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Peximyr 0.18 mg. 30 tablets

€19

Peximyr belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain, which helps control body movements.

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What is Peximir and what is it used for?

Peximir belongs to a group of medicines called dopamine agonists, which stimulate dopamine receptors in the brain. Stimulation of dopamine receptors triggers nerve impulses in the brain, which helps control body movements.

Peximir is used for:

Treatment of symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).

Treatment of moderate to severe restless legs syndrome.

2. What you need to know before you take Peximir?

Do not take Peximir if you are allergic (hypersensitive) to pramipexole or any of the other ingredients of this medicine (see section 6).

Warnings and precautions

Talk to your doctor before taking Peximir.

Tell your doctor if you have (or have had) any medical condition or symptoms, especially the following:

Kidney disease

Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual.

Dyskinesia (unusual, involuntary movements of the limbs). If you suffer from advanced Parkinson's disease and are also taking levodopa, dyskinesias may occur when increasing the dose of Peximir.

Drowsiness and episodes of sudden sleep onset.

Psychosis (eg symptoms similar to schizophrenia).

Visual disturbances. You should have regular eye examinations during treatment with Peximir.

Severe heart or vascular disease. You should check your blood pressure regularly, especially at the beginning of treatment, to avoid postural hypotension (drop in blood pressure when standing up from a horizontal to a vertical position).

Deterioration. Symptoms may start earlier than usual, be more intense and affect other limbs.

Excessive use and overwhelming need to take the product.

Tell your doctor if you or a member of your family / carers notice that you develop a tendency or an indefinite desire to behave in a way that is not typical of you and you cannot resist the urge to perform certain activities that may to harm you or others. Such manifestations are called impulse control disorders and may include, such as gambling addiction, overeating and spending, unusually increased desire for sex. Your doctor may need to adjust the dose or stop treatment.

Tell your doctor if you or your family / carer notice that you develop mania (anxiety, excitement or excitement) or delirium (weakening of the instinct for self-preservation, confusion, loss of sense of reality).

Your doctor may need to adjust the dose or stop treatment.

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your intake of Peximir. If the problem persists for more than a few weeks, your doctor may need to change your treatment.

Children and adolescents

Peximir is not recommended for children and adolescents under 18 years of age.

Other drugs and Peximir

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

This includes medicines, herbal preparations, healthy foods and supplements that you have bought without a prescription.

You should avoid taking Peximir with antipsychotic medicines.

Be careful if you are taking the following medicines:

Cimetidine (used to treat high stomach acidity and stomach ulcers); Amantadine (which can be used to treat Parkinson's disease);

Mexiletine (for irregular heartbeat, a condition known as ventricular arrhythmia);

Zidovudine (used in HIV / AIDS);

Cisplatin (used to treat various types of cancer);

Quinine (used to prevent painful nocturnal leg cramps and to treat malaria);

Procainamide (used to treat irregular heartbeat).

If you are taking levodopa, it is recommended that the dose of levodopa be reduced when you start treatment with Peximir. Be careful if you are taking sedatives (have a sedative effect) or if you drink alcohol. In these cases, Peximir may affect your ability to drive and use machines.

Peximir with food, drinks and alcohol

Special care should be taken when drinking alcohol during treatment with Peximir. Peximir can be taken with or without food.

Pregnancy, lactation and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will discuss with you whether you should continue to take Peximir.

The effect of Peximir on the unborn child is unknown. Therefore, do not take Peximir if you are pregnant unless your doctor tells you to.

The usual maintenance dose is 1.1 mg daily. However, your dose may need to be increased even more. If necessary, your doctor may increase your dose to a maximum of 3.3 mg Peximir per day. A lower maintenance dose of 3 Peximir 0.088 mg daily tablets is also possible.

Lowest maintenance dose Lowest maintenance dose Highest maintenance dose

Number of tablets 1 tablet Peximir 0.088 mg three times a day 1 tablet Peximir 1.1 mg three times a day

Total daily dose (mg) 0.264 3.3

Patients with renal impairment

If you have moderate or severe kidney disease, your doctor will prescribe a lower dose. In this case, you will only need to take the tablets once or twice a day. If you have moderate kidney disease, the usual starting dose is 1 tablet of Peximir 0.088 mg twice a day. In severe kidney disease, the usual starting dose is only 1 tablet of Peximir 0.088 mg per day.

Restless legs syndrome

The dose is taken once (once) daily - in the evening, 2-3 hours before bedtime.

The usual daily dose for the first week is 1 tablet of Peximir 0.088 mg once a day (equivalent to 0.088 mg a day):

1st week

Number of tablets 1 tablet Peximir 0.088 mg times

Total daily dose (mg) 0.088

The dose will be increased every 4-7 days, as recommended by your doctor, until your symptoms are controlled (maintenance dose).

Week 2 Week 3 Week 4

Number of tablets

1 tablet Peximir 0.18 mg

OR 2 tablets of Peximir

0.088 mg

1 tablet Peximir 0.35 mg OR 2 tablets

Peximir 0.18 mg

OR 4 tablets Peximir 0.088 mg

1 tablet Peximir 0.35 mg

and 1 tablet Peximir 0.18 mg OR 3 tablets

Peximir 0.18 mg OR 6 tablets Peximir 0.088 mg

Total daily dose (mg)

0.18

0.35

0.54

The daily dose should not exceed 6 tablets Peximir 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole as a salt).

