreksin.
Pramipreksin can be taken with or without food. The tablets should be swallowed with water.

Pregnancy, lactation and fertility
Ask your doctor or pharmacist before taking any medicine. Ask your doctor or pharmacist if you are pregnant, you think you may be pregnant or planning to become pregnant. Your doctor will discuss with you whether you should continue taking Pramipreksin.
The effect of Pramiprexin the newborn is not known. Therefore, do not take Pramipreksin if you are pregnant, unless in the opinion of the physician the benefit of treatment outweighs the possible risk to the infant.
Pramipreksin should not be used during breastfeeding. The medicine may decrease the amount of breast milk. Also, it can pass into breast milk and affect the baby. If necessary treatment Pramipreksin feeding should be discontinued.

Driving and using machines
Pramiprexin can cause hallucinations. In their appearance should not drive or operate machinery.
Treatment with Pramiprexin may appear somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. If these side effects should not drive or operate machinery. You should tell your doctor if this happens.

3. How to take Pramiprexin
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The tablet can be divided into equal halves.
Your doctor will advise the correct dosage.
Pramiprexin can be taken with or without food. The tablets should be swallowed with water.

Parkinson's disease
The daily dose is distributed to three separate doses evenly.
During the first week, the usual dose is 0,088 mg 3 times daily.
The dose is gradually increased every 5-7 days, as recommended by the physician to control the symptoms of the disease and reaching the maintenance dose.
During the second week, the usual dose is 0,18 mg 3 times per day (0.54 mg daily).
During the third week, the usual dose is 0,35 mg 3 times daily (1,1 mg per day).
The usual maintenance dose is 1,1 mg per day. It may be necessary to further increase your dose. If necessary, your doctor may increase the dose to a maximum of 3,3 mg pramipexole a day. It is also possible the maintenance dose to be lower - as 0.088 mg 3 times daily. Common lowest maintenance dose of pramipexole is 0,264 mg, while the highest is 3,3 mg.

Patients with kidney disease
If you have moderate or severe kidney disease, your doctor will prescribe a lower dose than recommended. In this case, it is taken only 1 or 2 times daily. If you have moderate kidney disease, the usual starting dose is 0,088 mg two times daily. In severe kidney disease, the usual starting dose is just 0,088 mg once daily.

Restless Legs Syndrome
The dose should be administered once (single dose) daily, preferably in the evening, 2-3 hours before bedtime. During the first week, the usual daily dose is 0,088 mg once. Every 4-7 days the dose may be increased as recommended by your doctor to control the symptoms of the disease and reaching the maintenance dose.
In the second week, the usual daily dose is 0,18 mg once.
During the third week, the usual daily dose is 0,35 mg once.
In the fourth week, the usual daily dose is 0,54 mg once.
The daily dose should not exceed 0,54 mg.
Upon discontinuation of the medicinal product for more than a few days resumption of therapy should be restarted at the lowest dose. Then again, it may increase the dose as you did the first time. Talk to your doctor about it.
Your doctor will review your treatment after 3 months to decide whether to continue treatment or not.

Patients with kidney disease
If you have severe renal impairment, treatment with Pramipreksin may be suitable for you.

Use in children and adolescents
Not recommended for use Pramiprexin in children and adolescents under 18 years.

If you take more dose Pramiprexin
If you accidentally take more than prescribed, you should immediately contact your doctor or go to the nearest emergency medical care to seek advice. In such cases may experience vomiting, restlessness, or any of the side effects that are described in section 4 (Possible side effects).

If you forget to take Pramiprexin
Do not worry. Just skip that dose completely and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Pramiprexin
Do not stop taking Pramiprexin without prior consultation 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 have Parkinson's disease, you should not stop treatment abruptly Pramiprexin. A sudden stop could cause you to develop a 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 (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, this medicine can cause side effects, although not everybody gets them.

Assessment of adverse reactions is based on the following categories of frequency:
very common - affecting more than 1 in 10 patients;
common - affecting less than 1 in 10 patients;
Uncommon - affects less than 1 in 100 patients;
rare - affecting fewer than 1 in 1000 patients;
very rare - affecting fewer than 1 in 10,000 patients;
Not known - from the available data can not be estimated.
In the treatment of patients with Parkinson's disease may experience the following side effects:
Very common: dyskinesia (abnormal, involuntary movements of the limbs), changes in sleep as insomnia or drowsiness, dizziness, nausea, hypotension (low blood pressure);
Common: hallucinations, confusion, fatigue, fluid retention, usually in the legs (peripheral edema), headache, abnormal dreams, constipation;
Uncommon: Paranoia (eg. Excessive fear for one's health), delusion, excessive daytime somnolence and sudden sleep onset episodes, hyperkinesia (increased movements and inability to retain at rest), weight increase, increased sexual desire, allergic reactions (eg. rash, itching, hypersensitivity reactions); Pathological gambling, especially when taking drug in high doses, hypersexuality, increased eating (binge eating, hiperfa-ogy).
In the treatment of Restless Legs Syndrome may experience the following side effects:
Very common: nausea (feeling sick);
Common: changes in sleep as insomnia or sleepiness, tiredness, headache, abnormal dreams, constipation, dizziness;
Uncommon: hallucinations, confusion, excessive daytime sleepiness and sudden onset of sleep, weight increase, increased sexual desire, hypotension (low blood pressure), fluid retention, usually in the legs (peripheral edema), allergic reactions (rash, pruritus hypersensitivity reactions);
Not known: Pathological gambling, especially when taking drug in high doses, hypersexuality, increased eating (binge eating, hyperphagia), dyskinesia (abnormal, involuntary movements of the limbs), hyperkinesia (increased movements and inability to stand still at rest), paranoia (eg. excessive fear for one's health), delusion.
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.

5. How to store Pramiprexin
Store in the original container, dry and dark place at a temperature below 30 ° C.
Keep out of reach of children.
Do not use Pramiprexin after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information
What Pramiprexin
Pramiprexin 0.18 mg
The active substance is: 0,18 mg pramipexole base, equivalent to 0,25 mg pramipexole dihydrochloride monohydrate per tablet.
The other ingredients are pregelatinised maize starch, mannitol; cellulose, microcrystalline; povidone, talc, magnesium stearate.

Pramiprexin 0.7 mg
The active substance is: 0.7 mg pramipexole base, equivalent to 1 mg pramipexole dihydrochloride monohydrate per tablet.
The other ingredients are pregelatinised maize starch, mannitol; cellulose, microcrystalline; povidone, talc, magnesium stearate.

Pramiprexin looks like and contents of the pack
Pramiprexin 0,18 mg - white, round tablet, marked on one side with 1 (one) scored the other side without defects with a diameter of 6 ± 0,1 mm and a thickness of the tablet 3 ± 0,2 mm.
10 tablets in a blister of aluminum / aluminum foil.
3 blisters in a cardboard box together with a leaflet.

Pramiprexin 0,7 mg - white, round tablet, marked on one side with 3 (three) scored the other side without defects with a diameter of 6 ± 0,1 mm and a thickness of the tablet 3 + 0,2 mm.
10 tablets in a blister of aluminum / aluminum foil.
3 blisters in a cardboard box together with a leaflet.
€ 17.00
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