► Aparxon PR (ropinirol) - Medycyna Praktyczna

Aparxon PR (ropinirole) - prolonged release tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Aparxon PR prolonged release tablets; 2 mg; 21 tabl. Teva Pharmaceuticals Polska b / d Check
Aparxon PR prolonged release tablets; 2 mg; 28 tabl. Teva Pharmaceuticals Polska 28.34 0.00
Aparxon PR prolonged release tablets; 4 mg; 28 tabl. Teva Pharmaceuticals Polska 54.35 0.00
Aparxon PR prolonged release tablets; 8 mg; 28 tabl. Teva Pharmaceuticals Polska 108.70 0.00

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:ropinirole

The drug is available on prescription

What is Aparxon PR?

A Dopamine rgic medicine suitable for Parkinson's disease.

What does Aparxon PR contain and how does it work?

The active substance is ropinirole, a drug activating dopamine D2 and D3 receptors, used to treat Parkinson's disease. Parkinson's disease belongs to neurodegenerative diseases and its symptoms are caused by degenerative changes of nerve cells that produce dopamine. Dopamine is an endogenous neurotransmitter with the ability to activate specific receptors called dopamine receptors. Disorders of dopaminergic transmission have been observed in the course of many neuropsychiatric disorders, and pharmacological modulation of dopamine receptor activity is used in their treatment. Ropinirol, by activating dopamine receptors, affects dopaminergic transmission and dopamine-dependent functions. By acting on the hypothalamus and pituitary gland, ropinirole inhibits prolactin secretion.

The prolonged-release tablets ensure that the therapeutic effect of the drug persists for over 24 hours. The maximum concentration of ropinirole in the blood is obtained after about 6 -10. hours after taking the preparation. Metabolism occurs in the liver to inactive derivatives. Metabolites are mainly excreted in the urine.

When should I use Aparxon PR?

The preparation is indicated for the treatment of Parkinson's disease:

• in initial treatment as monotherapy to delay the introduction of levodopa

• in combination with levodopa, when the effect of levodopa becomes insufficient or becomes variable and there is a fluctuation of the therapeutic effect ('end-of-dose' effect).

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used.You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients.

Contraindication is contraindicated in patients:

• with severe renal impairment (creatinine clearance less than 30 ml / min) who are not subjected to regular hemodialysis

• with hepatic impairment.

The preparation is not recommended in pregnant women.

It should not be used in women who are breast-feeding.

Take special care with Aparxon PR?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.

Drowsiness and sudden sleep seizures may occur during the use of the preparation. Sudden sleep may occur during the day, including unconscious and not preceded by any warning signs. Sudden falling asleep can lead to a fall. If these symptoms occur, please consult your doctor; Your doctor may consider reducing your dose or changing your treatment. One should remember about the possibility of sudden sleep attacks and be especially careful when performing activities requiring increased concentration. Patients who experience drowsiness or sudden sleep attacks must refrain from driving vehicles and operating equipment / machines.

Drugs activating dopamine receptors, including the preparation, should not be used in people with severe psychiatric or psychotic disorders unless the expected benefits clearly outweigh the possible risks in the physician's opinion.

The use of the preparation may be related to impulse control disorders (instabilities), which may lead to changes in behavior and manifest themselves, eg:

• addiction to gambling

• increasing libido

• hypersexuality (sexual hyperactivity)

• compulsive spending of money

• shopping compulsion

• compulsive or paroxysmal overeating.

In case of the above-mentioned symptoms, please consult your doctor; Your doctor may consider reducing your dose or changing your treatment.

Do not suddenly stop using the product. If treatment is planned to be terminated, the dose should be reduced gradually, as directed by the physician. Abrupt discontinuation of the preparation may cause symptoms of malignant neuroleptic syndrome.

The preparation is in the form of prolonged-release tablets, which ensures the therapeutic effect of the drug for over 24 hours. If an accelerated gastro-intestinal passage occurs, the drug can not be fully released and its residues excreted in the faeces.

Monitoring of blood pressure is recommended, especially in the initial period of application and with particular emphasis on patients with coronary insufficiency or other cardiovascular diseases. Use of the preparation (similar to other dopamine activating drugs) may result in hypotension.

Additional information about the other ingredients of the preparation:

• the product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of Glucose -galactose should not use this preparation.


Does this preparation affect the ability to drive vehicles?

People who experience sleepiness and / or sleep attacks must refrain from activities that require increased concentration, such as driving and operating equipment / machines.



Dosage of Aparxon PR

The preparation is in the form of prolonged-release tablets. It is intended for oral use. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.


The doctor will adjust the dose individually depending on the effectiveness and tolerance. Adjusting the dosage will help determine the lowest effective dose that should be used during the treatment period.

