Risperdal (Risperidon) 20 Tablets

• Active substance: Each 1 ml solution contains 1 mg risperidone.

• Excipients: Tartaric acid, benzoic acid, sodium hydroxide, pure water

Pleasethis INSTRUCTIONS carefully before using this medicine

read, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• Whenthis medicinedoctor that you are taking this medicinego to a doctor or hospital

using, tell yourwhen you.

• Follow the instructions in this manual. Dohighother than the recommended dose for the

not useor low dosesdrug.

1. What is RISPERDAL and what is it used for?

• RISPERDAL contains 1 mg risperidone per 1 ml solution as active ingredient.

• RISPERDAL is a colorless, clear solution. RISPERDAL100 ml oral solution

is available with bottles containing.

• RISPERDAL isas antipsychotics and in the case of some form of mental disorder

included in the group of drugs used(psychosis).

• RISPERDAL is used to treat the following conditions.

• Hallucinations aredelusions, feelings,

confusion, aggression, extreme skepticism (paranoia), emotional and social

situations that affect your thoughts, feelings, and / or behaviors, such asinsecurity

used to treat. RISPERDAL alsofelt by people in this situation

reduces symptoms such as mental depression, feelings of guilt, anxiety and tension.

• used to compensate for impaired mental status [in sudden and long

-term conditions;bipolar disorder (contrastingin the mood

in controllingchanges);

in the treatment of behavior and otherin which aggressive or other destructive behaviors are prioritized

destructive behavioral disorders; in children and adolescents in theautistic

of restlessness (aggressive symptoms, self-harm, angerdisorder

treatmentattacks, sudden mood changes) of.

if:

• You are allergic to any of the excipients in the composition of Risperidone or RISPERDAL

(see list of excipients)

• Prolonged QT syndrome (severe arrhythmia in the heart and sudden a condition that can lead to death)

or torsades de pointes (life-threatening irregular heart rhythm) Ifpatients.

you use risperdal

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RISPERDAL CAREFULLY USE

- If there is a problem with your heart. This may be an irregular heart rhythm orblood pressure

low(blood pressure), or you may be using blood pressure medications.

RISPERDAL may cause a lower blood pressure. Your drug dosetoadjusted

may needbe.

- If there is any situation that may lead to a stroke. These arehigh blood pressure,

conditions such ascardiovascular disease or impairment of brain circulation.

- Previously, your language, mouth or face if you want to move outside of your request

.

- If you've had a disease called Neuroleptic Malignant Syndrome.this

Symptoms ofdisease include fever, stiffness in the muscles, sweating or loss of consciousness

.

- Parkinson's disease If you have a dementia or dementia

- If you have a decrease in the number of white blood cells beforehand (this maycertain medications

be due to the use ofor for some other reason).

- you have diabetes (diabetes) or if you have a risk of developing diabetes

- heart or blood vessels  diseases related to you or brain blood vessel disease

haveif

- epilepsy (epilepsy) or if you have Parkinson's disease

- If you are male and prolonged or painful, a an erection (erectile)

have had

- if you are having difficulty in controlling your body temperature or your body is too hot

- Heart attack or transient ischemic attack (temporary reduction of cerebral blood flow)

have had

- if you have liver or kidney disease

- the amount of the hormone prolactin in your blood more, or if a prospective If you have a prolactin-related

tumor

- If you have a hereditary long QT syndrome (heart beat rhythm)

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- If you or any of your family has a history of blood clotting (antipsychotics

are associated with blood clot formation).

In patients receiving RISPERDAL very rarelyrequired to fight infection

, there have been dangerous decreases in the number of white blood cells in some species that are. Therefore, your

doctor may want to check your white blood cell counts.

RISPERDAL can cause you to gain weight. Significant weight gainhealth

may adversely affect your. Your doctor should check your weight regularly.

Your, as patients with RISPERDAL taking diabetesdiabetes or pre-existing diabetes

doctorsymptoms of an increase in blood sugarmay worsen

should check the. In patients with diabetes previously, blood glucose (glucose)beregularly

shouldmonitored.

During eye surgery due to blur (cataract) of the eye lens, the pupil

(the black circle in the center of the eye) may not expand as required. At the same time, the iris

(the colored part of the eye) can loosen during the operation, which can cause eye damage.

If you are planning an eye operation, pleasedoctor that you are taking this medicine

tell your.

Elderly patients with dementia Anin elderly patients with dementia

increased risk of stroke may occur.stroke-induced

If you havedementia, you should not use risperidone.

If you or your caregiver notice a sudden change in your mental state, aface,

sudden weakness or numbness in yourarms and legs, or a speech

disorder, contact your doctor immediately. These may be signs of a stroke.

Also;

- Conventional and atypical antipsychotic drugsof elderly patients with dementia

cause an increased risk of death when used in the treatment.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

If you are pregnant or plan to become pregnant,for advice before taking this medicine

consult your doctor or pharmacist. If youRISPERDAL in the last three months of your pregnancy, you

usedmay experience tremors in your newborns, which may vary in severity following,muscles

tensiontension in the, drowsiness, restlessness, respiratory distress or malnutrition

. If your baby experiences any of these symptoms, contact your doctor

. RISPERDAL may elevate your il prolactin ene hormone level andthis

affectfertility (fertility). (See 4. Possible side effects)

If you notice that you are pregnant during your treatment,doctor or pharmacist immediately

consult your.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Do notRISPERDALdoctor decides that it is absolutely necessary during breastfeeding

useas long as your.

Use ofand machinesmay

toolsRISPERDAL treatmentcause dizziness, fatigue and vision problems

. Do not use tools and machines before talking to your doctor about this.

Important information about some of the excipients in the content of

RISPERDAL contains sodium hydroxide as the RISPERDAL pH adjuster. Nodue to sodium are

negative effectsexpected.

Use with other drugsuse

If youany of the following medicines, be sure to telldoctor

your:

- Calming drugs (benzodiazepines) acting on your brain;for pain

some medications taken(opiates); allergy medications (some antihistamines). Risperidonetheir

may increasesedative effects.

- drugs that affect the electrical activity in your heart; eg. malarial drugs,the heart rhythm

which regulatemedications, allergy medications (antihistamines),some medications for depression  mental

other drugs used forandillness

- heart slowing down the shot medications

- reducing potassium in the blood medications (certain diuretics)

- Parkinson's medication you are taking medication for the disease or epilepsy treatment (such as levodopa

- High blood pressure therapy drugs. RISPERDAL may decrease blood pressure.

-of swelling due to problems in the heart or fluid accumulation in one part of your body

Diuretic drugs (eg furosemide or chlorothiazide) used for the treatment.alone

Risperdal  or taken together with furosemide in elderly patients with dementia

may increase the risk of stroke or death.

The following drugs may reduce the effect of risperidone

- Rifampicin (a drug used in the treatment of certain infections)

- Carbamazepine, phenytoin (epilepsy drugs)

- Phenobarbital (epilepsy and sleeping medication)

If you have started or stopped using such drugs, you maya different dose of risperidone

need.

The following drugs may increase the effect of risperidone

- Quinidine (a drug used in the treatment of certain types of heart diseases)

- Depression drugs such as paroxetine, fluoxetine, tricyclic antidepressants

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