If you have stopped taking the tablets for more than a few days and want to resume treatment, you should start again with the lowest dose. You can then increase the dose again, as you did the first time. Consult your doctor.

Your doctor will review your treatment after 3 months and decide whether to continue treatment or not.

Patients with renal impairment

If you have severe kidney problems, treatment with Peximir may not be suitable for you.

If you take more Peximir than you should

If you accidentally take more than the prescribed dose of tablets:

Contact your doctor immediately or go to the nearest emergency room for advice.

Nausea, anxiety or any of the side effects described in section 4 Possible side effects may occur.

If you forget to take Peximir

Skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Peximir

Do not stop taking Peximir without first talking to 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 taking Peximir suddenly. Abrupt discontinuation of treatment can lead to the development of a condition called neuroleptic malignant syndrome, which can be a significant health risk.

These symptoms include:

akinesia (loss of muscle mobility);

stiff muscles;

fever;

unstable blood pressure; tachycardia (fast heart rate); confusion;

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, Peximir can cause side effects, although not everybody gets them.

If you suffer from Parkinson's disease, you may experience the following side effects:

Very common (may affect more than 1 in 10 people):

Dyskinesia (eg abnormal, involuntary movements of the limbs);

Drowsiness;

Dizziness;

Nausea.

Common (may affect up to 1 in 10 people):

Urge for unusual behavior;

Hallucinations (seeing, hearing or feeling unreal things);

Confusion;

Fatigue;

Insomnia;

Fluid retention, usually in the legs (peripheral edema);

Headache;

Hypotension (low blood pressure);

Unusual dreams;

Constipation;

Visual impairment;

Vomiting;

Weight loss, including decreased appetite.

Uncommon (may affect up to 1 in 100 people):

Paranoia (ie excessive fear for one's own health);

Madness;

Excessive drowsiness during the day or sudden falling asleep;

Amnesia (memory impairment);

Hyperkinesias (frequent movements and inability to rest);

Weight gain;

Allergic reactions (eg rash, itching, hypersensitivity);

We make it worse;

Heart failure (heart problems that can lead to difficulty breathing or more

If you suffer from restless legs syndrome, you may experience the following side effects:

Very common:

Nausea (lifting).

Common:

Changes in sleep such as insomnia or drowsiness;

Fatigue;

Headache;

Vivid dreams;

Constipation;

Dizziness;

Vomiting.

Uncommon:

urge for unusual behavior *

heart failure (heart problem that can cause shortness of breath or swelling of the ankles) *

impaired secretion of antidiuretic hormone *

dyskinesia (unnatural, involuntary movements of the limbs)

hyperkinesia (frequent movements and inability to rest) *

paranoia (eg excessive fear for one's own health)

insanity *

amnesia (memory impairment) *

hallucinations (seeing, hearing or feeling things that do not really exist) confusion

excessive daytime sleepiness and episodes of sudden sleep onset

weight gain

hypotension (low blood pressure)

fluid retention, usually in the lower extremities (peripheral edema)

allergic reactions (eg rash, itching, hypersensitivity reactions)

nausea

anxiety

visual impairment

weight loss, including decreased appetite

dyspnoea (difficulty breathing)

hiccups

pneumonia (lung infection) *

Inability to resist an impulsive desire or temptation to perform activities that may be dangerous, such as:

- strong desire for gambling;

- altered or increased sexual interest and disturbing behavior for the patient or others;

- uncontrollable, excessive shopping or spending money;

- overeating (ingestion of huge amounts of food for a short period or intake of more food than normal to satisfy hunger). *

- delirium (weakening of the instinct for self-preservation, confusion, loss of sense of reality)

Not known:

Depression, apathy, anxiety, fatigue, sweating or pain (called dopamine agonist withdrawal syndrome or DAWS) may occur after stopping or reducing Peximir.

Tell your doctor if you experience any of these behavioral symptoms; he will discuss ways to relieve the symptoms.

How to store Peximir?

Keep out of reach of children.

Do not use Peximir after the expiry date which is stated on the carton after EXP. And BHR. The expiry date refers to the last day of that month.

Store below 30 ° C.

Store in the original package.

Do not throw away any medicines 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 package and additional information

What Peximir contains:

Peximir 0.18 mg

- The active substance is 0.18 mg pramipexole base, equivalent to 0.25 mg pramipexole dihydrochloride monohydrate in one tablet.

Peximir 0.7 mg

- The active substance is 0.7 mg pramipexole base, equivalent to 1.0 mg pramipexole dihydrochloride monohydrate in one tablet.

The other ingredients are: pregelatinised maize starch (maize starch 1500), mannitol, microcrystalline cellulose, povidone, talc and magnesium stearate.

What Peximir looks like and contents of the pack

Peximir tablets are packed in AI / AI blisters, in a carton, accompanied by a Lithuanian for the patient.

Peximir is available in packs of 30 tablets.

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