The prolonged-release tablets should be taken once a day, at the same time of the day. The tablets should be swallowed whole (they must not be crushed, chewed or divided because the tablet coating provides prolonged release). Can be taken with or without food.

Initially 2 mg 1 once a day, starting at 2.treatment week 4 mg once daily; if necessary, your doctor may recommend increasing the dose by 2 mg at intervals of at least 1 week, up to a dose of 8 mg once a day. If 8 mg once daily is not enough to achieve or maintain symptom control, your doctor may advise you to increase your dose by 2-4 mg at intervals of at least 2 weeks; the maximum dose is 24 mg per day.

If the preparation is discontinued daily or longer, it may be necessary to restart the dose adjustment period; you should follow the doctor's instructions.

During combination treatment your doctor may advise you to gradually reduce the dose of levodopa by around 30%.

In patients with advanced Parkinson's disease taking levodopa in parallel, dyskinesias (involuntary movements) may occur during the adjustment of the dose. If you get dyskinesia, reducing the dose of levodopa may ease dyskinesias.

If it is necessary to stop treatment, the dose should be reduced gradually, strictly according to the doctor's instructions. Do not suddenly stop using the product.

If the form of the immediate release tablet formulation is changed into prolonged-release tablets, the dose must be adjusted - the doctor's instructions should be strictly followed.

In people over the age of 65, the clearance of the drug is reduced by about 15%. Although dose adjustment is not required, your doctor will decide your dose individually depending on your clinical response to treatment. For people over 75, your doctor may recommend a slower dose increase when starting treatment.

No dose adjustment is required in patients with mild or moderate renal dysfunction (creatinine clearance 30-50 ml / min). In patients undergoing hemodialysis, initially 2 mg once daily, then the doctor will increase the dose depending on efficacy and tolerability; the maximum dose is 18 mg per day. No additional doses are required after hemodialysis.

Use of the preparation in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min) who are not subjected to regular hemodialysis is contraindicated.

Children and youth:

There is no data on the safety and efficacy of the preparation in children and adolescents up to 18 years of age and should not be used in this age group.

Can I use Aparxon PR during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!

It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.

It is not recommended for pregnant women unless the doctor considers it absolutely necessary and in his opinion the expected benefits clearly outweigh the possible risks. Only a doctor can assess the benefit / risk ratio in your case!

It should not be used in women who are breast-feeding.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.

The concomitant use of ropinirole and levodopa or domperyidone does not require dose adjustment of any of the above-mentioned medications.

The combination should be avoided in parallel with neuroleptics and other drugs blocking central dopamine receptors, such as Metoclopramide or sulpiride.

High doses of estrogen may increase the level of ropinirole in the blood. During the use of hormone replacement therapy (HRT), the preparation can be started (according to the usual dosing schedule). However, if ritinirole dosing is initiated or discontinued during the treatment period, dosage adjustment may be necessary.

Drugs that inhibit the activity of the cytochrome P450 1A2 isoenzyme, such as, eg, Ciprofloxacin , enoxacin or fluvoxamine, may increase the ropinirole level and therefore the dosage of ropinirole may need to be adjusted.

There were no significant interactions between ropinirole and theophylline.

Starting or stopping smoking during ropinirole may require dose adjustment of ropinirole.

Medicines from the group of vitamin K antagonists used in parallel with ropinirole may affect the prothrombin time (INR). INR should be monitored in this group of patients.

What side effects can occur?

Like all medicines, Aparxon PR can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.

Very common: nausea, drowsiness, fainting, dyskinesia (involuntary movements). Common or uncommon: dizziness, hypotension, including orthostatic, sudden sleep seizures, uncontrollable daytime sleepiness, gastrointestinal disorders (constipation, indigestion, vomiting, bloating, abdominal pain), hallucinations (visual, auditory, mixed) , psychotic disorders (delusions, delirium), peripheral edema. In addition, possible side effects for which the frequency of their occurrence has not been determined, including impulse control disorders (addiction to gambling, increased libido, hypersexuality (excessive sexual activity), compulsive shopping and spending, binge eating), aggression, increased liver enzymes , hypersensitivity reactions (urticaria, rash, pruritus, angioneurotic edema ). After the sudden discontinuation of the preparation, a neuroleptic malignant syndrome may occur.

Other preparations on the Polish market containing ropinirole

Adartrel (coated tablets)
ApoRopin (prolonged release tablets)
Aropilo (coated tablets)
Aropilo SR (prolonged release tablets)
Ceurolex SR (prolonged release tablets)
Nironovo SR (prolonged release tablets)
Polpix SR (prolonged release tablets)
Raponer (prolonged release tablets)
Repirol SR (prolonged release tablets)
Requip (coated tablets)
Requip-Modutab (prolonged release tablets)
Rolpryn SR (prolonged release tablets)
Ropodrin (prolonged release tablets)